Autoclave Qualification and Process Validation With Evidencia GmbH

Research, pharmaceuticals, life sciences and food: many laboratories rely on steam sterilizers or equipment where processes are monitored using pressure and temperature control. Thanks to Systec's collaboration with Evidencia GmbH, they now offer the services of a strong team of technical experts.

As soon as a piece of equipment is part of a production process, it needs to be tested to ensure it is fit for use. Consequently, laboratory operators are required to have their equipment qualified at regular intervals to make sure that physical and chemical test systems are working properly and to ensure that their design and optimal efficiency are fit for purpose.
The company Evidencia GmbH produces GLP- and GMP-compliant documentation for the following:

• Qualification of equipment and validation of processes
• Requalification
• Heat distribution report
• Process evaluation
• Calculations of Fo value
• Consulting service

Trained technicians carry out the qualifications and validations on site using high-quality measuring equipment traceable to a national standard.

On request, the company can instruct a calibration laboratory accredited to ISO 17025 to carry out an “as found” and an “as left” calibration of the temperature loggers used. Evidencia GmbH maintains a quality management system in accordance with ISO 9001 to demonstrate that it meets the high-quality requirements of customers from the fields of science and research, biotechnology, pharmacy, quality control and production.

Find out the latest news and updates from analytica 2018 in our dedicated Special Feature >>

New website of Evidencia GmbH

The new website of Evidencia GmbH provides information on the range of services offered and current events. The team headed by Managing Director and Industrial Engineer, Mathias Umbach, looks forward to answering any questions you may have.

The new company will be exhibiting with Systec GmbH, the leading manufacturer of laboratory autoclaves, at analytica 2018, the international trade fair for laboratory technology, analysis and biotechnology. The joint company stand will not only be presenting over 70 types of autoclave with a chamber volume of 23 to 1,580 litres but also the services required for their validation and qualification. Systec and Evidencia can be found at Stand 308 in Hall B1.