Qualification

The validation ensures the safety of your product. It is the documented proof that production plant and product comply at all times with the required high quality standards. For this purpose it is necessary to comply with the directives of the EU and the FDA (GMP requirements), to identify vulnerabilities, assess risks correctly and to use optimization possibilities.

With our knowledge and experience we support you with the smooth handling of validation work. Our systematic validation master plan specifies procedures and responsibilities – from the design qualification via the alignment of the mounted equipment and systems with flow diagrams and specifications as well as the functional testing to final process qualification and process validation. We always keep the continually increasing requirements of licensing and inspection authorities.

Quality Assurance

The Quality Management System of our company meets the requirements of our customers in the highest degree. Best product quality, transparency of internal processes and employee motivation through quality speak for themselves. The quality of our products is during manufacture and after completion of vessels and equipment by different test methods to ensure:

• water pressure test up to 600 bar
• non-destructive weld testing by dye penetrant inspection, wall thickness measurement
• ferrite content measurement
• surface examination
• Air-Neckal-Test
• calibration of our used measuring instruments
• material identification testing (by own staff)

Upon customer request the following test methods are available:

• X-ray inspection
• helium leak detection in pressure and vacuum range

Documentation

All qualification and validation work we keep clearly in writing. A first-class documentation is indispensable. They occupied the GMP inspection of the system and processes in the context of an inspection.

• material certificates (3.1 certification of product-contacting, pressure-bearing parts)
• welding certificates according to DIN EN ISO 9606-1
• weld protocols
• test report on the pressure and leak test
• certificate of surface treatment and final cleaning
• interface protocols
• ferit measurements
• wall thickness measurements
• isometrics and drawings
• endoscopic examination
• weld schedules and X-plans
• creation of test plans
• technical documents such as drawings, component and spare parts list, operating instructions, etc.