Qualification & Validation of Aseptic Filling Lines
For aseptic processing an extensive validation of the aseptic conditions additional to a risk-based qualification is mandatory.
For aseptic processing an extensive validation of the aseptic conditions additional to a risk-based qualification is requested by EU GMP guideline, annex 1 and 15 and the "FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice, (Sept., 2004)".
Please contact us if you need advice or support for the GMP-compliant validation of your aseptic process by our competent and experienced consultants and engineers.
Via direct contact to one of the leading manufacturer (Syntegon Technology GmbH) of aseptic filling lines Valicare engineers have extensive technical knowledge and long lasting practical expertise in qualification and validation of aseptic filling processes.
On request we will support you with planning, execution and documentation of design (DQ), installation (IQ), operational (OQ) and performance (PQ) qualification.
Mapping of the temperature, room classification, filter integrity and air pressure tests as well as smoke studies in isolators belong to our service spectrum. In addition, we offer challenge tests to check the cleaning efficiency of your washing machine with riboflavin (a fluorescence test) or glass particles and the depyrogenation performance of your dry heat sterilizer with endotoxins.
With biodecontamination process development and validation of your isolator we complete our service. You can be sure, that your equipment and process is qualified and validated in a GMP-compliant way and that the documentation fulfills the official requirements of the FDA and EMA.
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.
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).
As a 100% daughter of Syntegon Packaging Technology GmbH, the manufacturer of inspection machines, the Valicare engineers are well experienced with inspection systems especially with fully automated ones. We therefore 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.
Automated inspection of sterile filled vials.
Additional to the special technical expertise Valicare GmbH has a long experience in risk-based qualification and validation of pharmaceutical equipment and processes.
Our specialists are well experienced in moderating workshops at customer site to determine the validation strategy and process optimization aiming the efficient performance qualification (PQ) and optimal inspection results in routine application. These workshops result in the definition of the parameters for efficient validation such as the relevant product and failure types, test samples and the optimization of the inspection process based on Knapp-Kushner.