AS 2252.5:2017 PDF
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Controlled environments, Part 5: Cytotoxic drug safety cabinets (CDSC) – Design, construction, installation, testing and use
Standards Australia , 07/27/2017
File Format: PDF
- Description
Description
AS 2252.5:2017 PDF
The objective of this Standard is to specify the basic requirements for cytotoxic drug safety cabinet (CDSC) design, construction, installation, testing and use.
These are open-fronted safety cabinets which are primarily designed to be used with substances that are incapable of gaseous inactivation. The design of the CDSC provides greater protection to maintenance personnel than is possible with a Class II biological safety cabinet. CDSC design provides protection to the operator via an air barrier provided by an inward flow of air, protection to the product via a top-mounted fan and HEPA filter that provides clean, unidirectional air to the work zone of the cabinet and protection of maintenance personnel by a HEPA filter under the work zone that protects the cabinet internals from contamination.
A CDSC is designed to provide both an aseptic environment and containment of cytotoxic materials. It should be noted however that not all processes that occur within a CDSC are aseptic, such as work with prions (as specified in AS 2243.3) or other non-sterile processes where cytotoxic materials are potentially exposed.
NOTE: Appendix C deals with the use of CDSC with prions in microbiological containment laboratories.
Further to this, some processes will require regulation by local or national health authorities which may require additional testing, monitoring or enhanced design features.
