GMP-compliant qualification of filling lines and validation of aseptic processes

Valicare offers special tests to check the cleaning efficiency of your pharmaceutical washing machine or depyrogenation performance of your tunnel

Syntegon has a specially equipped pharma lab in Crailsheim, where pharmaceutical test procedures can be executed or prepared for application at customer sites. Lab and equipment are state-of-the-art in terms of science and technology and can be used by our engineers without any restrictions.

This enables Valicare to 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. We use the vials you would normally use in your daily operations for coating with riboflavin, endotoxin, or glass particles to check your individual process. We will detect remaining particles or fluorescence in the pharmaceutical laboratory. Endotoxin-coated and depyrogenated vials will be tested quantitatively with the turbidimetric kinetic test method to see whether a 3-log reduction has been reached.

All methods are based on SOPs and validated for special applications. Plan, execution, and report are documented in a GMP-compliant way.

You can find more information on cleaning efficiency tests here.

Valicare engineers have profound expertise in automated inspection systems

Automated visual inspection of medicinal products for parenteral use should detect any readily identifiable visible container defect and ensure constant quality of the product in terms of absence of particular matter, turbidity, other defects, and correct or uniform appearance of a lyo cake (Visual Inspection of medicinal products for parenteral use, ECA Good Practice Guide Version 3.2).

Automated inspection of sterile filled vials

What we offer

Our parent company Syntegon is a well-known manufacturer of inspection machines. Hence, our engineers are well experienced with inspection systems, and especially with fully automated ones. We offer an excellent validation and qualification support for automated inspection systems independent of the manufacturer and help you to fulfill the official requirements regarding a 100% optical control of parenterals.

In addition to our special technical expertise, Valicare has extensive experience in risk-based qualification and validation of pharmaceutical equipment and processes.

Our specialists are experienced in moderating workshops at customer sites to determine your validation strategy and process optimization, with the goal of achieving an efficient performance qualification (PQ) and optimal inspection results in routine applications. These workshops result in the definition of the parameters for efficient validation such as relevant product and failure types, test samples, and the optimization of the inspection process based on Knapp-Kushner.