Membrane cartridges

LifePure Plus Pharma

Sterilizing-grade PES membrane cartridge

Sterilization of pharmaceutical and biological solutions

Sterilizing-grade asymmetric PES membrane filter cartridge from 0.1 to 1.2 µm, evaluated to ASTM F838-20, USP <88>, and USP <665>, for pharmaceutical solutions.

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

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LifePure Plus Pharma, sterilizing-grade PES membrane cartridge by Exova

Description

The LifePure Plus Pharma is an asymmetric polyethersulfone (PES) membrane filter cartridge for the sterilization of pharmaceutical and biological solutions. Each unit is tested at the plant by diffusive flow and bubble point, and is delivered engraved and with a quality certificate.

The membrane has open pores on the outer face that narrow down to the final pore: high flow rates, low pressure drop, and a high contaminant retention capacity. It has 8,000 cm² of filtration area per 10″ and is offered in six ratings, from 0.1 to 1.2 µm.

The filter was evaluated to ASTM F838-20 (bacterial retention), USP <88> (biological reactivity, Class VI plastics), and USP <665> (extractables), and a validation guide is available. It withstands sanitization with hot water at 80 °C and with chemicals, as well as repeated sterilization in an autoclave or with in-line steam.

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.

100 % integrity tested

Each cartridge is tested at the plant by diffusive flow and bubble point, and is delivered with a quality certificate.

Engraved traceability

Each cartridge is engraved with lot, model, pore size, and part number. Validation guide available.

8,000 cm² per 10″

Extended filtration area with an asymmetric membrane: high flow rates and low pressure drop.

Manufactured in an ISO 7 cleanroom

Rinsed with purified water after manufacturing. Materials compliant with FDA 21 CFR 177.

Microbial retention

Values stated in the LifePure Plus 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)
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-coated Viton

Dimensions

Nominal filtration area	8,000 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
Maximum 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> (intraperitoneal injection, systemic injection, and intramuscular implantation): meets the acceptance criteria 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, by diffusive flow and bubble point
Each cartridge engraved with lot number, model, pore size, and part number
Quality certificate with each cartridge
Validation guide available

Applications

Injectable solutions
Small- and large-volume pharmaceutical products (SVP and LVP)
Ophthalmic solutions
Biological fluids
Culture media
Antibiotics
Water for injection (WFI)
Buffer solutions
Process chemicals
Cleaning and sanitizing agents

Industries

Pharmaceutical and biotech SaniFlow filter housings

Frequently asked questions

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.

Does it comply with USP Class VI?

Yes. The biological reactivity tests per USP <88> (intraperitoneal injection, systemic injection, and intramuscular implantation) met the acceptance criteria for Class VI plastics.

How is the integrity tested?

100 % of the cartridges are tested at the plant, unit by unit, by diffusive flow and bubble point.

Can it be autoclaved?

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

LifePure line