Autoclave Validation
Autoclave Validation for Biological Sterilisation
Finding the right autoclave validation equipment
As a predominant process in the pharmaceutical and biomedical industries, autoclave validation is strictly governed by the FDA, WHO & other bodies. This critical process is scrutinized by quality control auditors because it’s effect on product safety.
Autoclaving is the safeguarding process of destroying any bacteria, viruses and other microorganisms through sterilisation. To ensure that an autoclave is effective in preventing microbial contamination, the instrument(s) require specific validation.
Withnell Sensors has worked closely with autoclave validation equipment providers to ensure that we offer every best in sterilisation products to enhance workflows and associated regulatory compliance.
Autoclave validation can be achieved with two types of equipment, a wired sensor system that include thermocouples or dedicated data loggers suitable for sterilisation conditions.
Meet Kaye: Autoclave Validation
Finding the right autoclave validation equipment
Kaye Instruments is a market leader in validation equipment specifically for thermal applications. This means process measurement equipment which is equipped to deal with the extreme conditions of steam sterilisation and autoclaving.
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 validation and calibration of the equipment. We also offer rental of the Kaye Validator to cover additional project requirements and plant commissioning. Check out our calibration services for Kaye products in more detail below:
The importance of the right autoclave validation equipment
Alongside Kaye, other suitable products and loggers are available for autoclave validation, depending on the size and scale of the instrument. Autoclave validation is performed using measurements of internal temperatures and pressure data, which means a core function of the logger deployed must withstand harsh parameters.
From temperature, pressure, saturated steam and much more, experience in validation processes is paramount for successful autoclave validation. Not only do you need to be equipped with the right products and equipment, but you also need to be proficient in using temperature and humidity sensors, data loggers, and compliant calibration processes.
Familiarity with ISO, FDA and other industry-specific standards across healthcare, food, production, biotechnology and pharmaceuticals is also a basic requirement. Once you have highlighted your deviations, technical expertise is how to resolve these for the perfect environmental conditions is also necessary.
At Withnell Sensors, we pride ourselves on our unbiased advice and guidance for proper temperature and humidity management. This means that we go beyond the supply of equipment and instruments and instead can help you with your entire application.
Whether you're looking for guidance from our Engineers on performing proper autoclave validation with your new data loggers, or ideally want a completely outsourced solution, we can help.
Suitable Autoclave Validation Brands
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, the number of measurement locations, the purpose of the monitoring and its impact on your entire operation, IT infrastructure and many other factors.
Two of our brands lend themselves to this type of application:
