Sterility Testing and Endotxin Testing

So, your product has been manufactured and fill/finished under sterile conditions. A major milestone accomplished. However, it now needs to be transferred offsite for testing. With potential for loss, breakage, documentation issues and delays - it’s not always ideal. Here comes the anxiety… 

To help address this issue, here at SCM Pharma we have just introduced not one, but two new services – sterility testing and endotoxin testing.

So now you don’t need to worry about sub-contractors taking care of your product - we can do it for you.

Sterile fill/finish of novel, difficult and dangerous drug products is what we do. Partner with us and you can feel safe in the knowledge that we can now fill, test and release your product all under one shiny GMP-compliant roof.

Sterility testing is performed within a validated grade A environment utilising a sterility test isolator situated within our clean room facility.
 
Bacterial Endotoxin Testing (BET) is performed in a designated area of our microbiology laboratory using the quantitative turbidimetric assay technique.

These testing services go hand-in-hand with our established in-house aseptic processing and terminal sterilisation capabilities and sit alongside our stability testing, analytical testing and microbiology services. By letting us take care of your entire project, we can allocate testing slots straight after sterile filling, so you get your product quicker and with less risk.

As with everything at SCM Pharma, all testing services take place within our MHRA-licensed facility and are carried out by our team of experts. To read more about our other services, click away using the links above.

And whether your testing needs form part of a radio-labelled pilot ADME study, a tricky looking clinical trial manufacturing project such as the aseptic processing of a potent product or a small batch needing to be terminally sterilised, or maybe as part of the ongoing supply of a licensed product - Why not test us today?


A bit more about our Sterility Testing service…

A validated isolator environment when compared to conventional testing using a laminar air flow within a grade B background greatly minimises the risk of obtaining false positives, reducing the potential for costly delays and lengthy investigations in your project.

You’ll also be pleased to know that our VHP gassing cycle and isolator loading pattern have been fully validated using thermal mapping, VHP chemical indicators and biological indicator analysis. Furthermore, sterility test method development and validation can be performed on site, allowing the smooth and efficient progression of your project.


A bit more about our Bacterial Endotoxin Testing (BET) service…

Utilising the quantitative turbidimetric assay technique in a designated area of our microbiology laboratory, all BET at SCM Pharma is performed using GMP-compliant computer software allowing quick generation of COAs and results reporting. In addition, testing methods can be developed and validated on site, helping drive your project’s efficiency.

As with our sterility testing service, using our BET offering help you minimise the risk of delays, documentation discrepancies, losses and damaged goods associated with using off site contract laboratories. 

Although our testing services complement our existing sterilisation services, you can use them as a stand alone service if required.