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.

Aseptic process simulation (APS) is a mandatory requirement from EU-GMP Annex 1, PIC/S and the FDA.

Proof that an aseptic pharmaceutical manufacturing process (including personnel, facilities, materials, and procedures) produces reproducibly contamination-free products and is robust against interference and intervention is provided by the APS, also called media fill.

The approach for a modern GMP-compliant APS is risk-based and includes a complete process simulation.

If the regular APS risk assessment is thoroughly done as part of the process risk analysis, then APS risks can be easily traced.

To meet the compliance requirements of this risk assessment, an APS plan and report and a successful (contamination-free) execution of the APS are expected.

For the execution of APS, a sufficient scope (process steps, batch size, container/closure combinations) plays a key role. In a simulated production process suitable worst-case scenarios for interventions such as interruptions, needle changes, manual transfers and exposure times, complex operations, critical openings, or connections must be considered.

Do you need support in planning and implementing an APS?

Valicare offers a comprehensive APS service package:

• Consulting on a suitable GMP-compliant APS concept
• Creation of a master work instruction (APS SOP) that describes the procedure and provides documentation templates (APS RA, protocol, report) for the CUSTOMER’s processes
• Process risk analysis (if required) with implemented traceability of risks related to aseptic procedures and conditions
• APS-specific risk assessment (APS RA) to define the scope (e.g., process steps, batch size, container/closure combinations) and identify worst case scenarios (e.g., longest exposure times, most complex interventions, most critical openings/connections) and establish acceptance criteria, Alert/action levels, and escalation paths
• Preparation of a detailed APS protocol, which, for example, describes a production-equivalent situation, selection of operators, worst-case interventions, process steps to be conducted during simulation, monitoring data to be recorded in parallel and so on
• Training of staff in the APS procedure and execution
• Control of the operation and analysis (if necessary), including selection, preparation, or purchase of the medium, conducting a growth promotion test, conducting the growth test procedure and collecting the results, and microbiological identification of positive samples.
• Preparation of a detailed APS report to compare the results with the acceptance criteria, documentation of deviations, analysis of the root causes and corrective measures, clear final statement on the success or failure of the APS procedure, requirements for requalification

Are you planning an APS?