What is CACI in compounding?
Compounding Aseptic Containment Isolator (CACI) provides a safe and clean environment for compounding of hazardous, sterile drug preparations in compliance with USP 797 and 800 criteria. It is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications.
What is the current version of USP 797?
The currently official <797>, last revised in 2008, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals.
Can you eat in the ante room?
Eating, drinking, and gum chewing are allowed in the ante area but not inside the buffer area surrounding the laminar air flow workbenches.
What does USP 797 cover?
USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.
What is the difference between CAI and CACI?
Compounding Aseptic Isolators (CAI) are used to protect product. Compounding Aseptic Containment Isolators (CACI) are used to protect product and personnel. The “containment” part of the name refers to the negative pressure environment that is needed when compounding hazardous drugs.
What is the airflow direction in CACI?
The system is equipped with a unidirectional airflow with positive/negative pressure with respect to the lab environment.
What is the difference between USP 797 and USP 800?
The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.
Which piece of garb should be donned first?
Garbing is done from dirtiest to cleanest. Shoe covers, hair and beard covers, and the face mask are donned first. If an eye covering is used, it is also one of the first items donned.
What ISO Class is ante room?
Anteroom (ISO 7 or 8) The anteroom, also called ante-room, ante-area or antechamber, is a closed passage between the cleanroom and the support zone in which technicians perform support tasks (gowning, hand and forearm hygiene, labelling, etc.).
Why is USP 797 important?
The intent of USP 797 is to prevent patient harm and death through minimum practice and quality standards expected of any entity or individual involved in storage, handling, preparation and transportation of CSPs.
What are the requirements for USP 797-garbing and donning?
USP 797 2019 – Garment Requirements – (Revision Bulletin) (Pg. 7) Any person entering a compounding area must be properly garbed in accordance with the facility’s SOPs. Garb must be donned and doffed in an order that reduces the risk of contamination.
What’s the difference between a Cai and a CACI?
Only a CACI is used for compounding hazardous drugs, not to be confused with a CAI which is only used only for nonhazardous drugs. An area with defined particle and microbiological cleanliness standards.
Do you need sterile compounding gloves for USP 797?
USP 797 Sterile Compounding Requires: All gloves must be sterile and IPA compatible Sterile USP-grade Isopropyl alcohol or is required for intermittent disinfection of gloves. Allow 30 seconds of air drying for isopropyl alcohol kill time before resuming.