Throughout the production of biopharmaceuticals, contaminating microorganisms can enter the process at several stages. Once released, bacteria or fungi can replicate exponentially, seriously compromising the final product. The existence of germs in vaccines and other biopharmaceuticals can over time equally spoil the solution and pose a significant threat to patient health. Therefore, regulatory bodies such as the FDA and EMA have rigorous tests set up to guarantee contamination hasn’t occurred. This is determined through Bioburden testing of representative samples of a batch, to recognize the existence of any viable microorganisms from the material. The evidence of sterility is part of instruction needed for the lot release of biopharmaceuticals.
There are numerous sources of contamination throughout the production of biopharmaceuticals. This includes raw materials, personnel, equipment and the production environment. Regulatory agencies offer advice for reducing the risks of introducing bacterial or fungal contamination, for example, use of sterilizing techniques on raw material, ensuring aseptic conditions and through implementing GMP. However, despite these precautions, it is impossible to eliminate risk entirely. As such, it is crucial to regularly test for sterility during fabrication. The guidelines for bioburden testing are present in various Pharmacopoeias worldwide, such as the United States Pharmacopeia and the European Pharmacopeia EP. This advice has been harmonized by the IHC. Bioburden testing performed by Sartorius Tedim Bio Outsource is to GMP regulations and in compliance with the EP and USP <71> Sterility tests.
Determining sterility involves the use of test substance to inoculate media which supports microbial growth. After inoculation, the press is monitored for 14 days for visual signs of bacterial or fungal contamination. If expansion is observed, this may be confirmed using agar plates and the microorganism identified. This may help understand the way the item was compromised. The guidelines detail testing for sterility through inoculation of Both fluid thioglycolate medium and soya-bean casein digest medium. A combination of both of these media has been chosen to encourage rapid development of a wide-range of microorganisms, including both aerobic and anaerobic bacteria and fungi. If you are a lab that routinely Performs Bioburden testing, enroll today and Gain access to our high-value, pre-screened leads!