Sanitation and Hygiene

1. Basic Principles of GMP Sanitation and Hygiene Section 3

2. Sanitation and Hygiene Objectives • Review measures to ensure good sanitation in: • Premises and personnel • Equipment and apparatus • Processes, materials and containers • To review measures to ensure good personal hygiene • Group session - to discuss the situation in your country and to look at some bad sanitation and hygiene practices

3. Sanitation and Hygiene Scope High level of sanitation and hygiene practised – in every aspect of manufacturing. It covers: • Personnel • Premises • Equipment and apparatus • Production materials and containers • Products for cleaning and disinfection • All potential sources of cross-contamination 3.1

4. Sanitation and Hygiene Personal Hygiene (1) • Health examinations: • Before and during employment • Periodic eye examinations for those who do visual inspections • Training: • Practices in personal hygiene • Written procedures and instructions • Signs in areas 11.1 - 2

5. Basic Principles of GMP • Written procedures and instructions - to wash hands before entering production areas • Some also use disinfectants 11.1 - 2

6. Basic Principles of GMP • Wash hands before entering production areas • Signs in areas (e.g. changing rooms) 11.1 - 2

7. Sanitation and Hygiene Personal Hygiene (2) • Illness or open lesions: • May affect the quality of products • Should not handle starting materials, intermediates or finished products, etc. • Instruction and encouragement to report to supervisors • Direct contact between product and operator: • Should be avoided • Starting materials, primary packaging materials, intermediate and bulk product 11.2 - 5

8. Sanitation and Hygiene Personnel Hygiene (3) • Protection of product from contamination: • Clean clothes appropriate to personnel activities • Including hair covering (e.g. caps) • Check change rooms/changing facilities • Hand washing, signs, drying of hands • Used clothing stored in separate closed containers while awaiting cleaning • Laundering of clean area clothing according to an SOP and in an appropriate facility • Procedure for disinfecting and sterilizing when required 11.6

9. Sanitation and Hygiene Personnel Hygiene (4) • Smoking, eating and drinking not allowed in production areas, laboratories and storage areas • No chewing (e.g. gum), or keeping food or drinks allowed • No plants kept inside these areas • Rest and refreshment areas should be separate from manufacturing and control areas 11.7, 12.11

10. Basic Principles of GMP • Toilets should not open directly into production or storage areas 12.12

11. Sanitation and Hygiene Personnel Hygiene (5) • Personal hygiene procedures including wearing protective clothing apply to all persons entering into production areas: • Full-time employees • Temporary workers • Contractor's employees • Visitors • Managers • Inspectors 11.8

12. Sanitation and Hygiene Design of Premises • Design • Walls, floors, ceilings, ledges, drains, air supply, dust extraction • Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination • Cleaning programme, appropriate cleaning, cleaning records • Effective cleaning and disinfection • choice of materials and chemicals, validation • Drains – prevent backflow 12.2, 12.3, 12.7, 12.9, 12.29

13. Basic Principles of GMP • Protection from insects, birds, vermin and weather • from receipt of raw materials to dispatch of released product 12.9

14. Sanitation and Hygiene Avoidance of Cross-Contamination (1) • Special precautions should be taken to prevent generation and dissemination of dust • Proper air control – supply and extraction, suitable quality • Due to uncontrolled release of: • dust, gas, particles, vapours, sprays, organisms, residue, insects 16.10 - 11

15. Basic Principles of GMP Measures that can be taken to prevent cross-contamination also include: • Segregated areas • Ventilation systems • Airlocks • Clothing • Closed processing systems • Cleaning and decontamination

16. Sanitation and Hygiene Avoidance of Cross-Contamination (2) • Dedicated and self-contained areas for: • Live vaccines • Live bacterial preparations • Certain other biological materials • Penicillin products 16.12(a)

17. Sanitation and Hygiene Avoidance of Cross-Contamination (3) • Campaign production: • Separation in time • Followed by appropriate cleaning • Validated cleaning procedure 16.12(b)

18. Sanitation and Hygiene Avoidance of Cross-Contamination (4) • Ventilation systems and airlocks • Appropriately designed ventilation system with air supply and extraction systems • Supply or incoming air should be filtered • Recirculation of air versus 100% fresh air supply • Proper airflow patterns • Pressure differentials • Appropriately designed airlocks 16.12 (c and d)

19. Basic Principles of GMP • Appropriately designed ventilation system with air supply and extraction systems • Supply or incoming air should be filtered • Detailed modules in the supplementary training deal with recommendations for HVAC systems

20. Sanitation and Hygiene Avoidance of Cross-Contamination (5) • Clothing • Protection of operator and product • Highly potent products or those of particular risk - need for special protective clothing • Personnel should not move between areas producing different products • Garments need to be cleaned 16.12(e)

21. Sanitation and Hygiene Avoidance of Cross-Contamination (6) • Cleaning and decontamination • Procedure for removing soil and dirt • Remove all cleaning chemical residues or disinfectant residues • Remove and/or reduce micro-organisms • Validated (known effectiveness of the procedure) • Use cleanliness status labels • Test for residues 16.12(f, h and i)

22. Sanitation and Hygiene Avoidance of Cross-Contamination (7) • Closed processing systems • For example: totally enclosed water purification systems • Tanks fitted with appropriate filtration - without removable lids • Present special cleaning difficulties, sometimes use clean-in-place (CIP) 16.12(g)

23. Sanitation and Hygiene Production Operations – Sanitation (1) • Cleaning and cleaning validation • Degree of cleaning depends on whether consecutive batches are of same or different product • Check cleaning agent is fully removed • If possible hot water alone used for cleaning • all cleaning and disinfecting solutions carefully prepared and expiry dated • Final rinse with purified water, or water for injection (for sterile products) • Full records kept

24. Sanitation and Hygiene Production Operations – Sanitation (2) • Full records kept • Water systems • Water - major constituent of most products • SOP for cleaning and sanitization of the water purification system should include distribution line • Validation and removal of disinfectant before reuse

25. Sanitation and Hygiene Production Operations – Sanitation (3) • Maintenance and repair • activities inevitable in manufacturing area • Should present no risk to product • Whenever possible, all planned maintenance outside normal operating hours • Emergency work in working area followed by thorough clean down and disinfection before manufacturing recommences • Area clearance by QC

26. Basic Principles of GMP

27. Sanitation and Hygiene Group Session - Option 1 Look at the photographs in the handout and record as many sanitation and hygiene issues as you can

28. Sanitation and Hygiene Group Session - Option 2 You are inspecting a new factory. What are the key issues for sanitation and the key issues for personnel hygiene that the company should have in place?

29. Sanitation and Hygiene Possible Issues – I Sanitation • Mixed production • Penicillins • Product versus batch changeovers • Water systems • How long should a “cleaned” status last for? • What should happen if a clearance check is requiredwhen no QC personnel are on duty? • Procedures and records

30. Sanitation and Hygiene Possible Issues – II Hygiene • Personal hygiene • Health checks • Dealing with health problems • Personal responsibility • Training records • Frequency of handwashing