Sterile Manufacturing 4 Flashcards
Layout of a terminally sterilised injectable cleanroom
Pressure cascade =
low quality where material initially comes in
Highest quality in filling / sterilisation room so need to minimise human beings in room ( have the lowest level required )
Layout of aspect of filling cleanroom
Risks are much higher as no terminally sterilised process and container is open
Need a filtration step
Need multiple changes between rooms before entering final area
Isolators
Free standing enclosures
Use for cytotoxic manufacturing full step
Quite spaced out and open area
Minimal equipment - only use what is required
Isolator environment concerns
How the operator will manipulate product (fixed position for a while) Barrier integrity Transfer techniques Internal pressurisation How to sanitise isolator
Pressure regulations
- positive pressure protects product
- Negative pressure protects operator
Product safety should always be paramount
Pharmaceutical formulation of sterile injection
Active ingredient Antioxidant Preservative pH adjuster Isotonicity agents Other excipients How to scale? Diluents e.g. water for injection Primary and secondary packaging Labelling = what environment is needed
Cleanroom clothing
Head cover Mask Body suit Gloves Overshoes Dedicated shoes Disposable = higher expense Recyclable
All these must be examined for
Pore size
Air permeability
Particle removal efficiency
Sterilisation
Clean every day
3 different colour codes = different types of antibacterial agents
Deep clean = shut down unit every now and then to complete
Sterilisation is far better than disinfection
Don’t want gas sterilisation agent to affect the properties of bag
Basic rules for working in cleanroom
Minimum number of people required No long nails, jewellery, illness Proper gowning techniques Can’t return to air lock and come back out without regowning and resterilising Clean up immediately Know how to disinfect
