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Questions and Answers
Why are spores difficult to destroy with autoclave?
Why are spores difficult to destroy with autoclave?
What is the mechanism of action behind dry heat sterilization on microbial proteins?
What is the mechanism of action behind dry heat sterilization on microbial proteins?
Why is pasteurization not effective in destroying spores?
Why is pasteurization not effective in destroying spores?
What characteristic makes spores resistant to destruction with autoclave?
What characteristic makes spores resistant to destruction with autoclave?
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Why does dry heat sterilization require higher temperatures for shorter exposure times?
Why does dry heat sterilization require higher temperatures for shorter exposure times?
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Which method would be most effective for destroying spores in solutions and water?
Which method would be most effective for destroying spores in solutions and water?
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Study Notes
USP 797 Guidelines
- Outlines standards for compounding sterile preparations (CSPs) in healthcare settings.
- Ensures the safety and effectiveness of sterile drug preparations.
Controlled Environments
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ISO Class 5 Primary Engineering Control:
- Maintains a highly controlled environment for aseptic compounding.
- Minimizes airborne particulates to protect CSPs.
-
ISO Class 7 Positive Pressure Buffer Area:
- Area around the primary engineering control that provides an additional layer of sterility.
- Ensures airflow is maintained to prevent contamination.
-
ISO Class 8 Positive Pressure Ante Room:
- Transitional area leading into the cleaner environments.
- Supports the transfer of materials while minimizing contamination risks.
Risk Levels of Compounding Sterile Preparations (CSPs)
- Divided into three distinct risk levels according to the likelihood of contamination:
- Low-risk: Simple manipulations, involving sterile ingredients and no more than three products.
- Medium-risk: Complex manipulations, pertaining to multiple doses or prolonged compounding processes.
- High-risk: Involves non-sterile ingredients or environmental conditions posing high contamination risks.
Temperature Conditions
- Room Temperature: Ranges from 20°C to 25°C.
- Cold Temperature (Refrigerated): Maintained between 2°C to 8°C.
- Freezer Temperature: Ranges from -25°C to -10°C for storage.
Drug Administration Routes
- Fastest to Slowest routes of drug administration:
- Intravenous (IV)
- Intramuscular (IM)
- Subcutaneous (SC)
- Oral
Sterilization Techniques
- Sterile pharmaceutical products can be achieved through aseptic technique or terminal sterilization.
-
Autoclave (Steam Sterilization):
- Uses steam under pressure to eliminate microorganisms.
- Effective method for ensuring the sterility of equipment and materials.
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Description
Test your knowledge on USP 797 regulations, ISO Class requirements, risk levels of compounding sterile preparations, and drug administration routes. Explore topics like primary engineering controls, temperature requirements for sterile preparations, and the hierarchy of drug administration routes from fastest to slowest.
