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 Center 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.
With a project as large as our plant expansion, an experienced partner is essential, especially at the beginning. We are glad to have found a competent project partner in Testo Industrial Services, who not only has the technical know-how but also project management skills. From the very beginning of the project, I could tell that all the people involved in the project are absolute experts in their field. The technical support and the realisation of the project scope were carried out flawlessly. Furthermore, the continuous status comparison ensured a transparent project flow and avoided unforeseen delays. The staff at Testo Industrial Services were an essential part of the solution and impressed me with their commitment and flexibility.
Markus Manger
Senior Manager Quality
Paul Hartmann AG
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
Cleanroom qualification
Security and compliance for your cleanrooms
Qualification of plants and utilities
Risk-based qualification of air handling units, process gases, sterilizers, water and water systems
Validation
Ensures process stability and robustness