Industry · Pharmaceuticals and Biotechnology
There is no margin for error in pharmaceutical manufacturing: validatable, fully GMP-compliant sterile filtration engineering down to 0.11 micron on liquid, gas and air lines.
0,22 µm
Bacterial sterilization standard
0,11 µm
For mycoplasma and viral risk
CIP / SIP
AISI 316L hygienic housing
Critical points
In pharmaceutical and biotechnology manufacturing, microbiological purity is not a quality choice but a precondition for market release. Sterile filtration at every point, from vaccines to serum and from bioreactor outlet to filling line, ensures product safety and meets the inspection requirements of authorities such as the EMA and the Turkish Medicines and Medical Devices Agency (TİTCK).
In the production of liquid drugs, physically retaining bacteria, viruses and pyrogens requires safety that is repeatable in every batch. Absolute filters rated at 0.11 micron are designed for this requirement. Filters whose Beta ratio values meet the industry’s strictest standards ensure batch-to-batch consistency and validatable performance. Regulatory authorities want to be sure that each filter delivers its stated performance every time. Filters must therefore be systems that pass integrity tests such as Bubble Point and Diffusion and come with complete documentation. Validation is not the outcome of this process but a design requirement.
Solution: Integrity-testable absolute filters
In pharmaceutical plants, it is vital that equipment can be cleaned between production runs without creating a contamination risk. Dead-leg-free filter housings made of AISI 316L stainless steel are fully compatible with CIP and SIP processes. Resistant to high-temperature steam sterilization and aggressive chemical cleaning, these designs minimize downtime and maintain operational continuity. 0.22 micron filters are the industry standard for routine bacterial sterilization. In biotechnology processes where smaller organisms such as mycoplasma or a viral load pose a risk, absolute filters rated at 0.11 micron are preferred to maximize the safety margin.
Solution: Dead-leg-free 316L housing
Sterilizing the air entering storage tanks creates a critical barrier that prevents sensitive raw materials and water for injection (WFI) from being spoiled by atmospheric contamination. Tank venting filters are at the center of this barrier. The precious metal catalysts used in biotechnological synthesis, especially in active pharmaceutical ingredient (API) production, are very costly. Precisely designed recovery filters separate these particles from the production stream, protecting product purity and allowing valuable materials to be reused, which contributes directly to plant economics.
Solution: Sterile air barrier
Production line
Select a stage on your line to see the Prosestim filters and micron range used at that point.
01 · Pre-filtration
Pre-filtration on process water and WFI lines protects the final-stage membranes.
02 · Bioburden reduction
Pre-filtration ahead of the sterile filter reduces bioburden and particles.
03 · 0,22 µm
0.22 micron filters are the industry standard for routine bacterial sterilization.
04 · 0,11 µm
In processes where mycoplasma or a viral load poses a risk, 0.11 micron absolute filters are preferred.
05 · Sterile air
Sterilizing the air entering storage tanks protects sensitive raw materials and WFI.
Applications
The same filtration principles apply across applications, with different material and micron choices.
Absolute filtration on liquid lines.
Bioreactor and harvest filtration.
Water preparation and distribution.
Catalyst recovery.
Products used in this industry
Each product page lists the micron range, material compatibility and operating conditions.
Pleated micro cartridge filter with PES, PTFE, PVDF and PP membranes; 0.11–50 µm for sterile and precision filtration
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Stacked disc module cartridge filter, 0.2–60 µm, for wine, beer, juice and pharmaceutical lines
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Hygienic AISI 316L/304 stacked disc filter housing with 1–4 module capacity; bypass-free lenticular filtration for pharmaceuticals, beverages and chemicals
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Chlorine, odor, taste and VOC removal with CTO and GAC activated carbon cartridge filters; suitable for food, pharmaceutical and chemical lines
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100% pure PP, binder-free melt-blown cartridge filter (sediment filter); 1–150 µm for RO pre-filtration and process water
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Stainless steel cartridge filter housing with AISI 304L/316L/316Ti body and 1–60 cartridge capacity
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Invoice name (registered company name)
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