Media Fills

Multiple Tested, Granulated TSB and Animal-Free
Peptone Broth

For media fill trials in the pharmaceutical industry, Merck provides dehydrated, low-dust granulated media fills based on either TSB or animal-free peptone broth.

Media Fill Trials to Demonstrate Aseptic Production Conditions

Manufacturers of pharmaceuticals must regularly test and document that their aseptic filling lines produce sterile products. To do so, they perform media fill trials (or process simulation studies), in which culture media replaces the pharmaceutical product. The entire process is run through to test for microbiological contamination. Simulation and evaluation of the complete manufacturing process is recommended by the EU/PIC/S guide to GMP to ensure that the routine production of commercial batches is safe and reliable and that it generates products showing the required quality.

Keep Your Validated Processes in Mind

A major concern in media fill tests is that the media used does not compromise validated processes. Merck provides high quality media fills which meet all requirements for safe testing of both solid and liquid filling lines. Highly soluble and filterable dehydrated culture media (DCM) are available in exclusive, low-dust granulated form. For its media fill products, Merck uses Tryptic Soy Broth (TSB) or a vegetable, animal-free peptone broth. Vegetable peptone broth of non-animal origin eliminates the possibility of contamination by BSE or TSE.

Media Fills are Designed to Provide Maximum
Safety and Convenience

• Gamma-irradiated at 48-76 kGy to prevent media related false positives
• Triple-bagged and ready for clean room use
• Growth promotion and sterility tested exceeding USP/EP requirements
• Produced and tested according to ISO standard 11133
• Excellent filterability and solubility for reduced preparation time
• Every lot tested for absence of Mycoplasmas

Keeping-Out BSE/TSE: Quality in Accordance with
International Standards

All Merck culture media for media fill trials – both dehydrated and ready to use – comply with the requirements in the Note for Guidance (EMA/410/01 Rev. 03) aimed at minimizing the risk of infection from animal spongiform encephalopathy via pharmaceutical products. In addition, the culture media meet the strict USDA standards and – if containing TSB of bovine origin – already comply with the future EU Directive on minimizing the risk of transmitting BSE through products of animal origin. Furthermore, Merck sources its bovine ingredients exclusively from countries which are classified by the EU as low-risk in relation to BSE/TSE.