RSSL has opened a purpose built cleanroom, launching a responsive and flexible sterility testing service. Sterility testing is a vital regulatory requirement for manufacturers of any terminally sterilised or aseptic products and needs to be undertaken when bringing a product to market or assessing the post-launch safety of a drug product or medical device.  


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
  • For aqueous, alcohol, solvent and oil-based products
  • The test material is passed through a size exclusion membrane designed to retain microbial contaminants

Direct Inoculation
  • For non-solubles and medical devices
  • The test material is aseptically added to inoculate the media


Turn Around Time

Flexible turnaround times to meet your needs:

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


Additional Support


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



Sterility Partnership for the Future

Reading Scientific Services Limited (RSSL) is a world leading Contract Research Organisation, recent winner of Best CRO at 2019 OBN awards, pride ourselves on our excellence in science, quality and service.

 


First Year Offer for New Clients

To mark the launch of our new cleanroom and sterility testing service, we are offering an exclusive cost-saving offer to every client who engages in our sterility test services in the first 12 months of our new sterility testing suite being fully operational (February 2020).

We are also extending an open invite out to any potential new clients interesting in partnering with us the opportunity to visit our new sterility testing suite and discuss how our full-service microbiology offering can help to achieve individual safety goals.

To discuss your sterility testing requirements with one of our specialists please contact us.



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