Contamination Flashcards
What are the three types of contamination in Pharmaceuticals?
- Chemical
- Biological
- Bacteria, Fungal, Viral - Physical
What are the control measures to reduce risk?
Environmental controls
- Clean or aseptic preparation areas
• Clean room
• Laminar flow cabinets
• Isolators
• Air/water controls
Personal Controls
- PPE
- Hand Hygeine
Disinfection/Antisepsis
- Cleaning / disinfection of working environment/personnel
Sterilisation
- Destruction of potential contaminants prior to release
Preservation
-Reduces risk of longer term contamination and spoilage
How can the Risk of Contamination be reduced?
- Bunsen Burner
- Used for heat sterilising metal and glass tools on lab bench - Biosafety Cabinets
- Laminar Flow Cabinet
- Glovebox/Isolator
What are Grade C&D of an aseptic area?
Clean areas for carrying out less critical stages in the manufacture of sterol products
What are Grade B of an aseptic area?
In case of aseptic preparation and filling, the background environment for grade A zone.
What are Grade A of an aseptic area?
The local zone for high risk operations, e.g. filling zone, stopper bowls, open ampoules and vials, making aseptic connections.
What does HEPA Filtration stand for and what does it do?
High Efficiency Particulate Air Filteration
• Defined in US as removal of at least 99.97% of 0.3 µm diameter airborne particles
• EU has multiple classifications based on level of filtration
What are the two standards of water used in Pharmaceutical Manufacturing?
- Purified
- Water for Injection
What is the purified water used for?
Used for non-sterile applications
• Media preparation
• Basic preparations e.g cough syrup
What is Water for injection used for?
Water for injection (WFI) is used in sterile applications
• Stricter quality guidelines than purified water
• Endotoxin levels
