Aseptic technique: Personnel Flashcards
What are some aseptic compounding requirements?
Facilities
- Validated for the protections necessary
- Check the certificates
Currently validated operators
- For the tasks to be done
Correct Equipment
Validated and Documented Procedures (SOPs)
- Up-to-date; evidence that they are used
Quality Control Documentation
- Records for periodic review or for incident evaluation
What are some requirements for the personnel preparation in a sterile area?
- Only the minimum number of personnel required should be present in clean areas –> particularly important during aseptic processing
- Inspections and controls should be conducted outside the clean areas as far as possible
- All personnel employed in such areas should receive regular training in disciplines relevant to the correct manufacture of sterile products
- Wristwatches, make-up and jewellery should not be worn in clean areas
Bacteria Containing Particles (BCP) released every minute gives a “shedding rate”. What affects the shedding rate?
Clothing affects dispersal
- physical barrier to release into room
- Low activity –> tight gown (LEAST AMOUNT OF BCP)
- High activity –> loose garments (MOST AMOUNT OF BCP)
Gender affects dispersal
- males are more heavily colonised than females
- males usually larger (more skin area)
- average 3.5X higher release by males compared to females
What should be applied to contact areas of gloves whenever nonsterile surfaces such as vials and countertops are touched
70% IPA (isopropyl alcohol)
Before compounding, personnel should scrub hands and arms to the elbows with an appropriate cleanser. Provide 3 reasons WHY.
Surfaces under fingernails –> harbor high concentrations of bacteria
Artificial nails –> harbor G-ve pathogens (more than natural nails)
Wet hands –> transfer more bacteria to various surfaces than thoroughly dried hands
After hands and arms are scrubbed using alcohol-based antimicrobial in the clean area, what is done?
- Dry hands and arms
- Use sterile powder-free gloves with sterile 70% isopropyl alcohol
- Repeatedly apply sterile 70% IPA to contact areas of gloves whenever nonsterile surfaces are touched (vials. countertops, carts)
Why can’t normal soaps be used for handwashing? What antimicrobial ingredients are used as hand-washing products instead?
Plain soaps have minimal antimicrobial activity
Antimicrobial ingredients
- Isopropyl and ethyl alcohol hand rinses, gels. or foams
- Chlorhexidine gluconate
- Chloroxylenol
- Iodophors
- Quaternary ammonium compounds
- Triclosan
What does the term aseptic technique mean?
- Product protection from contamination
- LAFW is an example of where this is done
What does the term personnel protection mean? Provide a few examples
Requirement when the article is a biohazard to the operator
- Cytotoxic drugs and microorganisms
- Biological safety cabinets class I and II are an example of where this is used.
What is the difference between Class I and Class II biological safety cabinets?
Both protect the human but class II protects the product
ISO CLASS 7
What should vials be swabbed with before needle entry? How should the needle be inserted?
All vials should be swabbed with 70% isopropyl alcohol before needle entry and left to dry
- When vials are pierced with needles, the needle should be inserted so that the rubber closure is penetrated at the same point with both the tip and heel of the bevel
- Needle should be at angle –> non-coring method
What is the process for sterilizing an ampoule?
- Solution visible in the top portion should be moved to the bottom before an ampoule is opened
- Its neck should be swabbed with alcohol and the swab should be left in place
- Ampoule should not be opened toward the HEPA filter of the LAFW or toward other sterile products within the workbench –> will disrupt the airflow if there are droplets that are dispersed
- Open ampoule facing the side of the LAFW to avoid this from happening
What is the term first air refer to?
Clue: In the use of LAFW
The critical principle in the use of LAFWs is that nothing should interrupt the airflow between the HEPA filter and the sterile object. The Sterile object should receive the ‘First Air’.
LAFW = workflow bench
What is the critical area/site?
Critical area: central location for performing sterile manipulations which should be a laminar flow, ISO 5 environment
Critical area: sterilised drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility
A location that includes any component or fluid pathway surface (injection ports, beakers) or openings (e.g. opened ampoules, needle hubs) exposed and at risk of direct contact with air or touch contamination. The risk of microbial particulate contamination of critical sites increases with the size of the openings and exposure time.
What does the zone of turbulence refer to? How to prevent this?
Large materials placed within the LAFW can disturb the patterned flow of air from the HEPA filter
- This “zone of turbulence” created behind an object could extend outside the workbench, pulling or allowing contaminated room air into the aseptic environment.
- Prevention: spaced products out to avoid turbulence and reduce the size of products
