Sterility testing

To help you meet regulatory requirements for your terminally sterilised or aseptic products, RSSL provides reliable, cost-effective sterility testing compliant with Ph. Eur., JP and USP regulations.

 

Sterility testing is a vital requirement when bringing new products to market or assessing the safety of a drug product or medical device post-launch. Utilising our purpose-built clean room, we can offer a fast and flexible sterility testing service, supporting you in meeting these requirements. 

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Sterility testing methods

 

RSSL offers two sterility testing methods, both of which are compliant to Ph. Eur. 2.6.1, JP 4.06 and USP <71>. We will work with you to determine the best test method to use based on your product:

 

Membrane filtration is designed for aqueous, alcohol, solvent and oil-based products. This sterilisation method passes test material through a size exclusion membrane, which is designed to retain microbial contaminants.

 

Direct inoculation is designed for non-soluble products and medical devices. In this method, test material is aseptically added to inoculate the media. 

  • Pharmachem RD 4821 HR

    Turnaround time

    Our flexible turnaround times aim to meet your needs. We offer:  

     

    • 14-day incubation (with intermittent and final observation) 
    • Standard 21-day turnaround 
    • Expedited 16-day turnaround 
    • Fast 14-day turnaround 
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    Additional support

    We aim to support our clients throughout sterility testing by offering:  

     

     

    *As part of a complete package of required biopharmaceutical tests. 

Sterile manufacturing webinars

A series of complimentary webinars, focusing on sterile manufacturing. Each webinar is designed to better support organisations, tackling key challenges and providing best practices for sterile product manufacturing, control testing and release.  

Contact us

Need to get in touch? Either complete the enquiry form or call us:

Switchboard: +44 (0)118 918 4000

Customer Services: +44 (0)118 918 4076

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