Checking of cleaning efficiency and depyrogenation performance through valicare engineers
Valicare offers special tests to check the cleaning efficiency of your pharmaceutical washing machine or depyrogenation performance of your tunnel.
The Syntegon Technology GmbH at Crailsheim has a specially equipped pharma lab in operation where pharmaceutical test procedures can be executed or prepared for application at customer sites.
Lab and equipment are on current state-of-the-art of science and technology and can be used by engineers of the Valicare GmbH without any restrictions.
For this reason Valicare GmbH can offer special test procedures like checking the cleaning efficiency of washing machines or the depyrogenation performance of tunnels, which are essential parts of the whole qualification process.
For coating with riboflavin, endotoxin or glass particles we use the vials which are normally used in routine by customer and check your individual process.
Glass particles or roboflavin coated and on-site washed vials will be proved on remaining particles or fluorescence in the pharmaceutical laboratory. Endotoxin coated and on-site depyrogenated vials will be tested quantitatively with the turbidimetric kinetic test method to see whether a 3 log reduction has been reached.
All the methods are based on SOPs and validated for special applications. Plan, execution and report will be documented in a GMP-compliant way.
A proceeding appreciated by inspectors.