Autoclave Validation – Thermal Mapping
QualUs excel in the Thermal Mapping Validation of Autoclaves to current international regulatory sterilization standards and guidelines for Porous Loads, Micro Liquid Waste Loads, Terminal Sterilization Liquid Loads and Miscellaneous Waste Loads.
We fully understand current EU and US regulatory requirements such as EN285, HTM2010, HTM 01-05, EN17665, PDA Technical Report 01.
Our validation engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols in either a QualUs format or in a client specific format.
QualUs are available to perform Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Load Design, Cycle Development (CD) of new loads, Performance Qualification (PQ) of new loads and annual re-qualification (RQ) of existing loads.
We can generate justification documents for the rotational re-qualification of Autoclave loads. We can also perform upgrades to existing non-compliant autoclaves and subsequently perform Air Detector setups.