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Basic Principles of GMP. Sanitation and Hygiene. Section 3. 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

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Basic Principles of GMP

Sanitation and Hygiene

Section 3

sanitation and hygiene
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
sanitation and hygiene3
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

sanitation and hygiene4
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

basic principles of gmp
Basic Principles of GMP
  • Written procedures and instructions - to wash hands before entering production areas
  • Some also use disinfectants

11.1 - 2

basic principles of gmp6
Basic Principles of GMP
  • Wash hands before entering production areas
  • Signs in areas (e.g. changing rooms)

11.1 - 2

sanitation and hygiene7
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

sanitation and hygiene8
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

sanitation and hygiene9
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

basic principles of gmp10
Basic Principles of GMP
  • Toilets should not open directly into production or storage areas

12.12

sanitation and hygiene11
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

sanitation and hygiene12
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

basic principles of gmp13
Basic Principles of GMP
  • Protection from insects, birds, vermin and weather
    • from receipt of raw materials to dispatch of released product

12.9

sanitation and hygiene14
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

basic principles of gmp15
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
sanitation and hygiene16
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)

sanitation and hygiene17
Sanitation and Hygiene

Avoidance of Cross-Contamination (3)

  • Campaign production:
    • Separation in time
    • Followed by appropriate cleaning
    • Validated cleaning procedure

16.12(b)

sanitation and hygiene18
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)

basic principles of gmp19
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
sanitation and hygiene20
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)

sanitation and hygiene21
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)

sanitation and hygiene22
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)

sanitation and hygiene23
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
sanitation and hygiene24
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
sanitation and hygiene25
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
sanitation and hygiene27
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

sanitation and hygiene28
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?

sanitation and hygiene29
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
sanitation and hygiene30
Sanitation and Hygiene

Possible Issues – II

Hygiene

  • Personal hygiene
  • Health checks
  • Dealing with health problems
  • Personal responsibility
  • Training records
  • Frequency of handwashing