Autoclave Validation Equipment
Autoclave validation is required for all machines used for biological sterilisation, in the biomedical and pharmaceutical industries within the FDA, WHO & EU controlled areas. This critical process is commonly scrutinized by quality control auditors and regulators due to it's impact on product safety and overall quality. We understand the importance of ensuring that the thermal qualification process is accurate, consistent and repeatable. In order to deliver this a high specification of autoclave validation equipment is required. There are two main types of autoclave validation equipment- a wired sensor system that involves the use of thermocouples or the use of dedicated data loggers for sterilisers.
The Kaye equipment has long been associated with thermal validation in the pharmaceutical manufacturing industry, so reliable is the Kaye Validator 2000 that it is sometimes specified in SOP's. We support the full range of Kaye equipment including UKAS accredited calibration of the Kaye validator and the production of made-to-measure thermocouples. We also offer rental of the Kaye Validator to cover additional project requirements and plant commissioning.
We are also official distributors of DataTrace equipment, they offer a range of compact, wireless data loggers for sterilisers. These wireless data loggers significantly speed up qualification preparation and also offer additional benefits such as in-study live data. We are seeing a movement towards wireless systems by some of the largest manufacturers-speak to us today to understand whether these loggers are suitable for your needs.
Data loggers for sterilisers
We stock a range of data loggers and temperature monitoring equipment therefore our advice is always independent and will be tailored to your needs. We are specialists in temperature and humidity and our engineers will consider several things before making a recommendation. They will consider your measurement parameters, number of measurement locations, the purpose of the monitoring and it's impact on your entire operation, IT infrastructure and many other factors.
Two of our brands lend themselves to this type of application, we have summarised them below and included links to the product pages to discover more about the technical specifications.