Sterile Filtration of Biotech Fermenter Off-Gas
Many of the major multi-national Pharmaceutical companies have Biotech manufacturing operations, typically producing high value products. This application is to found at one of these Bio-tech sites where they produce pharmaceutical material by fermentation of microorganisms. The organisms are genetically modified so they produce the pharmaceutical product required.
The microorganisms require a constant stream of air to enable them live, grow and manufacture product. This is bubbled through the culture liquid that the microorganisms grow in and as the air exits the fermenter it is sterile filtered to prevent any carry-over of the microorganisms into the surrounding environment.
At this site the operator has many fermenters. Due to the need for very high air flows and very low pressure drops the Off-Gas systems consist of large multi-round housings and depending on the size of the fermenter they contain either 20” or 30” cartridges. The filters are required to last many, many months to ensure the operation is economically viable and to maintain the sterility of the system are subjected to frequent in-situ steam sterilisation. Therefore the filter need to be qualified to demonstrate they are able to provide sterile air, withstand multiple steam cycles and offer low pressure drops.
Amazon's alternative solution
The customer was using another filter suppliers 0.2 µ rated PTFE filters and Amazon’s equivalent specification filter is SupaPore TPB, which were supplied as same length cartridges. This ‘like for like’ offer made it easier for the user to make the switch.
The filters fully met the user’s quality specifications and passed the steam life tests and are now replacing the previous product. The benefits for the client are a lower cost filter and 30% lower pressure drop. The lower pressure drop is a significant benefit as it reduces energy costs associated with compressing and temperature controlling large volumes of air.
Due to the high number of filters used each year the customer had stipulated very specific packaging requirements and Amazon was able to offer identical packaging.
Another significant benefit for the customer is that by utilising locally inventory we are able to offer shorter lead times and more flexibility in ordering patterns.
Filtration of ‘Off-gas’ air for Biotech fermentation applications typically involves large filter systems to minimise differential pressure and requires the filters to withstand multiple steam sterilisations to ensure he filters can be reused and costs are kept to a minimum. This Case Study demonstrates that Amazon Filters by utilising its high specification SupaPore TPB filters can provide systems for this application that reduce the cost of operation.