Laboratory analysis for the healthcare industry

We have more than 30 years’ experience in the provision of laboratory analysis, surveillance projects and technical services for the Healthcare Industry. Our services meet relevant standards, including: HTM01-06, HTM01-01 and Renal Association guidelines. *This service is now provided by Normec
Healthcare Advanced

Laboratory analysis for the healthcare industry

Our UKAS accredited laboratory offers a high quality, tailored service for sterile service departments, medical device manufacturers and service contractors.

Why choose Healthcare Advanced?

  • Account handled by a dedicated healthcare client liaison officer who will report all your results and handle your logistical needs.
  • Choice and flexibility in testing methodology including rapid microbiological methods and molecular capabilities, providing accurate, reliable data to help inform decisions.
  • Bespoke validation kits for endoscope reprocessors will be available at the right time and in the right place using our fleet of refrigerated, GPS tracked vans, providing a fully auditable chain of custody.
  • UKAS accredited 5-day shelf life of disinfection efficacy surrogates allowing kits to be delivered to site in advance of an engineer’s visit.
  • Expert analytical data interpretation and customised results certificates providing you with the information you need quickly and accurately.
  • Direct access to a fully trained and experienced microbiologist via a dedicated phone number for specialist support and guidance.
Renal dialysis

Microbiological and chemical testing for kidney dialysis

Our renal dialysis service provides all the relevant microbiological and chemical testing requirements to ensure that the ultrapure water required for dialysis, including hemodiafiltration, is of the appropriate standard.

  • Microbiological and chemical analysis for dialysis water quality
  • Microbiological testing at the required sensitivity depending on the type of dialysis
  • Low level limit of detection for endotoxins <0.01 eu/ml
  • Rapid turnaround options available for chemical testing

Endoscopy validation kits in line with HTM01-06

Validation Kits for endoscope reprocessors (AERs – Automated Endoscope Reprocessors)

Our endoscopy validation kits have been designed to simplify on-site testing. All of the components for validation are included and have been tested to work together accurately. A full range of Logistics solutions ensure representative results.

Kits contain elements required to complete on-site testing:

  • Disinfection efficacy surrogates
  • Self-disinfection test surrogates
  • Test soils
  • Pre-labelled bottles
  • Other consumables as required
  • Customised kits available
  • Annual and quarterly validation kits available as required
  • Validation kits delivered/collected from site
  • Kits provided in line with HTM01-06, ISO 15883, WHTM 01-06
Mycobacteria by PCR

Mycobacteria testing by qPCR

We offer detection of Mycobacterium species in water used in clinical settings. This enables the risk of infection generated by mycobacteria to be managed.

Mycobacteria, including NTM (Non Tuberculous Mycobacteria), are ubiquitous and able to cause secondary respiratory and skin infections to immunocompromised patients. Testing allows potential outbreaks to be prevented and vulnerable patients to be protected.

Our mycobacterial testing can be done via qPCR with results being issued within 48 hours. This compares to over 6 weeks when using the culture method for M. chimaera detection. The fast turnaround allows equipment to stay up and running and decisions to be made quickly and accurately. We’re also able offer speciation for three main species of concern (M. abscessus, M. avium, and M. chimaera.), allowing clinical settings to prioritise remedial action effectively. While we can test for any combination of these species as required from water samples, we can even perform such testing on positive samples from culture.

Our tailored analytical service also meets the requirements of the Public Health Guidelines published in November 2015 entitled “Infections Associated with Heater Cooler Units Used in Cardiopulmonary Bypass and ECMO Information for healthcare providers in England”.
Medical device analysis

Sterility and bioburden testing on medical devices

Sterility testing is a quality control process used in healthcare settings to verify efficacy of cleaning processes, ensuring the introduction of contaminants is prevented and contamination risks reduced.

Bioburden testing is similar to sterility however instead it identifies and quantifies viable microorganisms on a medical device before it is sterilised.

We’ve developed analytical methods which are based on The Sterilisation of Healthcare Products: BS EN ISO 11737-1:2019 for bioburden testing and BS EN ISO 11737-2:2019 for sterility testing.

Our sterility and bioburden testing is an extension to our medical device analytical capability.