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Mitarbeitende stehen im Reinraum mit Mundschutz

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.


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

More about our services

Überprüfung eines HEPA-Filters auf Lecks

Cleanroom qualification

Security and compliance for your cleanrooms

Kalibrierung direkt an Ihren Anlagen

On-site calibration

Overcoming distances and reducing downtimes

Kalibrierung eines Sensors in einem Tauchbecken

Service portfolio

Your partner for calibration, test equipment management, qualification and validation