Cytotoxic Standard Changes, Publication of AS2252.5.
Standards Australia has published a new document, AS 2252.5, which concerns the construction and performance validation for Cytotoxic Drug Safety Cabinet’s (CDSC’s). The aim of this letter is to provide you with a brief on some of those changes and how they may impact on your laboratory in the future.
AS2252.5 incorporates several key aspects of room design where previously this was contained in other standards. Notably, there is a requirement for a capture exhaust within the cytotoxic suite and certification requirements surrounding room pressures, air change rates and temperatures, to name a few. The standard draws these requirements from a number of source documents including ISO 14644 parts 1 & 3, AS 1668.2, HEPA standards and 1807 test method standards.
CDSC’s have carbon filters fitted in order to reduce the risk to the environment and personnel of potential gaseous contamination that could be generated within the work zone of a CDSC. It has been determined that the carbon filter, due to the nature of its use, is required to be replaced annually, at point of service. This is a significant cost to the regular annual certification process of any CDSC. The replacement of the carbon filter has been determined as necessary due to an inability to validate, on-site, the remaining adsorption capacity of the carbon within the media.
An ISO Class 5 cleanliness rating is required within the work zone of the CDSC. This test requires a technician to undertake particle counting within the work zone of the CDSC while the unit is ‘at rest’, the validating technician will be responsible for the reporting of the results. This is an additional process, beyond the current annual certification requirements, and will likely see an increase in service cost due to use of specialist equipment and labour.
Minor changes include a relaxation of sound level tests and lighting intensity tests. With the sound level range moving higher, to allow for a greater operating sound level and the lighting intensity reducing, to allow for lower lighting levels. This is in line with the requirements of AS2252.2, Class II Biological Safety Cabinet’s (BSC’s) and the tests are now considered optional.
In addition to the above, there are also a number of changes related to cabinet design. Those have been omitted from this document as it will have little impact on the annual certification of the equipment that you currently have in your laboratory.
For more information related to the above or if you would like to discuss further how these changes may impact on your facility, then please feel free to contact the AES team at your convenience.