Qualification of the filling line and validation of the aseptic process need GMP standard
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 wel as smoke studies in isolators belong to our service spectrum. In addition, we check the cleaning efficiency of your washing machine with riboflavin (a fluorescence test) or glass particles and depyrogenation studies with endotoxin inside your dry heat sterilizer.
With cycle 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.