Sterile Process Filtration and Single-Use Systems
Liquid and gas filtration from clarification through bioburden reduction to sterile filtration and mycoplasma removal, and automated single-use bioprocessing systems. Available across the UAE, Saudi Arabia and Egypt.
What process filtration has to achieve
Biologics and many sterile drugs cannot be sterilised by heat, so filtration is the step that makes them sterile. A filter train has to remove particles and cell debris, reduce microbial load, and finally deliver a sterile fluid, without losing product or slowing the process.
Each stage protects the next. Clarification and prefiltration keep the expensive sterilising membrane from blocking early; bioburden reduction lowers the microbial challenge; the sterilising-grade filter at the end must be validated and integrity-tested. Mycoplasma is a separate concern: these small, wall-less organisms can pass filters rated for bacteria, so cell culture media and some process fluids need mycoplasma-retentive filtration.
Stainless-steel systems add their own burden: cleaning, cleaning validation and changeover between products. Single-use assemblies remove much of that work, but have to be chosen with extractables and leachables, scale and supply in mind.
A filtration train and single-use systems from one partner
Parker provides biopharmaceutical liquid and gas filters and housings for the whole sequence: clarification, bioburden reduction, sterile filtration and mycoplasma removal. Gas and vent filters protect bioreactors, tanks and lines from airborne contamination.
Sterilising filters are integrity-tested before and after use, typically by bubble point or diffusion testing. EU GMP Annex 1 also expects a pre-use, post-sterilisation integrity test unless a risk assessment justifies otherwise, so filter and assembly design should make that test practical.
For single-use processing, Parker incorporates SciLog technology into scalable, automated single-use bioprocessing systems for upstream and downstream applications. They can be configured as manual, semi-automated or fully automated, so the level of automation matches the process and the batch size.
Clarification and prefiltration
Depth and prefilters that protect downstream membranes.
Bioburden reduction
Lower microbial load before critical process steps.
Sterile filtration
Sterilising-grade liquid filters and the housings to hold them.
Mycoplasma removal
Filtration stages that extend to mycoplasma retention.
Gas and vent filtration
Sterile air and gas filtration for vessels and lines.
Automated single-use
SciLog-based systems, manual to fully automated.
Partner technology
Parker covers the filtration train and the automated single-use systems around it.
Frequently asked questions
What makes a filter sterilising grade?
A sterilising-grade filter is validated to retain a defined bacterial challenge, typically Brevundimonas diminuta, and produce a sterile filtrate under the conditions of the process.
Why is mycoplasma removal a separate step?
Mycoplasma are very small and lack a cell wall, so they can pass filters rated for bacteria. Media and process fluids at risk are filtered through mycoplasma-retentive filters.
What is filter integrity testing?
A non-destructive test, such as bubble point or diffusion, that confirms a sterilising filter is intact. It is performed before and after use, and EU GMP Annex 1 expects a pre-use test after sterilisation unless justified.
When does single-use processing make sense?
It suits multi-product facilities, clinical and early commercial scale, and processes where cleaning validation and changeover time are a burden. Extractables, leachables and supply continuity are assessed as part of the choice.
Can single-use systems be automated?
Yes. Parker’s SciLog-based systems can be configured as manual, semi-automated or fully automated for upstream and downstream applications.
From the blog
Single-Use Bioprocessing in the Middle East: When It Makes Sense
When single-use bioprocessing beats stainless steel, when it does not, and what Middle East manufacturers should assess before committing.
Read articleSterile Filtration in Pharmaceutical Manufacturing: Bacteria, Mycoplasma and Filter Integrity
Sterile filtration in pharmaceutical manufacturing: filter ratings, bacterial retention validation, mycoplasma removal and integrity testing.
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