Expertise

Our knowledge and experience within processes span widely

We possess extensive experience within the pharmaceutical industry. Our customers will, therefore, be met by experienced Confirm validation experts. We can help you with:

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    • All types of SIP (Steam in Place) plants
    • Bioreactors and fermentors
    • SIP stations
    • Tanks
    • Bottle Pack
    • Bulk process equipment
    • Isolators
    • Depyrogenation tunnels
    • Dry-sterilization tunnels
    • Autoclaves
    • Qualification of loggers, e.g. Yokogawa and similar
    • VHP (Vaporized Hydrogen Peroxide)
    • Cycle development
    • Temperature distribution
    • BI-test including D-value calculations

Our experience with autoclaves is unique

Qualification and validation

Cycle- and load development

    • F0–value calculations
    • Bioburden, overkill and half-cycle approach
    • D-value calculations

Revalidation

Check of effective air removal and steam penetration
(Bowie-Dick test)

Qualified

    • Program changes
    • Cycle development and changes
    • Copying and migration of existing programs

Our work is based on standards such as EN 285, HTM 2010 and PDA technical report (no. 48)