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. 3.1
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
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. 11.2 - 5
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
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 T
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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. 16.10 - 11
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
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. 16.12(a)
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
17. 16.12(b)
Sanitation and Hygiene
Avoidance of Cross-Contamination (3)
Campaign production:
Separation in time
Followed by appropriate cleaning
Validated cleaning procedure
18. 16.12 (c and d)
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
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. 16.12(e)
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
21. 16.12(f, h and i)
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
22. 16.12(g)
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)
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
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 required when 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
