Questions and Answers
What is the ISO air quality standard for critical areas exposed to sterile drugs?
What does BUD stand for?
Beyond Use Date
Which of the following is considered a Primary Engineering Control (PEC)?
The laminar airflow moves air in turbulent patterns.
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What is the function of a biological safety cabinet?
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Regular room air is considered ______ air.
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What type of recall is indicated by serious adverse health consequences or death?
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What is the role of HEPA filters in PECs?
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When preparing compounded sterile preparations (CSPs), hand hygiene should include washing hands and forearms for at least how many seconds?
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Match the following types of sterile products with their descriptions:
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Study Notes
ISO Air Quality
- ISO standards dictate air quality based on particle counts; cleaner air has a lower particle count.
- ISO 5 (3,520 particles/m³) must be maintained in critical areas where sterile drugs and containers are exposed.
- Buffer area requires ISO 7 (352,000 particles/m³); ante area adjacent to buffer needs adequate air change rates.
- Regular room air is classified as unclassified; HEPA filters maintain cleanliness by removing over 99.97% of particles ≥0.3 micrometers.
- Staff must clean Primary Engineering Controls (PEC) regularly before shifts, after spills, and every 30 minutes using 70% IPA and lint-free wipes.
Determining BUD
- Low-risk sterile compounding involves drawing sterile drugs in a sterile hood resulting in a Beyond Use Date (BUD) of 14 days if refrigerated.
Primary Engineering Controls (PEC)
- PECs create an ISO Class 5 environment; rely on HEPA filters to provide continual airflow that removes contaminants.
- Air pressure varies: positive for non-hazardous drugs and negative for hazardous drugs.
- Examples include laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), and isolators.
Laminar Airflow Workbench
- Common PEC used for non-hazardous compounding; features stainless steel for easy cleaning.
- Laminar airflow ensures particles do not collide, minimizing contamination risks.
- Cleanest working area is approximately 6 inches from the hood's front edge; airflow can be horizontal or vertical.
Sterile Compounding Definitions
- Biological Safety Cabinet: used for hazardous compounding; employs negative pressure for safety.
- CACI and CAI are types of isolators utilized in PECs for safe compounding.
- Positive pressure prevents contamination, while negative pressure protects staff handling toxic substances.
- Secondary Engineering Controls (SEC) provide additional air quality control in ante and buffer areas.
Recalls
- Procedures must exist for recalling high-risk compounded sterile preparations (CSPs) if sterility tests show contamination.
- Class I recalls involve serious health risks; Class II and III recalls involve temporary issues and unlikely harm, respectively.
Commercially Available Sterile Products
- Ampules are sealed and broken by snapping; require filtration upon use.
- Vials can contain liquid or lyophilized powder; the latter must be reconstituted with sterile diluents.
- Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs) are common IV solutions.
- Ready-to-use products are pre-packaged without CSP risk and have manufacturer-provided BUDs.
Sterile Compounding How Tos
- Preparation steps include reviewing orders, cleaning the hood, and visually inspecting the CSPs after compounding.
- Hand hygiene requires washing up to elbows for at least 30 seconds using appropriate soap.
- Garbing protocol involves multiple steps to ensure cleanliness, including wearing sterile gloves and gowns.
How to Clean the Hood
- Use lint-free sterile wipes; clean from top to bottom and front to back in a systematic order.
- Ensure the hood is operational at least 30 minutes prior to compounding to maintain air quality.
How to Transfer Solutions
- Swab vial tops with 70% IPA before puncturing with a needle—do not inject air into cytotoxic drug vials.
- Visual inspections should confirm the proper volume in syringes prior to further compounding processes.
How to Determine Risk Levels
- CSP risk levels are categorized as Low, Low non-HD, and Low and Medium HD based on environmental standards and manipulation types.
- Low risk includes specific criteria on equipment and ingredient usage, with limitations on the number of components and manipulation entries.
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Description
This set of flashcards focuses on key concepts in sterile compounding, specifically the standards set by the International Standards Organization (ISO) regarding air quality. It emphasizes the importance of maintaining ISO classifications in critical areas that deal with sterile drugs. Perfect for students and professionals in pharmacy and compounding.
