Professional Documents
Culture Documents
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
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
examinations: Before and during employment Periodic eye examinations for those who do visual inspections
Training:
production areas
Some also use
disinfectants
areas
Signs in areas (e.g. changing rooms)
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
F T R AC O Y
C AN E H G R O O M
AIR LO K C T ILET O S
C T AN EEN
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
Design of Premises
Design
Walls, floors, ceilings, ledges, drains, air supply, dust extraction
records
Protection from insects, birds, vermin and weather from receipt of raw materials to dispatch of released product
Measures that can be taken to prevent cross-contamination also include: Segregated areas Ventilation systems Airlocks Clothing Closed processing systems Cleaning and decontamination
Dedicated and self-contained areas for: Live vaccines Live bacterial preparations Certain other biological materials Penicillin products
Campaign production: Separation in time Followed by appropriate cleaning Validated cleaning procedure
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
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
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
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
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)
Check cleaning agent is fully removed If possible hot water alone used for cleaning
all cleaning and disinfecting solutions carefully prepared
Final rinse with purified water, or water for injection (for sterile products)
Group Session - Option 1 Look at the photographs in the handout and record as many sanitation and hygiene issues as you can
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?
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 required when no QC personnel are on duty? Procedures and records
Possible Issues II Hygiene Personal hygiene Health checks Dealing with health problems Personal responsibility Training records Frequency of handwashing
THANK YOU