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Clean room with production facilities at a medical technology company

New clean room construction: Project support & qualification

Testo Industrial Services supports the company Paul Hartmann AG in Heidenheim in the commissioning and qualification of new clean room production areas as well as in the plant qualification of new and existing plants.

The Hartmann Group is a leading European supplier of medical and hygiene products with a focus on wound treatment, incontinence care and infection prophylaxis. The portfolio is supplemented by products for compression therapy, immobilisation and first aid.

At the Heidenheim site, Paul Hartmann AG planned the construction of new clean room production areas in an existing building. Two existing production facilities for the manufacture of modern wound dressings and surgical sets were to be relocated to the newly created premises of the Medical Innovation Centre after completion of the work. For this purpose, the existing building was converted into a clean room area in accordance with ISO 14644 Class 8, based on Class D of the EU GMP Guidelines, Annex 1 or the internal requirements of Paul Hartmann AG. A multi-level quality control concept has also been established. Within the scope of the conversion, both the clean room qualifications and the plant qualification of new and existing plants were handled by Testo Industrial Services.

Your advantage: Our competence

  • Holistic support during construction and commissioning in the area of cleanroom qualification
  • Risk-based planning and coordination of cleanroom qualification according to ISO 14644
  • Preparation of the complete qualification documentation and execution of the qualification measurements
  • Relocation and requalification of a PW plant incl. new pipe connections - from the preparation of the URS to the qualification report
  • Prospective qualification of a steam generator and a dosing station
  • Risk-based requalification of production facilities for the manufacture of wound dressings

More about our services

Checking a HEPA filter for leaks

Cleanroom qualification

Security and compliance for your cleanrooms

Execution of a qualification measurement at a production plant in pharmaceutical manufacturing area

Qualification of plants and utilities

Risk-based qualification of air handling units, process gases, sterilisers, water, and water systems

GxP-compliant validation according to the V-model


Ensures process stability and robustness