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17 June 2005

ASSURING PHARMACEUTICAL PROCESSES WITH THE EXPERTS

Oxoid offers much more than culture media for pharmaceutical media fill trials

Following publication of the ‘Guidance to Industry’ relating to aseptic production in the pharmaceutical industry, there has been a renewed emphasis on process control. As a part of this, media fill trials are playing an increasingly important role in the manufacture of parenteral drug products. The new guidelines require that the media fill trials mimic the production process as closely as possible. Drawing from its wealth of experience and expertise, Oxoid has designed culture media products meeting the demands of modern media fill trials; that comply with pharmacopoeial specifications and that include a range of quality assurance and validation documents as part of the “package”.

Oxoid Director of Regulatory Affairs, Colin Booth, has been driving the development of Oxoid products to be ready to meet the changing needs of the pharmaceutical industry. “We understand the challenges that face the pharmaceutical industry today,” he explains. “By monitoring potential changes in regulations and keeping on top of the needs of the industry, we have been proactive in the development of products that allow pharmaceutical manufacturers to keep their processes in control.”

A prime example of this is Oxoid Cold filterable Tryptone Soya Broth (TSB) (product code: CM1065), for use in media fill trials. The new guidelines state that manufacturers should mimic their production process in their media fill trials as closely as possible. As a result, TSB now needs to be passed through filter trains. With standard TSB, problems of slow filtration or filter blockage can arise.

Oxoid Cold filterable TSB has been specially developed to meet the requirements of the new method. The product is readily dissolved in cold water and is designed to pass freely through a 2 µ m filter. By providing faster filtering (without the need to heat the medium or change filters), this product saves valuable time for the production team. Furthermore, V_cap (or V_max ) data is provided for each batch, giving assurance of high filterability.

Oxoid Cold filterable TSB is irradiated to ensure yeasts, moulds, bacteria, bacterial spores and mycoplasmas are eliminated. For quality assurance purposes, a variety of documentation can be obtained in support of the medium, including certificates of analysis, material safety data sheets, filterability studies, irradiation dosage studies, specific density and viscosity studies and certificates of origin.

Another requirement of some pharmaceutical companies is for the availability of products that are completely free from animal derived materials. To meet this demand, an Oxoid meat-free alternative to cold filterable TSB has also been launched. Oxoid Cold filterable Vegetable Peptone Broth (VPB) (VG104) utilises a pea peptone digested using fungal enzymes. This highly nutritious, general purpose medium supports the growth of a wide range of bacteria, yeasts and moulds and comes with similar filterability data, support and documentation as its TSB equivalent.

Oxoid Pharmaceutical Marketing Manager, John Pleasants, comments, “The Oxoid range offers so much more than the products. Each item offers valuable reassurance to pharmaceutical customers, with the knowledge that they have been developed with their specific needs in mind and with assurances of quality, performance and reliability. We also have very experienced professionals on hand to advise customers when required.”

The performances of Oxoid Cold filterable TSB and Oxoid Cold filterable VPB are tested according to specifications for growth of control micro-organisms laid down by the European, British, US and Japanese Pharmacopoeias. In addition, all Oxoid culture media are manufactured in dedicated BS EN ISO 9001:2000 registered premises and prepared media products are processed in an ISO 13485/1996 accredited Prepared Media facility.

Some of the world’s largest pharmaceutical companies are already benefiting from the quality and performance of Oxoid products for media fill trials and many of these companies have visited the Oxoid manufacturing site to audit their processes.

Speak to your local Oxoid representative for further details.