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The origin of sanitary is the Latin word sanitas, or "health," from the root sanus, which means both
"healthy" and "sane."
Objectives
• 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
• Health examinations:
ä Training:
ä Signs in areas
ä Written procedures and instructions - to wash hands before entering production areas
ä Should be avoided
• Smoking, eating and drinking not allowed in production areas, laboratories and storage areas
• Rest and refreshment areas should be separate from manufacturing and control areas
ä Full-time employees
ä Temporary workers
ä Contractor's employees
ä Visitors
ä Managers
ä Inspectors
Design of Premises
• Design
l Segregated areas
l Ventilation systems
l Airlocks
l Clothing
ä Live vaccines
ä Penicillin products
• Campaign production:
ä Separation in time
ä Appropriately designed ventilation system with air supply and extraction systems
ä Pressure differentials
ä Appropriately designed ventilation system with air supply and extraction systems
• Detailed modules in the supplementary training deal with recommendations for HVAC systems
• Clothing
ä Highly potent products or those of particular risk - need for special protective clothing
removable lids
clean-in-place (CIP)
ä all cleaning and disinfecting solutions carefully prepared and expiry dated
• Final rinse with purified water, or water for injection (for sterile products)
• Water systems
• Emergency work in working area followed by thorough clean down and disinfection before
manufacturing recommences
• Area clearance by QC
• Group Session
• 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?
Possible Issues
Hygiene
• Personal hygiene
• Health checks
• Personal responsibility
• Training records