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.

 


Sterility Price Freeze

The pandemic has impacted so many parts of our lives, but not everything changes!

We are thrilled to be able to offer our 2019 prices for our sterility testing service for new clients!

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



RSSL Webinar Series - Pharmaceutical Sterile Products

As part of our drive to support organisations through the complexities of sterile products manufacturing, control testing and release, RSSL is running a series of webinars - Sterile Pharmaceuticals. These complimentary, hour-long webinars tackle some of the key challenges and provide guidance on best practice. Upcoming webinars can be viewed here while previous webinars are available on-demand below.

Click below to view:

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