This document discusses the importance of maintaining proper cold chain management for pharmaceutical products, especially clinical trial materials. It covers definitions of active and passive cold chain systems, requirements for validation of cold chain processes, challenges in global clinical trials, and the roles of service providers and regulations. Proper cold chain is crucial for ensuring product quality and safety.
This document discusses infection control and hospital acquired infections. It covers the chain of infection, types of nosocomial infections, their causes and modes of transmission. It also summarizes the principles of medical and surgical asepsis, isolation precautions including different types of isolation, and the importance of hand washing in infection control.
The Centers for Disease Control and Prevention (CDC) is a federal agency that conducts and supports health promotion, prevention and preparedness activities in the US with the goal of improving overall public health. It was established in 1946 and is headquartered in Atlanta, Georgia. The CDC monitors and prevents disease outbreaks, implements disease prevention strategies, and maintains national health statistics. It focuses on infectious diseases, foodborne pathogens, environmental health, and more. The CDC is organized into centers, institutes, and offices to effectively address public health concerns. It works with partners at local, state, and national levels.
CSSD stands for Central Sterile Supply Department and is responsible for processing, sterilizing, storing, and distributing sterile and non-sterile supplies throughout a hospital. The modern concept of CSSD emerged during World War II to ensure aseptic technique and prevent sepsis. CSSD is now an integral part of every hospital, with its location and size dependent on the hospital bed size. Key functions of CSSD include receiving, sorting, cleaning, inspecting, assembling, packing, sterilizing, storing, and distributing supplies to all departments of the hospital.
The document discusses India's cold chain system for transporting and storing vaccines. It defines the cold chain as maintaining vaccines at recommended temperatures from manufacture to point of use. Key components of the cold chain system include equipment like walk-in freezers and coolers, refrigerators, cold boxes, vaccine carriers and day carriers. Vaccines are stored at different levels from national stores down to local health centers. Proper temperature maintenance is important to preserve vaccine potency and effectiveness of immunization programs.
The document discusses key concepts of infection control including definitions of terms like nosocomial infection, disinfection, and sterilization. It also addresses factors that influence nosocomial infections like microbial agents, patient susceptibility, and environmental factors. Nosocomial infections are a major problem that increase healthcare costs and can be prevented through proper infection control programs and practices in healthcare facilities.
The Central Sterile Supply Department (CSSD) provides sterilized equipment and instruments to hospital departments. It cleans, disinfects, sterilizes, stores and distributes items. The CSSD aims to reduce hospital infections by following sterilization standards. It has four zones - dirty, clean, sterilization and sterile areas. The CSSD sterilizes items using autoclaves, hot air ovens and ethylene oxide. It monitors sterilization effectiveness using chemical and biological indicators. The CSSD aims to efficiently provide sterile supplies to all hospital units.
The document discusses the importance and functions of the Central Sterile Supply Department (CSSD) in hospitals. It outlines the history and objectives of CSSDs, which aim to provide sterilized medical supplies from a central location. The optimal design principles are described, including workflow zones and layout. Key areas like cleaning, sterilization, storage and distribution are explained. Finally, the document provides an inventory of recommended equipment for setting up an ideal CSSD.
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning procedures are important because contamination can be invisible. Operators must be well-trained in gowning to avoid introducing contamination. Gowning includes showering and hygiene at home, changing at work while avoiding contact with floors, and wearing multiple layered garments specific to each cleanroom grade that fully cover the body and shed no particles. Proper gowning allows entry to production areas while avoiding contamination.
This document discusses infection control and hospital acquired infections. It covers the chain of infection, types of nosocomial infections, their causes and modes of transmission. It also summarizes the principles of medical and surgical asepsis, isolation precautions including different types of isolation, and the importance of hand washing in infection control.
The Centers for Disease Control and Prevention (CDC) is a federal agency that conducts and supports health promotion, prevention and preparedness activities in the US with the goal of improving overall public health. It was established in 1946 and is headquartered in Atlanta, Georgia. The CDC monitors and prevents disease outbreaks, implements disease prevention strategies, and maintains national health statistics. It focuses on infectious diseases, foodborne pathogens, environmental health, and more. The CDC is organized into centers, institutes, and offices to effectively address public health concerns. It works with partners at local, state, and national levels.
CSSD stands for Central Sterile Supply Department and is responsible for processing, sterilizing, storing, and distributing sterile and non-sterile supplies throughout a hospital. The modern concept of CSSD emerged during World War II to ensure aseptic technique and prevent sepsis. CSSD is now an integral part of every hospital, with its location and size dependent on the hospital bed size. Key functions of CSSD include receiving, sorting, cleaning, inspecting, assembling, packing, sterilizing, storing, and distributing supplies to all departments of the hospital.
The document discusses India's cold chain system for transporting and storing vaccines. It defines the cold chain as maintaining vaccines at recommended temperatures from manufacture to point of use. Key components of the cold chain system include equipment like walk-in freezers and coolers, refrigerators, cold boxes, vaccine carriers and day carriers. Vaccines are stored at different levels from national stores down to local health centers. Proper temperature maintenance is important to preserve vaccine potency and effectiveness of immunization programs.
The document discusses key concepts of infection control including definitions of terms like nosocomial infection, disinfection, and sterilization. It also addresses factors that influence nosocomial infections like microbial agents, patient susceptibility, and environmental factors. Nosocomial infections are a major problem that increase healthcare costs and can be prevented through proper infection control programs and practices in healthcare facilities.
The Central Sterile Supply Department (CSSD) provides sterilized equipment and instruments to hospital departments. It cleans, disinfects, sterilizes, stores and distributes items. The CSSD aims to reduce hospital infections by following sterilization standards. It has four zones - dirty, clean, sterilization and sterile areas. The CSSD sterilizes items using autoclaves, hot air ovens and ethylene oxide. It monitors sterilization effectiveness using chemical and biological indicators. The CSSD aims to efficiently provide sterile supplies to all hospital units.
The document discusses the importance and functions of the Central Sterile Supply Department (CSSD) in hospitals. It outlines the history and objectives of CSSDs, which aim to provide sterilized medical supplies from a central location. The optimal design principles are described, including workflow zones and layout. Key areas like cleaning, sterilization, storage and distribution are explained. Finally, the document provides an inventory of recommended equipment for setting up an ideal CSSD.
Gowning refers to wearing special garments to control particulate contamination in cleanrooms. Correct gowning procedures are important because contamination can be invisible. Operators must be well-trained in gowning to avoid introducing contamination. Gowning includes showering and hygiene at home, changing at work while avoiding contact with floors, and wearing multiple layered garments specific to each cleanroom grade that fully cover the body and shed no particles. Proper gowning allows entry to production areas while avoiding contamination.
This document outlines different types of precautions - airborne, contact, and droplet - that should be taken for various infectious diseases. It then lists diseases that require each type of precaution, including chickenpox, flu, measles, mumps, whooping cough, meningitis, diphtheria, pneumonia, and tuberculosis.
Surveillance of healthcare associated infectionsTHL
This document discusses the role of nurses in healthcare-associated infection (HAI) surveillance in Finland. It describes how HAI surveillance is conducted nationally through several programs coordinated by the Finnish Hospital Infection Program. Nurses, particularly infection control nurses, play a key role in HAI data collection, reporting, and feedback. They work with link nurses and other staff to identify HAI cases using standardized protocols. The data are used to monitor HAI rates and prevent infections by informing guidelines. Nurses receive training to build their competencies in infection control and HAI surveillance.
Hospital acquired infections, also known as nosocomial infections, are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting. These infections can spread through direct contact or indirectly through hands, equipment, and the environment. Standard precautions like proper hand hygiene and the use of personal protective equipment are important for preventing the transmission of infections between patients and staff. Additional precautions tailored to specific infection types may also be implemented, such as isolating patients, wearing protective masks, and limiting movement. Regular surveillance and adherence to infection control guidelines and manuals are necessary to effectively reduce hospital acquired infections.
The document discusses surveillance of healthcare-associated infections (HAIs). It defines surveillance as the ongoing systematic collection, analysis, and interpretation of healthcare data to inform public health practices. The goals of surveillance include defining endemic infection rates, identifying risks and outbreaks, and evaluating interventions. The key components of surveillance are collecting relevant data, managing and organizing the data, analyzing and interpreting the results, and communicating the findings to stakeholders.
The document provides an overview of the Central Sterile Supply Department (CSSD) in a hospital. It discusses the mission, activities, definitions, aims, functions, advantages, planning, equipment, sterilization processes, storage, and role of the manager of the CSSD. The CSSD is responsible for cleaning, sterilizing, storing, and distributing sterile surgical instruments, supplies and linen in a timely, efficient and cost-effective manner to reduce infection rates and ensure quality patient care.
Cold chain refers to the process of maintaining optimal temperature conditions for vaccines from manufacturer to administration. It involves receipt, storage, and delivery of vaccines using various equipment like cold boxes, vaccine carriers, refrigerators, and freezers. Temperature must be monitored daily and vaccines discarded if exposed to unsuitable temperatures as this impacts potency. Proper estimation, documentation, and emergency procedures are important for ensuring vaccine quality during transportation and storage in the cold chain.
The document discusses the cold chain system used for storing vaccines. It defines cold chain as a series of links that keep vaccines within the recommended temperature range from manufacture to administration. Key aspects of cold chain discussed include various equipment used like walk-in cold rooms, deep freezers, ice-lined refrigerators, cold boxes, vaccine carriers and ice packs. The document outlines the temperature requirements for different vaccines and nurses' responsibility in maintaining the cold chain to ensure vaccine potency.
The document discusses the Central Sterile Supply Department (CSSD) at King Georg's Medical University. The CSSD aims to provide sterile supplies to hospital departments through centralized sterilization activities. Key functions of the CSSD include receiving, cleaning, sterilizing, storing, and distributing instruments and supplies. The CSSD follows strict procedures and uses various sterilization methods like steam, ethylene oxide and dry heat. Quality control measures like sterilization indicators help ensure sterility is achieved. Proper facility design, equipment, and management are necessary for the CSSD to efficiently provide sterile items and reduce infection risks.
The document discusses the cold chain system for storing and transporting vaccines. It describes key elements like personnel, equipment, and procedures to ensure vaccines are safely stored and transported within the recommended temperature range. Various types of cold chain equipment are outlined, including walk-in freezers and coolers, deep freezers, ice-lined refrigerators, vaccine carriers, and cold boxes. Placement of vaccines, temperature monitoring, and checking vaccine potency are also covered. The cold chain system is crucial for maintaining vaccine effectiveness from the point of manufacture to administration.
hospital acquired infection unit 1.pptxwichamjailiu
This document discusses hospital acquired infections (HAIs), also known as healthcare associated infections. Some key points:
- HAIs affect 7-10% of patients in hospitals worldwide and cause mortality in around 10% of affected patients.
- HAIs are infections acquired in a hospital by patients not originally admitted for an infection.
- Factors that can increase risk include a patient's immune status, hospital environment, interventions, and poor administration.
- Common HAIs include those related to catheters, ventilators, and after surgery. Care bundles can help prevent specific HAIs.
- Hospitals should conduct HAI surveillance to monitor rates, identify issues, and provide feedback to clinicians to
Central sterile supply department(cssd)anees fatima
The Central Sterile Supply Department (CSSD) is responsible for receiving, processing, sterilizing, storing and distributing sterile supplies and equipment for hospitals. Key functions of the CSSD include cleaning, packaging, sterilizing items using autoclaves or ethylene oxide, storing sterile supplies, and issuing items to different hospital units. CSSDs aim to provide safe sterile supplies efficiently while standardizing equipment and assisting in infection control.
This document discusses patient safety indicators (PSIs) as a way to measure and improve healthcare quality. It defines PSIs as a subset of quality indicators focused on preventable complications during or after hospitalization. The document then provides details on 20 specific PSIs, including definitions, calculation methods, and sample results for Portugal between 2000-2005. It analyzes PSI rates by gender, economic hospital group, administrative hospital group, and year to identify safety trends and differences between hospital types. The goal is to understand PSI prevalence, evaluate hospital safety over time, and identify opportunities to enhance patient safety.
This document defines vulnerable patients as those unable to protect or care for themselves, and lists several categories of vulnerable patients including the elderly, children, disabled individuals, and patients undergoing medical procedures. It describes how nurses should assess and care for vulnerable patients, with an emphasis on safety. Key safety measures include identification bands, regular checks, grab bars, non-slip surfaces, adequate lighting, and ensuring vulnerable patients are not left unattended. The goal is to minimize risks for these patients like falls, injuries, neglect, and infections.
The document discusses hospital-associated infections (HAIs), also known as nosocomial infections. It defines HAIs as infections that patients acquire during treatment in a hospital setting. The document outlines some key points about HAIs, including that they account for significant illness and death worldwide. It also discusses factors that contribute to HAIs spreading in hospitals, such as host susceptibility, infectious agents, and environmental conditions. Finally, it provides recommendations for preventing HAIs, such as implementing infection control committees, surveillance systems, proper sterilization and hygiene practices, and isolating infected patients.
This document discusses the transfer of a patient from one unit or hospital to another. It defines a patient transfer as discharging a patient from one unit or agency and admitting them to another without going home in between. The two main types of transfers discussed are between units in the same hospital and between different hospitals. The key steps outlined for an intra-hospital transfer are obtaining a physician order, informing the patient and receiving unit, completing documentation, arranging transportation, and ensuring the receiving unit admits the patient. The nurse's role in the process involves communication, documentation, collecting patient belongings, and assisting in the physical transfer of the patient between units.
isolation precautions and use of PPE.pptxwichamjailiu
This document discusses isolation precautions and personal protective equipment (PPE) used to prevent the spread of infectious diseases in healthcare settings. It defines isolation as separating infected patients from others, and outlines different types of isolation including strict, respiratory, protective, and others based on transmission route. Standard precautions like hand hygiene and PPE are the minimum precautions to be used with all patients. Transmission-based precautions including contact, droplet, and airborne precautions provide additional measures for certain infectious diseases based on their transmission method. The document details the specific infection control measures for each type of precaution.
The Central Sterile Supply Department (CSSD) is responsible for cleaning, sterilizing, packaging, storing and distributing medical equipment and supplies. Key functions of the CSSD include decontamination, sterilization using steam or radiation, and distribution of sterile supplies to patient care areas. Strict protocols are followed around packaging, sterilization, and storage to ensure sterility of supplies. The CSSD aims to provide sterile materials efficiently while reducing burden on nursing staff.
The document provides an introduction to Central Sterile Supply Departments (CSSDs) in hospitals. It discusses the history and development of CSSDs, their aims and objectives, advantages, and key components including physical layout, functions, personnel, finances, preventive measures, equipment, and quality management. CSSDs are responsible for receiving, processing, storing, distributing, and controlling sterile and non-sterile medical supplies and equipment used in patient care. The modern CSSD concept was derived during World War II to help ensure a safe and efficient sterilization and distribution system.
The document discusses occupational diseases and hazards. It notes that there are over 100 million occupational injuries worldwide each year according to WHO, including 17 million non-fatal and 45,000 fatal injuries in India alone. It defines occupational health and lists factors that can affect worker health like physical, chemical, biological, and psychosocial hazards. Common occupational diseases mentioned include pneumoconiosis, lead poisoning, and cancers. The document outlines preventive measures against occupational hazards including pre-placement exams, engineering controls, protective equipment, legislation, and the roles of health providers in prevention, treatment, and rehabilitation.
This document provides an overview and agenda for a multi-day conference on market access in Latin America for pharmaceutical and medical device companies. The conference will cover topics such as demonstrating product value to local health technology assessment agencies and payers, market growth and access trends in Latin America, and generating real-world evidence. Speakers will include representatives from industry, academia, health technology assessment organizations, regulators, and payers. Attendees will learn about different approaches to market access across Latin America and how to develop strategies to partner with customers. The conference aims to help companies successfully bring products to these diverse and dynamic healthcare markets.
8th Cold Chain Distribution for Pharmaceuticals Global ForumAbby Lombardi
The document announces an upcoming conference on cold chain distribution for pharmaceuticals to be held in Philadelphia from September 20-23, 2010. The conference will feature presentations, panel discussions, and specialist forums on various topics related to ensuring safe international distribution of temperature-controlled pharmaceutical products while maintaining regulatory compliance and cost effectiveness. Speakers will include representatives from pharmaceutical companies, logistics providers, government agencies, and industry associations. Attendees will learn about strategies for distributing to new international markets, developing industry best practices, temperature mapping and profiling of products, transportation and security issues, and collaborating with supply chain partners.
This document outlines different types of precautions - airborne, contact, and droplet - that should be taken for various infectious diseases. It then lists diseases that require each type of precaution, including chickenpox, flu, measles, mumps, whooping cough, meningitis, diphtheria, pneumonia, and tuberculosis.
Surveillance of healthcare associated infectionsTHL
This document discusses the role of nurses in healthcare-associated infection (HAI) surveillance in Finland. It describes how HAI surveillance is conducted nationally through several programs coordinated by the Finnish Hospital Infection Program. Nurses, particularly infection control nurses, play a key role in HAI data collection, reporting, and feedback. They work with link nurses and other staff to identify HAI cases using standardized protocols. The data are used to monitor HAI rates and prevent infections by informing guidelines. Nurses receive training to build their competencies in infection control and HAI surveillance.
Hospital acquired infections, also known as nosocomial infections, are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting. These infections can spread through direct contact or indirectly through hands, equipment, and the environment. Standard precautions like proper hand hygiene and the use of personal protective equipment are important for preventing the transmission of infections between patients and staff. Additional precautions tailored to specific infection types may also be implemented, such as isolating patients, wearing protective masks, and limiting movement. Regular surveillance and adherence to infection control guidelines and manuals are necessary to effectively reduce hospital acquired infections.
The document discusses surveillance of healthcare-associated infections (HAIs). It defines surveillance as the ongoing systematic collection, analysis, and interpretation of healthcare data to inform public health practices. The goals of surveillance include defining endemic infection rates, identifying risks and outbreaks, and evaluating interventions. The key components of surveillance are collecting relevant data, managing and organizing the data, analyzing and interpreting the results, and communicating the findings to stakeholders.
The document provides an overview of the Central Sterile Supply Department (CSSD) in a hospital. It discusses the mission, activities, definitions, aims, functions, advantages, planning, equipment, sterilization processes, storage, and role of the manager of the CSSD. The CSSD is responsible for cleaning, sterilizing, storing, and distributing sterile surgical instruments, supplies and linen in a timely, efficient and cost-effective manner to reduce infection rates and ensure quality patient care.
Cold chain refers to the process of maintaining optimal temperature conditions for vaccines from manufacturer to administration. It involves receipt, storage, and delivery of vaccines using various equipment like cold boxes, vaccine carriers, refrigerators, and freezers. Temperature must be monitored daily and vaccines discarded if exposed to unsuitable temperatures as this impacts potency. Proper estimation, documentation, and emergency procedures are important for ensuring vaccine quality during transportation and storage in the cold chain.
The document discusses the cold chain system used for storing vaccines. It defines cold chain as a series of links that keep vaccines within the recommended temperature range from manufacture to administration. Key aspects of cold chain discussed include various equipment used like walk-in cold rooms, deep freezers, ice-lined refrigerators, cold boxes, vaccine carriers and ice packs. The document outlines the temperature requirements for different vaccines and nurses' responsibility in maintaining the cold chain to ensure vaccine potency.
The document discusses the Central Sterile Supply Department (CSSD) at King Georg's Medical University. The CSSD aims to provide sterile supplies to hospital departments through centralized sterilization activities. Key functions of the CSSD include receiving, cleaning, sterilizing, storing, and distributing instruments and supplies. The CSSD follows strict procedures and uses various sterilization methods like steam, ethylene oxide and dry heat. Quality control measures like sterilization indicators help ensure sterility is achieved. Proper facility design, equipment, and management are necessary for the CSSD to efficiently provide sterile items and reduce infection risks.
The document discusses the cold chain system for storing and transporting vaccines. It describes key elements like personnel, equipment, and procedures to ensure vaccines are safely stored and transported within the recommended temperature range. Various types of cold chain equipment are outlined, including walk-in freezers and coolers, deep freezers, ice-lined refrigerators, vaccine carriers, and cold boxes. Placement of vaccines, temperature monitoring, and checking vaccine potency are also covered. The cold chain system is crucial for maintaining vaccine effectiveness from the point of manufacture to administration.
hospital acquired infection unit 1.pptxwichamjailiu
This document discusses hospital acquired infections (HAIs), also known as healthcare associated infections. Some key points:
- HAIs affect 7-10% of patients in hospitals worldwide and cause mortality in around 10% of affected patients.
- HAIs are infections acquired in a hospital by patients not originally admitted for an infection.
- Factors that can increase risk include a patient's immune status, hospital environment, interventions, and poor administration.
- Common HAIs include those related to catheters, ventilators, and after surgery. Care bundles can help prevent specific HAIs.
- Hospitals should conduct HAI surveillance to monitor rates, identify issues, and provide feedback to clinicians to
Central sterile supply department(cssd)anees fatima
The Central Sterile Supply Department (CSSD) is responsible for receiving, processing, sterilizing, storing and distributing sterile supplies and equipment for hospitals. Key functions of the CSSD include cleaning, packaging, sterilizing items using autoclaves or ethylene oxide, storing sterile supplies, and issuing items to different hospital units. CSSDs aim to provide safe sterile supplies efficiently while standardizing equipment and assisting in infection control.
This document discusses patient safety indicators (PSIs) as a way to measure and improve healthcare quality. It defines PSIs as a subset of quality indicators focused on preventable complications during or after hospitalization. The document then provides details on 20 specific PSIs, including definitions, calculation methods, and sample results for Portugal between 2000-2005. It analyzes PSI rates by gender, economic hospital group, administrative hospital group, and year to identify safety trends and differences between hospital types. The goal is to understand PSI prevalence, evaluate hospital safety over time, and identify opportunities to enhance patient safety.
This document defines vulnerable patients as those unable to protect or care for themselves, and lists several categories of vulnerable patients including the elderly, children, disabled individuals, and patients undergoing medical procedures. It describes how nurses should assess and care for vulnerable patients, with an emphasis on safety. Key safety measures include identification bands, regular checks, grab bars, non-slip surfaces, adequate lighting, and ensuring vulnerable patients are not left unattended. The goal is to minimize risks for these patients like falls, injuries, neglect, and infections.
The document discusses hospital-associated infections (HAIs), also known as nosocomial infections. It defines HAIs as infections that patients acquire during treatment in a hospital setting. The document outlines some key points about HAIs, including that they account for significant illness and death worldwide. It also discusses factors that contribute to HAIs spreading in hospitals, such as host susceptibility, infectious agents, and environmental conditions. Finally, it provides recommendations for preventing HAIs, such as implementing infection control committees, surveillance systems, proper sterilization and hygiene practices, and isolating infected patients.
This document discusses the transfer of a patient from one unit or hospital to another. It defines a patient transfer as discharging a patient from one unit or agency and admitting them to another without going home in between. The two main types of transfers discussed are between units in the same hospital and between different hospitals. The key steps outlined for an intra-hospital transfer are obtaining a physician order, informing the patient and receiving unit, completing documentation, arranging transportation, and ensuring the receiving unit admits the patient. The nurse's role in the process involves communication, documentation, collecting patient belongings, and assisting in the physical transfer of the patient between units.
isolation precautions and use of PPE.pptxwichamjailiu
This document discusses isolation precautions and personal protective equipment (PPE) used to prevent the spread of infectious diseases in healthcare settings. It defines isolation as separating infected patients from others, and outlines different types of isolation including strict, respiratory, protective, and others based on transmission route. Standard precautions like hand hygiene and PPE are the minimum precautions to be used with all patients. Transmission-based precautions including contact, droplet, and airborne precautions provide additional measures for certain infectious diseases based on their transmission method. The document details the specific infection control measures for each type of precaution.
The Central Sterile Supply Department (CSSD) is responsible for cleaning, sterilizing, packaging, storing and distributing medical equipment and supplies. Key functions of the CSSD include decontamination, sterilization using steam or radiation, and distribution of sterile supplies to patient care areas. Strict protocols are followed around packaging, sterilization, and storage to ensure sterility of supplies. The CSSD aims to provide sterile materials efficiently while reducing burden on nursing staff.
The document provides an introduction to Central Sterile Supply Departments (CSSDs) in hospitals. It discusses the history and development of CSSDs, their aims and objectives, advantages, and key components including physical layout, functions, personnel, finances, preventive measures, equipment, and quality management. CSSDs are responsible for receiving, processing, storing, distributing, and controlling sterile and non-sterile medical supplies and equipment used in patient care. The modern CSSD concept was derived during World War II to help ensure a safe and efficient sterilization and distribution system.
The document discusses occupational diseases and hazards. It notes that there are over 100 million occupational injuries worldwide each year according to WHO, including 17 million non-fatal and 45,000 fatal injuries in India alone. It defines occupational health and lists factors that can affect worker health like physical, chemical, biological, and psychosocial hazards. Common occupational diseases mentioned include pneumoconiosis, lead poisoning, and cancers. The document outlines preventive measures against occupational hazards including pre-placement exams, engineering controls, protective equipment, legislation, and the roles of health providers in prevention, treatment, and rehabilitation.
This document provides an overview and agenda for a multi-day conference on market access in Latin America for pharmaceutical and medical device companies. The conference will cover topics such as demonstrating product value to local health technology assessment agencies and payers, market growth and access trends in Latin America, and generating real-world evidence. Speakers will include representatives from industry, academia, health technology assessment organizations, regulators, and payers. Attendees will learn about different approaches to market access across Latin America and how to develop strategies to partner with customers. The conference aims to help companies successfully bring products to these diverse and dynamic healthcare markets.
8th Cold Chain Distribution for Pharmaceuticals Global ForumAbby Lombardi
The document announces an upcoming conference on cold chain distribution for pharmaceuticals to be held in Philadelphia from September 20-23, 2010. The conference will feature presentations, panel discussions, and specialist forums on various topics related to ensuring safe international distribution of temperature-controlled pharmaceutical products while maintaining regulatory compliance and cost effectiveness. Speakers will include representatives from pharmaceutical companies, logistics providers, government agencies, and industry associations. Attendees will learn about strategies for distributing to new international markets, developing industry best practices, temperature mapping and profiling of products, transportation and security issues, and collaborating with supply chain partners.
- India produces large quantities of fruits and vegetables but suffers significant post-harvest losses of around 30% annually worth $13 billion due to lack of cold storage infrastructure and proper cold chain.
- The use of solar-powered refrigerated containers can help transport perishables from farms to cold storages and markets, reducing post-harvest losses by around 35% and saving $4.5 billion annually.
- An investment of $2.5 billion for 42,000 solar-powered containers would pay for itself within 6-9 months and help lift farmers out of poverty while improving food quality, health, and export potential.
Maheshwar, Chilukuri Challenges In Export And Import Of Temperature Control...Maheshwar Chilukuri
This document summarizes the key challenges in exporting temperature controlled pharmaceuticals from India. It outlines the complex export process involving manufacturers, ground transport, airports, airlines, warehouses, and consumers. Maintaining proper temperature control and monitoring throughout transportation and storage is critical but difficult given India's developing cold chain infrastructure and hot climate. Addressing issues like power reliability, training, regulation compliance, and partnerships across the supply chain is needed to improve pharmaceutical exports from India while ensuring drug safety and efficacy.
Bangladesh pharma industry: Prospects and Challenges (2015)shawkat haider
The pharmaceutical industry in Bangladesh has grown significantly over the last three decades and now meets 97% of the country's drug demands domestically. It is one of the most technologically advanced sectors in Bangladesh, employing many professionals. While successful in developing the domestic market, the industry faces challenges in becoming a major exporter, including lack of infrastructure like an API technology park and central bioequivalence testing laboratory. Addressing issues like backward integration into API production, regulatory strengthening, and industry-academia collaboration could help Bangladesh realize the industry's export potential and economic benefits.
Africa has the potential to be a major global food supplier, but its small farmers and traders are not well integrated into global supply chains. A lack of infrastructure and logistical difficulties have hindered Africa's ability to export its agricultural production. Developing cold storage facilities at container terminals could help Africa export the 5% of fruits and vegetables it currently ships overseas, tapping into growing global demand and creating lucrative opportunities for African farmers and traders.
A cold chain is a supply chain that involves storing and transporting temperature-sensitive products like food and pharmaceuticals at a specific temperature range. It uses refrigerated trucks, railcars, and warehouses to keep products at the right temperature. A cold chain is important because it helps maintain product quality, shelf life and ensures the value of perishable goods is realized. Managing the cold chain effectively requires integrating all the different parts like procurement, transportation, storage and distribution while also considering product and customer requirements. New technologies are also being developed and adopted to improve the efficiency, sustainability and traceability of cold supply chains.
The document discusses the importance of cold chain systems for horticultural crops like grapes. It outlines the various steps in a cold chain, including careful harvesting, pre-cooling, storage, transportation and marketing. Proper cold chain practices can reduce losses, improve quality and increase profits for growers. The seminar focuses on reducing costs, improving product integrity and customer satisfaction for grape farmers through utilizing improved cold chain systems from the field to consumers.
The document discusses cold chain logistics. It defines cold chain as a logistics system that maintains ideal storage conditions for perishables from origin to point of sale. This helps reduce wastage and spoilage, keeping products intact. The current Indian cold chain market is worth $3 billion and expected to grow to $12.4 billion by 2015. Key drivers for growth of cold chain infrastructure include the organized retail sector, processed foods, and government initiatives. The document outlines cold chain models and applications in various industries. It also discusses challenges in cold chain logistics and infrastructure components.
7th Cold Chain Distribution for PharmaceuticalsAbby Lombardi
This document provides information about the 7th Annual Cold Chain Distribution for Pharmaceuticals conference taking place from September 21-24, 2009 in Philadelphia, Pennsylvania. The conference will focus on partnerships, transportation processes, risk mitigation and temperature-controlled shipment of pharmaceutical products and supplies. Topics will include re-evaluating transportation and logistics strategies, ensuring regulatory compliance, establishing qualified shipping lanes and processes, and implementing effective "last mile" logistics. The conference will feature speakers from various pharmaceutical and logistics companies and government agencies. Pre-conference discussion forums and conference tracks will address issues such as cold chain program management, new refrigeration technologies, biological materials and clinical supplies shipping, and clinical logistics.
The universal immunization program and supplementary immunization activities in India face challenges in cold chain management due to aging equipment, inadequate trained staff, and poor monitoring. Maintaining the cold chain is essential for vaccine potency but is made more difficult during large scale immunization campaigns due to the increased vaccine volumes and need for careful planning, equipment preparation, and vaccine delivery and storage. Regular assessment and timely repairs of the cold chain system are needed to ensure vaccines are kept at the proper temperature.
This presentation contains Complete cold chain system, Importance and requirement of cold chain, detail of each equipment of cold chain system.
This presentation contain brief detail of THE SHAKE TEST, Reverse cold chain.
This is fully equipped with knowledge of Field facts of cold chain system.
Material handling involves the efficient movement of materials and products throughout the supply chain. It aims to move the right materials to the right place at the right time in the most cost-effective manner. Material handling equipment includes transport equipment like conveyors, cranes, and automated guided vehicles; storage systems like racks and bins; and unitizing equipment. The goals of material handling are to reduce production costs, maintain quality, promote safety, and increase productivity through principles such as planning, system integration, simplification, gravity usage, space optimization, and automation.
A healthy manufacturing sector is very essential for the development of any economy. But talking about pharmaceutical manufacturing then it is not something which everyone and every economy can perform. Nepal as being naturally rich country it have some advantage and competitiveness in this industry if the capacities are utilized. due to which there are many foreign Ayurvedic companies which made their way to Nepal to have such herbs. A well developed pharmaceutical system promotes investment by the identified investors in the country leading to various business opportunities, mobilizing funds and effective utilization of resources.
The document discusses material handling, which involves moving materials efficiently through the production process. It defines material handling and lists its goals as reducing costs, maintaining quality, and promoting safety, productivity and facility usage. The document outlines principles for effective material handling system design, such as considering material characteristics, plant layout, simplification, use of gravity, standardization, and maintenance. It also discusses various material handling equipment options.
Cold Storage Warehouse Best Practices: Warehouse Layout OptimizationAngela Carver
Cold storage warehouse facilities, just like other warehouses and distribution centers, struggle to make the most of their labor resources. One way warehouse operators in the refrigerated environment are addressing these concerns are by focusing on warehouse layout optimization. When facilities are laid out inefficiently or improperly marked many labor hours can be wasted on travel time. Taking the time to address warehouse layout design can help your warehousing operation to achieve maximum space utilization and process improvement. The first stage of warehouse layout optimization is the designation of functional zones. This is done using analytics on past activity and estimates on future needs. These reports will help your team to identify the proper size and location of each zone. This information should be accessible from your warehouse management system where inventory and activity data is recorded. The top 4 functional warehouse zones identified using forecasting and projections are storage, yard/dock, picking and VAS/kitting zones. To identify the proper size of the storage area evaluate key factors such as project inventory levels, temperature requirements, product dimensions, fulfillment rules, flow through rates and more. All of these factors will play a part in determining proper storage layout. Data must also be collected to determine yard and dock door requirements. Too little staging space and dock doors can create a significant bottle neck, slowing down warehouse productivity. When determining picking and shipping size and location identifying your picking strategy will help to make these decisions. Consider the space requirements needed for all types and which will work best for your available resources. If your refrigerated warehousing operation provides any variety of value added services such as kitting space and layout must also be considered for this. Determine what areas require their own designated space and which can operate in shared space. Planning this space effectively will promote faster inventory flow through rates. Leaders in the refrigerated and frozen supply chain are constantly evaluating these factors to ensure their space utilization provides growth opportunities. Do not let an inefficient warehouse layout stop your business from growing. Learn more about this cold storage warehouse best practice in this brief SlideShare.
- Learn a step-by-step description of an ideal approach to benchmarking.
- Why qualitative and quantitative benchmarking go hand-in-hand.
- Steps to setting up a benchmarking program
Presented by: Michael Mikitka, CEO, Warehousing Education & Research Council (WERC)
November 28, 2012 - Consumer Goods Supply Chain Officer Summit 2012 - Shanghai Pudong, China
This document discusses material handling equipment and its uses. Material handling involves the efficient movement of goods within facilities using various types of equipment. It improves efficiency, productivity, and profits. Popular brands utilize material handling solutions to gain competitive advantages. Common material handling equipment includes conveyors, cranes, forklifts, pallets, racks, and identification tools like barcodes and RFID tags. Safety for both materials and humans is also an important consideration.
Pfizer strategy for internationalizationAamir chouhan
This document provides an overview of Pfizer, a global pharmaceutical company. It discusses Pfizer's vision, mission, strategic moves, organizational structure, and key financial metrics. Pfizer discovers, develops, and markets prescription medicines for humans and animals. It has grown through acquisitions and partnerships, and restructured in 2014 to focus on innovative pharmaceuticals, vaccines, and consumer healthcare. Pfizer faces challenges from patent expirations and increasing costs of drug development.
Pfizer Inc. is a Delaware corporation that was originally incorporated in 1942 as Chas. Pfizer & Co. Inc. Pfizer has since grown to be the largest pharmaceutical company in the world. The document outlines Pfizer's history from its founding in 1849, leadership structure, board of directors, product portfolio, market share and competitors. It also discusses Pfizer's corporate social responsibility initiatives and corporate governance policies.
Các sản phẩm nhạy cảm với nhiệt độ như hóa chất, thịt, thực vật, thuốc và vắc-xin yêu cầu phải kiểm soát nhiệt độ từ khâu sản xuất đến tiêu dùng và mọi bước trung gian.
Tính nhất quán về nhiệt độ đảm bảo chất lượng của các sản phẩm này khi chúng di chuyển qua các chuỗi cung ứng tương ứng. Tuy nhiên, đảm bảo tính nhất quán nhiệt độ là một thách thức.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.
Maintaining end-to-end cold chain integrity is a critical focus for all cold storage operations as much of their inventory is consumed directly by end customers. If any instance of impropriety throughout the supply chain occurs it could lead to widespread sickness or death. On average, 10% of all pharmaceutical inventory is temperature controlled and a significantly larger portion of food products are also temperature controlled. Any contamination could result in thousands or even millions of dollars in inventory loss, logistics costs and settlement fees. Preventing inventory contamination in the cold chain has increased in complexity as the supply chain has globalized. A larger portion of temperature regulated goods are crossing international borders creating both regulatory challenges as well more opportunities for failure and/or complication before goods reach their final destination. Some of the most notable regulations impacting the cold chain are the Sanitary Food Transportation Act, Food Safety Modernization Act (FSMA) and EU Good Distribution Practices. These pieces of legislation impact all key supply chain players including those that manufacture, store, transport and sell refrigerated and frozen products. Much of this legislation closely regulates the tracking and storage of handling and temperature related inventory data.
In an effort to solve cold chain challenges related to temperature maintenance, monitoring and recording supply chain operators handling temperature regulated inventory have begun to implement some successful industry best practices. Inventory pre-cooling has proven successful in reducing the wear and tear on refrigeration equipment and helps to guarantee temperature consistency from the time it is loaded until it is unloaded. Many cold chain businesses have also installed trailer condition monitoring systems that monitor temperature conditions in real time and send alerts if any unacceptable temperature variations are encountered. Packaging optimization has also proven useful in extending shelf life and improving product condition. In addition to monitoring trailer conditions, cold chain operators are also implementing inventory temperature monitoring technologies to track inventory status on a piece by piece or pallet by pallet basis. Retailers have also been encouraged to develop standard operating procedures (SOPs) for receiving to ensure only inventory of the highest quality ends up on their shelves and in consumer hands. With capacity increasing and the supply chain growing globally it is more critical than ever that the cold chain implement these best practices in order to keep consumers safe.
Cold chain integrity visibility for safety and complianceCalamp corp
Transport and storage of temperature and condition-sensitive products such as pharmaceuticals and food is complex, demanding, and expensive. The risk of loss or damage to the cargo has the potential to grow as global shipping drives least cost transport and complicates the cold storage chain. Regulations are tightening, while at the same time both quality standards and shipping volume make logistics ever more sensitive. For more details visit https://www.calamp.com/
AntTail - Temperature control in Pharmaceutical Supply ChainMark Roemers
Research results of last mile and storage of vaccins in patient (home) environments. Temperature monitoring records provide insight in maintaining correct storage conditions at supplier’s facilities. Pharmacies do not execute audits at their suppliers locations often.
THE SMARTER COLD CHAIN - four essentials every company should adopt (LR)Simon Daggett
This document discusses the growing importance of temperature-controlled supply chains for life sciences and healthcare companies. It notes two major trends: 1) a shift towards more complex biologic drugs that require strict temperature control and 2) escalating global regulatory requirements for compliance. The document advocates for a "smarter cold chain" approach using specialized logistics providers with expertise in temperature control and compliance. It outlines four essential components for next-generation cold chains to address these challenges: specialized knowledge, standard operating procedures, regulatory expertise, and dedicated IT systems.
Cold chain conference nov 7 2013 chicagoNick Pacitti
This document discusses vulnerabilities in cold chains that transport temperature-sensitive products like food. It begins by outlining various types of refrigerated facilities and vehicles used in cold chains. It then emphasizes the importance of establishing clear cold chain protocols, standards, and continuous temperature monitoring. Examples are provided showing how average temperatures over time impact product quality. The document suggests evaluating fleet operations and rationalizing asset sizes once cold chain standards are established. Overall it promotes a scientific, data-driven approach to cold chain management to improve food safety, quality control and supply chain efficiency.
The document discusses reengineering the pharmaceutical supply chain to address pressures from changing business models, regulations, and markets. It describes how companies are reducing costs through streamlining logistics and expanding product uses. Third-party logistics providers are helping clients transition to more value-based models through integrated solutions. Maintaining proper temperature controls and meeting various global regulatory standards also poses challenges to reengineering pharmaceutical supply chains.
Cold Storage Warehouse Best Practices: Forecasting & End-to-End Temperature M...Angela Carver
As products evolve and consumer demands change cold storage warehouse space is a more critical branch of the supply chain than ever. Products being stored in these refrigerated warehouses include frozen and refrigerated food, pharmaceuticals, petro-chemicals and high-tech electronics. Many of these products are strictly regulated by government agencies such as the FDA. To maintain compliant with these regulations many cold storage operations are focusing on implementing industry best practices. A top priority has continued to be temperature forecasting and monitoring and technology upgrades.
Forecasting temperature demand helps businesses operating in the cold chain to accommodate to changes in product demand and the financial implications. Completing inventory forecasts often will help to give your business a clear understanding of storage space requirements and what changes can be made the make the most of your existing facility space.
One way cold storage warehouses are making the most of their space is by implementing temporary curtains that allow them to break up facility space in order to create, expand or reduce the square footage of temperature zones. The flexibility of this tool helps refrigerated warehouse operators to reduce energy consumption while also ensuring temperature consistency to avoid spoiling.
In an effort to avoid the average 6 recalls that occur in the U.S. each day cold storage warehouses are implementing new and cutting edge technologies to aid in the tracking and monitoring of inventory temperature and condition. These tools include: thermometers for manual QA readings on an inventory or temperature zone level, RFID tags for passive temperature monitoring and location identification, data loggers for in-transit deliveries direct-to-customer, smart shipping containers for LTL and FTL shipments, and WMS for a centralized data collection and storage database. All of these tools used in varying combinations can help cold storage warehouses to reduce costs, improve data accuracy, guarantee product quality and maintain regulatory compliance.
Evaluate how these technologies can help your refrigerated warehouse implement industry best practices in temperature monitoring and tracking and solve any pre-existing QA issues today. Contact Datex experts with questions or for more information on this topic at marketing@datexcorp.com or 800.933.2839 ext 243.
Holistic management of risk in temperature controlled shipments – an operatio...ELSCC
Identify and implement proper risk management to ensure both shelf life and quality of products. Developing the right storage conditions and packaging infrastructure in your cold chain.
This document summarizes a study comparing two methods for shipping living cells while maintaining their viability. The study found that cells shipped in CryoStor CS5 media and transported in a CRYO evo smart shipper, which monitors temperature in real-time, maintained higher viability and function compared to cells shipped in traditional media and an EPS container without temperature monitoring. Specifically, cells transported with CryoStor CS5 and the smart shipper did not experience any decline in viability or delayed functional recovery after shipping, unlike cells transported with traditional media and an EPS container. The study demonstrates the importance of optimized cryopreservation media and temperature-controlled shipping containers with real-time monitoring to maintain cell health during transportation.
This document discusses efficiency and reliability in food retail business. It notes that urbanization is increasing demand for convenience in shopping. This is driving more small store formats, creating challenges around profitability and food quality preservation. The document then discusses how DC technology solutions like variable speed compressors and electronic expansion valves can help meet key needs of energy savings, reliability, food preservation and cost optimization. It provides examples of DC technology condensing units, multi-compressor racks, and semi-plugin units that can provide benefits for different store sizes.
Nimble Wireless - Temperature Monitoring Solution for Medical AssetsNimble Wireless Inc
The objective of this primer is to provide the reader with an understanding of Medical Supply Chain Management. The challenges pharma companies face during logistics and storage of medical goods and how to overcome it.
This document provides guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (TTSPPs). It covers topics such as port handling and customs clearance, warehouse site selection and layout, storage building requirements, temperature control, transport qualifications, and quality management procedures. The guidance is intended to help minimize risks to these sensitive products from factors like theft, temperature excursions, and delays in the supply chain.
Strategies for a Resilient Cold Chain Supply Chain for Cargo SafetyLarry Savage Jr
The notion of “cold chain” might not conjure up concepts of revolutionary logistics, yet it is a vital aspect of contemporary living. The cold chain is an unknown network that guarantees temperature-sensitive products such as pharmaceuticals, fresh food, and even vaccinations stay at the right temperature throughout transportation. Preserving the quality of these things is a challenging endeavor that requires a steady and planned approach to preserving durability.
Monitoring Temperature Trends: The Power of Temperature Data LoggersInfyiot Solutions
In today’s interconnected world, where precise data drives decisions across various industries, the importance of monitoring temperature trends cannot be overstated. Whether you’re managing a pharmaceutical warehouse, operating a food production facility, or preserving artefacts in a museum, maintaining optimal temperature conditions is critical. This is where Temperature Data Logger steps in as an invaluable tool, offering real-time insights that help ensure quality, safety, and compliance.
Global regulatory agencies are pushing for comprehensive cold chain monitoring programs that extend from raw materials to distribution to patients. Proper validation and qualification of storage facilities has become necessary to demonstrate compliance with good manufacturing practices. Sensitech provides a variety of validation services including installation, operational, and performance qualification to ensure storage environments consistently meet acceptance criteria and protect product quality throughout the supply chain.
This document provides an overview of the global food supply chain. It discusses key aspects of food logistics including supply chain management, food categories, warehousing, processing and packaging, transportation, cold chain management, and the use of technology. Maintaining proper temperatures is essential throughout the supply chain to preserve food freshness. Transportation requires an unbroken cold chain using refrigeration and temperature monitoring. Technology helps manage operations and track food from farm to table.
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
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.
Hdbs15, phụ lục 9 gmp who, hệ thống theo dõi nhiệt độ độ ẩm trong khi vận chuyển
Cold Chain May 2015
1. Dr. Marlene Llópiz Avilés
CEO
Investigación Farmacológica y
Biofarmacéutica, S.A.P.I. de C.V.
IFaB
2. Cold Chain – Definition
Importance of Cold Chain
Logistics and Management
Validation
Cold Chain Challenges
Impact of Cold Chain Failure on Clinical Trial Material
Service Providers and Partners
Regulatory Trends
Realistic Approach
Shipping Systems
Take-aways
Conclusions
3. The storage, handling, and
distribution of temperature-
sensitive drugs represent an
increasingly important
component of the global
pharmaceutical supply chain.
Clinical trial material (CTM) or
investigational medicinal
products (IMP) are an important
part of the earliest stages of
the life science supply chain.
4. Given the increased number
of global regulatory and
standards-based guidance
documents issued over the
past two years, members of
the pharmaceutical supply
chain are taking notice and
making changes to ensure
product quality and protect
patient safety for both the
CTMs/IMPs and commercial
products.
5. Of the greater than $980
billion of pharmaceutical
product sold world wide in
2013 and 1 trillion dollars in
2014, over 10% or $98 billion
were biopharmaceuticals.
There is rapid growth in the
market and research
environment in emerging
economies such as Mexico,
Brazil, China and India, leading
to a gradual migration of
economic and research
activities from Europe to these
fast-growing markets.
6. In 2013 the Brazilian and Chinese markets
grew by 17% and 14% respectively compared to
an average market growth of 1% for the five
major European markets and 3% for the USA
market (source: IMS Health, IMS Retail Drug
Monitor, March 2014).
In 2013 North America accounted for 41.0% of
world pharmaceutical sales compared with
27.4% for Europe. According to IMS data, 55%
of sales of new medicines launched during the
period 2009-2013 were on the US market,
compared with 23% on the European market.
7. At the end of 2013 some 3,500
molecules were in development,
up 7% from 2012 levels.
In addition, a promising range of
drugs are now in Phase II clinical
trials or pre-approval stage.
Of the total pipeline, 27% of these
products are biologic in nature.”
8. A cold chain is a temperature
controlled supply chain.
An unbroken cold chain is an
uninterrupted series of storage and
distribution activities which
maintain a given temperature
range.
It is used to help extend and ensure
the shelf life of products –
pharmaceutical products (drugs,
blood samples, tissue samples, etc.)
9. Active Cold Chain (Materials for producing cold)
These include active thermal systems that do not use any
phase change materials (PCM) such as water/ice or dry ice.
These systems use mechanical or electric systems powered
by an energy source, combined by thermostatic control to
maintain proper product temperatures.
The equipment used in active cold chain is split into two
categories as follows:
◦ compression refrigerators/freezers;
◦ absorption refrigerators/freezers.
10. Absorption models
The energy sources are: kerosene, gas, electricity (heating resistor). They
use more energy and require more maintenance. They produce less cold
and are slower. However, they are suitable for situations where
electricity is not available or reliable.
Since the cooling circuit is closed, it is not possible to fill it with gas or
repair it if there is a leak. However, these models are very reliable.
Models used to store vaccines are particularly well insulated and
equipped with a temperature stabilizing device, except for the kerosene
model which does not have a thermostat (the best known manufacturers
are Sibir and Electrolux). They are used extensively for the Extended
Vaccinations Programs (EVP).
Domestic absorption models are generally insulated less well and it is
occasionally difficult to maintain a low temperature for storing vaccines,
particularly when the external temperature is high (higher than 32°C).
The efficiency of the models that run on oil depends on the quality of
the fuel. Decanting and filtering are often required. A kit is available to
modify certain burners, in order to improve operating efficiency, despite
oil of inferior quality.
11. Passive Cold Chain (Shipping/storage materials)
These include passive thermal systems that commonly use phase change materials (PCM) such
as water/ice or dry ice. These shipping systems are the most basic and cost effective. Some of
the basic systems in use are as follows:
◦ freezers for province, county and sometimes at the township level;
◦ refrigerators and, in some areas, the new water-jacket refrigerators for province, county and township
levels.
Some villages do not have access to a refrigerator for vaccine storage and therefore use:
◦ cold/cool Boxes at all levels for transporting vaccines;
◦ vaccine carriers to store vaccines during the immunization session or round;
◦ isothermal packaging/control materials like paper to wrap the vaccines up when using a vaccine carrier;
◦ ice packs or ice, as a last resort, to keep the vaccines at a temperature between +2°C and 8°C;
a thermometer to measure the temperature inside the vaccine refrigerator and cold boxes; and
a chart to record the day and time of the temperature of the vaccine refrigerator. The chart
should be used to record the temperature two times a day (morning and night).
12. Cold chain management includes all of the means used to
ensure a constant temperature (between +2°C and +8°C) for a
product that is not heat stable (such as vaccines, serums,
tests, etc.), from the time it is manufactured until the time it is
used.
It involves the equipment and people needed to keep vaccines
at the correct temperature (between +2°C to +8°C) during
transport and storage from the time they are manufactured up
until they are administered.
The cold chain must never be broken!
13. The Logistics staff must be trained to both
use and manage these materials.
They must acquire knowledge about the cold
chain, must develop thorough work
techniques, specifically with respect to
maintenance, and must be stable in order to
ensure better follow-up.
Without training, the program will be
seriously compromised and put at risk.
14. Cold chains need to be evaluated and controlled:
◦ Carriers and logistics providers can assist shippers. These providers have the technical
ability to link with airlines for real time status, generate web-based export documentation
and provide electronic tracking.
◦ The use of refrigerator trucks, refrigerator cars, reefer ships, reefer containers, and
refrigerated warehouses is common.
◦ Shipment in insulated shipping containers or other specialised packaging are often used.
◦ Temperature data loggers tags help monitor the temperature history of the truck,
warehouse, etc. and the temperature history of the product being shipped.They also can
help determine the remaining shelf life.
Documentation is critical. Each step of the custody chain needs to follow
established protocols and to maintain proper records.
Customs delays occur due to inaccurate or incomplete customs paperwork, so
basic guidelines for creating a commercial invoice should be followed to ensure
the proper verbiage, number of copies, and other details.
15. Cold chain management has two categories:
◦ managing equipment and,
◦ managing people.
Evaluations of existing means revealed that some countries needed to improve their systems of vaccines
management. Although there were many positive aspects to the functioning of the cold chain, the following
weaknesses were observed:
◦ frequent breakdowns in cold chain (sometimes for a long time) because of the lack of fuel, spare parts and
back-up energy source;
◦ lack of planning for maintenance and cold chain rehabilitation;
◦ incorrect use of the Vaccines Vial Monitor (VVM) as a management tool; and
◦ lack of planning for emergencies resulting in organizations not having effective cold chain systems during
responses.
These problems slow down improvement in routine vaccination services and hinder efforts to eliminate and
eradicate disease. To solve these problems, it is necessary to:
◦ identify problems in the cold chain and their causes;
◦ undertake specific actions to remove these causes; and
strengthen management systems to prevent recurrence of the same or similar problems.
16. A cold chain can be managed by a quality management system. It
should be analyzed, measured, controlled, documented,
and validated.
The overall approach to validation of a distribution process is by
building more and more qualifications on top of each other to get to
a validated state.
This is done by executing a Component Qualification on the
packaging components, an Operational Qualification to demonstrate
that the process performs at the operational extremes and finally a
Performance Qualification that demonstrates that what happens in
the real world is within the limits of what was demonstrated in the
Operational Qualification limits.
17. Clinical trials are being run on a global scale and in
some cases in markets with less than ideal logistics
infrastructure.
The complex clinical supply chain creates a
challenging distribution environment because of
shipping large volumes of refrigerated patient kits
worldwide while maintaining and documenting
appropriate environmental conditions.
Given the great number of clinical sites, there is
increased complexity for maintaining product quality
and mitigating the risk of thermal excursions.
18. The globalization of clinical trials
is driving programs in more
remote locations.
This has fueled the need for
personnel to work with specialty
couriers, contracted depots, and
shipper manufacturers to improve
the performance of the supply
chain and build a more robust
clinical trial distribution process.
Specialty service providers have
responded to changing market
needs.
19. Product availability for test
shipments.
Planning time to test shipping
containers.
Short product life cycle - Is all
this really necessary?
Urgency always associated with
trial start up.
Shipping channels - many one
off or infrequent shipments.
Shipping quantities vary
significantly.
Clinical Trials require one system
to meet all needs.
20. Temperature excursions during the storage,
handling, or distribution of temperature sensitive
clinical trial material pose significant safety and
financial risks.
Cold chain failure may lead to 4 key risks:
1. The patient could be administered an unsafe
product
2. A lack of compliance with global regulatory and
standards-based requirements can increase
liability
3. Thermal variability can lead to inconsistency of
results between and within batches
4. The shipment can be rejected by the Quality
department therefore leading to costly delays –
increasing the complexity of trial management
21. Many clinical trials include the shipping,
distribution, and delivery of temperature sensitive
articles whether it is the study drug, the clinical
specimens, or the ancillary supplies.
As such, cold chain pre-qualified packaging plays a
critical role in safely and effectively transporting
the temperature-sensitive items shipped in small
amounts in high frequency to the clinics.
Vendors have to prove their packaging and
insulated container/refrigerant systems provide
adequate protection for temperature-sensitive
items.
As supply chains grow more complex product life
cycles decrease and regulatory authorities become
increasingly concerned about product integrity
during delivery.
22. The pharmaceutical industry has
progressed from the point of
shipping being an afterthought to
exact controls on
materials/product in-transit and
proof of custody at the destination.
The pharmaceutical
developer/manufacturer is paying
attention to temperature and/or
physical conditions which may
affect the good storage and good
distribution practices (GSP/GDP) of
their materials/products.
23. Documentation and control for the
storage, handling, and distribution of
temperature-sensitive goods is most
appropriately addressed through a
sound shipping qualification.
The cold/frozen chain Shipping
Qualification is a process involving
integration of the shipping system, the
product and the transportation
medium/route.
The partners in this process: the
packaging designer/manufacturers,
testing labs, product development
scientist, corporate owners of the
product, carriers and shipper vendors,
mutually work together to produce the
best system for the entire cycle of
shipping and storage.
24. When we consider shipping
Cold Chain products we must
start from the premise that
things may go wrong.
Because of the nature of the
product this means that the
risks are extensive.
It is our job to minimize this
risk and reduce the effect of
those things that can go wrong.
25. Shipping
This involves:
◦ Cool Box – Vaccine Carrier
◦ Isothermal Packaging
◦ Control Materials
◦ Monitoring Means
All shipping documents for vaccine shipments should be sent in advance of
arrival of shipment.
The number of days will be determined by the destination country rules.
This requirement has been established to facilitate the pre-customs
formalities for clearance of vaccines to ensure prompt clearance of the heat
or cold sensitive items upon arrival.
Some countries have an exceptional early release procedure pending
document processing during emergencies.
26. Storage
After arrival vaccines are cleared and
immediately offloaded from the
aircraft and directly loaded onto
trucks for further transportation to
the cold storage facility.
Delivery of vaccines at the cold
storage is strictly monitored to
ensure maintenance of the cold chain
in an appropriate manner.
Some countries have special
requirements for vaccines. There is
therefore no standard clearing
process.
27. Utilize the expertise and service of
the solution providers.
Understand exactly how the
systems works.
Choosing the right system for your
drug and study requirements is key.
Climate concerns - country of
origin, country of destination, and
time of the year.
Qualify or Validate? - monitor
temperature?
Air temperature versus product
temperature.
28. Four primary regulatory trends have been
identified:
1.Accountability for the cold chain ultimately
resides with the Manufacturer but
responsibility is shared across all supply
chain partners.
2.Increased oversight, management, and
control of environmental conditions across
the entire supply chain.
3.Increased importance of temperature
control and monitoring.
4.Heightened priority of patient safety – with
focus on product quality.
29. Remaining compliant with
global regulatory requirements
for the storage, handling, and
distribution of clinical trial
materials can be a daunting
task.
While the requirements tend to
be similar for both
investigational drugs and
finished goods, it is imperative
to first understand the specific
requirements for the countries
in which a trial will occur.
30. The growth in the bio-pharmaceutical market
combined with the complexity of the clinical
supply chain and global regulatory environment
require that all supply chain partners are aware
of appropriate regulations, local requirements,
pharmacopeial standards, and industry best
practices related to the storage, handling and
distribution of temperature-sensitive products.
Regulatory guidance and inspectional trends
demonstrate a focus on Good Cold Chain
Management Practices.
All partners should have the distinct common
goal in terms of ensuring that each patient and
site is supplied with the correct medication at
the right time and in the right condition.
31. Be Informed about the shipping process - your
knowledge will help protect your product.
Question every aspect of the supply chain, don’t
assume your contractors will protect your product
as a matter of course.
Plan time into your project for adequate testing
and analysis of the supply chain.
Work to minimize the risk to your product at every
step of the process.
32. 32
IFaB has grown tremendously over the last
decade and will continue to do so over the
next few years.
Much of our success has been and is
attributed to our team’s experience,
commitment and desire to positively
contribute towards our society, clients, and
stakeholders by upholding the highest
standards in the pharmaceutical industry.
Going forward, the delivery on our
promises, goals and visions will continue to
play an instrumental role in achieving
further success so that together we can
continue on the road to achieving
sustainable and continued growth.
MARLENE LLOPIZ
CHIEF EXECUTIVE
OFFICER