Hygiene

From the Greek word “hygies”(Hygiea- Goddess of Health)

Meaning “healthy, sound”

The origin of sanitary is the Latin word sanitas, or "health," from the root sanus, which means both
"healthy" and "sane."

Objectives

• Review measures to ensure good sanitation in:

ä Premises and personnel

ä Equipment and apparatus

ä 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

Personal Hygiene (1)

• Health examinations:

ä Before and during employment

ä Periodic eye examinations for those who do visual inspections

ä Training:

ä Practices in personal hygiene

ä Written procedures and instructions

ä Signs in areas
 ä Written procedures and instructions - to wash hands before entering production areas

ä Some also use disinfectants

ä Wash hands before entering production areas

ä Signs in areas (e.g. changing rooms)

Personal Hygiene (2)

• Illness or open lesions:

ä May affect the quality of products

ä Should not handle starting materials, intermediates or finished products, etc.

ä Instruction and encouragement to report to supervisors

• Direct contact between product and operator:

ä Should be avoided

ä Starting materials, primary packaging materials, intermediate and bulk product

Personnel Hygiene (3)

• Protection of product from contamination:

ä Clean clothes appropriate to personnel activities

ä Including hair covering (e.g. caps)

• Check change rooms/changing facilities

ä Hand washing, signs, drying of hands

ä Used clothing stored in separate closed containers while awaiting cleaning

ä Laundering of clean area clothing according to an SOP and in an appropriate facility

ä Procedure for disinfecting and sterilizing when required

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

• Toilets should not open directly into production or storage areas

Personnel Hygiene (5)

 • Personal hygiene procedures including wearing protective clothing apply to all persons entering
into production areas:

ä Full-time employees

ä Temporary workers

ä Contractor's employees

ä Visitors

ä Managers

ä Inspectors

Design of Premises

• Design

ä Walls, floors, ceilings, ledges, drains, air supply, dust extraction

• Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination

ä Cleaning programme, appropriate cleaning, cleaning records

• Effective cleaning and disinfection

ä choice of materials and chemicals, validation

• Drains – prevent backflow

• Protection from insects, birds, vermin and weather

-- from receipt of raw materials to dispatch of released product

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:

ä dust, gas, particles, vapours, sprays, organisms, residue, insects

Measures that can be taken to prevent cross-contamination also include:

l Segregated areas

l Ventilation systems

l Airlocks

l Clothing

l Closed processing systems

 l Cleaning and decontamination

Avoidance of Cross-Contamination (2)

• Dedicated and self-contained areas for:

ä Live vaccines

ä Live bacterial preparations

ä Certain other biological materials

ä Penicillin products

Avoidance of Cross-Contamination (3)

• Campaign production:

ä Separation in time

ä Followed by appropriate cleaning

ä Validated cleaning procedure

Avoidance of Cross-Contamination (4)

• Ventilation systems and airlocks

ä Appropriately designed ventilation system with air supply and extraction systems

ä Supply or incoming air should be filtered

ä Recirculation of air versus 100% fresh air supply

ä Proper airflow patterns

ä Pressure differentials

ä Appropriately designed airlocks

ä Appropriately designed ventilation system with air supply and extraction systems

ä Supply or incoming air should be filtered

• Detailed modules in the supplementary training deal with recommendations for HVAC systems

Avoidance of Cross-Contamination (5)

• Clothing

ä Protection of operator and product

ä Highly potent products or those of particular risk - need for special protective clothing

ä Personnel should not move between areas producing different products

ä Garments need to be cleaned

Avoidance of Cross-Contamination (6)

• Cleaning and decontamination

ä Procedure for removing soil and dirt

ä Remove all cleaning chemical residues or disinfectant residues

ä Remove and/or reduce micro-organisms

ä Validated (known effectiveness of the procedure)

ä Use cleanliness status labels

ä Test for residues

Avoidance of Cross-Contamination (7)

• Closed processing systems

ä For example: totally enclosed water purification systems

ä Tanks fitted with appropriate filtration - without

removable lids

ä Present special cleaning difficulties, sometimes use

clean-in-place (CIP)

Production Operations – Sanitation (1)

• Cleaning and cleaning validation

ä 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

ä 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

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

Production Operations – Sanitation (3)

• Maintenance and repair

ä activities inevitable in manufacturing area

ä 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

• 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

• Dealing with health problems

• Personal responsibility

• Training records

• Frequency of hand washing