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Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (a): Introduction and overview

Supplementary Training Modules on Good Manufacturing Practice. Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (a): Introduction and overview. WHO Technical Report Series, No. 937, 2006. Annex 2. HVAC. Objectives To understand: The need for HVAC systems (Part 1a)

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Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (a): Introduction and overview

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  1. Supplementary Training Modules on Good Manufacturing Practice Heating, Ventilation and Air- Conditioning (HVAC)Part 1 (a): Introduction and overview WHO Technical Report Series, No. 937, 2006. Annex 2

  2. HVAC Objectives To understand: • The need for HVAC systems (Part 1a) • The role of HVAC in protection: • Product • Personnel • Environment • The role of HVAC in dust control (Part 1b) • HVAC system design and its components (Part 2) • Commissioning, qualification and maintenance (Part 3) 1, 2

  3. HVAC Introduction and Scope • HVAC systems can have an impact on product quality • It can provide comfortable conditions for operators • The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage • Temperature, relative humidity control where appropriate • Supplement to basic GMP text 1, 2

  4. Personnel Validated processes Procedures Starting materials Equipment Packing materials Premises Environment HVAC Factors contributing to quality products

  5. HVAC • The manufacturing environment is critical for product quality. Factors to be considered include: • Light • Temperature • Relative humidity • Air movement • Microbial contamination • Particulate contamination • Uncontrolled environment can lead to product degradation • product contamination (including cross-contamination) • loss of product and profit

  6. HVAC What is contamination? It is "the undesired introduction of impurities (chemical/ microbial/ foreign matter into or on to starting material or intermediate – during sampling, production, packaging or repackaging". Impurities could include products or substances other than the productmanufactured, foreign products, particulate matter, micro-organisms, endotoxins (degraded microorganisms), etc. Glossary

  7. HVAC What is Cross-contamination? "Contamination of a starting material, intermediate product, or finished product with another starting material or product during production". Cross-contamination can result from, e.g. • Poorly designed, operated or maintained air-handling systems and dust extraction systems • Inadequate procedures for, and movement of personnel, materials and equipment • Insufficiently cleaned equipment Glossary, 4.1.11

  8. Contamination Contaminant from Environment Operators Contaminant from Equipment Cross Contamination Product from Environment Operators Product from Equipment HVAC Cross-Contamination

  9. HVAC Cross-contamination can be minimized by, e.g. • Personnel procedures • Adequate premises • Use of closed production systems • Adequate, validated cleaning procedures • Appropriate levels of protection of product • Correct air pressure cascade

  10. HVAC The guideline further focuses on three concepts of the system: • Product protection • Contamination • Cross-contamination • Environmental conditions • Personnel protection • Prevent contact • Comfort conditions • Environment protection 2

  11. HVAC Protection: Product and personnel • Areas where materials and products are exposed, should be classified as "clean areas" • Achievement of clean area classification depends on factors such as: • Building finishes and structure • Air filtration • Air change rate • Room pressure • Temperature • Relative humidity • Material and personnel flow • Outside environment • Occupancy and type of product 4.1.1 - 4.1.3

  12. HVAC • Air filtration and air change rate should ensure attainment of classification • Air change rate is dependent on factors, e.g. • Level of protection required • Quality and filtration of supply air • Particulates generated • Room configuration • Containment effect • Room heat load • Room pressure • Air change rate normally varies between 6 – 20 air changes per hour 4.1.4 - 4.1.6

  13. HVAC The classification should be achieved in the state as specified (1): • "As built" • Bare room, without equipment or personnel 4.1.7 - 4.1.8

  14. HVAC The classification should be achieved in the state as specified (2): • "At rest" • Equipment may be operating, but no operators present 4.1.9

  15. HVAC The classification should be achieved in the state as specified (3): • "In operation" • Normal production process with equipment and personnel, • Clean up time validated – normally in the order of 20 minutes 4.1.10

  16. HVAC Control of contaminants • External contaminants removed through effective filtration • Internal contaminants controlled through dilution and flushing, or displacement airflow • Airborne particulates and level of filtration considered critical 4.1.12 - 4.1.15

  17. HVAC Manufacturing Environment requirements Cleanroom Class A / B Cleanroom Class C Cleanrm. Class D Others Therapeutic risks

  18. HVAC Level of protection and air cleanliness determined according to: • Product to be manufactured • Process to be used • Product susceptibility to degradation 4.1.16

  19. HVAC Parameters influencing Levels of Protection • Number of particles in the air, number of microorganisms in the air or on surfaces • Number of air changes for each room • Air velocity and airflow pattern • Filters (type, position) • Air pressure differentials between rooms • Temperature, relative humidity

  20. Air Handling System Production Room With Defined Requirements Supply Air Outlet Air HVAC Tools to help achieve the desired Level of Protection

  21. HVAC Tools to help achieve the desired Level of Protection (2) • Air-handling system can be the main tool for reaching required parameters • May not be sufficient as such • Need for additional measures such as • appropriate gowning (type of clothing, proper changingrooms) • validated sanitation • adequate transfer procedures for materials and personnel

  22. HVAC Tools to help achieve the desired Level of Protection (2) Cleanroom Class defined by Critical Parameters Additional Measures Air Handling System

  23. HVAC Examples of Levels of Protection Types of Clean room classes • WHO, EC, PIC/S: A, B, C, D • US FDA: Critical and controlled • ISPE:Level 1, 2 or 3 • ISO: Class 5, 6, 7 or 8

  24. Comparing International Cleanroom Classifications HVAC

  25. HVAC Examples of levels of protection 4.1.16

  26. A B C D Washing of containers X Preparation of solution for terminal sterilisation X Preparation of solutions for aseptic filling X X X Depyrogenisation of containers X Filling for terminal sterilisation X Filling for aseptic process X etc. HVAC All operationswithin a pharmaceutical facilility should be correlated to well-defined clean room classes, and can be included in a hygiene concept. Example: Cleanroom Class

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