Questions and Answers
The ____________________________ sets the standards for air quality, which is determined by the number of particles per volume of air of a specified particle size.
International Standards Organization (ISO)
The _____________ the particle count, the cleaner the air.
lower
The farther away from the primary engineering control (PEC), the __________ the air.
dirtier
The Primary engineering control (PEC) must be at least ISO ____
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The buffer area (the air in the room around the PEC) must be at least ISO ____
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The ante area (adjacent to the buffer area, where hand washing and garbing is done) must be at least ISO ___ if it opens into a positive pressure buffer area.
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The ante area (adjacent to the buffer area, where hand washing and garbing is done) must be at least ISO ___ if it opens into a negative pressure buffer area.
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CSPs can be prepared in a primary engineering control (PEC) located in a buffer area and an ante area with at least ____ air changes per hour.
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BUDs are determined by the risk of contamination. The _________ the risk, the longer the BUD.
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The primary engineering controls are the hood or isolator that provides the ______________ environment for preparing CSPs.
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The laminar airflow workbench (LAFW) is the most common PEC used for preparing ___________________ CSPs.
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Classification of how clean the air is depending on the number of particles present per volume of air. The smaller the number, the cleaner the air.
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The area where the PEC is located. It is sometimes called the IV room since most hospital pharmacies make only IV CSPs. The buffer area must be at least ISO 7.
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The space directly adjacent to the buffer area where non-sterile activities related to sterile compounding are performed, such as reviewing orders, storing sterile drug stock and equipment, garbing and hand washing.
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The net airflow is flowing inward (e.g., into the hood/room) in order to protect the staff from toxic drug fumes. The air is vented to the outside. Required for preparing HDs.
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The net airflow is flowing outward (e.g., out of the hood/room) to prevent contamination of the CSPs. ______ is used for preparing non-HD CSPs.
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________________________ drugs: use compounding aseptic containment isolators (CACIs), which have negative pressure.
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__________________________ drugs: use compounding aseptic isolators (CAIs), which have positive pressure.
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Passing the ______________________ requires ____ consecutive gloved fingertip samples with _______ CFUs for both hands.
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The gloved fingerprint test is required at initial training and on an ongoing basis (annually for personnel who compound low- and medium-risk CSPs and _______________ for those who compound high-risk CSPs).
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The evaluator will collect a gloved fingertip sample from both hands of the personnel onto _______________________ plates by lightly pressing each fingertip onto the agar.
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The ___________________ is used to evaluate the aseptic technique.
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Media-fill testing must be performed at training (before preparing any CSPs) and at least ____________ for low- and medium-risk level compounding and semiannually for high-risk level compounding.
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Surfaces should be cleaned with a germicidal detergent and disinfected with ________________________.
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Study Notes
Air Quality Standards
- Air quality standards are set by the International Standards Organization (ISO).
- Cleaner air is indicated by a lower particle count.
- Air quality decreases with distance from the primary engineering control (PEC).
ISO Classifications
- PEC must meet ISO Class 5 standards.
- Buffer area must meet at least ISO Class 7 standards.
- Ante area requires ISO Class 8 if it opens to a positive pressure buffer area, and ISO Class 7 for negative pressure.
Air Changes and BUDs
- Cleanroom must have a minimum of 30 air changes per hour.
- Beyond contamination risk, a lower risk allows for longer beyond-use dates (BUDs).
Primary Engineering Controls
- Primary engineering controls include hoods or isolators that maintain an ISO Class 5 environment for compounding sterile preparations (CSPs).
- Laminar airflow workbench (LAFW) is common for preparing non-hazardous CSPs.
Cleanroom Designations
- Buffer area, also known as the IV room, primarily produces intravenous CSPs and must meet ISO Class 7.
- Ante room allows for non-sterile activities near the buffer area.
Airflow Dynamics
- Negative pressure systems protect staff from hazardous drug fumes by drawing air inward.
- Positive pressure systems prevent CSP contamination by expelling air outward.
Compounding Aseptic Isolators
- Hazardous drugs utilize compounding aseptic containment isolators (CACIs) with negative pressure.
- Non-hazardous drugs use compounding aseptic isolators (CAIs) that maintain positive pressure.
Testing and Aseptic Technique
- The gloved fingertip test involves three consecutive samples with zero colony-forming units (CFUs).
- Required initial training and annual testing for low- and medium-risk compounding; semi-annual for high-risk compounding.
- Trypticase soy agar (TSA) plates are used for sampling.
Media-Fill Tests
- Media-fill testing evaluates aseptic technique, done at initial training and periodically (annually for low/medium-risk and semi-annually for high-risk).
Cleaning Protocol
- Surfaces must be cleaned with a germicidal detergent and disinfected using 70% isopropyl alcohol (IPA).
Segregated Compounding Area
- The segregated compounding area (SCA) has controlled air quality but specific standards for preparation are detailed elsewhere.
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Description
Test your knowledge on cleanroom standards, air quality measures, and ISO classifications. This quiz covers the necessary air changes, engineering controls, and designations required for maintaining sterile environments in compounding sterile preparations. Assess your understanding of air quality and engineering controls relevant to pharmaceutical settings.
