Services and Support
Everything from a Single Source

Choosing us, means killing various birds with only one stone: With our know-how and experience, we at CAT Clean Air Technology GmbH are your service provider when it comes to designing cleanrooms conforming to the law and in line with practical requirements, qualifying and validating them after completion and regularly monitoring them in daily operation. So, you are always equipped in the best possible way for all challenges around the construction and operation of cleanrooms.

Extract from the regulatory requirements that are the basis of our work:


  • VDA 19 Part 2 – Technical Cleanliness in Assembly
  • DIN 1946-4 – Ventilation in Buildings and Rooms of Healthcare
  • AMWHV (Ordinance on the Productions of Drugs and Drug Substances) for Germany
  • EU-GMP Guideline Part I – Manufacture of Sterile Medicinal Products
  • EU-GMP Guideline Annex 15 – Qualification and Validation
  • PIC/S Guideline PI 006 Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation
  • ZLG Aide-Mémoire Inspection of Qualification and Validation in Pharmaceutical Production and Quality Control
  • DIN EN ISO 14644-ff – Cleanrooms and associated contolled areas
  • FDA (U.S. Food and Drug Administration)

Extract from the regulatory requirements that are the basis of our work:


  • Definition of the strategy and scope of the planned qualification activities to achieve a valid plant condition in the qualification plan.
  • Identification of critical parameters of a system which can have a negative effect on product quality. Definition of measures to reduce the critical parameters through a risk analysis.
  • Preparation of a requirement specification based on customer requirements with target values as a catalogue of requirements for future qualification activities.
  • Formulation of technical solutions to realize requirements from the specification sheet by creating functional specifications.
  • Comparison of the specification sheet and the functional specifications on the basis of the design qualification. Proof that the design intended for facilities, installations and equipment is suitable for the intended use.
  • Verification of the installation in the installation qualification. Checking whether the equipment, clean room and equipment comply with the design documentation.
  • Proof of proper function through functional qualification. Across the entire range of process-critical parameters, it is checked whether the values obtained within the framework of acceptance measurements and investigations correspond to the valid requirements defined in the specification sheet.
  • Documentation of the qualification in the final qualification report. Summary of the procedure and results of the tests carried out within the framework of the qualification and presentation of whether the technical system meets the requirements from the specification sheet.

              

CAT Clean Air Technology GmbH
Motorstr. 51 | 70499 Stuttgart | Germany

Email: info@catgmbh.de
Phone: +49(0)7 11-3 65 91 99 - 0
Fax: +49(0)7 11-3 65 91 99 - 99