Validating an autoclave
An autoclave temperature study may feature unique user load configurations and a vent filter SIP cycle.This validation discipline primarily uses Kaye Validator T-type thermocouples or remote temperature sensors (Ellab, Data Trace, etc.) along with biological indicators to provide a biological test complement.The common method to secure the thermocouple/sensor and biological indicator in place is by using zip-ties.But, these thermocouples and sensors come in a variety of sizes and shapes and there is no guarantee that your testing environment will be a perfect fit to these measuring instruments. A primary load configuration conundrum is how to handle minimal-sized tubing diameter (1/8’’ and smaller).The primary challenge is to secure the biological indicator and thermocouple within the filter core.This can be achieved by wrapping the biological indicator with wire mesh.Using tubing adapters is the best solution to this issue.Adapters help enlarge the tubing diameter which allow for greater maneuverability for thermocouple and biological indicator placement.
Lastly, another way to combat small spaces is to reduce the size of the biological indicator strip.
Temperature Mapping is an intrinsic part of equipment validation.
It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s standards.
Plus, I would have connected a longer length on my larger-sized diameter tubing to the fitting adapters to expand the executable volume for steam penetration.
One final thing with autoclave temperature mapping, even if one solves these configuration issues, there is no guarantee that the test will automatically pass.