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 understand the challenges that face the pharmaceutical industry today. 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, Vcap (or Vmax ) 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.
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.
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.

For further details, please call us on (021) 32218 972, 32626 250 or email microbiology@musajisons.com