The following Guidelines, Part 1 of 2, outlining “Sanitary Equipment Standards and Design Criteria”, including various sited attachments such as 3-A standards and example views, is intended to drive a level of self-awareness and basic instruction when managing the process designs and facility layout of operations for a food manufacturing environment. Although the guide is not intended to be inclusive of all methodology, it will support in all sanitary design and improvement efforts to better understand the requirements and methods that optimally work for the project and specific conditions.
Sanitary Design An Introduction to Standards of Design Excellence November 2015Bob (Robert L.) Long
This document discusses sanitary design principles for food processing facilities and equipment. It covers several key topics:
- It defines 4 sanitary zones within a facility based on cleanability and risk of contamination.
- It emphasizes that equipment, facilities, and processes must be designed for effective cleaning and maintenance in order to control pathogens. Proper design is important from both food safety and cost perspectives.
- It provides examples of industry standards and guidelines for sanitary design in food processing, including those from 3A Sanitary Standards and EHEDG. Factors like smooth surfaces, drainability, and easy disassembly are important.
- It discusses how to prioritize sanitary risks based on likelihood and impact,
The document introduces Clean-in-Place (CIP) technology, which allows for cleaning of processing equipment internally without disassembly using automated cleaning cycles. It discusses the benefits of CIP systems including improved cleaning results, safety, and resource savings. The document also provides an overview of CIP system design considerations and optimization strategies.
The document provides sanitary design principles and a checklist for food processing equipment. It was created by an Equipment Design Task Force comprised of various meat and poultry companies. The task force identified 10 principles of sanitary design for equipment. These principles are aimed at reducing risks of contamination and include requirements for equipment to be cleanable, made of compatible materials, accessible for cleaning, self-draining, sealed, free of niches, and ensure sanitary operational performance. The checklist can be used by equipment manufacturers and processors to evaluate if equipment meets these principles. The design principles are intended to promote a standard for sanitary equipment design industry-wide.
The food industry is responding to the increasing threat of food fraud by developing strategies and guidelines. A global think tank on food fraud proposed that companies conduct vulnerability assessments to identify threats, consider socioeconomic and behavioral factors, and monitor their supply chains. The Global Food Safety Initiative is making food fraud prevention an integral part of food safety management systems, requiring companies to prevent both unintentional and intentional adulteration. GFSI aims to provide guidance to help companies implement food fraud prevention plans and controls within their existing food safety systems and management schemes.
Food industries are currently in need of different innovative technologies to meet the consumer demand.
There are some of the technologies like HPP, pulsed electric field, high intensity pulsed light etc.
But attention is now focused on the ozone as a powerful sanitizer.
Currently more than 3000 water treatment installation and more than 300 portable water treatment plants all over the world.
This document discusses good practices related to the food industry. It defines good practice as ensuring consistent and controlled quality procedures in food systems. There are three categories of good practices: those directly related to food like GMP; those indirectly related like GRP; and those that should exist but may not in reality like GKP. Many specific good practices are outlined like GAP, GHP, GLP, GMP, etc. along with brief definitions and principles for each. The prerequisite for implementing food safety and quality systems is adherence to GHP and GMP from initial production through retail trade.
Sanitary Design An Introduction to Standards of Design Excellence November 2015Bob (Robert L.) Long
This document discusses sanitary design principles for food processing facilities and equipment. It covers several key topics:
- It defines 4 sanitary zones within a facility based on cleanability and risk of contamination.
- It emphasizes that equipment, facilities, and processes must be designed for effective cleaning and maintenance in order to control pathogens. Proper design is important from both food safety and cost perspectives.
- It provides examples of industry standards and guidelines for sanitary design in food processing, including those from 3A Sanitary Standards and EHEDG. Factors like smooth surfaces, drainability, and easy disassembly are important.
- It discusses how to prioritize sanitary risks based on likelihood and impact,
The document introduces Clean-in-Place (CIP) technology, which allows for cleaning of processing equipment internally without disassembly using automated cleaning cycles. It discusses the benefits of CIP systems including improved cleaning results, safety, and resource savings. The document also provides an overview of CIP system design considerations and optimization strategies.
The document provides sanitary design principles and a checklist for food processing equipment. It was created by an Equipment Design Task Force comprised of various meat and poultry companies. The task force identified 10 principles of sanitary design for equipment. These principles are aimed at reducing risks of contamination and include requirements for equipment to be cleanable, made of compatible materials, accessible for cleaning, self-draining, sealed, free of niches, and ensure sanitary operational performance. The checklist can be used by equipment manufacturers and processors to evaluate if equipment meets these principles. The design principles are intended to promote a standard for sanitary equipment design industry-wide.
The food industry is responding to the increasing threat of food fraud by developing strategies and guidelines. A global think tank on food fraud proposed that companies conduct vulnerability assessments to identify threats, consider socioeconomic and behavioral factors, and monitor their supply chains. The Global Food Safety Initiative is making food fraud prevention an integral part of food safety management systems, requiring companies to prevent both unintentional and intentional adulteration. GFSI aims to provide guidance to help companies implement food fraud prevention plans and controls within their existing food safety systems and management schemes.
Food industries are currently in need of different innovative technologies to meet the consumer demand.
There are some of the technologies like HPP, pulsed electric field, high intensity pulsed light etc.
But attention is now focused on the ozone as a powerful sanitizer.
Currently more than 3000 water treatment installation and more than 300 portable water treatment plants all over the world.
This document discusses good practices related to the food industry. It defines good practice as ensuring consistent and controlled quality procedures in food systems. There are three categories of good practices: those directly related to food like GMP; those indirectly related like GRP; and those that should exist but may not in reality like GKP. Many specific good practices are outlined like GAP, GHP, GLP, GMP, etc. along with brief definitions and principles for each. The prerequisite for implementing food safety and quality systems is adherence to GHP and GMP from initial production through retail trade.
Foodborne illness is caused by consuming contaminated food or drink. It often causes vomiting, diarrhea and abdominal pain. Each year in the US, foodborne illness affects 48 million people, hospitalizes 128,000, and kills 3,000. Food can become contaminated through chemicals, physical hazards or microorganisms like bacteria. Cross-contamination is a major cause of foodborne illness. Conditions like moisture, warm temperature, neutral pH and adequate time allow microbes to grow. Proper cooking, cleaning, separation of foods and refrigeration are key to preventing foodborne disease.
Validation & Verification Study for Metal Detection CCP - AG - LinkedIn profi...Adrian Garcia
This project contains an example of a validation and verification study for 3 models of metal detectors posed as an alternative to replace current aging models in current food manufacturing lines.
This is a Validation & Verification for BRC Global Standards Course Assignment, MAR 2022
This document discusses various cleaning methods used in the food industry, including manual cleaning, mechanical cleaning using foam, immersion cleaning, cleaning-out-of-place (COP), and cleaning-in-place (CIP). It provides details on how each method works, advantages and disadvantages, and recommendations for effective cleaning.
This document summarizes physical hazards in food products. Physical hazards are foreign objects unintentionally introduced during food production that can harm consumers. They include glass, metals, plastics, stones, and wood. Such objects can cause cuts, damage teeth/gums, and injuries to the digestive tract if consumed. Physical hazards are a risk at any stage of food production and proper control measures like inspections and hair restraints during preparation are important to prevent contamination. Objects 7mm or longer pose a significant hazard.
Freezing is a method of food preservation that involves lowering the food's temperature to below the freezing point. It allows food to be preserved by slowing microbial growth and preventing spoilage. There are different freezing methods like air blast freezing, which uses cold air circulated over food on a conveyor belt, and immersion or spray freezing, which sprays or immerses food in refrigerated liquid. The key is freezing food quickly to form small ice crystals that do not damage cells and affect quality. Larger ice crystals from slow freezing can damage texture and flavor.
This presentation from the FAO discusses personal hygiene in food production. It outlines that food handlers can contaminate food through direct and indirect contact with microorganisms from their bodies. Proper handwashing, protective clothing, illness policies, and clean facilities are important to prevent contamination. Personal hygiene is a management responsibility that requires training workers and monitoring compliance with hygiene protocols.
This document outlines differences between food safety and food defense from a presentation given by Dr. Carol Maczka of the USDA Food Safety and Inspection Service. Food safety aims to prevent unintentional contamination, while food defense focuses on intentional contamination by biological, chemical or radiological agents. Key differences include outcomes (food safety incidents often cause illness while food defense risks death), contaminants (food defense considers heat-resistant and toxic agents), and prevention strategies (food safety uses HACCP plans while food defense uses vulnerability assessments and countermeasures). The document provides examples of both unintentional and intentional food contamination incidents.
This document discusses various tests that are conducted on food packaging materials and packages. Some key tests mentioned include thickness testing, which measures the thickness of materials like paper and film using a dial or digital gauge under a constant pressure. Pinhole testing checks for pinholes in aluminum foil laminates, which can impact barrier properties. Peel or delamination testing measures the bond strength between layers in laminates. Seal strength testing determines the force required to separate seals in flexible pouches and laminates. Permeation tests quantify the barrier properties of plastic films to moisture vapor and gases like oxygen.
PRP are steps or procedures including GMP & SSOP that control conditions within a food establishment to promote safe food production. They establish basic hygienic requirements including facility location and construction, equipment cleaning, utilities like water and air, cleaning and sanitation programs, personal hygiene facilities, and more. Requirements include proper drainage, separation of raw and processed areas, smooth cleanable surfaces, pest control, and documented cleaning procedures.
MODIFIED ATMOSPHERE AND INTELLIGENT PACKAGING OF FOODÜlger Ahmet
This document discusses modified atmosphere packaging (MAP) and intelligent packaging techniques for food. It provides an overview of MAP, describing common gas mixtures used and considerations for packaging materials. MAP can extend shelf life by creating different gas compositions than air in packages. The document also outlines various packaging systems and the author's own research on using MAP to store mushrooms and bakery products.
This document describes the application of Hazard Analysis and Critical Control Points (HACCP) quality control method to the production of pastry products without yeast. It identifies potential hazards in the production process and establishes critical control points to monitor and control hazards. Key points include identifying raw materials and the production process, establishing physicochemical and microbiological standards for the finished product, and procedures for verifying and reviewing the HACCP plan on a regular basis to ensure food safety.
Waste management & sanitation in food industrySubhana Aziz
This document discusses waste management and sanitation in the food industry. It notes that large amounts of food are wasted throughout the supply chain, from production to distribution to consumption. The Food and Agriculture Organization estimates that one third of food produced for human consumption is lost or wasted annually. For food service establishments, reducing portion sizes can help reduce waste. The most common types of waste include organic materials and various recyclables. With proper planning, waste can be reduced, reused and recycled to conserve resources and reduce disposal costs. The waste management hierarchy prioritizes prevention, reduction, reuse and recycling over disposal. Sanitation in the food industry ensures hygienic conditions through proper treatment, handling and disposal of wastes and wastewater
This document discusses various modern food processing and preservation techniques. It begins by defining food processing as any method used to transform fresh foods into food products, which may include adding ingredients. It then describes several common preservation methods: pasteurization, freeze drying, vacuum packing, irradiation, chemical preservatives, high pressure processing, biopreservation, hurdle technology, nonthermal plasma, and modified atmosphere packaging. For each method, it provides details on the process and its purpose in extending shelf life and ensuring food safety.
This document is an auditor checklist and site self-assessment tool for the BRC Global Standard for Food Safety. It contains requirements for senior management commitment and food safety plans incorporating Hazard Analysis and Critical Control Points (HACCP) principles. The checklist covers topics such as the food safety team and developing food safety plans, identifying hazards and critical control points, establishing monitoring procedures, and corrective actions. It provides a tool for auditors and sites to assess conformance with the BRC Global Standard.
This document discusses three types of prerequisite programs for food safety: PRPs, OPRPs, and CCPs. PRPs are general control measures that maintain a safe environment but do not control specific hazards. OPRPs control specific hazards but are not based on critical limits and their failure does not automatically mean a product is unsafe. CCPs are steps that control hazards through critical limits, which if not met, would make a product unsafe.
This manual provides guidance to food workers on preventing foodborne illness through proper personal hygiene like frequent handwashing, maintaining safe food temperatures, and avoiding cross-contamination. It explains that germs are the most common cause of foodborne illness and outlines practices for workers to follow regarding hygiene, temperature control of potentially hazardous foods, and preventing contamination. The goal is for food workers to understand and implement these three key food safety defenses to protect customers from foodborne illness.
This document contains the standard operating procedures (SOPs) for Lyallpur Food Industries' food safety management system which complies with ISO 22000:2015. It includes 15 SOPs covering topics such as purchase inspection and stores, process control, document control, control of records, calibration, product identification and traceability, internal audits, management reviews, and more. For each SOP, it describes the goal, responsibilities, and detailed procedures to be followed.
Sanitary Facility Design Guidelines - Part 2 of 2PPM Services
The following Guidelines, Part 2 of 2, outlining “Sanitary Facility Design Criteria”, including various example views, is intended to drive a level of self-awareness and basic instruction when managing the process designs and facility layout of operations for a food manufacturing environment. Although the guide is not intended to be inclusive of all methodology, it will support in all sanitary design and improvement efforts to better understand the requirements and methods that optimally work for the project and specific conditions.
Zones of Control Focus:
• Create a controllable environment with multiple levels of protection
• Control the transfer of physical, chemical or microbial hazards into facilities
• Control the transfer of physical, chemical, or microbial hazards from one area of facility to another
• Control the transfer of allergens
• Control post-process contamination
Foodborne illness is caused by consuming contaminated food or drink. It often causes vomiting, diarrhea and abdominal pain. Each year in the US, foodborne illness affects 48 million people, hospitalizes 128,000, and kills 3,000. Food can become contaminated through chemicals, physical hazards or microorganisms like bacteria. Cross-contamination is a major cause of foodborne illness. Conditions like moisture, warm temperature, neutral pH and adequate time allow microbes to grow. Proper cooking, cleaning, separation of foods and refrigeration are key to preventing foodborne disease.
Validation & Verification Study for Metal Detection CCP - AG - LinkedIn profi...Adrian Garcia
This project contains an example of a validation and verification study for 3 models of metal detectors posed as an alternative to replace current aging models in current food manufacturing lines.
This is a Validation & Verification for BRC Global Standards Course Assignment, MAR 2022
This document discusses various cleaning methods used in the food industry, including manual cleaning, mechanical cleaning using foam, immersion cleaning, cleaning-out-of-place (COP), and cleaning-in-place (CIP). It provides details on how each method works, advantages and disadvantages, and recommendations for effective cleaning.
This document summarizes physical hazards in food products. Physical hazards are foreign objects unintentionally introduced during food production that can harm consumers. They include glass, metals, plastics, stones, and wood. Such objects can cause cuts, damage teeth/gums, and injuries to the digestive tract if consumed. Physical hazards are a risk at any stage of food production and proper control measures like inspections and hair restraints during preparation are important to prevent contamination. Objects 7mm or longer pose a significant hazard.
Freezing is a method of food preservation that involves lowering the food's temperature to below the freezing point. It allows food to be preserved by slowing microbial growth and preventing spoilage. There are different freezing methods like air blast freezing, which uses cold air circulated over food on a conveyor belt, and immersion or spray freezing, which sprays or immerses food in refrigerated liquid. The key is freezing food quickly to form small ice crystals that do not damage cells and affect quality. Larger ice crystals from slow freezing can damage texture and flavor.
This presentation from the FAO discusses personal hygiene in food production. It outlines that food handlers can contaminate food through direct and indirect contact with microorganisms from their bodies. Proper handwashing, protective clothing, illness policies, and clean facilities are important to prevent contamination. Personal hygiene is a management responsibility that requires training workers and monitoring compliance with hygiene protocols.
This document outlines differences between food safety and food defense from a presentation given by Dr. Carol Maczka of the USDA Food Safety and Inspection Service. Food safety aims to prevent unintentional contamination, while food defense focuses on intentional contamination by biological, chemical or radiological agents. Key differences include outcomes (food safety incidents often cause illness while food defense risks death), contaminants (food defense considers heat-resistant and toxic agents), and prevention strategies (food safety uses HACCP plans while food defense uses vulnerability assessments and countermeasures). The document provides examples of both unintentional and intentional food contamination incidents.
This document discusses various tests that are conducted on food packaging materials and packages. Some key tests mentioned include thickness testing, which measures the thickness of materials like paper and film using a dial or digital gauge under a constant pressure. Pinhole testing checks for pinholes in aluminum foil laminates, which can impact barrier properties. Peel or delamination testing measures the bond strength between layers in laminates. Seal strength testing determines the force required to separate seals in flexible pouches and laminates. Permeation tests quantify the barrier properties of plastic films to moisture vapor and gases like oxygen.
PRP are steps or procedures including GMP & SSOP that control conditions within a food establishment to promote safe food production. They establish basic hygienic requirements including facility location and construction, equipment cleaning, utilities like water and air, cleaning and sanitation programs, personal hygiene facilities, and more. Requirements include proper drainage, separation of raw and processed areas, smooth cleanable surfaces, pest control, and documented cleaning procedures.
MODIFIED ATMOSPHERE AND INTELLIGENT PACKAGING OF FOODÜlger Ahmet
This document discusses modified atmosphere packaging (MAP) and intelligent packaging techniques for food. It provides an overview of MAP, describing common gas mixtures used and considerations for packaging materials. MAP can extend shelf life by creating different gas compositions than air in packages. The document also outlines various packaging systems and the author's own research on using MAP to store mushrooms and bakery products.
This document describes the application of Hazard Analysis and Critical Control Points (HACCP) quality control method to the production of pastry products without yeast. It identifies potential hazards in the production process and establishes critical control points to monitor and control hazards. Key points include identifying raw materials and the production process, establishing physicochemical and microbiological standards for the finished product, and procedures for verifying and reviewing the HACCP plan on a regular basis to ensure food safety.
Waste management & sanitation in food industrySubhana Aziz
This document discusses waste management and sanitation in the food industry. It notes that large amounts of food are wasted throughout the supply chain, from production to distribution to consumption. The Food and Agriculture Organization estimates that one third of food produced for human consumption is lost or wasted annually. For food service establishments, reducing portion sizes can help reduce waste. The most common types of waste include organic materials and various recyclables. With proper planning, waste can be reduced, reused and recycled to conserve resources and reduce disposal costs. The waste management hierarchy prioritizes prevention, reduction, reuse and recycling over disposal. Sanitation in the food industry ensures hygienic conditions through proper treatment, handling and disposal of wastes and wastewater
This document discusses various modern food processing and preservation techniques. It begins by defining food processing as any method used to transform fresh foods into food products, which may include adding ingredients. It then describes several common preservation methods: pasteurization, freeze drying, vacuum packing, irradiation, chemical preservatives, high pressure processing, biopreservation, hurdle technology, nonthermal plasma, and modified atmosphere packaging. For each method, it provides details on the process and its purpose in extending shelf life and ensuring food safety.
This document is an auditor checklist and site self-assessment tool for the BRC Global Standard for Food Safety. It contains requirements for senior management commitment and food safety plans incorporating Hazard Analysis and Critical Control Points (HACCP) principles. The checklist covers topics such as the food safety team and developing food safety plans, identifying hazards and critical control points, establishing monitoring procedures, and corrective actions. It provides a tool for auditors and sites to assess conformance with the BRC Global Standard.
This document discusses three types of prerequisite programs for food safety: PRPs, OPRPs, and CCPs. PRPs are general control measures that maintain a safe environment but do not control specific hazards. OPRPs control specific hazards but are not based on critical limits and their failure does not automatically mean a product is unsafe. CCPs are steps that control hazards through critical limits, which if not met, would make a product unsafe.
This manual provides guidance to food workers on preventing foodborne illness through proper personal hygiene like frequent handwashing, maintaining safe food temperatures, and avoiding cross-contamination. It explains that germs are the most common cause of foodborne illness and outlines practices for workers to follow regarding hygiene, temperature control of potentially hazardous foods, and preventing contamination. The goal is for food workers to understand and implement these three key food safety defenses to protect customers from foodborne illness.
This document contains the standard operating procedures (SOPs) for Lyallpur Food Industries' food safety management system which complies with ISO 22000:2015. It includes 15 SOPs covering topics such as purchase inspection and stores, process control, document control, control of records, calibration, product identification and traceability, internal audits, management reviews, and more. For each SOP, it describes the goal, responsibilities, and detailed procedures to be followed.
Sanitary Facility Design Guidelines - Part 2 of 2PPM Services
The following Guidelines, Part 2 of 2, outlining “Sanitary Facility Design Criteria”, including various example views, is intended to drive a level of self-awareness and basic instruction when managing the process designs and facility layout of operations for a food manufacturing environment. Although the guide is not intended to be inclusive of all methodology, it will support in all sanitary design and improvement efforts to better understand the requirements and methods that optimally work for the project and specific conditions.
Zones of Control Focus:
• Create a controllable environment with multiple levels of protection
• Control the transfer of physical, chemical or microbial hazards into facilities
• Control the transfer of physical, chemical, or microbial hazards from one area of facility to another
• Control the transfer of allergens
• Control post-process contamination
This document provides a 3-paragraph summary of the PAS 220:2008 public available specification:
The PAS 220:2008 specification provides detailed guidance for implementing prerequisite programs (PRPs), which are basic conditions and activities necessary to maintain hygiene and prevent food contamination throughout the food chain. It is intended to be used in conjunction with BS EN ISO 22000 as supporting documentation for food safety management systems. The PAS specifies requirements for the construction, design, and maintenance of facilities and equipment; control of purchased materials; cleaning and sanitation programs; pest control; and employee hygiene practices. It aims to control food safety hazards and meet the requirements of BS EN ISO 22000 for any organization involved in food manufacturing.
The document
Good Manufacturing Practices (GMP) are a set of guidelines and standards designed to ensure the consistent production and control of high-quality pharmaceutical, food, and medical products. GMPs encompass every aspect of the manufacturing process, from raw materials to finished goods, emphasizing safety, cleanliness, and efficiency. Key elements include proper documentation, employee training, quality management systems, equipment maintenance, and environmental monitoring. By adhering to GMPs, manufacturers can minimize risks, maintain product quality, and ultimately safeguard consumer health.
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
The document outlines 11 principles of sanitary facility design for food production facilities. The principles establish distinct hygienic zones; control personnel and material flows to reduce hazards; and control water accumulations, temperature, humidity, airflow, and air quality. Additional principles address site elements, building envelopes, interior spatial design, building components, utility systems design, and integrating sanitation into the overall facility design. Thorough cleaning and sanitation are critical to maintaining food safety and quality.
This document contains the AIB International Consolidated Standards for Inspection of Grain Handling Facilities. It includes an introduction that describes the categories and how to read the standards. The categories cover operational methods, maintenance, cleaning practices, integrated pest management, and adequacy of prerequisite programs. The document then lists the specific standards for each category, including critical and minor requirements.
114. Validation - EHEDG requirements - 2016.08.01.pdfTien Din Tran
This document provides guidelines for the hygienic design of food processing equipment. Its objective is to prevent microbial contamination of food products during processing and packaging. Key points covered include:
- Materials used must be non-toxic, corrosion resistant and able to withstand cleaning and disinfectants.
- Equipment design should eliminate areas where microbes could survive cleaning or grow, such as crevices and dead zones.
- Functional requirements include easy cleanability, prevention of microbe ingress, and compatibility with sterilization where needed.
- Guidelines aim to balance engineering and hygienic demands to ensure food safety is not compromised.
The document provides an overview of the design process for orthopedic implants. It discusses the main stages as follows:
1) Feasibility which includes design inputs, commercial aspects, planning, and regulatory requirements.
2) Design reviews to evaluate requirements and identify problems.
3) Design including concept design, detail design, design verification through methods like finite element analysis and risk analysis, and rapid prototyping.
4) Manufacture and ensuring processes are repeatable.
5) Design validation through mechanical testing, clinical evidence, and investigations.
6) Design transfer including finalizing instructions, training, and packaging.
7) Design changes after market release to ensure safety based on feedback.
The document provides an overview of the design process for orthopedic implants. It discusses the main stages as follows:
1) Feasibility which includes design inputs, commercial aspects, planning, and regulatory requirements.
2) Design reviews to evaluate requirements and identify problems.
3) Design including concept design, detail design, design verification through methods like finite element analysis and risk analysis, and rapid prototyping.
4) Manufacture and ensuring processes are repeatable.
5) Design validation through mechanical testing, clinical evidence, and investigations.
6) Design transfer including finalizing instructions, training, and packaging.
7) Design changes after market release to ensure safety based on feedback.
A Review on Design Process of Orthopedic Implantsiosrjce
The design process for medical devices is highly regulated to ensure the safety of patients. This
paper will present a review of the design process for implantable orthopedic medical devices. It will cover the
main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design
transfer and design changes
Quality Function Deployment (QFD) for Design ControlsEMMAIntl
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. Within the larger quality system requirement, a methodology to control device design and development of medical devices is required. This set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be covered. A Quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.
Cleaning-in-place (CIP) is a well-established cleaning method in food and beverage manufacturing operations that uses turbulent cleaning fluid to remove residual product and biofilms from processing lines and equipment without dismantling the equipment. Find such more interesting topics, news and highlights on food & beverage industry in this week's PMG TECHKNOWLEDGE.
Fda quality system regulation 21 CFR820_Medical devices_k_trautmanLatvian University
This document provides an overview and introduction to the Quality System Regulation 21 CFR 820, which establishes requirements for medical device manufacturers. It discusses the key quality system subsystems including management, design and development controls, production and process controls, corrective and preventive actions, and describes some of the main requirements within each subsystem such as establishing procedures, conducting audits and reviews, ensuring training, controlling design changes, validating processes, handling nonconforming products, and managing complaints. The goal of the regulation is to provide a framework for manufacturers to develop a quality management system commensurate with the risks and complexities of their devices and processes.
The document outlines the key quality, technical, and business issues to consider when upgrading part of a manufacturing facility while maintaining production in the remaining area, including obtaining regulatory acceptance of upgrade plans, conducting risk analysis, ensuring containment and preventing cross-contamination, requalifying and validating equipment and software, and managing costs, timelines, and documentation.
The document discusses strategies for improving the hygienic design of dairy equipment to reduce the environmental impact and costs of cleaning. It advocates designing equipment to be fully cleanable in place using automated systems which can recirculate cleaning chemicals and reuse water, reducing water and chemical usage by 50% or more. Specifically, it recommends applying zoning principles to separate product contact surfaces from areas designed for effective cleaning, and ensuring all surfaces can be fully washed without dead spaces or gaps where soils can accumulate. Open equipment could be redesigned with movable shells to contain soils during cleaning. These eco-hygienic design approaches aim to minimize fouling and waste while enhancing food safety.
White paper - Key factors for developing a pharmaceutical cleaning strategyFedegari Group
Pharmaceutical Cleaning Strategies: What are the key factors to consider when developing a quality procedure?
Cleaning is an essential practice for any pharmaceutical activity: it is impossible to manufacture drugs in dirty conditions, even if dirt is not evident. Many aspects need to be considered in setting up a cleaning procedure. This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Contributions of all these areas together can lead to a robust and reproducible cleaning process.
In these conditions, even regulatory bodies struggle. Essentially, they allow manufacturers considerable flexibility in establishing their own cleaning specifications. The FDA, for example, does not define methods describing how a cleaning process should be validated.
Therefore, there are many aspects to be considered when approaching the issue of pharmaceutical cleaning. First of all, one has to consider where to perform cleaning activity: in-place (CIP) or out-of-place (COP).
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào chế không vô trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
Sanitary Equipment Design Principles by American Meat Institute Foundation Up...Héctor Lousa @HectorLousa
The document provides sanitary design principles and a checklist for food processing equipment. It was created by an Equipment Design Task Force comprised of various meat and poultry companies. The task force identified 10 principles of sanitary design for equipment. These principles are aimed at reducing risks of contamination and include requirements for equipment to be cleanable, made of compatible materials, accessible for cleaning, self-draining, sealed, free of niches, and ensure sanitary operational performance. The checklist can be used by equipment manufacturers and processors to evaluate if equipment meets these principles. The goal is to promote a standard design that reduces contamination and recalls across the industry.
Similar to Sanitary Equipment Design Guidelines - Part 1 of 2 (20)
Sanitary Equipment Design Principles by American Meat Institute Foundation Up...
Sanitary Equipment Design Guidelines - Part 1 of 2
1. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 1 of 22
Primary Topics Page
1.0 Food Safety Criteria Background 2
2.0 Food Surface Types and Requirements 3
3.0 Eleven (11) Food Sanitary Criteria 3
3.1 Cleanable to acceptable microbiological level 3-4
3.2 Equipment Construction 5
3.2.1 Compatible materials 5
3.2.2 Construction and Fabrication 6-7
3.2.3 Internal Angle criteria 8
3.2.4 Permanent Joints 8-9
3.2.5 Connections, Attachments, and Ancillary Equipment 9-10
3.2.6 Openings, Covers, and Top Rims 11
3.3 Accessible for Inspection, Maintenance, Cleaning and Sanitation 11
3.4 Food Equipment Installation 12-13
3.5 No Product or Liquid Collection 14
3.6 Hollow Areas - Hermetically Sealed 14-15
3.7 No Niches 15
3.8 Sanitary Operational Performance: 16
3.9 Hygienic Design of Maintenance Enclosures: 16
3.10 Hygienic Compatibility with Other Plant Systems: 17
3.11 Validate Cleaning and Sanitizing Protocols: 17
4.0 Non-Product Contact Surfaces 18
5.0 Appendix, including [Company] & Industry Accepted References 19
5.1 Quality Operational Standards x-xxx-xx-xxx 19
5.1.1 x-xxx-xx-xxx: Hygienic Design 19
5.1.2 x-xxx-xx-xxx: Hygienic Design – Implementation Guidance 19
5.1.3 x-xxx-xx-xxx: Equipment Design 19
5.2 3-A Sanitary Standards and Accepted Practices Documentation Catalog Index 19-21
5.3 EHEDG Guideline Documentation Catalog Index 21-22
2. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 2 of 22
1.0 Food Safety Criteria Background
1.1 As part of the [X] mission statement and on-going efforts to insure all facilities continue to adhere to current best
manufacturing practices and standards within [X] and throughout similar-type industries, it is the policy to incorporate basic
“Guidelines” for all process designs that reinforce food safety, that specifically target sanitary design principles.
1.2 To ensure safe food and adequate sanitation programs, BOTH THE EQUIPMENT AND THE FACILITY used for
processing and handling food products must be designed, fabricated, constructed, and installed per sound sanitary design
principles. This will ensure the equipment and facility can be effectively operated, cleaned, and sanitized, where surfaces are
resistant to corrosive food products, cleaning, and sanitizing chemicals. Equipment that does not meet basic sanitary design
principles, or is installed and used improperly cannot be adequately operated, cleaned, and sanitized, resulting in a higher
risk of cross contamination.
1.3 It is important to consider that even though standards for sanitary fabrication, construction, and design of food equipment
have been developed, mandated, and enforced by a variety of organizations with subtle differences between these standards,
the primary intent of each of the following organizations referenced is the application of sound sanitary principles in food
equipment manufacturing that primarily focus on Food Cross Contamination Prevention.
1.3.1 3-A SSI: 3-A Sanitary Standards, Inc.
1.3.2 USDA: United States Department of Agriculture
1.3.3 USFDA - cGMP: United States Food and Drug Administration – current Good Manufacturing Practices
1.3.4 NSF: National Sanitation Foundation
1.3.5 USPHS: United States Public Health Service
1.3.6 IAFP: International Association of Food Protection
1.3.7 IAFIS: International Association of Food Industry Suppliers
1.3.8 EHEDG: European Hygienic Engineering & Design Group
1.4 Since it is the expectation to mitigate the risks of cross contamination associated sometimes with poor design and operations
while driving toward lower operating costs that strategically requires a balance in the return-on-investment associated with
high processing equipment costs, it becomes critical to ensure the completed equipment meets both regulatory compliance
and industry/nationally accepted criteria prior to installation.
1.5 It is accepted industry practices that sanitary processing conditions are essential for wholesome, high quality food products.
Beyond the current known regulatory impact managed by every food manufacturing facility such as with USDA enforced
compliance, it is intention to provide the assurance that equipment designs and fabrication meet acceptable standards and
can be effectively cleaned to produce wholesome, high quality products. The production of such products depends upon
processing equipment which can be effectively maintained, cleaned, and sanitized.
1.6 Sanitary design requires the application of specific materials and engineering techniques to ensure the products processed
are protected always. For example, mechanical cleaning of equipment while fully assembled (e.g. CIP) requires exacting
sanitary design characteristics to be effective, equipment that is to be manually cleaned requires “easy” disassembly design
features.
1.7 The following Guidelines, Part 1 of 2, outlining “Sanitary Equipment Standards and Design Criteria”, including
various sited attachments such as 3-A standards and example views, is intended to drive a level of self-awareness and basic
instruction when managing the process designs and facility layout of operations for a food manufacturing environment.
Although the guide is not intended to be inclusive of all methodology, it will support in all sanitary design and improvement
efforts to better understand the requirements and methods that optimally work for the project and specific conditions.
3. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 3 of 22
2.0 Food Surfaces
The general aspects of sanitary construction and design of food equipment begin with the kind of food surfaces, normally
subdivided in the following two (2) categories:
2.1 Food product contact surfaces:
Defined as a surface in direct contact with any food residue or where food residue can migrate (e.g. drip, drain,
diffuse, or be drawn)
Because these surfaces, if contaminated, can directly result in food product contamination, sanitary design criteria
must be followed
2.2 Non-product contact surfaces:
Locations that are part of the equipment (e.g. legs, supports, housings, guards) but not in direct contact
As contamination of non-product contact surfaces can cause indirect contamination of the food product, these
surfaces shall be considered regarding sanitary design
2.3 In terms of sanitary design, all food contact surfaces should be:
2.3.1 Smooth
2.3.2 Impervious
2.3.3 Free of cracks and crevices
2.3.4 Nonporous
2.3.5 Nonabsorbent
2.3.6 Non-contaminating
2.3.7 Nonreactive
2.3.8 Corrosion resistant
2.3.9 Durable and maintenance free
2.3.10 Nontoxic; and
2.3.11 Cleanable
2.4 If the surface is coated with metal alloy or non-metal (e.g. ceramics, plastic, rubber) in any way, the final surface must
meet the above requirements. Various nationally accepted standards require that such coatings maintain corrosion
resistance, and be free of surface de-lamination, pitting, flaking, chipping, blistering, and distortion under conditions of
intended use.
2.5 Similarly, if any other modification or process is used in fabrication (e.g. welded, bonded, or soldered) it should be done
using appropriate materials and in a manner, that ensures the final surface meets the sanitary design criteria.
3.0 The following Eleven (11) food sanitary criteria shall be considered in “All Food Process Equipment Designs”:
3.1 Cleanable to Acceptable Microbiological AND Allergen levels:
Food equipment to be constructed to ensure effective & efficient cleaning over its entire life-cycle
Equipment shall be designed as to “PREVENT” bacterial ingress, survival, growth and reproduction on both
product and non-product contact surfaces of the equipment.
Equipment shall be designed in such a manner to adequately divert potential Allergen contamination away during
the cleaning process.
Level of “Cleanability” shall be identified for both Microbiological and Allergens during initial project stages
4. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 4 of 22
Although the examples views below highlight recommendations to the types of “sanitary processes utilized” to
mitigate cross contamination and improve operating costs, the remaining criteria and attach examples will assist in
identifying how equipment shall be designed to mitigate the risks of “Unacceptable” microbiological and allergen
levels, including mitigating issues with ineffective/inefficient processes.
5. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 5 of 22
3.2 Equipment Construction:
3.2.1 Compatible materials
While meeting the conditions for food contact surfaces outlined above, construction materials used for
equipment must be completely compatible with the product, environment, cleaning, and sanitizing
chemicals and the methods of cleaning and sanitation.
Typically, Stainless steel is the preferred general use metal for food contact surfaces because of its
corrosion resistance and durability in “MOST” food applications.
Although 3A Sanitary Standards calls out 300 series steel for “MOST” surfaces, specifically 304 or 316
types, understanding the impact of the product & chemistry on the materials will support the final material
of construction decision in whether an alternative surface is necessary such as Titanium for high acid type
product in the cooking stage.
Specifically, [X] products such as ketchup & concentrated tomato based sauces, may require more
resistant materials such as AL6XN or Hastelloy-C22 depending upon corrosive nature.
3A Sanitary Standards for materials in contact with product shall be ground or polished stainless steel
surfaces meet at least a No. 4 ground surface and unpolished surfaces meet a No. 2B or mill finish.
Materials in contact with product should be at least 304 Stainless Steel polished to a #4 (32 Ra) finish
Keep in mind that the properties of stainless steel can change with continued use, especially under
conditions where the chromium oxide layer is altered, such as from incompatible cleaners, abrasive cleaners
& cleaning pads, chlorine and related sanitizers, and even from low pH/high acid products.
To extend the life of the above process pipe and improve the corrosion resistance of stainless steel when
first installed, it is recommended “passivation” be employed, where nitric acid or other strong oxidizing
agents are used initially and on a regular frequency thereafter, to maintain a passive (non-reactive) oxide
film on the surface.
o Passivation has two purposes where the acid dissolves any contaminant iron and accelerates the
formation of the passive chromium oxide film.
o It is critical to the overall passivation of stainless steel surfaces that all contaminant metals, (e.g. fines,
free iron, from welds, manufacturers oil protestants) be thoroughly removed.
o The absence of a passivation process will act as an initiation site for corrosion and result in a reduction
of the overall life of the metal, leading to product contamination and leaks.
o Although passivation of all food contact surfaces is recommended after any surface change, polishing,
or working such as in tanks and pipes, take note of exact equipment materials and where passivation is
not recommended or required, such as in plate heat exchangers and nickel plated surfaces
o When considering Surface Texture and/or Finishes, if any surface is ground, polished, or textured in
any way, it is advised passivation be performed so the final surface is smooth, durable, and free of
cracks and crevices, while meeting the other sanitary design requirements described above.
Examples of Incompatible Materials Utilized
6. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 6 of 22
3.2.2 Construction and Fabrication:
Food equipment should be designed and fabricated in such a way that all food contact surfaces are free of
sharp corners and crevices (Example Views below)
All mating surfaces must also be continuous (e.g., substantially flush).
All food handling or processing equipment should allow for easy disassembly for cleaning and inspection.
Equipment (e.g., vessels, chambers, tanks), should be self-draining and pitched to a drainable port with no
potential hold up of food materials or solutions.
The attached 3A Sanitary Standards outlines criteria and reinforces the recommendation:
o Polished Metal Tubing, Number 33-01
o Blending Equipment, Number 35-02
35-02 3-A Blending
Equipment.pdf
33-01 3-A Polished
Tubing.pdf
Piping systems not designed for routine disassembly must be sloped to drain
Stainless Steel, Smooth Body Motor
Skid Mounted Process Standard & Assembly Tubing Configuration
7. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 7 of 22
Piping systems installed in food processing systems designed for cleaning-in-place (CIP), require special
consideration and close monitoring regarding drainage.
Minimal amount of horizontal piping and conduits – eliminate potential for standing water, reduce overall
number of fasteners,
Eliminate ‘step’ areas for potential for settling of any liquids
Process and CIP piping should be installed to pitch properly to a low point to allow water to completely
drain at the end of CIP operations
Attached: 3-A Accepted Practices for Permanently Installed Product and Solution Pipelines and Cleaning
Systems, Number 605-04
605-04 3-A Pipe Line
& Cleaning Systems.pdf
Attached views: Hanger supports & wall penetrations
Process Pipe &
Round Support
Wall Penetration
Boot Covers
8. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 8 of 22
3.2.3 Internal Angle criteria
As outlined in 3-A standard above for Blending Equipment and the view below, Internal angles should be
coved or rounded with defined radii
Equipment standards specify appropriate radii for specific equipment applications and components.
For example, radii requirements stated in the 3A Sanitary Standards indicate that “all internal angles 135
degrees or less should have a minimum radius of 1/4 inch (6.35 mm).
The standards allow for a smaller radius where needed for function within certain specifications.
3.2.4 Permanent Joints
All joints should be smooth, durable, and meet all sanitary design criteria.
Equipment standards generally require that welded joints on stainless steel surfaces be continuous, butt-type
joints (view below) and ground to at least as smooth as a No. 4 finish.
If welded joint is at a corner, it must be covered to the appropriate radius and ground smooth (View below
& section 3.2.3).
Use of soldered joints should be limited by application with use of only non-toxic materials.
Press fits and shrink fits are generally discouraged and should be limited only to applications where welded
joints are not possible (e.g. bushings).
Permanent welded joints showing butt weld vs. to lap weld Corner welds in food equipment
Square
Corner results in soil
accumulation
Unacceptable
Radius,
Area easily
Cleaned & inspected
Acceptable
Required Radius Size is
Application Dependent
9. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 9 of 22
Become familiar with the following Basic Types Welding Methods, to identify acceptable food contact
surface methods
3.2.5 Connections, Attachments, and Ancillary Equipment
Care to be taken when connecting pipes, gauges, thermometers, probes, or other equipment to food contact
surfaces.
It is necessary to ensure the connection does not create a dead end or an area where food product can
accumulate and is not accessible to cleaning solutions.
Such connections should be close coupled (e.g., pipe connection should not be of length greater than one
(1) pipe diameter) as shown below.
Closed connection length (a) no greater than the pipe diameter (d)
Example view of an acceptable and an unacceptable instrument connection are shown below
(1) Square Butt Joint: Difficult to achieve smooth flat surface
(2) Single-V Joint: Preferred in Sanitary Design
(3) Lap Joint: Leads to a niche area, permitting for trapped debris
(4) T-Joint: Leads to a niche area, permitting for trapped debris
Unacceptable Instrument
Connection- Dead Space Acceptable Instrument Connection
10. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 10 of 22
Shafts, bearings, agitators, and other attachments or ancillary components should be attached to food
equipment in such a way that the food contact zone is sealed from contamination caused by leakage of
lubricants or other contaminants into the product zone.
Such components should be accessible and removable for cleaning.
Threads of food equipment are to be avoided in or over the food product zone
Machine guard design to include considerations for sanitary design – stainless steel mesh is preferred over
any plastics (Example view below) to avoid long term etching and reduced visibility
Minimal number of mechanical fasteners – utilize welded construction whenever possible.
Unacceptable Connected Wire Ties
Bundled Wiring against Flat Frame
Acceptable Sealed Wire Connection Away
from Support for Improved Cleaning
Versus
11. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 11 of 22
3.2.6 Openings, Covers, and Top Rims
Any opening or cover should be designed, fabricated, and constructed in such a manner to adequately
protect food products from contamination and to divert potential contamination away from the food product
zone.
Openings should be lipped and covered with a “shoe box type” design. And, the top rims of equipment
should be constructed and fabricated to avoid the collection of water droplets or dust (See View Below).
Acceptable shoe box design openings and covers Top rim of food equipment
3.3 Accessible for Inspection, Maintenance, Cleaning and Sanitation:
All parts of the equipment shall be readily accessible for inspection, maintenance, & cleaning without use of tools
Quick release design fasteners/pins/knobs will be attached via lanyards or have hanger on equipment (view below)
Quick Release, Pins, Knobs, and Storage Location
Lift Out for Easy Cleaning
12. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 12 of 22
3.4 Food Equipment Installation:
Food equipment should be installed in a logical sequence to avoid cross contamination.
Space around and between equipment, and walls should be adequate to allow for sufficient cleaning.
There should be no potential harborages for insects and rodents.
Unless sealed to walls, food equipment should be at least 4 inches from walls.
Table mounted equipment should be sealed to the table, or be no less than 4 inches from the counter top
Acceptable
Access below & behind equipment, exhibiting no niches or areas for settling debris
Versus
Low Clearance Limited Access Area for Settling Debris
13. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 13 of 22
Floor mounted equipment should be sealed to the floor, platform, or pedestal or should be no less than 6 inches
from the floor to avoid niche areas for microbiological growth (See Example and instructions Below)
Threads used on all leveling components should be of a sanitary design and enclosed as shown below in the views
and the 3-A Attachment, 88-00, ‘3-A Standard for Sanitary Machine Leveling Feet and Supports”
88-00 3-A Machine
Leveling.pdf
How to install anchors for
legs/feet on plates
• Rotary hammer - drill a
hole in floor – gas/air to
remove dust
• SS threaded rod cut on
angle on one end
• 2-part epoxy in hole
• Insert rod angle end in
and slightly turn back
forth while pushing
down
• Set 15 minutes
• Set foot over rods
• Install hardware
Versus
How to install components
with House Keeping Pads
• Rotary hammer - drill
a hole in floor –
gas/air to remove dust
• SS threaded rod cut
on angle on one end
• 2-part epoxy in hole
• Insert rod angle end
in and slightly turn
back forth while
pushing down
• Set 15 minutes
• Install leveler nut for
underside of plate
• Install plate over rods
• Level plate
• Install plates on here
or in the field.
14. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 14 of 22
3.5 No Product or Liquid Collection:
Equipment should be self-draining to assure that liquid, which can harbor and promote the growth of bacteria, does
not accumulate, pool or condense on the equipment.
Structural members should round or rotated to slope to eliminate horizontal flat surfaces (See Views below and
Sections 3.2.2 & 3.4)
3.6 Hollow Areas Should Be Hermetically Sealed:
Hollow areas of equipment such as frames & rollers must be eliminated whenever possible or permanently sealed.
Bolts, studs, mounting plates, brackets, junction boxes, nameplates, end caps, sleeves and other such items should
be applied using welded stand-offs, or be continuously welded to the surface, not attached via drilled and tapped
holes (See Connections views above and Below).
Control Panels Self Draining and Sloped
Structural Supports Round and Rotated
15. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 15 of 22
3.7 No Niches:
Equipment parts should be free of niches such as pits, cracks, corrosion, recesses, open seams, gaps, lap seams,
protruding ledges, inside threads, bolt rivets and dead ends.
UHMW wear strip example – inaccessible areas (See below)
No plastic fasteners or tie-wraps, minimize potential of foreign material (See Section 3.2.5, Connections above)
Views above & below of acceptable elimination of niche
Versus
Unacceptable Connections:
Washers (Niche Areas) & Drilled to Support
Acceptable Connected Equipment
Sloped, capped & sealed equipment seen below compared to un-sealed,
exposed, hidden, & product catching ledges seen above
16. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 16 of 22
3.8 Sanitary Operational Performance:
During normal operations, the equipment must perform so it does not contribute to unsanitary conditions or the
harborage and growth of bacteria.
All equipment requiring lubricants of any kind for operation near food processing areas, including
open/expose product and/or ingredients, shall be a lubricant acceptable for incidental food contact
designated at least a category code H1.
The attached 3A Sanitary Standards and summary outlines criteria and reinforces the recommendation:
A Method of Producing Culinary Steam, Number 609-03
o This 3-A Accepted Practice outlines the sanitary aspects of the equipment and filters used in the supplying
of steam of culinary quality which comes in direct contact with food products or product contact surface.
Producing Culinary
Steam
Supplying Air Under Pressure in Contact with Product Contact Surfaces, Number 604-05
o This 3-A Accepted Practice outlines the sanitary aspects of the equipment and filters used in the supplying
of air under pressure for contact with food products or product contact surface.
Supplying Air Under
Pressure
3.9 Hygienic Design of Maintenance Enclosures:
Maintenance enclosures and human machine interfaces such as push buttons, valve handles, switches and touch
screens, must be designed to ensure food product, water, or product liquid does not penetrate or accumulate in or on
the enclosure or interface.
Physical design of the enclosures should be sloped or pitched to avoid use as storage area (See view below and
Section 3.5)
HMI Controls on Skids in Production
Area Built for Wash Down
17. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 17 of 22
3.10 Hygienic Compatibility with Other Plant Systems:
Equipment design should ensure hygienic compatibility with other equipment and systems, such as electrical,
hydraulics, steam, air and water. (See Views and See Section 3.8)
3.11 Validate Cleaning and Sanitizing Protocols:
Procedures for cleaning and sanitation must be clearly written, designed and proven effective and efficient.
Chemicals recommended for cleaning and sanitation must be compatible with the equipment and the manufacturing
environment. (See Section 3.2.1)
Air Compressor Installation
HVAC systems in ceilings not located
directly above product flow
To Improve the Production Area Functions,
All Electrical Control Panels Installed on
Walk-on Ceiling out of the Process Area
18. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 18 of 22
4.0 Non-product contact surfaces
4.1 Non-Product contact surfaces of food equipment are a source for environmental contamination of a food facility with
pathogens (e.g. Listeria monocytogenes). These areas can also be harborage areas for insects and rodents. Therefore,
care should be used in evaluating these surfaces of equipment regarding sanitary construction and design.
4.2 Non-product surfaces of equipment should be constructed with appropriate materials and fabricated in such a manner as
to be reasonably cleanable, corrosion resistant, and maintenance free. As much as practicable, tubular steel framework
equipment should be entirely sealed and not penetrated (e.g. bolts, studs) to avoid creating niches for microorganisms.
4.3 Whenever practicable, attachments should be welded to the surface of the tubing and not attached via drilled and tapped
holes. In addition, unused framework penetrations (e.g. Unbolted areas, seams) should be capped or eliminated to
reduce the potential for areas of cross contamination (see view below& supporting sections above: 3.2.5, 3.5, 3.6, &
3.7)
4.4 Ledges or areas where dust and water can collect should be avoided. Tops of equipment, shields, covers, or boxes,
should be sloped at 45-degree angle or more. (See views below & section 3.5 No product or liquid collection)
Versus
Versus
Unacceptable
Acceptable[Company] STANDARDS DOCUMENT
19. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 19 of 22
5.0 Appendix, including [Company] & Industry Accepted References
5.1 Quality Operational Standards: TBD
5.1.1 X-XXX-XX-XX: HYGIENIC DESIGN
HYGIENIC DESIGN
5.1.2 X-XXX-XX-XX: HYGIENIC DESIGN – IMPLEMENTATION GUIDANCE
HYGIENIC
DESIGN-Implementation
5.1.3 X-XXX-XX-XX: EQUIPMENT DESIGN
EQUIPMENT DESIGN
5.2 3-A Sanitary Standards and Accepted Practices Documentation Index
5.2.1 3-A SANITARY STANDARDS
5.2.1.1 01-08 Storage Tanks 11/2001
5.2.1.2 02-10 Centrifugal and Positive Rotary Pumps 1/2006
5.2.1.3 04-04 Homogenizers and Reciprocating Pumps 11/1996
5.2.1.4 05-15 Stainless Steel Automotive Transportation Tanks 11/2002
5.2.1.5 10-04 Filters Using Single Service Filter Media 11/2000
5.2.1.6 11-08 Plate-Type Heat Exchangers 1/2007
5.2.1.7 12-07 Tubular Heat Exchangers 11/2003
5.2.1.8 13-10 Farm Milk Cooling and Holding Tanks 11/2003
5.2.1.9 16-05 Product Evaporators and Vacuum Pans 8/1997
5.2.1.10 17-10 Formers, Fillers, and Sealers of Containers for Fluid Products 11/2002
5.2.1.11 18-03 Multiple-Use Rubber and Rubber-Like Materials 8/1999
5.2.1.12 19-05 Batch and Continuous Freezers Ice Cream, Ices, and Other Similarly Frozen Foods 11/1999
5.2.1.13 20-25 Multiple-Use Plastic Materials 7/2007
5.2.1.14 21-01 Centrifugal Separators and Clarifiers 11/2006
5.2.1.15 22-08 Silo-Type Storage Tanks 11/2004
5.2.1.16 23-05 Equipment for Packaging Viscous Products 10/2006
5.2.1.17 24-02 Non-Coil Type Batch Pasteurizers 11/1989
5.2.1.18 25-03 Non-Coil Type Batch Processors 11/2002
5.2.1.19 26-05 Sifters for Dry Products 4/2007
5.2.1.20 27-05 Equipment for Packaging Dry Products 11/2002
5.2.1.21 28-03 Flow Meters 11/1995
5.2.1.22 29-02 Air Eliminators 11/2000
5.2.1.23 30-01 Farm Milk Storage Tanks 9/1984
5.2.1.24 31-04 Scraped Surface Heat Exchangers 1/2006
5.2.1.25 32-02 Un-insulated Tanks 8/1994
5.2.1.26 33-01 Polished Metal Tubing 11/1994
20. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 20 of 22
5.2.1.27 34-02 Portable Bins for Dry Products 09/1992
5.2.1.28 35-02 Blending Equipment 12/2005
5.2.1.29 36-01 Inline Rotor-Stator Mixers 11/2003
5.2.1.30 38-00 Cottage Cheese Vats 8/1997
5.2.1.31 39-01 Pneumatic Conveyors for Dry Products 11/2003
5.2.1.32 40-03 Bag Collectors 7/2006
5.2.1.33 41-02 Mechanical Conveyors for Dry Products 11/2005
5.2.1.34 42-01 In-Line Strainers 11/1997
5.2.1.35 44-03 Diaphragm Pumps 11/2001
5.2.1.36 45-02 Cross-flow Membrane Modules 11/2003
5.2.1.37 46-03 Refractometers and Energy-Absorbing Optical Sensors 11/2002
5.2.1.38 49-01 Air Driven Sonic Horns for Dry Products 11/2001
5.2.1.39 50-01 Level Sensing Devices for Dry Products 11/2001
5.2.1.40 51-01 Plug-Type Valves 11/1998
5.2.1.41 52-02 Plastic Plug-Type Valves 11/1998
5.2.1.42 53-03 Compression-Type Valves 12/2006
5.2.1.43 54-02 Diaphragm-Type Valves 11/1997
5.2.1.44 56-00 Inlet and Outlet Leak-Protector Plug-Type Valves 5/1993
5.2.1.45 57-01 Tank Outlet Valves 11/1996
5.2.1.46 58-00 Vacuum Breakers and Check Valves 6/1992
5.2.1.47 59-00 Automatic Positive Displacement Samplers 11/1993
5.2.1.48 60-00 Rupture Discs 9/1983
5.2.1.49 61-01 Steam Injection Heaters 9/2006
5.2.1.50 62-01 Hose Assemblies 11/1996
5.2.1.51 63-03 Sanitary Fittings 11/2002
5.2.1.52 64-00 Pressure Reducing and Back Pressure Regulating Valves 11/1993
5.2.1.53 65-00 Sight and/or Light Windows and Sight Indicators in Contact with Product 11/1994
5.2.1.54 68-00 Ball-Type Valves 11/1996
5.2.1.55 70-01 Italian-Type Pasta Filata Style Cheese Cookers 11/2002
5.2.1.56 71-01 Italian-Type Pasta Filata Style Cheese Molders 11/2002
5.2.1.57 72-01 Italian-Type Pasta Filata Style Molded Cheese Chillers 11/2002
5.2.1.58 73-01 Shear Mixers, Mixers, and Agitators 10/2005
5.2.1.59 74-03 Sensors and Sensor Fittings and Connections Used on Equipment 1/2006
5.2.1.60 75-00 Belt-Type Feeders 11/1998
5.2.1.61 78-01 Spray Cleaning Devices Intended to Remain in Place 11/2003
5.2.1.62 81-00 Auger-Type Feeders 11/1998
5.2.1.63 82-00 Pulsation Dampening Devices 11/2002
5.2.1.64 83-00 Enclosed Cheese Vats and Tables 11/2003
5.2.1.65 84-02 Personnel Access Ports for Wet Applications 6/2007
5.2.1.66 85-00 Double-Seat Mix Proof Valves 11/2004
5.2.1.67 88-00 Machine Leveling Feet and Supports 12/2006
21. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 21 of 22
5.2.2 3-A ACCEPTED PRACTICES
5.2.2.1 603-07 Sanitary Construction, Installation, Testing, and Operation of High-Temperature Short-Time
and Higher-Heat Shorter-Time Pasteurizer Systems 11/2005
5.2.2.2 604-05 Supplying Air Under Pressure for Contact with Product or Product Contact Surfaces 11/2004
5.2.2.3 605-04 Permanently Installed Product and Solution Pipelines and Cleaning Systems 8/1994
5.2.2.4 606-05 Design, Fabrication, and Installation of Milking and Milk Handling Equipment 11/2002
5.2.2.5 607-05 Spray Drying Systems 11/2004
5.2.2.6 608-02 Instantizing Systems 11/2001
5.2.2.7 609-03 Method of Producing Steam of Culinary Quality 11/2004
5.2.2.8 610-01 Sanitary Construction, Installation, and Cleaning of Crossflow Membrane Processing Systems
11/2003
5.2.2.9 611-00 Farm Milk Cooling and Storage Systems 11/1994
5.2.3 E-3-A SANITARY STANDARDS
5.2.3.1 E-600 Egg Breaking & Separating Machines 1/1998
5.2.3.2 E-1500 Shell Egg Washer 1/1998
5.3 EHEDG Guideline Documentation Index
5.3.1 Doc.01 Microbiologically safe continuous pasteurization of liquid foods
5.3.2 Doc.02 A method for assessing the in-place Cleanability of food processing equipment,
5.3.3 Doc.03 Microbiologically safe aseptic packing of food products
5.3.4 Doc.04 A method for the assessment of in-line pasteurization of food processing equipment
5.3.5 Doc.05 A method for the assessment of in-line steam sterilization of food processing equipment
5.3.6 Doc.06 The microbiologically safe continuous flow thermal sterilization of liquid foods
5.3.7 Doc.07 A method for the assessment of bacteria tightness of food processing equipment
5.3.8 Doc.08 Hygienic equipment design criteria
5.3.9 Doc.09 Welding stainless steel to meet hygienic requirements
5.3.10 Doc.10 Hygienic design of closed equipment for the processing of liquid food
5.3.11 Doc.11 Hygienic packing of food products
5.3.12 Doc.12 The continuous or semi-continuous flow thermal treatment of particulate foods
5.3.13 Doc.13 Hygienic design of equipment for open processing
5.3.14 Doc.14 Hygienic design of valves for food processing
5.3.15 Doc.15 A method for the assessment of in-place Cleanability of moderately-sized food processing
equipment
5.3.16 Doc.16 Hygienic pipe couplings
5.3.17 Doc.17 Hygienic design of pumps, homogenizers and dampening devices
5.3.18 Doc.18 Passivation of stainless steel
5.3.19 Doc.19 A method for assessing the bacterial impermeability of hydrophobic membrane filters
5.3.20 Doc.20 Hygienic design and safe use of double-seat mix-proof valves
5.3.21 Doc.21 Challenge tests for the evaluation of the hygienic characteristics of packing machines for liquid and
semi-liquid products
5.3.22 Doc.22 General hygienic design criteria for the safe processing of dry particulate materials
5.3.23 Doc.23 Production and use of food-grade lubricants
22. STANDARDS DOCUMENT
Title: Sanitary Design Guidelines: Equipment Principles & Criteria Product: Anything Demanding Precision & Accuracy
Department: Facilities, Manufacturing, Engineering. QA, R&D Reason: Outlining Sanitary Design Expectations
Location: Your Company, Facility Version: xx-xx-xxxx
Support: Joe Petrochko
Contact #: 609-605-2715
E-mail: joe@petrochko.com
Page 22 of 22
5.3.24 Doc.24 The prevention and control of Legionella spp (including Legionnaires’ Disease) in Food
Factories
5.3.25 Doc.25 Design of mechanical seals for hygienic and aseptic applications
5.3.26 Doc.26 Hygienic Engineering of Plants for the Processing of Dry Particulate Materials
5.3.27 Doc.27 Safe Storage and Distribution of Water in Food Factories
5.3.28 Doc.28 Safe and Hygienic Water Treatment in Food Factories
5.3.29 Doc.29 Hygienic Design of packing systems for solid foodstuffs
5.3.30 Doc.30 Guidelines on Air Handling in the Food Industry
5.3.31 Doc.31 Hygienic engineering of fluid bed and spray dryer plants
5.3.32 Doc.32 Materials of construction for equipment in contact with food
5.3.33 Doc.33 Hygienic engineering of discharging systems for dry particulate materials
5.3.34 Doc.34 Integration of hygienic and aseptic systems
5.3.35 Doc.35 Hygienic welding of stainless steel tubing in the food processing industry
5.3.36 Doc.36 Hygienic engineering of transfer systems for dry particulate materials