Sigma-Aldrich to manufacture and supply CRMs for PHE
The NCTC/NCPF CRM in LENTICULE disc format will be available worldwide.
The bacterial and fungal strains are prepared from those selected from PHE's National Collection of Type Cultures (NCTC) and National Collection of Pathogenic Fungi (NCPF).
CRMs are used for quality control of culture media and for process controls (including the preparation of spiked samples).
Examples of CRMs covered by the agreement include Salmonella, Listeria monocytogenes and Legionella.
Previous work
Trevor Jones, VP for the Sigma-Aldrich Analytical Business, said the firm and PHE have worked together on previous occasions.
“Sigma-Aldrich has developed microbiological CRM and PHE has its own line, called LENTICULE, during a discussion regarding general projects this came up as a possible area of synergy to help both of us,” he told FoodQualityNews.
“We reach a global customer base and PHE has a focus on the UK. We signed the agreement earlier this year and customers should see the benefits by autumn time.
“CRM are used by quality control labs to run procedures and ensure the method works correctly. Food and beverage labs want to demonstrate their competency, especially when regulatory bodies and customers audit their lab.
“Labs at the moment make their own control strains and store as frozen cultures on beads. This work needs to be undertaken with proper strains that have remained authentic without degradation.”
What are LENTICULE discs?
LENTICULE discs are reference materials that contain a certified quantity of pure cultures of NCTC or NCPF microorganisms, mainly those used as controls for food, water and environmental microbiology examinations.
The discs consist of bacteria, fungi or viruses in a solid water-soluble matrix that is stable for at least one year from manufacture.
They are produced in accordance with ISO Guide 34:2009 and individually packed.
Each pack of 10 LENTICULE discs comes with instructions and a certificate of analysis.
Julie Russell, Head of PHE's Culture Collections, said the agreement will enable more scientists to easily access the NCTC/NCPF CRMs.
"Licensing the LENTICULE disc technology to Sigma-Aldrich means the PHE microbiologists can concentrate on the development of new products to improve health outcomes, while end users benefit from Sigma-Aldrich's expertise in manufacturing and global distribution."
The CRMs will be produced in accordance with ISO Guide 34 and individually packed at Sigma-Aldrich.
"We have invested in a new, dedicated Biosafety Level 2 facility and expanded the scope of our ISO 17025/ ISO Guide 34 accreditation to manufacture this product range in full accordance with our Environmental Health and Safety (EHS) and quality guidelines," said Fabian Wahl, business development director at Sigma-Aldrich.
LENTICULE discs must be stored at -20°C ± 5°C, although short periods at ambient temperature such as during transportation, does not affect viability.
