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Sterile Products

Products that are to be administered by an enteral route are required to be sterile.  As these products are going to be placed directly into blood or body tissue it is vital that they are sterile to avoid infection occurring as a result of their use.  Sterility is also important for any material or device likely to come into contact with broken skin or internal organs. 

We provide a full range of services and tests required to confirm sterility assurance of products.

Our state-of-the-art facility comprises of cleanroom and isolator technology to control the environment and assure absence of any contamination during the test process.  Many contract labs perform sterility testing using the traditional method of wiping samples into a Grade A environment. This leads to potential contamination of samples and increases the risk of false positives. At Helvic we have invested in market leading technology and all of our sterility testing is performed in our purpose built, VHP gassed sterility test isolator, thereby eliminating the possibility of false positives

 Tests

  • Sterility Test
  • Bacterial Endotoxin
  • Microbial contamination (bioburden analysis)
  • Organism Identification
  • Environmental Monitoring
  • Disinfectant Testing

Industry

  • Pharmaceuticals
  • Medical Devices
  • Biologics & Biopharmaceuticals

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