Sterile manufacturing 3 - clean rooms Flashcards
What is the purpose of a pre-filter?
Pre-filtration of HEPA allows removal of coarse/large particles
- prolongs the survival of the expensive HEPA filter
What are the factors that affect filter efficiency?
Particle density
Velocity and mean free path of particle
Thickness of filter medium
Velocity, pressure and temperature of transporting gas
- air
Sizing and distribution of fibres within the filter medium
What are the design objectives for a cleanroom?
Exclusion of environment
- particles on operators
Removal/dilution of contamination from processes
- including operators
Containment of hazards from product/protection of operators
Optimum working conditions for operators
- lighting
- temperature
- humidity
Special environments for certain products
Effective monitoring of room conditions
What are the design objectives of cleanrooms?
Control and management of the flow of material through the process steps by means of layout and configuration
Control and management of operator movement by optimising the arrangement and connection of individual rooms
Overall security of the operation processes by control of the entry and exit of operators and materials
What is an isolator?
Free standing enclosures equipped with integral HEPA filtered air supply that allows employees to manipulate products using either flexible sleeves and gloves, or flexible suits that comprise part of one wall of the isolator
A containment device which utilises barrier technology for the enclosure of a controlled workspace
What concerns are there regarding the environment in an isolator?
Process risk
Barrier integrity
Manipulation technique
Transfer technique
Internal pressurisation
Sanitisation technique
Regulatory requirement
Give examples of constituents in a sterile injection
Active constituents
Antioxidants
Preservatives
pH adjusters
Isotonicity agents
Other additives
Diluents
- water for injections
Primary and secondary packaging
Labelling
Give examples of cleanroom clothing
Head cover
Mask
Body suit
- one piece
- two piece
Gloves
Overshoes
- dedicated shoes
What are the advantages and disadvantages of disposable vs recyclable clothes in a cleanroom?
Disposable - higher expense?
Recyclable - washing, drying, resterilisation
What are the properties of cleanroom clothes?
Pore size
Air permeability
Particle removal efficiency
- 0.5 um
- 5 um
What are the basic rules for working in a cleanroom?
Minimise number of people
No personal articles
- long nails
- jewellery
No illness
Know proper gowning technique
- never reuse a garment without re washing and resterilising
Once inside, cannot return to air lock and come back without re-gowning and resterilising
Know disinfection techniques
Clean up immediately
Use intercom for external communications
