Hygiene Master Plan Flashcards
what is the main aim of the hygiene master plan
protection of product, prevention from contamination of the product
Sources of contamination?
particulate, biological and chemical
Aims of HMP?
- Product quality (related to contamination)
- Health prevention of employees [when working with microorganisms or highly potent drugs] (and patients)
- Proper use and handling of cleaning agents and disinfectants
By general principles
- Definition of the material and personnel flow
- Definition of processes
- Premises and installations
Responsibilities
•
Head of manufacturing
•
Head of quality control (for laboratories)
personnel hygiene, source of contamination?
Clothing, hygiene behaviour, process behaviour and health status
clothing concept?
the higher the requirements on the product, the higher the requirements on clothing
clothing concept?
Directly correlated with zone division
It has to be defined, if clothes have to be changed when entering a new zone
For each zone questions regarding the related clothing rule have to be answered:
Clothing –technical aspects to be considered
Particle emission, Filtration quality, Wear properties,Electrostatic behaviour,Stability,Costs
Testing particle emission of clothing?
ASTM-F51-68 Method (Standard Test Method for Sizing and Counting Particulate Contaminant in and on Clean Room Garments)
HelmkeDrum Test (Garment System Considerations for Cleanrooms and Other Controlled Environments)
Hygienic hand disinfection defined where?
EN 1500
Chemical disinfectants and antiseptics –Hygienic handrub–Test method and requirements
what is importance in developing a hygiene training?
RA and time and content of the hygiene training
Sourcesof contamination in production
Raw materials, pharmaceutical gases ambient air aids packaging material processess personnel surfaces
Clean zone concept as preventive measure (EU-GMP-Guideline Part I chapter 3,)
- minimizing the risk of contamination
- maximizing protection against the entry of insects or other animals
- prevent the entry of non-authorized people
Clean zone concept as preventive measure (Physical barriers protect)
processes and products
•air pressure and air exchange rate
•lock systems for personnel
•lock systems for material
Clean zone concept
A: environment for most critical processes (fillings of sterile products, aseptic production)
B: background environment for A
C and D: environment for less critical processes
Pressure cascade
In operation:
ΔP betweensubsequent zones: 10-15 Pa
The cleaner the zone, the higherthe pressure*
Pressure is monitored in real time
At rest:
Pressureis reduced but cascade is kept
the contaminat carrier in the clean zone concep is?
…human involvement is reduced
…the use of the equipment is reduced
…the use of air is regulated
…the use of water is regulated
Disinfectants important to state?
“The effectiveness of disinfectants and the minimum contact time on different surfaces should be validated.”
Factors influencing efficacy of disinfectants
• Temperature of the solution • Effective concentration of the solution • pH value • Saturation and penetration into the cell membrane of microorganisms • Contact time • Contaminants
General cleaning processes?
dry cleaning
cleaning
rinsing
drying
Beside considering:
- Hygiene design when rooms are planned and built
- Cleaning of installations
- Cleaning concepts
Mind the following aspects:
• Condensation points in premisesand installations • Use dust collecting mats in locks • Check wall, floor, ceilings regularly • Check sealing between wall and floor etc. • Pest control
Background of each hygiene plan?
identification of a risk
risk analysis and assessment
Risk control
documentation and evaluation
Identification of a risk
- Contaminants from processes and cleaning
- Direct and indirect ways of contamination
- Physico-chemical properties
Risk analysis and assessment
• Effectiveness and reproducibility of a cleaning process • Hygienic plant design • Environmental influences
Risk control
• Controlling the cleaning process • Verifying the cleaning success • Environmental monitoring
Room cleaning protocols should include information regarding
- The room - If action is cleaning or disinfection - What object is addressed (wall? Floor? Ceiling,…) - Lot numbers of cleaning agent and / or disinfectant - Signature of the cleaning person - Signature of the controlling person
Overall hygiene status should be checked by
• Evaluating Monitoring results • the documentation of the premises • Regular sanitary inspections
Adequate limits for warning levels
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For sterile production see: EU GMP guidance I
•
For non-sterile products: levels of action have to be defined