This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems in accordance with the Kyoto Protocol. The document provides recommendations for installation, maintenance, decommissioning of equipment, and training of staff to ensure proper handling of refrigerants.
The document provides guidance on transport route profiling qualification to ensure time and temperature sensitive pharmaceutical products are maintained within acceptable temperature ranges during distribution. It describes conducting studies using data loggers placed in sample shipments to collect temperature data over multiple routes and seasons. The degree-hour concept is introduced to analyze temperature exposures. Methods are presented for using the profile data to design packaging solutions or assess the suitability of passive container designs for different routes and climates.
This document provides guidance on the maintenance of refrigeration equipment used for storing and transporting temperature sensitive pharmaceutical products. It covers the maintenance needs for refrigerators, freezers, cold rooms, refrigerated vehicles, containers, and associated equipment. The guidance addresses inspection schedules, maintaining cooling systems, insulation, seals, and other aspects. Proper maintenance is important for ensuring refrigeration equipment functions as intended to keep products within required temperature ranges during storage and transport.
This document provides guidance on temperature and humidity monitoring systems for transport operations of time and temperature sensitive pharmaceutical products. It describes various device types for monitoring temperature and humidity during transport. The key types discussed are electronic data loggers and indicators. It emphasizes the importance of monitoring to ensure pharmaceutical quality and notes regulatory authorities may require documented evidence. Shippers are responsible for ensuring temperature compliance during transport using monitoring devices and agreements with carriers on device use and data collection/storage.
This document provides guidance on how to conduct a temperature mapping study of a temperature-controlled storage area. It describes a 4-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise using electronic data loggers, 3) analyzing the data and preparing a report, and 4) implementing recommendations from the report. The mapping establishes the temperature distribution and identifies hot/cold spots to ensure products are stored correctly. It helps determine if changes are needed to eliminate temperature issues.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses requirements for such systems including automated continuous monitoring, data collection via wireless or wired transmission, alarm systems, and adaptability. The guidance covers factors like maintenance needs, number and location of monitoring points, and post-installation qualification activities.
Supplement 7- Annex9- WHO guideline: Qualification of temperature controlled storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on estimating the storage capacity needs for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It outlines key concepts for inventory management that are important for accurately determining storage requirements, such as safety stock levels, product classification systems, and ideal inventory control models. The document also describes the types of product and storage data that should be collected, such as unit volumes, temperature storage needs, and security classifications. This information is critical for properly sizing pharmaceutical warehouses and ensuring adequate cold storage capacity is available within facilities.
This document provides guidance on selecting suitable sites for storage facilities for time and temperature sensitive pharmaceutical products. Key factors to consider include:
- Choosing a site that minimizes risks from natural hazards like floods, fires, and weather events.
- Locating the site to efficiently serve the target population using existing transport infrastructure.
- Establishing the required size of the warehouse before searching for sites.
- Narrowing down choices using local knowledge and online tools to evaluate potential sites.
- Choosing a secure site in a low crime area with good emergency response times.
- Selecting a site that allows for future expansion and has access to major transport routes.
- Ensuring the site has low risks of
The document provides guidance on transport route profiling qualification to ensure time and temperature sensitive pharmaceutical products are maintained within acceptable temperature ranges during distribution. It describes conducting studies using data loggers placed in sample shipments to collect temperature data over multiple routes and seasons. The degree-hour concept is introduced to analyze temperature exposures. Methods are presented for using the profile data to design packaging solutions or assess the suitability of passive container designs for different routes and climates.
This document provides guidance on the maintenance of refrigeration equipment used for storing and transporting temperature sensitive pharmaceutical products. It covers the maintenance needs for refrigerators, freezers, cold rooms, refrigerated vehicles, containers, and associated equipment. The guidance addresses inspection schedules, maintaining cooling systems, insulation, seals, and other aspects. Proper maintenance is important for ensuring refrigeration equipment functions as intended to keep products within required temperature ranges during storage and transport.
This document provides guidance on temperature and humidity monitoring systems for transport operations of time and temperature sensitive pharmaceutical products. It describes various device types for monitoring temperature and humidity during transport. The key types discussed are electronic data loggers and indicators. It emphasizes the importance of monitoring to ensure pharmaceutical quality and notes regulatory authorities may require documented evidence. Shippers are responsible for ensuring temperature compliance during transport using monitoring devices and agreements with carriers on device use and data collection/storage.
This document provides guidance on how to conduct a temperature mapping study of a temperature-controlled storage area. It describes a 4-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise using electronic data loggers, 3) analyzing the data and preparing a report, and 4) implementing recommendations from the report. The mapping establishes the temperature distribution and identifies hot/cold spots to ensure products are stored correctly. It helps determine if changes are needed to eliminate temperature issues.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses requirements for such systems including automated continuous monitoring, data collection via wireless or wired transmission, alarm systems, and adaptability. The guidance covers factors like maintenance needs, number and location of monitoring points, and post-installation qualification activities.
Supplement 7- Annex9- WHO guideline: Qualification of temperature controlled storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on estimating the storage capacity needs for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It outlines key concepts for inventory management that are important for accurately determining storage requirements, such as safety stock levels, product classification systems, and ideal inventory control models. The document also describes the types of product and storage data that should be collected, such as unit volumes, temperature storage needs, and security classifications. This information is critical for properly sizing pharmaceutical warehouses and ensuring adequate cold storage capacity is available within facilities.
This document provides guidance on selecting suitable sites for storage facilities for time and temperature sensitive pharmaceutical products. Key factors to consider include:
- Choosing a site that minimizes risks from natural hazards like floods, fires, and weather events.
- Locating the site to efficiently serve the target population using existing transport infrastructure.
- Establishing the required size of the warehouse before searching for sites.
- Narrowing down choices using local knowledge and online tools to evaluate potential sites.
- Choosing a secure site in a low crime area with good emergency response times.
- Selecting a site that allows for future expansion and has access to major transport routes.
- Ensuring the site has low risks of
This document provides guidance on maintaining storage buildings used for pharmaceutical products. It discusses the importance of maintenance for protecting assets and outlines different types of maintenance activities. The document emphasizes establishing preventative maintenance programs and schedules during building design and construction to minimize corrective maintenance needs long-term. Guidance is provided on creating operation and maintenance manuals and health and safety files to document building information for effective maintenance management.
This document provides guidance on designing storage facilities for time and temperature sensitive pharmaceutical products (TTSPPs). It discusses key considerations like environmental auditing, low-carbon design, and warehouse layouts. Regarding layouts, it describes the main types - U-flow and through-flow arrangements. It emphasizes designing for flexibility and efficiency to accommodate future changes. The target is to help readers act as informed clients when procuring medical warehouses and related facilities.
This document provides guidance on estimating the storage capacity requirements for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It covers how to collect product data, calculate maximum inventory volumes, and determine the net storage capacity needed based on factors like storage temperature, security classification, and load support systems. The target audience is organizations planning new or expanded storage facilities for vaccines and other medical products.
This document provides guidance on qualifying temperature-controlled storage areas according to good storage practices. It outlines the requirements and objectives of qualification, which involves three stages: installation qualification (IQ) to confirm proper installation, operational qualification (OQ) to confirm operation under controlled conditions, and performance qualification (PQ) to confirm performance under routine conditions. The document provides detailed guidance on conducting each stage of qualification, including procedures, acceptance criteria, and documentation requirements.
This document provides guidance on designing storage facilities for pharmaceutical products, including warehouses and dispensing facilities. It covers preparing a design brief, appointing a design team, choosing a procurement process, and roles during construction and commissioning. The guidance aims to help readers act as informed clients for procuring medical storage facilities. Specific topics covered include low-carbon design, warehouse layouts, temperature-controlled storage areas, and procuring cold rooms and freezers.
This document provides guidance on building security, fire prevention, detection and management for buildings used to store time and temperature sensitive pharmaceutical products (TTSPPs). It recommends perimeter security fencing, controlled access points, intruder alarms, fire detection systems, sprinklers, staff training and fire drills. Specific guidance is given for secured storage of controlled substances, installation and maintenance of fire protection equipment, and fire risk management procedures. The aim is to prevent unauthorized access, theft and fires in premises storing these thermo-labile medical products.
This document provides guidance on conducting temperature mapping of storage areas. It describes developing a detailed mapping protocol, carrying out the mapping exercise using data loggers, analyzing the results to identify hot/cold spots and temperature variations, and implementing recommendations. The objective is to document temperature distribution within storage areas to ensure time- and temperature-sensitive pharmaceutical products are stored correctly. Developing a comprehensive temperature map establishes storage zone requirements and identifies areas needing remedial action.
The document provides guidance on transport route profiling qualification for time and temperature sensitive pharmaceutical products. It outlines how to conduct a transport route study using data loggers, retrieve temperature data, analyze the data using degree-hour concepts, and organize the data to assess if packaging solutions maintain adequate temperature control along specific routes. The guidance aims to help qualify routes for known packaging by characterizing temperature exposures.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses key considerations for selecting a monitoring system such as preparing requirements, choosing between automated continuous or data logging systems, wireless vs wired data transmission, alarm systems, and expandability. The document also covers maintenance, number of monitoring points, deploying the system, and qualification activities.
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices used to track temperature and humidity during transport of pharmaceuticals. It covers different types of monitoring devices including electronic data loggers and indicators. It provides guidance on selecting appropriate monitoring devices and ensuring proper data collection, storage and retrieval.
Hdbs15, phụ lục 9 gmp who, hệ thống theo dõi nhiệt độ độ ẩm trong khi vận chuyểnTư vấn GMP, cGMP, ISO
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices, including device types like electronic data loggers and indicators. It also covers data collection, storage and retrieval from these monitoring devices. The target readership are those involved in the transport and distribution of time- and temperature-sensitive pharmaceutical products.
This document provides guidance on conducting temperature mapping of storage areas. It outlines a four-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise, 3) preparing a mapping report, and 4) implementing recommendations from the report. The guidance details what should be included in the mapping protocol, such as objectives, methodology, and a report template. It also describes the materials and equipment needed, including electronic data loggers, and how to analyze temperature data and interpret results.
This document provides guidance on selecting refrigerants and blowing agents for refrigeration equipment to minimize environmental impact, in accordance with the Montreal Protocol and efforts to reduce greenhouse gas emissions. It recommends phasing out ozone-depleting substances like CFCs and transitioning to alternatives with lower global warming potential, such as hydrocarbons for small systems and hydrofluoroolefins as they become available. Proper installation, maintenance, and disposal of equipment is advised to prevent refrigerant leakage into the atmosphere.
Hdbs16,phụ lục 9 gmp who, kiểm soát ảnh hưởng đến môi trường của các thiết bị...Tư vấn GMP, cGMP, ISO
This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems and proper installation, maintenance, and staff training practices. The target audience includes organizations operating refrigeration equipment used for storage and transport of temperature sensitive products.
The document provides guidance on maintenance of storage facilities for time and temperature sensitive pharmaceutical products. It discusses the importance of maintenance and outlines best practices for maintenance management, including establishing frameworks, developing preventative maintenance schedules, conducting periodic inspections, and organizing maintenance work. The document is intended to help facilities properly maintain storage infrastructure to ensure products are stored under appropriate environmental conditions.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
Supplement 4- Annex9- WHO guideline: Maintenance of storage facilities
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
Supplement 8- Annex9- WHO guideline: Temperature mapping of storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on conducting temperature mapping of storage areas to document temperature distribution and identify hot and cold spots. It outlines developing a detailed mapping protocol, carrying out the study using electronic data loggers, analyzing the results to determine minimum, maximum and mean temperatures, and making recommendations to address any issues identified. The goal is to ensure time- and temperature-sensitive pharmaceutical products are stored within their specified temperature ranges.
This supplement provides guidance aimed at more senior operations staff. Principally these will be the owners and operators of warehouses, pharmacies and other buildings used to store TTSPP’s and those responsible for property development and property acquisition on behalf of owners and operators.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
This document provides guidance on building security and fire protection for facilities that store time and temperature sensitive pharmaceutical products. It recommends perimeter security measures, controlled access, fire detection and suppression systems, compartmentation, and fire prevention procedures like staff training and inspections. Specific guidance is given for securing areas with hazardous substances and installing sprinkler systems. Standard operating procedures are included as annexes for fire safety, inspections, and drills.
This document provides guidance on maintaining storage buildings used for pharmaceutical products. It discusses the importance of maintenance for protecting assets and outlines different types of maintenance activities. The document emphasizes establishing preventative maintenance programs and schedules during building design and construction to minimize corrective maintenance needs long-term. Guidance is provided on creating operation and maintenance manuals and health and safety files to document building information for effective maintenance management.
This document provides guidance on designing storage facilities for time and temperature sensitive pharmaceutical products (TTSPPs). It discusses key considerations like environmental auditing, low-carbon design, and warehouse layouts. Regarding layouts, it describes the main types - U-flow and through-flow arrangements. It emphasizes designing for flexibility and efficiency to accommodate future changes. The target is to help readers act as informed clients when procuring medical warehouses and related facilities.
This document provides guidance on estimating the storage capacity requirements for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It covers how to collect product data, calculate maximum inventory volumes, and determine the net storage capacity needed based on factors like storage temperature, security classification, and load support systems. The target audience is organizations planning new or expanded storage facilities for vaccines and other medical products.
This document provides guidance on qualifying temperature-controlled storage areas according to good storage practices. It outlines the requirements and objectives of qualification, which involves three stages: installation qualification (IQ) to confirm proper installation, operational qualification (OQ) to confirm operation under controlled conditions, and performance qualification (PQ) to confirm performance under routine conditions. The document provides detailed guidance on conducting each stage of qualification, including procedures, acceptance criteria, and documentation requirements.
This document provides guidance on designing storage facilities for pharmaceutical products, including warehouses and dispensing facilities. It covers preparing a design brief, appointing a design team, choosing a procurement process, and roles during construction and commissioning. The guidance aims to help readers act as informed clients for procuring medical storage facilities. Specific topics covered include low-carbon design, warehouse layouts, temperature-controlled storage areas, and procuring cold rooms and freezers.
This document provides guidance on building security, fire prevention, detection and management for buildings used to store time and temperature sensitive pharmaceutical products (TTSPPs). It recommends perimeter security fencing, controlled access points, intruder alarms, fire detection systems, sprinklers, staff training and fire drills. Specific guidance is given for secured storage of controlled substances, installation and maintenance of fire protection equipment, and fire risk management procedures. The aim is to prevent unauthorized access, theft and fires in premises storing these thermo-labile medical products.
This document provides guidance on conducting temperature mapping of storage areas. It describes developing a detailed mapping protocol, carrying out the mapping exercise using data loggers, analyzing the results to identify hot/cold spots and temperature variations, and implementing recommendations. The objective is to document temperature distribution within storage areas to ensure time- and temperature-sensitive pharmaceutical products are stored correctly. Developing a comprehensive temperature map establishes storage zone requirements and identifies areas needing remedial action.
The document provides guidance on transport route profiling qualification for time and temperature sensitive pharmaceutical products. It outlines how to conduct a transport route study using data loggers, retrieve temperature data, analyze the data using degree-hour concepts, and organize the data to assess if packaging solutions maintain adequate temperature control along specific routes. The guidance aims to help qualify routes for known packaging by characterizing temperature exposures.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses key considerations for selecting a monitoring system such as preparing requirements, choosing between automated continuous or data logging systems, wireless vs wired data transmission, alarm systems, and expandability. The document also covers maintenance, number of monitoring points, deploying the system, and qualification activities.
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices used to track temperature and humidity during transport of pharmaceuticals. It covers different types of monitoring devices including electronic data loggers and indicators. It provides guidance on selecting appropriate monitoring devices and ensuring proper data collection, storage and retrieval.
Hdbs15, phụ lục 9 gmp who, hệ thống theo dõi nhiệt độ độ ẩm trong khi vận chuyểnTư vấn GMP, cGMP, ISO
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices, including device types like electronic data loggers and indicators. It also covers data collection, storage and retrieval from these monitoring devices. The target readership are those involved in the transport and distribution of time- and temperature-sensitive pharmaceutical products.
This document provides guidance on conducting temperature mapping of storage areas. It outlines a four-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise, 3) preparing a mapping report, and 4) implementing recommendations from the report. The guidance details what should be included in the mapping protocol, such as objectives, methodology, and a report template. It also describes the materials and equipment needed, including electronic data loggers, and how to analyze temperature data and interpret results.
This document provides guidance on selecting refrigerants and blowing agents for refrigeration equipment to minimize environmental impact, in accordance with the Montreal Protocol and efforts to reduce greenhouse gas emissions. It recommends phasing out ozone-depleting substances like CFCs and transitioning to alternatives with lower global warming potential, such as hydrocarbons for small systems and hydrofluoroolefins as they become available. Proper installation, maintenance, and disposal of equipment is advised to prevent refrigerant leakage into the atmosphere.
Hdbs16,phụ lục 9 gmp who, kiểm soát ảnh hưởng đến môi trường của các thiết bị...Tư vấn GMP, cGMP, ISO
This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems and proper installation, maintenance, and staff training practices. The target audience includes organizations operating refrigeration equipment used for storage and transport of temperature sensitive products.
The document provides guidance on maintenance of storage facilities for time and temperature sensitive pharmaceutical products. It discusses the importance of maintenance and outlines best practices for maintenance management, including establishing frameworks, developing preventative maintenance schedules, conducting periodic inspections, and organizing maintenance work. The document is intended to help facilities properly maintain storage infrastructure to ensure products are stored under appropriate environmental conditions.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
Supplement 4- Annex9- WHO guideline: Maintenance of storage facilities
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
Supplement 8- Annex9- WHO guideline: Temperature mapping of storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on conducting temperature mapping of storage areas to document temperature distribution and identify hot and cold spots. It outlines developing a detailed mapping protocol, carrying out the study using electronic data loggers, analyzing the results to determine minimum, maximum and mean temperatures, and making recommendations to address any issues identified. The goal is to ensure time- and temperature-sensitive pharmaceutical products are stored within their specified temperature ranges.
This supplement provides guidance aimed at more senior operations staff. Principally these will be the owners and operators of warehouses, pharmacies and other buildings used to store TTSPP’s and those responsible for property development and property acquisition on behalf of owners and operators.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
This document provides guidance on building security and fire protection for facilities that store time and temperature sensitive pharmaceutical products. It recommends perimeter security measures, controlled access, fire detection and suppression systems, compartmentation, and fire prevention procedures like staff training and inspections. Specific guidance is given for securing areas with hazardous substances and installing sprinkler systems. Standard operating procedures are included as annexes for fire safety, inspections, and drills.
Supplement 5- Annex9- WHO guideline: Building security and fire protection
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring systems
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
The document summarizes key aspects of the WTO Agreement on Sanitary and Phytosanitary Measures (SPS Agreement). It outlines that the SPS Agreement establishes basic rules for food safety and animal and plant health standards. It allows countries to set their own standards as long as they are based on scientific evidence and risk assessments. The agreement also encourages the use of international standards and harmonization where possible. Member countries can implement stricter standards than international levels as long as they are scientifically justified. The agreement aims to ensure SPS measures are necessary to protect health and are not disguised barriers to trade.
This document provides guidance on estimating the storage capacity required for time and temperature sensitive pharmaceutical products (TTSPPs). It discusses collecting product data such as volume, storage temperature and security requirements. It also covers concepts like stock-keeping units (SKUs), load support systems, utilization factors and calculating net storage capacity. The objective is to determine the minimum storage capacity needed to reliably meet demand, based on factors like resupply frequency, safety stock levels and product consumption patterns. The guidance is intended to help size new warehouses and storage facilities, and assess capacity of existing ones.
The document summarizes the 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The report adopted several new guidelines and guidance texts related to good manufacturing practices, data integrity, regulatory practices, specifications for medicines including those for COVID-19, and other quality assurance areas. It also recommended texts for inclusion in The International Pharmacopoeia and outlined the Committee's views and recommendations.
The document provides information on the International Conference on Harmonization (ICH). ICH is an initiative to discuss and establish common guidelines for pharmaceutical product registration requirements between regulators in the EU, Japan, and the US. The objectives of ICH include increasing international harmonization of technical requirements to ensure safe, effective, and high-quality medicines and minimizing duplication of clinical trials. ICH guidelines cover topics like quality, safety, efficacy, and multidisciplinary issues.
The document summarizes the key points of the SPS Agreement, which establishes rules for food safety, animal and plant health standards in international trade. It entered into force in 1995 with the establishment of the WTO. The agreement aims to allow countries to set health standards while preventing unjustified barriers to trade. It outlines 10 principles member countries should follow, including basing measures on risk assessments, ensuring transparency, and controlling diseases and pests. Complying with the agreement benefits member countries by improving market access.
The document summarizes the 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The report outlines the Committee's discussions and adoption of several new guidelines and standards related to good manufacturing practices, quality control of medicines, international reference materials, and regulatory guidance. Key items adopted include revised GMP guidelines for sterile products and water for pharmaceutical use, as well as new guidelines on data integrity, bioequivalence waivers for essential medicines, and certification schemes for medicine quality.
The ICH is an international body that works to harmonize technical requirements for pharmaceutical registration. Its goal is to ensure safe, effective and high quality medicines and to reduce unnecessary duplication of clinical trials. The ICH involves regulators and industry representatives from the EU, Japan and US. Key objectives include increasing international harmonization and developing pharmaceuticals efficiently.
The document summarizes the key aspects of ICH guidelines. It discusses that ICH is an international initiative involving regulators from the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. The objectives of ICH include increasing international harmonization, developing pharmaceuticals efficiently, promoting public health, and minimizing animal testing. ICH guidelines cover quality, efficacy, safety, and multidisciplinary topics. The ICH process involves drafting guidelines through working groups and endorsing them through a step system.
Hướng dẫn bổ sung về quy trình sản xuất tốt hệ thống hvac cho các hình thức bào chế không tiệt trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Similar to Hdbs16,phụ lục 9 gmp who, kiểm soát ảnh hưởng đến môi trường của các thiết bị lạnh (19)
Quy trình kiểm soát thay đổi sau khi cấp Giấy chứng nhận GMP/Giấy chứng nhận đủ điều kiện kinh doanh dược đối với cơ sở sản xuất thuốc, nguyên liệu làm thuốc
Quy trình đánh giá đáp ứng “Thực hành tốt sản xuất thuốc, nguyên liệu làm thuốc” (GMP) đối với cơ sở không thuộc diện cấp chứng nhận đủ điều kiện kinh doanh dược
This document lists 46 consulting projects completed or in progress by GMPc Vietnam Joint Stock Company between May 2011 and January 2024. The projects involve consulting services for clients seeking to establish, expand, or renovate pharmaceutical manufacturing facilities that meet Good Manufacturing Practice (GMP) standards set by the World Health Organization (WHO) and other regulatory bodies. Services provided include facility design, budgeting, training on GMP requirements, and assistance with drafting and finalizing GMP registration dossiers. Clients span the pharmaceutical, biotech, and healthcare industries in Vietnam.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
2. `
Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views
expressed in this publication.
3. Technical Supplement: Environmental management of refrigeration equipment 3
Acknowledgments
The author of this document is Richard Lawton, Technical Director, Cambridge
Refrigeration Technology, Cambridge, UK.
4. Technical Supplement: Environmental management of refrigeration equipment 4
Contents
Acknowledgments................................................................................................................................ 3
Contents................................................................................................................................................... 4
Abbreviations ........................................................................................................................................ 5
Glossary ................................................................................................................................................... 6
1. Introduction .................................................................................................................................. 8
1.1 Requirements...................................................................................................................................... 8
1.2 Objectives.............................................................................................................................................. 8
1.3 Target readership.............................................................................................................................. 8
2. Guidance ......................................................................................................................................... 9
2.1 Associated materials and equipment........................................................................................ 9
2.2 Montreal Protocol.............................................................................................................................. 9
2.3 Selection of refrigerants and blowing agents ......................................................................10
2.3.1 Use of chlorofluorocarbons (CFC’s)............................................................................................10
2.3.2 Use of hydrochlorofluorocarbons (HCFC’s)............................................................................10
2.3.3 Use of hydrofluorocarbons (HFC’s)............................................................................................10
2.3.4 Use of hydrofluoro-olefin (HFO’s)...............................................................................................10
2.3.5 Use of hydrocarbons (HC’s)............................................................................................................11
2.3.6 Ammonia and carbon dioxide.......................................................................................................11
2.3.7 Other cooling technologies ............................................................................................................11
2.4 Counterfeit refrigerants................................................................................................................12
2.5 Thermal insulation..........................................................................................................................12
2.6 CO2 emissions....................................................................................................................................12
2.6.1 Kyoto Protocol.....................................................................................................................................12
2.6.2 CO2 emissions from prime mover...............................................................................................13
2.6.3 ODP and high GWP refrigerants..................................................................................................13
2.7 Installation and maintenance.....................................................................................................14
2.8 Decommissioning............................................................................................................................14
2.9 Staff training......................................................................................................................................15
References ............................................................................................................................................16
Annex 1 – Montreal Protocol: non-Article 5 countries .........................................................17
Revision history..................................................................................................................................18
5. Technical Supplement: Environmental management of refrigeration equipment 5
Abbreviations
A2L An ASHRAE flammability class
ASHRAE American Society of Heating, Refrigerating & Air-Conditioning Engineers
ATP Agreement on the International Carriage of Perishable Foodstuffs and on the
Special Equipment to be Used for such Carriage: - UNECE
BS EN British Standard European Norm
CFC Chlorofluorocarbons
EN 378 European Norm (standard) on the safety of refrigerants
F-Gas Fluorinated Gas
GWP Global Warming Potential
HC Hydrocarbon
HCFC Hydrochlorofluorocarbons
HFC Hydrofluorocarbons
HFO Hydrofluoro-olefin
MOP-19 Nineteenth Meeting of the Parties to the Montreal Protocol
ODP Ozone Depletion Potential
ODS Ozone Depleting Substance
SOP Standard Operating Procedure
TEWI Total equivalent warming impact
TTSPP Time and Temperature-Sensitive Pharmaceutical Product
UNECE The United Nations Economic Commission for Europe (UNECE or ECE)
UNEP The United Nations Environment Programme
6. Technical Supplement: Environmental management of refrigeration equipment 6
Glossary
Article 5 country: The main objective of the Multilateral Fund for the Implementation of
the Montreal Protocol is to assist developing country parties to the Montreal Protocol
whose annual per capita consumption and production of ozone depleting substances
(ODS) is less than 0.3 kg to comply with the control measures of the Protocol. Currently,
147 of the 196 Parties to the Montreal Protocol meet these criteria (they are referred to as
Article 5 countries).
Non-Article 5 country: Parties to the Montreal Protocol that have an ODS consumption of
greater than 0.3kg per capita on the date of entry of the Montreal Protocol, or at any time
thereafter within ten years of the date of entry into force of the Protocol.
Pharmaceutical product: Any product intended for human use or veterinary product
intended for administration to food producing animals, presented in its finished dosage
form, that is subject to control by pharmaceutical legislation in either the exporting or the
importing state and includes products for which a prescription is required, products
which may be sold to patients without a prescription, biologicals and vaccines. Medical
devices are not included1
.
Refrigeration equipment: The term ‘refrigeration’ or ‘refrigeration equipment’ means
any equipment whose purpose is to lower air and product temperatures and/or to control
relative humidity.
Service Level Agreement (SLA): A service level agreement or contract is a negotiated
agreement between the customer and service provider that defines the common
understanding about materials or service quality specifications, responsibilities,
guarantees and communication mechanisms. It can either be legally binding, or an
information agreement. The SLA may also specify the target and minimum level
performance, operation or other service attributes2
.
Standard Operating Procedure (SOP): A set of instructions having the force of a
directive, covering those features of operations that lend themselves to a definite or
standardized procedure without loss of effectiveness. Standard operating policies and
procedures can be effective catalysts to drive performance improvement and improve
organizational results.
Third Party Accreditation: Accreditation or certification by an organization that issues
credentials or certifies third parties against official standards as a means of establishing
that a contractor is competent to undertake a specific type of work. Third party
accreditation organizations are themselves formally accredited by accreditation bodies;
hence they are sometimes known as "accredited certification bodies". The accreditation
process ensures that their certification practices are acceptable, typically meaning that
they are competent to test and certify third parties, behave ethically and employ suitable
quality assurance.
1
Definition from WHO/QAS/08.252 Rev 1 Sept 2009. Proposal for revision of WHO good distribution
practices for pharmaceutical products – Draft for comments.
2
Definition from IATA. 2013/2014 Perishable Cargo Regulations (ePCR) & Temperature Control
Regulations (eTCR)
7. Technical Supplement: Environmental management of refrigeration equipment 7
Time and temperature sensitive pharmaceutical product (TTSPP): Any
pharmaceutical good or product which, when not stored or transported within pre-
defined environmental conditions and/or within pre-defined time limits, is degraded to
the extent that it no longer performs as originally intended.
8. Technical Supplement: Environmental management of refrigeration equipment 8
1. Introduction
This technical supplement has been written to amplify the recommendations given in
section 10.2 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for
the storage and transport of time- and temperature-sensitive pharmaceutical products3
. It
gives guidance on the selection of refrigerant gases and blowing agents so that countries
can minimize the environmental impact of cold chain equipment used in fixed storage and
transport operations. Related topics are covered in the Technical Supplement:
Maintenance of refrigeration equipment.
1.1 Requirements
Ensure that all new refrigeration equipment for temperature-controlled storage and
transport is specified to:
• Use refrigerants that comply with the Montreal Protocol;
• Minimise or eliminate the use of refrigerants with high global warming potential
(GWP), and;
• Minimise CO2 emissions during operation.
Select equipment to minimise whole-life environmental impact and employ best practice
to eliminate leakage of refrigerant into the environment during installation, maintenance
and decommissioning of refrigeration equipment.
Follow SOP’s for purchase, maintenance and end of equipment life disposal, and ensure
compliance with international protocols and accords on climate change and
environmental protection. Train staff to avoid excessive release of refrigerants.
1.2 Objectives
The objectives of the Technical Supplement are to provide guidance on how to meet the
above requirements with regard to the environmental impact of fixed and mobile
refrigeration equipment, whilst ensuring the efficacy of TTSPP storage and transportation.
1.3 Target readership
The target audience is principally the owners and operators of warehouses, pharmacies
and other stores and owners and operators of refrigerated vehicles used to transport
TTSPP’s. Some of the content may also be useful to equipment manufacturers and
suppliers.
3
http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf
9. Technical Supplement: Environmental management of refrigeration equipment 9
2. Guidance
The component elements of refrigeration systems contain gases which can cause long-
term environmental damage; some products may also be toxic or flammable. The principal
focus of this Technical Supplement is to prevent these gases from leaking into the
atmosphere where they accumulate, or into the immediate environment where they may
affect occupants or become a fire hazard.
Refrigerant gases containing chlorine or bromine have a high Ozone Depletion Potential
(ODP) and damage the planet’s ozone layer. These and several other gases also have a high
Global Warming Potential (GWP) and contribute disproportionally to the continuing
increase in global warming.
The principal focus of the environmental impact is the refrigeration source and the prime
mover. However, the thermal performance of cold room and refrigerator insulation and
the insulation of the bodies of refrigerated vehicles also have an impact. Insulation limits
heat transmission. This reduces the size and refrigerant charge needed for the cooling
machinery, reduces energy consumption and hence limits CO2 emissions from the
refrigeration plant. However, the blowing agents used to manufacture many insulation
products may have a high ODP and/or high GWP. Leakage of these agents into the
atmosphere during the service life of the equipment and during end of life disposal can
therefore have an adverse environmental impact.
2.1 Associated materials and equipment
Minimising the emission of gases with high Global Warming Potential (GWP) requires
rigorous service procedures and appropriate service equipment. Service equipment
includes refrigerant recovery machines, refrigerant recovery bottles and leak detectors.
2.2 Montreal Protocol
Use of refrigerant gases and blowing agents is governed by the Montreal Protocol on
Substances that Deplete the Ozone Layer. This Protocol was subsequently adjusted and/or
amended in London in 1990, Copenhagen in 1992, Vienna in 1995, Montreal in 1997 and
Beijing in 1999.
Under the amendments and adjustments to the Protocol, non-Article 5 parties (see
Annex 1) were required to phase out production and consumption of: halons by 1994;
CFC’s, carbon tetrachloride, hydrobromochlorofluorocarbons and methyl chloroform by
1996; bromochloromethane by 2002; and methyl bromide by 2005. Article 5 parties were
required to phase out production and consumption of hydrobromochlorofluorocarbons by
1996, bromochloromethane by 2002, and CFC’s, halons and carbontetrachloride by 2010.
Article 5 parties must still phase out production and consumption of methyl chloroform
and methyl bromide by 2015. Under the accelerated phase-out of HCFC’s adopted at MOP
19, HCFC production and consumption by non-article 5 parties was frozen in 2004 and is
to be phased out by 2020, while for Article 5 parties, HCFC production and consumption is
to be frozen by 2013 and phased out by 2030 (with interim targets prior to those dates,
starting in 2015). There are exemptions to these phase-outs to allow for certain uses
lacking feasible alternatives.
10. Technical Supplement: Environmental management of refrigeration equipment 10
2.3 Selection of refrigerants and blowing agents
A numbering system is used for refrigerants (e.g. R-134a), developed by ASHRAE. Prefixes
can be: R, CFC, HCFC, HFC or HFO. The rightmost numeric value indicates the number of
fluorine atoms in the molecule, the next value to the left is the number of hydrogen atoms
plus 1, and the next value to the left is the number of carbon atoms less one (zeroes are
not stated). Remaining atoms are chlorine.
2.3.1 Use of chlorofluorocarbons (CFC’s)
A chlorofluorocarbon (CFC) is an organic compound that contains only carbon, chlorine,
and fluorine, produced as a substituted derivative of methane and ethane. It is an ozone-
depleting compound, which is highly damaging to the environment.
It is now illegal to operate refrigerated vehicles using CFC’s as the refrigerating fluid or to
have CFC’s within the insulation in non-article 5 countries. WHO recommends that fixed
refrigeration equipment and refrigerated vehicles containing CFC’s should not be
purchased or operated.
2.3.2 Use of hydrochlorofluorocarbons (HCFC’s)
Chlorofluorocarbons (HCFC’s) are similar to CFC’s but contain hydrogen and have a lower
ozone depleting potential.
It is now illegal to purchase new refrigerated vehicles using HCFC’s as the refrigerating
fluid or having HCFC’s within the insulation in non-article 5 countries, though they can still
be operated using recycled refrigerant. It is recommended that refrigerated vehicles
containing HCFC’s should not be purchased in article 5 countries though they can and
should be operated to the end of their design life.
2.3.3 Use of hydrofluorocarbons (HFC’s)
Hydrofluorocarbon refrigerants are composed of hydrogen, fluorine and carbon atoms
connected by single bonds between the atoms; they do not deplete the ozone layer
because they do not contain chlorine or bromine. However, they do have a high GWP;
some higher than others (see later section). Atmospheric concentrations of these gases are
rapidly increasing.
Currently most refrigerated transport solutions and most fixed refrigeration equipment
depend on the use of HFC’s and therefore there is no alternative, however HFC’s with
lower GWP should be considered. Hydrocarbons are recommended for smaller systems.
2.3.4 Use of hydrofluoro-olefin (HFO’s)
HFO (hydrofluoro-olefin) refrigerants are the fourth generation of fluorine-based
refrigerants. HFO refrigerants are composed of hydrogen, fluorine and carbon atoms, but
contain at least one double bond between the carbon atoms.
These compounds have zero ODP and a very low GWP. Therefore these products offer a
more environmentally friendly alternative, although there are issues with flammability.
At the time of writing, these products are in an early stage of development but are
beginning to be introduced into the market. When available they would be an acceptable
11. Technical Supplement: Environmental management of refrigeration equipment 11
alternative, providing machinery is correctly designed to take into account their
flammability.
2.3.5 Use of hydrocarbons (HC’s)
Several hydrocarbons have excellent refrigeration fluid properties, zero ODP, and very low
GWP. The sole disadvantage of using HC’s is their flammability and the risk of explosion. It
is recommended that small refrigerators with refrigerant charges of less than 150g should
be preferentially purchased where an option to do so exists. Larger charges can be used,
provided safety conditions are met.
The limiting factor associated with the use of hydrocarbon refrigerants is the refrigerant
charge size, the occupancy category and the room size. Systems with charge sizes of 0.15
kg or less may be installed in a room of any size. However, for systems with charge size of
more than 0.15kg and up to 1.5kg, the room size should be such that a sudden loss of
refrigerant does not raise the mean gas concentration in the room above the practical limit
0.008kg/m3. If it is proposed to use even large charges of HC, this is permitted though it
strongly recommended that Standard EN 378 be consulted for safety recommendations.
2.3.6 Ammonia and carbon dioxide
Ammonia has excellent refrigerant properties and has been used for many years in larger
cold stores. It is still widely used in gas and kerosene-fuelled absorption refrigerators and
freezers, which provide cold chain in places without a reliable electrical supply. Ammonia
is inexpensive and leaks can easily be detected by smell, it has no ODP and low GWP. Its
disadvantages are that it has moderate flammability and is toxic.
Carbon dioxide could well be the refrigerant of the future. It has mostly good
thermodynamic properties and it is starting to be used in supermarket, cold store and
bottle cooler applications. It has no ODP and a GWP, by definition, of 1. Its main
disadvantages are high operating pressures and a critical point (inability to condense) of
29°C, which makes it operate less efficiently, transcritically, in hot environments.
2.3.7 Other cooling technologies
Other technologies for cooling exist that do not, in themselves, have ODP but are less
common than vapour compression and absorption systems. However all passive systems
such as liquid nitrogen, ice-packs and PCM-packs rely on a source of mechanical cooling
using one of the gases described above. Examples include:
• Liquid nitrogen: used for cooling in some countries.
• Liquid or dry carbon dioxide: liquid carbon dioxide is used for cooling refrigerated
vehicles in some countries. Solid carbon dioxide (dry ice) is used to keep small
packs cool.
• Water-packs: Water-based coolant-packs may either be frozen (ice-packs) or
cooled (cool water-packs). They are placed in insulated containers to help
maintain the temperature of the stored product.
• Phase-change materials (PCMs): these are coolant-packs containing waxes or other
substances that are pre-cooled and placed in insulated containers like water-
12. Technical Supplement: Environmental management of refrigeration equipment 12
packs. PCMs have the specific advantage that they can be designed to change phase
at a desired temperature – e.g. +5°C.
• Peltier effect: Peltier cooling is an electronic system that can be used to maintain
the temperature of small cool boxes.
2.4 Counterfeit refrigerants
A problem with counterfeit refrigerants has emerged in recent years in response to the
restrictions put in place by the Montreal Protocol. These refrigerants are labelled as pure
HFC’s or HFC mixtures but in fact contain a cocktail of refrigerants including those with an
ODP potential. Some counterfeit blends contain methyl chloride, which is toxic and can
react with aluminium components, sometimes causing explosions. Counterfeit refrigerants
usually contain chlorine; they are cheaper than might be expected and do not come
through recognised supply channels. Refrigerants containing chlorine can be detected
using a flame halide torch.
2.5 Thermal insulation
Foam insulation in cold store panels, refrigerator casings and refrigerated vehicle bodies
has a considerable environmental impact. The insulation foam is expanded with a reagent
that can have a GWP or ODP and the efficacy of the insulation affects the fuel consumption
of the refrigeration equipment. Insulation also ages and can deteriorate by around 5%
each year. As the foam deteriorates, the blowing agent leaches away; this adds to GWP
and gives rise to additional fuel and electricity consumption.
2.6 CO2 emissions
Carbon dioxide emissions from the prime mover driving the refrigeration equipment are
affected by the efficacy of the insulation and contribute to GWP via the Total Equivalent
Warming Impact (TEWI). The more work the refrigeration system does, the more energy
is consumed and therefore the higher the CO2 emissions. ATP regulations for frozen
transport state that the insulation should have a value of <0.4W/m²K and for chilled
transport a value of <0.7W/m²K. It is recommended that new vehicles be selected with an
insulation coefficient <0.4W/m²K.
2.6.1 Kyoto Protocol
The Kyoto Protocol to the United Nations Framework Convention on Climate Change is an
international treaty that is supposed to set binding obligations on industrialised countries
to reduce emissions of GWP (“greenhouse”) gases. Whilst all countries agree that GWP
affects the climate, there is disagreement about accepting all of the reduction implications
and therefore some countries have not signed or ratified the agreement. Nevertheless,
responsible operators of fixed and mobile refrigeration equipment should take steps to
minimise energy consumption and GWP gas emissions. This is also likely to be in their
long-term economic interest, because of the savings in operational cost from using more
efficient equipment.
13. Technical Supplement: Environmental management of refrigeration equipment 13
2.6.2 CO2 emissions from prime mover
The sizing of the refrigeration equipment relative to the heat load has a significant effect
on carbon dioxide emissions. The ATP agreement stipulates an over-capacity of a least
1.75 times the overall heat ingress into the insulated body under operating conditions and
+30°C ambient. If the predicted ambient temperature is above +30°C, it would be prudent
to increase the over-capacity to 2.25.
2.6.3 ODP and high GWP refrigerants
When selecting fixed refrigeration systems and refrigerated vehicles, those involved in the
procurement procedure should consider the ODP and GWP of the refrigerating fluid used
in the cooling equipment and the blowing agent in the insulating foam. Table 1 gives the
ODP and GWP of popular refrigerating fluids used in refrigeration systems. When
specifying new equipment, the table can be used to help select reagents with zero ODP and
the lowest technically possible GWP.
Table 1 – ODP and GWP of common refrigerants and blowing agents
Refrigerant Name Structure GWP ODP
CFC-11 trichlorofluoromethane CCl3F 4,750 1
CFC-12 dichlorodifluoromethane CCl2F2 10,900 1
CFC-502 chlorodifluoromethane
chloropentafluoroethane
CHClF2
CClF2CF3
4,657 0.25
HCFC-141b 1,1-dichloro-1-fluoroethane CCl2FCH2 725 0.12
HCFC-22 chlorodifluoromethane CHClF2 1,810 0.05
HFC-134a 1,1,1,2-tetrafluoroethane CH2FCF3 1,430 0
HFC-404a pentafluoroethane
1,1,1-trifluoroethane
1,1,1,2-tetrafluoroethane
CHF2CF3
CH3CF3
CH2FCF3
3,922 0
HFC-407a difluoromethane
pentafluoroethane
1,1,1,2-tetrafluoroethane
CH2F2
CHF2CF3
CH2FCF3
2,107 0
HFC-410a difluoromethane
pentafluoroethane
CH2F2
CHF2CF3
2,088 0
HFO-1234yf 2,3,3,3-tetrafluoropropene CF3CF=CH2 4 0
HFO-1234ze trans-1,3,3,3-
tetrafluoropropene
CF3CH=CHF 6 0
N/A cyclopentane C5H10 11 0
HC-290 propane CH3CH2CH3 11 0
14. Technical Supplement: Environmental management of refrigeration equipment 14
Refrigerant Name Structure GWP ODP
HC-600s isobutane CH(CH3)2CH3 3 0
R-717 ammonia NH3 0 0
R-744 carbon dioxide CO2 1 0
CFC-11 and HCFC-141b were previously used as insulation foam blowing agents. Most
commonly these gases have now been replaced with cyclopentane, although various HFC’s
are sometimes used. First generation CFC refrigerants, such as CFC-12 and CFC-502, are
no longer used. HCFC-22, and blends containing this gas, have a lower ODP and are now
used less frequently; they are illegal in non-article 5 countries. HFC-134a and HFC-404a
are commonly used refrigerants. However, there is now pressure on HFC-404a because of
its high GWP and alternatives are being sought. HFO’s are the new generation of
refrigerants currently under development, but these have flammability concerns in the
form of ‘slow flame propagation’; they are classed by ASHRAE as A2L, low toxicity, low
flammability refrigerants with a maximum burning velocity of ≤ 10cm/s. Ammonia has
been used for many years in large stores; carbon dioxide is now used in larger equipment
and in development models of refrigerators and transport units.
2.7 Installation and maintenance
Only technicians trained in handling refrigerant gases should carry out the installation and
maintenance of refrigeration equipment.
Historically, vehicle-cooling systems have high levels of gradual leakage from mechanical
seals, glands, valves and mechanical joints. Generally, fixed equipment has lower leakage
rates.
Regular leakage checks can identify such leaks and minimise emissions. An inventory
should be maintained and an associated SOP detailing the following:
• Quantity and type of refrigerant charge in each piece of equipment.
• Quantities of refrigerant added at service.
• Quantities of refrigerant recovered in service.
• Dates and results of leakage checks.
• Identity of personnel undertaking checks.
2.8 Decommissioning
At the end of its economic life, fixed refrigeration equipment and refrigerated vehicles
need to be decommissioned. The life of a vehicle is likely to depend on the condition of the
insulated body, though it is unlikely to be in excess of 15 years, and more likely 12.
The following is recommended:
• A trained technician should remove the refrigerant from the cooling equipment. It
should be incinerated in an approved plant or recycled by a refrigerant
manufacturer with appropriate facilities.
15. Technical Supplement: Environmental management of refrigeration equipment 15
• The insulated enclosure, if it is to be used as a store, should be made safe to ensure
it is impossible for people to get trapped inside.
• If the insulation of the enclosure contains ODP or GWP reagents, it should, if
technically feasible, be crushed so that the foaming reagents can be recovered.
• Absorption refrigerators should be disposed of with care as they are pressurised
and older units contain a corrosion inhibitor (sodium dichromate). Some countries
restrict the disposal of this substance in landfill.
2.9 Staff training
All employees who are involved with the handling of refrigerants should be given training.
This should include:
Handling of refrigerant fluids;
Installation;
Maintenance;
Servicing.
Training should also include reference to the environmental impact of releasing high GWP
refrigerants into the environment and their effect in accelerating climate change.
16. Technical Supplement: Environmental management of refrigeration equipment 16
References
ASHRAE. Designation and safety classifications of refrigerants. 2010
www.ashrae.org/File%20Library/docLib/Public/20100309_34_2007_ak_final.pdf
IATA. 2013/2014 Perishable Cargo Regulations (ePCR) & Temperature Control
Regulations (eTCR)
http://www.iata.org/publications/Pages/temperature-control-regulations.aspx
Lawton, A.R., Marshall, N., Clarke, P. Counterfeit refrigerant in food transportation
sea containers; IIR/IIF Cold Chain. Paris; 2013
http://www.crtech.co.uk/papers/CounterfeitRefrigerantInFoodTransportationCo
ntainers.pdf
Lawton, A.R., Marshall, R.E. Developments in refrigerated transport insulation since
the phase out of CFC and HCFC refrigerants. International Congress of Refrigeration.
Beijing, 2007.
http://www.crtech.co.uk/papers/DevelopmentsInInsulation.pdf
Managing Fluorinated Gases.
https://www.gov.uk/managing-fluorinated-gases-and-ozone-depleting-
substances
Regulation (EC) no 1005/2009 of the European Parliament and of the Council of 16
September 2009 on substances that deplete the ozone layer.
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:286:0001:0030:EN:PDF
Regulation (EC) no 842/2006 of the European Parliament and of the Council of 17
May 2006 on certain fluorinated greenhouse gases.
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:161:0001:0011:EN:PDF
UK Department for Environment, Food & Rural Affairs and Department for
Business, Innovation & Skills. UNECE. Agreement on the International Carriage of
Perishable Foodstuffs and on the Special Equipment to be Used for such Carriage
(ATP).
http://www.unece.org/fileadmin/DAM/trans/main/wp11/wp11fdoc/ATP-
2011_final_e.pdf
UNEP. 2010 Report of the refrigeration, air conditioning and heat pumps technical
options committee.4
http://ozone.unep.org/teap/Reports/RTOC/RTOC-Assessment-report-2010.pdf
WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the
storage and transport of time- and temperature-sensitive pharmaceutical
http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf
4
Every four years a comprehensive report is produced by UNEP on substances that deplete the
ozone layer and the Montreal Protocol.
17. Technical Supplement: Environmental management of refrigeration equipment 17
Annex 1 – Montreal Protocol: non-Article 5 countries
1. Andorra
2. Australia
3. Austria
4. Azerbaijan
5. Belarus
6. Belgium
7. Bulgaria
8. Canada
9. Cyprus
10. Czech Republic
11. Denmark
12. Estonia
13. European Union
14. Finland
15. France
16. Germany
17. Greece
18. Holy See
19. Hungary
20. Iceland
21. Ireland
22. Israel
23. Italy
24. Japan
25. Kazakhstan
26. Latvia
27. Liechtenstein
28. Lithuania
29. Luxembourg
30. Malta
31. Monaco
32. Netherlands
33. New Zealand
34. Norway
35. Poland
36. Portugal
37. Russian Federation
38. Romania
39. San Marino
40. Slovakia
41. Slovenia
42. Spain
43. Sweden
44. Switzerland
45. Tajikistan
46. Ukraine
47. United Kingdom
48. United States of America
49. Uzbekistan
18. Technical Supplement: Environmental management of refrigeration equipment 18
Revision history
Date Change summary Reason for change Approved