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Qualification & Validation of Aseptic Filling Lines

  • next page

    Qualification & Validation of Aseptic Filling Lines

    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 the FDA Guidance for Industry.

    Call +49 69 7909 340 for support.

  • aseptic filling line
    next page

    Qualification & Validation of Aseptic Filling Lines

    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 the FDA Guidance for Industry.

    Call +49 69 7909 340 for support.

  • vials and ampoule
    next page

    Qualification & Validation of Aseptic Filling Lines

    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 the FDA Guidance for Industry.

    Call +49 69 7909 340 for support.

 
Content

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 the "FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice“, Sept., 2004).

Contact us, please, if you need any advice or support for the GMP-compliant validation of your aseptic process by our competent and experienced consultants and engineer.

Via direct contact to one of the leading manufacturer (Bosch Packaging Technology GmbH, BU Pharma) of aseptic filling lines Valicare engineer 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, smoke studies in isolators belong to our service spectrum as well as checking 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.