Membrane cartridges

UltraPure Protec Pharma

Dual-membrane nylon 6,6 cartridge

Dual-layer nylon 6,6 for pharmaceutical processes with a high contaminant load

Dual nylon 6,6 membrane cartridge with an integrated prefilter and 7,500 cm² per 10″, for pharmaceutical fluids with a high particle load or bioburden.

Line: UltraPure · Nylon 6,6
Pore sizes: 0.1 + 0.2 µm to 0.65 + 0.8 µm
Lengths: 10″ · 20″ · 30″ · 40″
Manufacturing: Argentina · ISO 7 cleanroom

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UltraPure Protec Pharma, dual-membrane nylon 6,6 cartridge by Exova

Description

The UltraPure Protec Pharma combines two nylon 6,6 membranes with different pore sizes in a single cartridge. The prefilter layer retains the larger contaminants and protects the final layer, which defines the filtration rating. This increases retention capacity, extends service life, and reduces replacement frequency in processes with a high particle load or bioburden.

There are four combinations (final layer + prefilter): 0.1 + 0.2 µm, 0.2 + 0.45 µm, 0.45 + 0.65 µm, and 0.65 + 0.8 µm, with 7,500 cm² (0.75 m²) of filtration area per 10″. The 0.1 and 0.2 µm final layers retain 10⁷ Brevundimonas diminuta per cm², according to the FDA definition of sterilizing-grade filters.

The membrane is naturally hydrophilic and free of resins and surfactants, suitable for aqueous and hydroalcoholic solutions and for solutions with organic solvents, where PES has chemical limitations.

It is manufactured in Argentina, in an ISO 7 cleanroom. Each unit is tested by diffusive flow and bubble point, is engraved with lot, model, pore size, and part number, and is delivered with a quality certificate. It withstands repeated steam sterilization and sanitization with hot water at 80 °C and chemical agents.

Integrated prefilter

The prefilter layer retains the larger contaminants and protects the final layer, which defines the rating of the cartridge.

Four pore combinations

Final layer + prefilter: 0.1 + 0.2 µm, 0.2 + 0.45 µm, 0.45 + 0.65 µm, and 0.65 + 0.8 µm.

Extended service life

More retention capacity and fewer replacements than a single-layer cartridge in fluids with a high particle load or bioburden.

Nylon 6,6 for solvents

Hydrophilic membrane without resins or surfactants, for hydroalcoholic solutions and solutions with organic solvents.

ASTM F838-20, USP <88>, and USP <665>

Bacterial retention per ASTM F838-20, USP <88> Class VI biological reactivity, and USP <665> extractables study.

Made in Argentina, ISO 7

Manufactured in an ISO 7 cleanroom, with integrity tested on 100 % of the cartridges and a quality certificate per unit.

Microbial retention

Values stated in the UltraPure Protec 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 (dual layer)
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	7,500 cm² (0.75 m²) 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 Argentina, 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

Selection data

Pore combinations
Final layer	Prefilter
0.1 µm	0.2 µm
0.2 µm	0.45 µm
0.45 µm	0.65 µm
0.65 µm	0.8 µm

The final layer defines the filtration rating of the cartridge.

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
Fluids with a high particle load or bioburden

Industries

Pharmaceutical and biotech SaniFlow filter housings

Frequently asked questions

What advantage does it have over a single-layer cartridge?

The prefilter layer retains the larger contaminants and protects the final layer. According to the catalog, this increases retention capacity, extends service life compared with single-layer cartridges, and reduces replacement frequency in processes with a high particle load or bioburden.

Which combination should I use for sterilizing filtration?

Those with a 0.1 or 0.2 µm final layer (0.1 + 0.2 µm and 0.2 + 0.45 µm): they retain 10⁷ Brevundimonas diminuta per cm², according to the FDA definition of sterilizing-grade filters.

How much filtration area does it have?

7,500 cm² (0.75 m²) per 10″. It is made in 10″, 20″, 30″, and 40″, with a 2.75″ (70 mm) diameter.

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 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, and a validation guide is available.

UltraPure line