Membrane cartridges

LifePure Protec Pharma

Sterilizing dual-membrane PES cartridge

Sterilizing filtration for the pharmaceutical and biotech industry

Dual PES membrane filter cartridge, from 0.1 + 0.2 to 0.8 + 1.2 µm, evaluated to ASTM F838-20 and USP <88>, for pharmaceutical sterilizing filtration.

Line: LifePure · Polyethersulfone (PES)
Pore sizes: 0.1 + 0.2 µm to 0.8 + 1.2 µm
Lengths: 10″ · 20″ · 30″ · 40″
Manufacturing: Argentina · ISO 7 cleanroom

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LifePure Protec Pharma, sterilizing dual-membrane PES cartridge by Exova

Description

The LifePure Protec Pharma is a filter cartridge with a dual asymmetric polyethersulfone (PES) membrane for sterilizing filtration in the pharmaceutical and biotech industry. The two membranes, with different pore sizes, form two filtration stages in a single element: the upstream layer acts as a prefilter and protects the tighter final membrane.

The result is high flow, high contaminant-holding capacity, and low pressure drop. PES is hydrophilic: it wets immediately and has low protein adsorption. There are five pore combinations, from 0.1 + 0.2 µm to 0.8 + 1.2 µm, with 6,500 cm² of filtration area per 10″.

The filter was evaluated to ASTM F838-20 (bacterial retention), USP <88> (biological reactivity, Class VI plastics), and USP <665> (extractables). 100 % of the cartridges are integrity tested at the plant; each one is delivered engraved and with a quality certificate, and a validation guide is available.

Two stages in a single element

The upstream membrane acts as a prefilter and protects the final membrane: more retention capacity and service life.

ASTM F838-20 with B. diminuta

Complete retention of Brevundimonas diminuta (ATCC 19146) with a challenge ≥ 10⁷ CFU/cm², as a 0.2/0.22 µm filter.

USP <88> Class VI and USP <665>

Biological reactivity within the criteria for Class VI plastics, and extractables with no significant levels.

Hydrophilic PES

Immediate wetting and low protein adsorption, for sensitive pharmaceutical and biological solutions.

100 % integrity tested

Each cartridge is tested at the plant and delivered engraved and with a quality certificate. Validation guide available.

Five pore combinations

From 0.1 + 0.2 µm, for sterilizing filtration, to 0.8 + 1.2 µm, for the initial reduction of coarse particles.

Microbial retention

Values stated in the LifePure Protec Pharma catalog.

0.1 µm and 0.2 µm 10⁷ /cm² Brevundimonas diminuta According to the FDA definition of sterilizing-grade filters

0.45 µm 10⁷ /cm² Serratia marcescens

0.65 µm 10⁷ /cm² Saccharomyces cerevisiae

Technical specifications

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Materials

Filter medium	Asymmetric polyethersulfone (PES)
Filter medium, prefilter layer	Asymmetric polyethersulfone (PES)
Outer support layer	Polypropylene
Inner support layer	Polypropylene
Outer cage	Polypropylene
Core	Polypropylene
Flat ends	Polypropylene
Fin	Polypropylene
Adapter (222 and 226)	Polypropylene with internal reinforcement
O-rings	Silicone, Viton, Buna, EPDM, PTFE-encapsulated Viton

Dimensions

Nominal filtration area	6,500 cm² per 10″
Nominal length	10″ (254 mm), 20″ (508 mm), 30″ (762 mm), and 40″ (1,016 mm)
Nominal diameter	2.75″ (70 mm)

Operating conditions

Maximum differential pressure	5.5 bar (80 psi) at 25 °C
Maximum differential pressure in reverse flow	0.69 bar (10 psi) at 25 °C
Recommended differential pressure for change-out	2 bar

Sterilization and sanitization

Steam sterilization	Multiple cycles of 30 to 60 minutes at 121 °C, in-line or in an autoclave, without loss of integrity
Hot water sanitization	Multiple cycles of 30 to 60 minutes with water at 80 °C
Chemical sanitization	Multiple cycles of 30 to 60 minutes with peracetic acid or sodium hydroxide, maximum concentration 1 % (10,000 ppm)
Restriction	Steam and hot water: only for single-open-end cartridges (configurations B, C, D, and E)

Quality and compliance

Bacterial retention per ASTM F838-20: complete retention of Brevundimonas diminuta (ATCC 19146) with a challenge ≥ 10⁷ CFU/cm²; meets the requirements for 0.2/0.22 µm sterilizing-grade filters
Biological reactivity per USP <88>: meets the acceptance requirements for Class VI plastics
Extractables per USP <665>: no significant levels of compounds that interfere with pharmaceutical processes or with the safety of the final product
Materials compliant with FDA 21 CFR 177 for food contact
Complies with European Commission Directive 2002/72/EC and its amendments up to 2008/39/EC
Non-toxic components according to the migration test of the Argentine Food Code and Mercosur SGT3 standards
Manufactured in an ISO 7 cleanroom
Rinsed with purified water after manufacturing to remove extractables
100 % of the cartridges integrity tested at the plant
Each cartridge engraved with lot number, model, pore size, and part number
Quality certificate with each cartridge
Validation guide available

Selection data

Pore combinations and recommended uses
Combination	Recommended use
0.1 µm + 0.2 µm	Sterilizing filtration of critical biological and pharmaceutical solutions
0.2 µm + 0.4 µm	Sterilizing filtration (0.2 µm) with high-efficiency prefiltration, for fluids with a high load
0.4 µm + 0.6 µm	Clarification before sterile filtration, for solutions with a moderate particulate load
0.6 µm + 0.8 µm	Prefiltration of complex liquids, biopharmaceutical applications, and processes with a high solids load
0.8 µm + 1.2 µm	Initial stage of coarse particle reduction, which improves the efficiency of the finer downstream filters

Applications

Sterile filtration of injectables
Ophthalmic solutions
Small- and large-volume parenteral solutions (SVP/LVP)
Sera and vaccines
Buffers and culture media
Water for injection (WFI)
Process acids, bases, and solvents

Industries

Pharmaceutical and biotech SaniFlow filter housings

Frequently asked questions

Which combination is used for sterilizing filtration?

The 0.1 + 0.2 µm combination, for critical biological and pharmaceutical solutions, or the 0.2 + 0.4 µm combination, which adds high-efficiency prefiltration and is recommended for fluids with a high load.

Is it validated as a sterilizing filter?

Yes. It was evaluated to ASTM F838-20 with Brevundimonas diminuta (ATCC 19146) and a challenge load ≥ 10⁷ CFU/cm². Retention was complete: it meets the standard's requirements for 0.2/0.22 µm sterilizing-grade filters.

What documentation comes with the cartridge?

Each cartridge is delivered with a quality certificate and is engraved with the lot number, model, pore size, and part number. A validation guide is available.

Why two membranes?

The more open upstream membrane acts as a prefilter and protects the tighter final membrane. This increases the retention capacity and service life of the cartridge.

How is it sterilized?

With steam in-line or in an autoclave: multiple cycles of 30 to 60 minutes at 121 °C without loss of integrity. Only in single-open-end configurations (B to E).

LifePure line