ISO 9001:2015 & BS EN ISO 13485:2003/2012

E&O Laboratories Ltd is certified to ISO 9001:2015 & BS EN ISO 13485:2003/2012 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.

HOME OFFICE PROJECT LICENCE 1986 CERTIFICATE

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

UKAS BS EN ISO/IEC 17025:2005

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

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.