ISO Classes
The ISO classification associated with the primary engineering controls.
What is ISO 5?
This is the correct first step of garbing upon entering the ante-room in a cleanroom suite.
What is donning shoe covers?
This is the practice of preventing contamination during sterile compounding.
What is aseptic technique?
This category of CSP has the shortest BUDs and may be prepared in an SCA.
What is Category 1?
Type of PEC used in the lab downstairs.
What is a horizontal laminar airflow workbench?
The ISO classification associated with the buffer room.
What is ISO 7?
These must be sanitized with sterile 70% IPA throughout compounding.
What are gloves?
These are the most contamination-prone parts of a syringe and must remain sterile.
What are the syringe tip and plunger shaft?
This CSP type must begin administration within 4 hours and is made outside ISO Class 5 conditions.
What is an immediate-use CSP?
This is used to disinfect gloves and surfaces during compounding.
What is sterile 70% IPA?
The ISO classification associated with the anteroom.
What is ISO 8?
This is required under USP <800> but not always under USP <797> when compounding sterile products.
What is double gloving (chemotherapy gloves)?
This airflow concept refers to the uninterrupted stream of HEPA-filtered air that must reach critical sites.
What is first air?
This is the maximum BUD for Category 1 CSPs at room temperature.
What is 12 hours?
This PEC provides personnel and environmental protection in addition to product protection.
What is a biological safety cabinet (BSC)?
The order of cleanest area to dirtiest for these 3 things. PEC, Anteroom, Buffer Room.
What is PEC, Buffer Room, Anteroom?
In a USP <797>-compliant sterile compounding environment, the secondary engineering control (SEC) must maintain this type of pressure relative to adjacent areas to minimize contamination.
What is positive pressure?
This is the MOST common source of contamination in sterile compounding.
What is personnel (human contamination, touch contamination)?
In the absence of passing sterility test, the storage period for Category 2 CSPs stored at room temperature.
What is 4 days?
Cleaning in the PEC should proceed in this direction to avoid contamination.
What is from cleanest to dirtiest (or top to bottom/back to front)?
This is the maximum allowable number of ≥0.5 micron particles per cubic meter of air in an ISO Class 5 environment.
What is 3,520?
The correct order for donning PPE.
What is shoe covers, hair cover, beard cover if applicable, wash hands, gown, gloves, wash hands?
This distance guideline helps minimize airflow disruption near critical sites.
What is 6 inches?
This storage condition allows Category 2 CSPs the longest BUD of 45 days.
What is frozen?
This is the overarching goal of USP <797> that connects aseptic technique, environmental control, personnel training, and documentation.
What is ensuring patient safety through sterility and prevention of contamination?