Sterility testing of difficult to filter product - can we help?

Sterility testing is tricky and its more when it is difficult to filter, viscous, oily products. How can we address these issues of clogging, slow filtration, low recovery, the formation of emulsions which are few problems and challenges that the pharmaceutical quality control microbiologist and laboratories face? These problem forces the quality control laboratories to direct inoculation method. Pharmacopeia standards, such as USP <71> and EP <2.6.1>, recommend membrane filtration as the preferred method for sterility testing whenever the nature of the product permits. Whatever said and done, filtration methods have the advantage of allowing large sample volumes to be tested for meeting standards requirements and recommendations. 

The question here is how can we make it better? Do we have a solution that is ergonomic, reliable, compliant, and efficient?

 When we look at viscous, oily and difficult to filter product the typical issues can be mitigated with the use of right membranes like Durapore (low binding), right canisters (inert wall of the canisters), clear fluid thioglycollate medium (CFTM containing synthetic agar) and most importantly use of Isopropyl myristate, ready to use pharmacopeia recommended rinse fluid A/D/K.

 Merck has the solution with the Steritest? family and objective is to build a first-time-right solution avoiding false results

Connect with us in case consultation is required for sterility testing, bioburden, environmental monitoring, or for pyrogen testing.

Rajasekhar Pandaarathil