asepsis 2 Flashcards
what methods are used to assess risk of microbial contamination?
–Hazard analysis critical control points (HACCP)
–Failure mode and effects analysis (FMEA)
–Fault tree analysis (FTA)
–And many others
what are the 7 principle of HACCP?
- Perform hazard analysis and identify preventative measures for each stage
- Determine Critical Control Points (CCP)
- Establish target levels and critical limits
- Establish a monitoring system of CCPs
- Establish what corrective action occurs when something goes wrong
- Establish a verification system to make sure its working properly
- Establish a record keeping system
what are the 4 grades for the manufacture of sterile medicinal products?
- Grades C and D:Clean areas for carrying out less critical stages in the manufacture of sterile products.
- Grade B:In case of aseptic preparation and filling, the background environment for grade A zone.
- Grade A:The local zone for high risk operations, e.g. filling zone, stopper bowls, open ampoules and vials, making aseptic connections.
what class of ISO is the cleanest?
class 1 is the cleanest and class 8 is the least clean
what classes of ISO correspond to the WHO/EU grades?
ISO 5= A/B
ISO 7=C
ISO 8=D
What is a cleanroom?
A cleanroom is a contained space where airborne particulates are controlled and environmental conditions controlled as needed
what is important in a clean room design?
design and layout?
floors,walls and ceilings: coated with chemically resistant materials
•All exposed surfaces are smooth and sealed to minimize accumulation of dirt
•Equipment and fixtures may be on movable surfaces to facilitate cleaning
what are the general considerations when designing a cleanroom?
- Air-locks: buffer zone prevention of contamination entry of all substances/personnel into a clean room must occur via air-lock systems
- An interlocking system: System which ensures that doors are never open at the same time
- Can be mechanical(at high risk areas) or an alarm(at lower risk areas)•Stops a direct connection between dirty and clean areas
- Separate entries and exits: For personnel, raw materials, and products
how are personnel a major source of potential contaminants?
microbes that humans carry
- normal talking can emit 1-50 particles per second
skin sheds 28-85mg of skin per hour
how do we reduce the risk of people contaminating the clean room?
- Ensure staff are adequately trained
- Provide specialized protective equipment (sterile gloves, face masks etc)
- Minimize personnel in the clean area at any given time
what kind of airflows are used in clean rooms?
Airflow in cleanrooms use either HEPAor ULPA filters
•HEPA removes 99.95% of particles ≥0.3μm
•ULPA removes 99.999% of particles ≥0.1μm
what are the two possible airflow principles that the airflow and airlocks use?
- Laminar: unidirectional (horizontal or vertical), constant velocity•Can be influence/directed by walls curtains, machinery etc (created air turbulence)
- Turbulent: random directions, non specific velocities
what are the 3 main types of airlocks in pharma?
cascade, bubble and sink
how does airflow and airlocks work?
- Uses pressure differences between spaces to stop particles moving between areas (usually 10-15 Pa between areas)
- The difference between the 3 is the way the air is handled
how do we environmentally monitor cleanrooms?
Takes regular samples from the following based on the risk analysis;
•Physical (pressure, particles, temperature, relative humidity etc)
•Microbiological
•Personnel (gloves, nails etc)
•Surfaces (swabs, contact plates)
