According to prevailing standards medical devices and equipment ought to be prepared sterile before use applying a validated and reliable sterilization process. Our logging systems are specifically designed for routine checks, validations and verifications of high temperature processes up to 140°C in a pressurized steam environment.
Steam autoclaves play a major role for sterilization processes in the pharmaceutical industry since the production of sterile products or pharmaceuticals underlies specific requirements to avoid the contamination or cross-contamination with microorganisms. The required sterilization processes carried out in autoclaves are essential in cGLP and cGMP environments. The process reliability and the quality of the sterilization are not only underlined by final sterility analyses, however professional validation of the process itself needs to be performed. Our logging systems allow for precise acquisition of relevant process parameters in a high temperature/pressure regime. In combination with a user friendly software, the gained data can be evaluated easily permitting a straight-forward and successful process validation.
The strong emphasis on the process monitoring of thermal sterilization procedures is caused by a constant increase of requirements for food manufacturer. These requirements state that manufactured products need to be exposed to a defined thermal treatment in order to ensure their sterility. The International Featured Standard (IFS) specifies the standard for auditing quality and food safety of food products. A performed process validation confirms the implementation of HACCP (Hazard Analysis Critical Control Point) principles. We offer an elegant tool for the detailed and reproducible acquisition and visualization of process parameters required for a successful validation.