Project support/qualification of a new cleanroom building as part of a plant expansion
Testo Industrial Services supports the company Paul Hartmann AG in Heidenheim with the commissioning and qualification of new cleanroom production areas as well as with the system qualification of new and existing systems.
The Hartmann Group is a leading European provider of system solutions for medicine and care. The Group's main areas of expertise are products in the fields of incontinence management, wound care and infection management. Paul Hartmann AG in Heidenheim is the heart of the Group. It is one of the oldest German industrial companies and dates back to a textile factory founded by Ludwig von Hartmann in 1818.
New cleanroom production areas were built in an existing building at the Heidenheim site. Two existing production facilities for the manufacture of modern wound dressings and surgical sets were to be relocated to the new premises of the Medical Innovation Center once the work had been completed. For this purpose, the existing building was converted into a clean room area in accordance with DIN EN ISO 14644 Class 8, based on Class D of the EU GMP guidelines, Annex 1 or the internal requirements of Paul Hartmann AG, and a multi-stage quality control concept was established. The aim was the GMP-compliant qualification of the new cleanrooms as well as the existing and new facilities, taking into account the validation strategy of Paul Hartmann AG.
With such a large project as our plant expansion, an experienced partner is essential, especially at the beginning. This is because, as the operator, we were concerned with many other issues in addition to the challenges of GMP compliance. We are pleased to have found a competent project partner in Testo Industrial Services, who not only has the technical know-how but also project management skills. All employees involved in the project are absolute experts in their field. The technical support and implementation of the project scope were flawless. Furthermore, the continuous status comparison ensured a transparent project flow and avoided unforeseen delays. The employees of Testo Industrial Services were an essential part of the solution and impressed me with their commitment and flexibility. Thanks to the efficient and cooperative partnership, we will continue to choose Testo Industrial Services as our service provider for quality assurance services in the future.
Markus Manger
Senior Manager Quality
Paul Hartmann AG
Heidenheim Medical (BHM)
Your advantage: Our competence
- Comprehensive support during construction and commissioning in the area of cleanroom qualification
- High flexibility and optimal resource management during the entire project and the qualification measurements
- Pragmatic, practice-oriented implementation of qualifications, including preparation of qualification documentation
- Risk-based management of requalification measures
- Project-adapted structuring and implementation of the qualifications in close coordination with the customer's project managers and QA managers, resulting in a prompt resumption of production
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