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Mitarbeitende stehen im Reinraum mit Mundschutz

Qualification of cleanrooms in sterile production for EVER Pharma Jena GmbH

Testo Industrial Services supports EVER Pharma Jena GmbH in the qualification/requalification of its cleanrooms  1,600 square meters. Qualification is carried out in accordance with DIN EN ISO 14644 and the EU GMP guidelines (Annex 1 & 15). 

EVER Pharma Jena GmbH is part of the EVER Pharma Group, headquartered in Austria. The Group's focus is on research, development, manufacture and marketing of products in the fields of neurology and specialising in injectables (such as oncology, intensive care, hormone therapy, pain therapy). Injectable medicines are manufactured at the Jena site. 

In the new building  of the company, Testo Industrial Services took over the initial cleanroom qualification of the four sterile production facilities (classes A-D), which are spread over three floors.

In addition to the clean rooms, this also includes corresponding airlock areas, sampling and weighing areas as well as the CNC (Controlled-Not-Classified) area. 


Your advantage: Our expertise

  • Production expansions and conversions: Implementation of cleanroom qualifications
  • Annual requalification of all cleanrooms according to DIN EN ISO 14644-1/Annex 1 & 15
  • Development of customer-specific measurement methods adapted to the structural conditions, taking into account the applicable standards
  • Dedicated GxP services team on site, thus minimizing coordination effort
  • Adaptation of the documentation structure to the customer-specific standard and handover of the documentation immediately after completion of the measurements

Learn more about this success story and take a look at the reference project.

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