Compounding Aseptic Isolators
Compounding Aseptic Isolator (CAI) refers to several types of glovebox-type engineering controls that have different design characteristics and uses. There are also design differences that affect the staging, aseptic, and sanitizing techniques that are required to operate these designs safely and effectively. Isolator designs vary in both pressurization and supply airflow characteristics. A recent study recommends the sole use of laminar airflow CAI designs in CSP compounding as the equivalent of a Laminar Airflow Device (LAFW) and discourages use of turbulent airflow designs due to the demonstrated comparative inefficiency of the turbulent airflow methodology. Learn more about this study.
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A Compounding Aseptic Containment Isolator (CACI) is necessary for the compounding of hazardous drugs. The designation Class III Biological Safety Cabinet (BSC) also applies to certain specific glovebox isolator designs, but not to others.
Selecting a CAI or CACI
The CAI or CACI should be carefully selected, installed, certified, operated, and maintained in accordance with specific policies and procedures. It is essential work-streaming and waste-streaming factors be carefully analyzed prior to incorporating a CAI into the CSP workflow. While the CAI purports to isolate and protect CSP compounding operations, there are numerous factors which bear upon its effective operation including:
- proper cleaning of the CAI interior
- proper pre-cleaning of supplies and components
- limited throughput volume
- workflow conflicts
- back strain associated with continued use
- space constraints.
These important factors should be considered prior to incorporating these designs into your CSP compounding practice.
A barrier isolator may be pressurized either positively or negatively. Positive pressurization assures air will flow out of any opening or structural/seal breach in the isolator’s exterior, thus preventing inward leakage and contamination of the working materials. A positively pressurized CAI is not acceptable for use in compounding hazardous substances. In order to protect the user and environment, a negatively pressurized CACI assures air will flow inward rather than outward through any opening or leak in the isolator's exterior. Dedicated, negative-pressure CACI designs should be used for compounding hazardous substances but are not desirable for non-hazardous sterile product compounding. Some models are available in either configuration; however, operation should be established at the time of manufacture and should not be changed following acquisition by the operator due to potential product cross-contamination issues.
Compounding Aseptic Isolators: Design, Installation, Operational, and Performance Qualifications
Understand the USP <797> mandate, and select the CSP Preceptor.