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sterile products
Chapter 2
| Question | Answer |
|---|---|
| The area in which the compounding will take place is referred to as | the clean room |
| The mandatory requirements and related suggestions appear in good professional guidelines such as those provided by the? | America Society of Health Systems Pharmacists(ASHP) |
| 4 key factors contribute to the preparation of high quality sterile products | *facilities * environmental control * components *operators |
| The area that is to be set up for compounding should have limited ____________________ and airflow______________ | traffic and unrestricted |
| considerations for the clean room should include at least these 8 items | *laminar airflow hood*provide proper storage for drugs and supplies*temperature*light*moisture*sanitation*ventilation *security |
| room located outside the clean room, where gowning and handwashing take place, also no drinks/food/low particulate | anteroom |
| what 3 things are highly regulated for a clean room | *air quality *temperature *humidity |
| Federal Standard 209D clean room air quality standards *class 10,000 | no more than 10,000 particulates larger than 0.5 micron in any given cubic foot of air |
| Federal Standard 209D clean room air quality standards *class 1000 | no more than 1000 particulates larger than 0.5 micron in any cubic foot of air |
| Federal Standard 209D clean room air quality standards *class 100 | no more than 100 particulates larger than 0.5 micron in any given cubic foot of air |
| how many doors does a clean room have | 1 |
| what is a positive pressure room | when the door is open, the air flows out of the room |
| usp 797 criteria for proper set up of aseptic preparations help evaluate these 8 areas | *facility design*microbial contamination risk levels*personal training and evaluation*clean room atmosphere*proper dress*quality assurance*validation*monitoring |
| what are the 2 types of air flow hoods? | *Laminar Airflow Hood(LAH) **Biological Safety Cabinet(BSC) |
| What are the 2 functions of the air flow hood | *to filter bacteria and other particulate matter from the air *to maintain a constant airflow out of the hood to prevent entry of any of the contaminants |
| RE: LAH where is the prefilter located ?? | front |
| RE: LAH when should the prefilter be changed | monthly |
| RE: LAH the HEPA filter removes particles that are what size | 2 microns and larger |
| how many times should a HEPA filter be tested for efficiency | Every 6 months |
| which air flow hood has 4 sides and a 8 to 12 inch opening in the front/also a sliding glass window in the front | BSC Biological Safety Cabinet |
| in this air flow hood the HEPA filter filters the air to 0.3 micron | BSC |
| a thorough cleaning of the hood should be done at least every ____ hrs or when it gets dirty | 8 |
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