The importance of sterility in pharmaceutical bioproducts

Bioproducts in the pharmaceutical industry have become increasingly relevant in recent years thanks to the development of new technologies. And just like traditional medications, quality assurance of these products is one of the cornerstones and challenges of the sector. 

Process control 

Quality control (QC) of a bioproduct generally depends on the nature of the end product, whether it is sterile or not. Some may be non-sterile, thus requiring specific analysis to identify contaminating microorganisms. 

Terminal sterilization can be used for sterile products; however, this is not a universal option as some active substances are temperature sensitive and the bioproduct's performance would be affected. 

In this sense, rather than analyzing the end product to verify its sterility, control of the manufacturing process is carried out, on the one hand to monitor the microbial load of the product and on the other hand to verify that the production process is carried out under aseptic conditions. As a result, environmental and process monitoring is performed regularly. 

One of the best-known methods is the aseptic filling validation or Media Fill Test (MFT), which basically consists of simulating the actual production process by exchanging the product for a culture medium that promotes microbial growth. The most commonly used culture medium is TSB, however, there are other options such as TSB with vegetable peptones or Thioglycollate Fluid Medium (TFM).  

Culture media used should be subject to sterility and quality controls, as well as growth promotion controls to corroborate their suitability and performance. 

What about end-product control? 

For a sterile product it is also necessary to determine if it is within the established parameters, and when required, to specifically identify the contaminating microorganism(s). The European Pharmacopoeia (Ph. Eur.) has established the Sterility Test to verify that a product meets this quality. The result will indicate whether or not there is microbial contamination in the sample tested. As in the MFT, a medium that supports the growth of microorganisms is required, so both TSB and TFM are used. 

At Condalab we have culture media available that follow standardized methods so that you can easily perform both the MFT and the Sterility Test, since all our batches are tested to meet high quality standards and thus ensure their sterility and performance. For further information on this topic, please register to watch our recorded CondalabTalk.  

We also have products for your production process, R&D reagents and raw materials as a nutrition source. Download our Industrial Bioprocesses catalogue for more information.