Contamination Control Flashcards
What is the difference between Non-sterile vs. Sterile products?
Non-sterile products:
- Limited microbial burden
- Absence of “objectionable” organisms (e.g. E. coli, Salmonella)
- Products include oral, topical, nasal, oitc, vag & ass
Sterile products:
- Free from micro-organisms, pyrogens & particulates
- Safe, Stable & Therapeutically effective
- Acceptable quality for administration to the patient
Define sterilisation
A process intended to kill or remove all micro-organisms (with an acceptable low probability of an organism surviving) e.g. 1 in a million
List two things that product sterility depends on
- Contamination control and sterility assurance procedures and practices
- Knowledge, skills and attitude of staff
Identify 8 sources of contamination
1) Air
2) Surfaces
3) Operator
4) Equipment
5) Containers
6) Drugs
7) Excipients
9) Vehicle (water)
What are some contamination control of area methods(6)
1) Segregated
2) Limited and authorised entry
3) Operational arrangement
4) Sterile production cleanrooms
5) Maintenance and monitoring
6) cGMP standards
What are some properties of a cleanroom that controls its contamination?
- Class 3.5, 350, 3500
- Positive pressure differential
- Air supply via HEPA filter
- Constant flushing of room with clean air
- Smooth impervious surfaces
What are some differences between Horizontal Flow Cabinet and Down Flow Cabinet?
Horizontal:
- Unidirectional horizontal air flow, with the cleanest zone being the Inner zone (closest to the HEPA filter)
- Protects the product FROM the operator
- Compounds non-toxic sterile products
Vertical (Down):
- HEPA filtered vertical air flow (downwards)
- Protects the product AND protects the operator from contamination
- Aseptic preparation of Cytotoxic drug
- Glass shield covers
- Cytotoxic cleanroom has negative pressure than the cytotoxic anteroom (airlock)
Describe the 3 zones of the Horizontal flow LFC and their purpose
Inner zone:
- Closest to the HEPA filter (cleanest zone)
- Set up of sterile work items
- Avoid shadowing of critical areas
Middle:
- For aseptic assembly
Outer:
- Finished and seal product
List 3 monitoring methods of LFC
1) Air flow tester
- to show air currents/pattern
2) Smoke test for HEPA filter leaks
- 0.5 micron particules
3) Microbiological monitoring
- Air sampling
- Surface sampling
- Sterile and Fertile nutrient agars
List some ways contamination can be reduced in an operator
- Hand washing
- Gowning procedure
- Aseptic techniques
- Training and checks
- Report medical conditions
- Remove cosmetics and jewellery
What are some container considerations? (5)
- Not interact with the fill contents
- Not generate particles or pyrogens
- Not retain any ingredients from the product
- Not release any substances into the product
- Heat stable for heat sterilisation
List 3 sterile manufacturing methods
1) Terminal Sterilisation
2) Aseptic Filtration
3) BFS - Blow Fill Seal technology
What are some main differences between terminal and aseptic filtraions
Terminal:
- Filtration with 0.45 micron filter and sealing in LFC
- Sterilisation of finished product in HEAT steriliser
Aseptic:
- Strict aseptic techniques (e.g. sterile equipment, containers, etc) where WFI must be used
- Sterilisation by filtration with a 0.22 micron filter
Both:
- Sterility testing of the finished product
List 8 contamination control in sterile dispensing
- Clean rooms
- Air quality
- Pressure differentials
- Operator and clean room procedures
- Equipment/containers
- Method of sterile manufacture
- Quality control of water
What are two readily applied checks of water quality?
- pH testing
(For acidity or alkalinity) - Conductivity testing
(For ion load of +ve or -ve ions)
