ISO 9001:2015 & BS EN ISO 13485:2016

E&O Laboratories Ltd is certified to ISO 9001:2015 & BS EN ISO 13485:2016 for the “The development, manufacture and supply of microbiological prepared culture media, dehydrated culture media, blood products, microbiological supplements/reagents and microbiological analytical services”

The Quality management system is designed and written to ensure accuracy and traceability throughout the business.

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UKAS BS EN ISO/IEC 17025:2005

All manufactured Culture Media & raw material testing is subcontracted to E&O Diagnostics Ltd for quality control. Test methods are accredited by UKAS in compliance with BS EN ISO/IEC 17025:2005. Methodology is based on ISO 11133:2014.

HOME OFFICE PROJECT LICENCE

E&O Laboratories Ltd’s farm division holds a Home Office Project License for the Animals (Scientific Procedures) Act 1986 to routinely harvest & process donor animal blood products. All Animal technicians hold personal licenses and two farms are licensed designated areas.

IVD CE MARKING

E&O Laboratories Ltd are an MHRA registered supplier and provide an extensive range of clinical reagents which are CE marked in compliance with the European In-Vitro Diagnostics Medical Devices Directive 98/79/EC.

INDUSTRIAL COMPLIANCE

Pharmaceutical culture media manufacture comply with the Harmonized MTL methods in the US/EU/JP Pharmacopoeias – International Standards and ISO criteria

cGMP/cGLP COMPLIANT

E&O Laboratories Management System incorporates the relevant criteria of Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) to ensure products are consistently manufactured and controlled to defined quality.

E&O Laboratories employ a very highly qualified team of scientists to formulate new media, improve on existing formulations and work with clients to design specialised diluents/reagents and new culture media. A dedicated laboratory area with calibrated modern equipment allows a wide variety of media assays to be performed and designed before scaling up for final customer verification. E&O can source raw materials worldwide and has the in-house expertise to mill, blend, sterilise, aliquot and quality control to any specification in volumes/weights and containers to satisfy clients individual requirements.

Once a new or improved product has completed the design stage within our research and development department, a new product specification document is completed (TDS) prior to being released for production. All new recipes have to be fully validated to meet all the quality standards plus customer/user/market sector regulatory requirements.

E&O have over 800 live media formulations to supply a variety of market sectors: Clinical & Veterinary, Food/ Water & Environmental, Pharmaceutical/Industrial & Cosmetic Microbiology Laboratories both here in the UK and throughout Europe/Asia.