When to change a filter cartridge: differential pressure and service life
When to change a filter cartridge based on differential pressure: what ΔP measures, clean and change-out ΔP, warning signs, and how to log it batch by batch.
Industries
Sterilizing filtration and single-use for pharma and biotech
From media and buffer preparation to sterilizing filtration of injectables: cartridges, housings, and single-use systems made in Argentina, with the documentation a regulated process requires.
What is filtered and why
In a pharmaceutical process, the final filter is the last barrier before the product. Exova's pharmaceutical-grade cartridges—the LifePure and UltraPure Pharma versions—are tested one by one at the plant and supplied with a quality certificate and a validation guide. Their catalogs state complete retention of Brevundimonas diminuta at a challenge of 10⁷ CFU/cm² per ASTM F838-20, biological reactivity per USP <88> Class VI, and extractables per USP <665>.
Working around the final filter are the prefilters that reduce bioburden and particle load, the SaniFlow sanitary housings in AISI 316L, and the single-use systems to prepare, store, and transport solutions: ExoFlex bags, AgileReact containers, and AgileConnect connectors. To prepare and mix in stainless steel, the holding tanks and the magnetically or mechanically agitated reactors.
Integrity tested at the plant
Every pharmaceutical-grade membrane cartridge is tested at the plant by diffusive flow and bubble point, and marked with its lot, model, pore size, and part number.
Validated retention
Complete retention of B. diminuta at a 10⁷ CFU/cm² challenge per ASTM F838-20 in the 0.1 and 0.2 µm sterilizing models.
Sanitary 316L stainless steel
STU and SNU housings, tanks and reactors in AISI 316L with the interior polished to Ra ≤ 0.4 µm. The SNU-01 complies with the Pressure Equipment Directive (PED 2014/68/EU).
ISO 7 cleanroom
Cartridges, bags, and single-use systems are manufactured in an ISO 7 cleanroom and rinsed with purified water after manufacturing.
Stage by stage
The process and the product for each stage
Solution preparation and storage
Closed 2D bags from 50 mL to 50 L with ULDPE/EVOH/HDPE film and silicone or TPE tubing, and stainless steel containers for 3D bags from 50 to 2,000 L.
Single-use system connections
Y and X connectors, reducers, the clamp set, aseptic quick connectors, disposable manifolds, and USP Class VI accessories to build and connect bags, filters, and equipment.
AgileConnect Y, X and Reducer ConnectorsHose barb fittings 
AgileConnect Clamp SetConnector, clamp, gasket and end cap 
AgileConnect Quick ConnectorsAseptic polysulfone couplings 
AgileConnect Disposable ManifoldsManifolds with 1 to 5 ways 
AgileConnect Luer and Syringe ConnectorsLuer Lock and sampling 
AgileConnect Closure and FasteningPinch clamps, sleeve and ties Preparation and mixing in stainless steel
Magnetically or mechanically agitated pharmaceutical reactors, bioreactors and holding tanks from 50 to 5,000 L, in AISI 316L with an interior Ra ≤ 0.4 µm, with a jacket, load cells and instrumentation to suit the process.
Clarification and bioburden reduction
Hybrid prefilters with a final membrane and glass microfiber prefilters that protect the sterilizing filter in protein solutions, sera, media, and buffers.
Sterilizing filtration
PES or nylon 6,6 membranes of 0.1 and 0.2 µm, in single or double layer. For hydroalcoholic and solvent-containing solutions, the pharmaceutical-grade UltraPure line.
Cartridge housings
Single-cartridge or multi-element sanitary housings in AISI 316L, steam sterilizable.
Air, gases, and tank venting
FluoroPure cartridges with a 0.2 µm hydrophobic PTFE membrane for sterile air, process gases, and tank venting, and housings with optional heating on the SNU-01 to keep condensation out of the vent filter.
Fine chemicals and active ingredients
Washable stainless steel mesh cartridge for chemical purification, bulk active ingredients, and recovery of catalyst solids.
Frequently asked questions
Pharmaceutical and biotech: common questions
Which cartridge is used for sterilizing filtration?
The 0.2 µm (or 0.1 µm) pharmaceutical-grade models: LifePure Plus Pharma and LifePure Protec Pharma with a PES membrane, and UltraPure Plus Pharma and UltraPure Protec Pharma with a nylon 6,6 membrane. Their catalogs state complete retention of Brevundimonas diminuta at a 10⁷ CFU/cm² challenge per ASTM F838-20, and they are supplied with a quality certificate and a validation guide.
PES or nylon for the final filter?
Asymmetric PES has open pores on the outer face that narrow toward the final pore size, which gives it flow rate and dirt-holding capacity. The UltraPure nylon 6,6 membrane is naturally hydrophilic; its pharmaceutical-grade version is indicated for hydroalcoholic and solvent-containing solutions. To choose based on data from your process, contact us.
Which is better: a double-layer cartridge or a separate prefilter?
Protec cartridges (LifePure Protec Pharma and LifePure Protec, UltraPure Protec Pharma) combine two membranes in a single element: fewer housings and fewer interfaces. With high particle or colloid loads, a separate prefilter (PreFiber or MicroFiber) is usually the better choice to protect the final membrane. We work it out with you based on the fluid and the volume.
Do you make custom single-use bags?
Yes. ExoFlex 2D bags are configured by volume (from 50 mL to 50 L), number of ports, and tubing type (silicone, peristaltic-pump silicone, or TPE), and are manufactured and tested in an ISO 7 cleanroom with a certificate for each lot.
Technical blog
Articles for pharmaceutical and biotech
AISI 304 vs. 316L stainless steel in sanitary equipment: differences and when to use each
AISI 304 vs. 316L stainless steel in sanitary equipment: molybdenum, carbon and welding, chlorides, passivation, Ra finish, and when to use each one.
Bacterial retention test (BRT): how sterilizing filtration is validated with your product
How sterilizing filtration is validated with your product in a bacterial retention test: worst case, bacterial viability, controls, and filter integrity.
Talk to engineering
Shall we design the filtration train for your plant?
Tell us the fluid, the flow rate and the operating conditions. We reply with the model, the ordering code and the technical documentation.