Our long experience in sterile filling technology with isolator technology gives our customers a high level of security. That is because we offer holistic support, in planning, design and implementation of regulation-compliant installations. If you wish, we will take over complete project management, leaving you to concentrate on other things, e.g., the development of new products.

Our services include:

• • Consultation in the procurement of new installations and machines for sterile filling processes
    and Fill & Finish appliances in sterile areas, as well as for solid production, such as tablets and capsules
  • Creation of tender documents
  • Evaluation of proposals
  • Conception of risk-analysis workshops
  • Mock-ups, which we conceive and implement either under own auspices or together with you

Water is the most widely used raw material in the pharmaceutical and biotech industry, so water and other ultrapure media, such as ultrapure steam, are indispensable components of numerous processes.
For reliable production without impurities, high-quality drinking water, purified water, water for injections and also ultrapure steam are required.

We know the complete process and know what is possible.

We advise you on the optimization of your systems and processes and are happy to support you in the implementation of qualification/validation or in studies for process optimization.​ Together with you, we develop and implement the best possible process solution, of course in compliance with the highest quality and safety standards.

We are a problem solver, project manager, auditors as well as gmp-hands-on consultants. Further, we offer interim solutions and support. This is done for the quality management, development, manufacturing and supplier quality management for medical device manufacturer and his suppliers. Relevant norms/ regulations and laws ISO 9001, ISO 13485, 21 CFR part 820 (FDA) will be considered at all times.

Our main focus covers:

• • • • Equipment and facility qualification, process validation, cleaning validation, computer system validation (CSV) and product validation
      • Deviation and complaint management
      • Document management incl. document reviews
      • Change management
      • Risk management
      • CAPA management
      • Audit management (audit preparation and follow up, conduct internal audits)
      • Supplier (quality) management that includes supplier selection, supplier qualification supplier audit and supplier
        monitoring (e.g. tool making, injection moulding, packaging, implants and surgical instruments manufacturing)