Qualification of clean rooms in sterile production for EVER Pharma Jena GmbH
Testo Industrial Services supports EVER Pharma Jena GmbH in the qualification/requalification of their clean rooms of GMP classes A to D on 1,600 sqm. 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 with headquarters in Austria. The focus of the group is on research, development, manufacturing and marketing of products in the fields of neurology and special injectables (such as oncology, intensive care, hormone therapy, pain therapy). Injectable drugs are manufactured at the site in Jena.
Testo Industrial Services took over the initial clean room qualification of the four sterile production areas (classes A-D) in the new building of the company, which are distributed over three floors. In addition to the clean rooms, this also includes the corresponding airlock areas, sample train and weighing area as well as the surrounding CNC (Controlled-Not-Classified) area.
We were very satisfied with the cooperation with Testo Industrial Services on our new building. During the project phase, as is always the case, a number of changes and challenges arose, which Testo Industrial Services always managed very flexibly and, as it were, "on the fly" with us. It was a close cooperation that worked very well - and that with such a high measurement effort in our new large cleanroom area. In the meantime, we are already working together on a strategy to ensure the requalification of the rooms, so we are happy to continue the cooperation.Michael Böhme
Ever Pharma Jena
Your advantage: Our expertise at EVER Pharma
- Production expansions and conversions: Carrying out cleanroom qualifications
- Annual re-qualification of all cleanrooms according to DIN EN ISO 14644-1/Annex 1 & 15
- Development of customised measurement procedures adapted to the structural conditions, taking into account the applicable standards
- Dedicated GxP services team on site, minimising coordination efforts
- Adaptation of the documentation structure to the customer-specific standard and handover of the documentation directly after completion of the measurements