E&O Laboratories Ltd sub-contracts all routine quality control testing of its manufactured product lines to its sister company E&O Diagnostics Ltd. The facility is located on site at Burnhouse and is accredited by UKAS to ISO/IEC 17025:2005.
Quantifiable, representative batch samples are collected during the manufacturing process in accordance with statistical sampling plans which are compliant with BS6001-1:1999 ISO 2859-11999. These samples are delivered with sample submission documentation for quality control testing in accordance with:
ISO/TS 11133 - 1:2009 and ISO/TS 11133 - 2:2003 - Guidelines on preparation and production of culture media.
Sterility Tests: All batches of solid and liquid media are sampled using a double sampling plan to ensure representative samples from throughout each batch. The samples are incubated at 37° C for 3 days and 15° C - 25° C for up to 8 days to ensure any low level contamination is detected. In addition, samples of liquid media products are subcultured on to non-selective solid media after 48 hours incubation at both temperatures. These subcultured samples are then incubated at 37° C for 3 days and 15° C - 25° C for up to 8 days.
Microbial Performance: The microbiological performance of each batch of media is assessed using defined suspensions of 1st generation national culture collection organisms. The Productivity ratio (PR) is established by comparison of the number of colonies observed on the media under test, with the number of colonies observed on a defined reference / control media, when each have been inoculated with an appropriate inoculum of a defined working culture. The productivity results are expressed as a % RGI (Relative Growth Index). Selectivity is expressed as a selectivity factor (SF ) and is the log unit difference between the control count of a non-target organism on a reference medium and the test count of the same organism on a selective medium.
Pharmaceutical products are analysed using control organisms specified in the relevant pharmacopoeias. Fresh working cultures are used to confirm productivity and selectivity as described above. Irradiated media products are analysed pre and post irradiation to ensure the process has not had a detrimental effect on the culture media products.
Sensitivity Test Media: Media is tested with an appropriate range of antibiotic discs and control strain organisms, to ensure zone diameters conform to the QC ranges specified in the British Society for Antimicrobial Chemotherapy (BSAC), Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) and European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines.
Physical Testing: The Moisture content of solid media is measured to ensure the concentration of water and raw materials are correct. The pH of all culture media is measured to ensure the materials and sterilization processes are correct. Every batch of culture media has a pre defined colour specification. Analysts compare the colour of the media to specified colour charts to ensure batch consistency. The Fill Quantity, and Appearance: are also assessed. to ensure only consistent products are released to the market place.
Specifications: Specifications are pre-defined for all media types. These exceed the expectations of the standards ISO/TS 11133-1:2009 and ISO/TS 11133-2:2003.
Calibration: All equipment is independently calibrated and verified in line with ISO 7218 recommendations to ensure the accuracy and consistency of ongoing analysis.
Traceability: E&O Diagnostics Ltd meets the requirements of GLP and maintains full traceability of the equipment, analysts and materials used for all analyses.
Validation: All test methods are validated. The uncertainty of measurement has been defined for each method. Uncertainty and repeatability are continually assessed through internal proficiency schemes to assure ongoing method and operator accuracy.
Providing all specifications are met the production batch is released for stock. A proportion of sample from every production batch is retained and stored at appropriate temperatures for expiry monitoring and any post delivery re-testing.
