Media Fills

 

Dehydrated Powder and
Ready-to-Use Liquid Media


Efficient Media Fill Trials

Manufacturers of pharmaceuticals must document their aseptic production conditions regularly. To do so, they perform so-called media fill trials (or process simulation studies). Here, culture media replace the pharmaceutical product which is usually filled. They run through the entire process and 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.

Your goal is zero false positives; so is ours.

A major concern in media fill trials is that the media used does not compromise the validated processes. EMD Millipore 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 dehydrated powder or exclusive, low-dust granulated form. For maximum flexibility and convenience, EMD Millipore provides ready-prepared liquid media in screw-cap bottles or H2O2-impermeable bags for aseptic connections. For its media fill products, EMD Millipore uses TSB or a vegetable (animal-free) peptone broth. Vegetable Peptone Broth of non-animal origin eliminates the possibility of contamination by BSE or TSE.

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

All EMD Millipore culture media – both dehydrated and ready to use – for media fill trials 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 BSE, which could emanate from products of animal origin. Furthermore, EMD Millipore sources its bovine ingredients exclusively from countries which are classified by the EU as low-risk in relation to BSE/TSE.

 
 
Media Fills Brochure

Brochure
Your goal is zero
positives


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