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Construction of a new cleanroom – project support & qualification by Testo Industrial Services

Construction of a new cleanroom – project support & qualification

Paul Hartmann AG.

Reference

Construction of a new cleanroom – project support & qualification

at Paul Hartmann AG, Heidenheim

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 cleanroom 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. In this respect, the existing building was converted into a cleanroom area in compliance with ISO 14644 class 8, in line with class D of the EU GMP Guideline, Annex 1 and the internal requirements of Paul Hartmann AG. A multi-level quality control concept was also established. Within the scope of the conversion, both the cleanroom qualifications and the system qualification of new and existing systems were carried out by Testo Industrial Services.

Construction of new cleanroom project

Our scope of services

at Paul Hartmann AG, Heidenheim

  • Comprehensive support during construction and commissioning in the area of clean room qualification
  • Flexible time management and resource control of project staff and measuring equipment
  • Risk-based planning and coordination of cleanroom qualification according to ISO 14644
  • Preparation of the complete qualification documentation
  • Verification of compliance with cleanroom classes D and E
  • Determination of air volume/air exchange rate
  • Flow visualisation
  • Determination of the particulate purity class
  • Filter leak test
  • Performance of recovery time measurements
  • Microbiological monitoring of the air
Clean room qualification by Testo Industrial Services
  • Relocation and re-qualification of a PW plant including new pipe connections – from the preparation of the URS to the qualification report
  • Prospective qualification of a steam generator and a metering station – from the design phase to commissioning
  • Risk-based re-qualification of production facilities for the manufacture of wound dressings
  • Conception and revision of qualification and validation templates such as qualification documentation, validation plans and a validation master plan
  • Evaluation of compressed air quality as a product-critical medium including the following measurements: Particulate purity, microbial purity, moisture/pressure dew point, oil content
Qualification of systems by Testo Industrial Services

Construction of new cleanroom project

The result

at Paul Hartmann AG, Heidenheim

“With such a big project like the extension of our premises, it is indispensable to have an experienced partner, especially at the beginning. We are really pleased to have found such a competent project partner in Testo Industrial Services, who, in addition to expertise, is also able to contribute with project management skills. Right from the start of the project, I could see that all the employees involved in the project, were absolute experts in their field. The technical support and realisation of the full project scope were carried out to perfection. Furthermore, the continuous status review ensured a transparent project progress and averted unforeseen delays. The employees of Testo Industrial Services were an essential  part of the solution and impressed me with their commitment and flexibility.”

Markus Manger, Senior Manager of Quality in Betrieb Heidenheim Medical (BHM)

Sie expansion by Paul Hartmann AG

More assurance, better service for your GMP compliance

What set us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Testo Industrial Services

Our services at a glance

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