Membrane cartridges

UltraPure Plus Pharma

Nylon 6,6 membrane cartridge

Sterilization and bioburden reduction in hydroalcoholic and solvent-based solutions

Nylon 6,6 membrane cartridge free of resins and surfactants, tested to ASTM F838-20, for sterilizing hydroalcoholic solutions and solutions containing solvents.

Line: UltraPure · Nylon 6,6
Pore sizes: 0.1 µm to 1.2 µm
Lengths: 10″ · 20″ · 30″ · 40″
Manufacturing: Argentina · ISO 7 cleanroom

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UltraPure Plus Pharma, nylon 6,6 membrane cartridge by Exova

Description

The UltraPure Plus Pharma is a nylon 6,6 membrane filter cartridge for sterilization and bioburden reduction in the pharmaceutical industry. It is designed for aqueous and hydroalcoholic solutions and mixtures with organic solvents: the fluids where PES membranes have chemical compatibility limitations.

The membrane is naturally hydrophilic, free of resins and surfactants, with low extractables and broad chemical compatibility. Its extended filtration area, 9,500 cm² per 10″, translates into higher flow rates, lower pressure drop, and longer service life.

The filters were evaluated to ASTM F838-20 with Brevundimonas diminuta (ATCC 19146) at a challenge load ≥ 10⁷ CFU/cm², with complete retention: they meet the standard's requirements for 0.2/0.22 µm sterilizing-grade filters. They also meet the USP <88> criteria for Class VI plastics and have an extractables study per USP <665>.

Each unit is tested at the plant by diffusive flow and bubble point, is engraved with lot, model, pore size, and part number, and is delivered with a quality certificate. A validation guide is available.

Where PES has limitations

For hydroalcoholic solutions, organic solvents, and non-aqueous formulations, with broad chemical compatibility.

Free of resins and surfactants

Naturally hydrophilic nylon 6,6 membrane, free of resins and surfactants, with low extractables.

Retention per ASTM F838-20

Complete retention of Brevundimonas diminuta (ATCC 19146) at ≥ 10⁷ CFU/cm²: qualifies as a 0.2/0.22 µm sterilizing-grade filter.

USP <88> Class VI and USP <665>

Biological reactivity per USP <88>, meeting the criteria for Class VI plastics, and an extractables study per USP <665>.

9,500 cm² per 10″

Extended filtration area: higher flow rates, lower pressure drop, and longer service life.

Traceability per cartridge

100 % integrity testing, engraving of lot, model, pore size, and part number, and a quality certificate with each unit.

Microbial retention

Values stated in the UltraPure Plus Pharma catalog.

0.1 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	Nylon 6,6
Outer and inner support layers	Polypropylene
Outer cage and core	Polypropylene
Flat ends and fin	Polypropylene
Adapter (222 and 226)	Polypropylene with internal reinforcement
O-rings	Silicone, Viton, Buna, EPDM, PTFE-coated Viton

Dimensions

Nominal filtration area	9,500 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
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 (1)
Hot water sanitization	Multiple cycles of 30 to 60 minutes at 80 °C (1)
Chemical sanitization	Multiple cycles of 30 to 60 minutes with peracetic acid up to 1 % (10,000 ppm), at room temperature
Chemical cleaning	Multiple cycles of 30 to 60 minutes with sodium hydroxide up to 1 % (10,000 ppm) (1)
Note (1)	Suitable only for single-open-end cartridges (configurations B, C, D, and E)

Quality and compliance

Bacterial retention per ASTM F838-20 with Brevundimonas diminuta (ATCC 19146) at a challenge load ≥ 10⁷ CFU/cm²: complete retention; 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 study per USP <665>, with representative solvents: no significant levels of compounds that interfere with the process or compromise product safety
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
Integrity of 100 % of the cartridges tested at the plant
Each cartridge engraved with lot number, model, pore size, and part number
Quality certificate with each cartridge
Validation guide available

Applications

Pharmaceutical solutions in hydroalcoholic mixtures
Filtration of solvents and of solutions with a high solvent content
Antibiotics in non-aqueous formulations
APIs and bulk pharmaceutical chemicals
HPLC mobile phases for analytical and preparative processes
Buffer solutions
Cleaning systems with organic solvents
Ophthalmic solutions with surfactants
Small- and large-volume pharmaceutical products (SVP and LVP)
Culture media

Industries

Pharmaceutical and biotech SaniFlow filter housings

Frequently asked questions

When is nylon 6,6 preferable to PES?

In fluids where PES membranes have chemical compatibility limitations. The catalog specifies it for hydroalcoholic mixtures, solvents and solutions with a high solvent content, HPLC mobile phases, antibiotics in non-aqueous formulations, and cleaning systems with organic solvents.

Is it validated as a sterilizing filter?

What documentation comes with each cartridge?

Each cartridge is delivered with a quality certificate and is engraved with the lot number, model, pore size, and part number. The integrity of 100 % of the cartridges is tested at the plant, by diffusive flow and bubble point.

Can it be steam-sterilized in place?

Yes: multiple cycles of 30 to 60 minutes at 121 °C, in-line or in an autoclave, without loss of integrity. It is suitable only for single-open-end cartridges (configurations B, C, D, and E).

What extractables does it release?

The membrane is free of resins and surfactants, with low extractables, and the cartridges are rinsed with purified water after manufacturing. The study per USP <665>, with representative solvents, found no significant levels of compounds that could interfere with the process or compromise product safety.

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