Propor BR | Filter Cartridges – Domnick

Description

PROPOR BR filters have been specifically designed for the fast and cost-effective bioburden reduction of pharmaceutical solutions.

PROPOR BR filters feature an integral meltblown prefilter layer to maximize dirt holding capacity whilst the polyethersulphone membrane guarantees a bioburden log reduction of greater than 5 giving excellent microbial protection. This makes PROPOR BR filters ideal for bioburden reduction of LVPs prior to terminal sterilization.

PROPOR BR filters are also ideally suited to prefiltration and bioburden reduction prior to sterilizing grade membrane filters. The robust construction of PROPOR BR filters guarantees consistent performance on multiple batches.

Features/ Benefits

Brevundimonas diminuta retention of LRV >5 for efficient bioburden reduction
Additional prefilter layer gives excellent throughput to blockage
Low binding for minimal product loss
MURUS and DEMICAPs can be gamma-ir

Performance Characteristics

Specifications

Materials of Construction

Filtration Membrane: Polyether sulphone
Prefilter Membrane: Polyether sulphone
Upstream Support: Polyester
Downstream Support: Polyester

Filter Cartridges

Inner Support Core: Polypropylene
Outer Protection Cage: Polypropylene
End Caps: Nylon
End Caps Insert: 316L Stainless Steel

MURUS Disposable Filter Capsules

Core: Polypropylene
Sleeve: Polypropylene
End Caps Insert: 316L Stainless Steel
Standard o-rings/gaskets: Silicone
Capsule Body: Polypropylene
Capsules Vent Seals: Silicone

DEMICAP Filter Capsules

Core: Polypropylene
Sleeve: Polypropylene
End Caps: Nylon
Capsule Body: Nylon
Capsules Vent Seals: Silicone
Filling Bell: Polycarbonate

Syringe Filters

Body: Polypropylene

Recommended Operating Conditions

Filter Cartridges

Up to 70 °C (158 °F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:

MURUS Disposable Filter Capsules

Up to 25 °C ( 77 °F) @ 5.5 barg (79.7 psig)
Up to 60 °C (140 °F) @ 2.8 barg (40.6 psig)

Parker Hannifin certify that this product complies with the current European Council Pressure Equipment Directive (PED) – Sound Engineering Practice (SEP). This product is intended for use with Group 1 & 2 Dangerous and Harmless Liquids and Group 2 Harmless Gases at the operating conditions stated in this document. The Pressure Equipment Directive mandates that category SEP product cannot bear the CE mark.

DEMICAP Filter Capsules

Up to 40 °C (104 °F) at line pressures up to 5.0 barg (72 psig).

Effective Filtration Area (EFA)

10¨ (250 mm): 0.55 m2(5.92 ft2)
K Size: 0.26 m2(2.79 ft2)
A Size: 0.20 m2(2.15 ft2)
B Size: 0.10 m2(1.07 ft2)
E Size: 0.05 m2(0.53 ft2)
Syringe ø50 mm: 14.50 cm2(2.25 in2)

Sterilization

Cleaning and Sterilization

PROPOR BR filter cartridges can be sanitized with hot water at up to 90 °C (194 °F) and are compatible with a wide range of chemicals. For detailed operational procedures and advice on cleaning and sterilization, please contact the Technical Support Group through your usual Parker domnick hunter contact.

Biological Safety

Materials conform to the relevant requirements of 21CFR Part 177 and current USP Plastics Class VI – 121 °C and ISO10993 equivalents.

Quality Standards

Pharmaceutical grade products are manufactured in accordance with cGMP, 100% flushed with pharmaceutical grade purified water and integrity tested prior to
dispatch. A sample of each lot is tested to demonstrate conformity to validated claims.

Gamma-Irradiation

PROPOR HC MURUS & DEMICAP disposable filters can be gamma-irradiated up to a maximum dosage of 40 kGy.

Performance Characteristics

Retention Characteristics

PROPOR BR filter cartridges are validated to an LRV > 5 by bacterial challenge testing with Brevundimonas diminuta to current ASTM F838-05 methodology (107
organisms / cm2 EFA minimum) with typical in-house challenge levels being 1011 organisms per 10¨ (250 mm) module.

*Protein binding on membrane materials

*Flow rate comparison for bioburden reduction filters

Integrity Test Data

All filters are integrity testable to the following limits when wet with water and using air as the test gas.

TOC / Conductivity

The filtrate quality from a 10¨ (250 mm) PROPOR BR conforms to the requirements of current USP <643> (TOC) and USP <645> (conductivity) within the fi rst 200 ml flush of purified water.

Endotoxins

Aqueous extracts from the 10¨ (250 mm) PROPOR BR contain < 0.25 EU / ml when tested in accordance with the Limulus Amoebocyte Lysate test.

Non-Volatile Extractables (NVE)

Total NVEs extracted in the first 5 liter flush of purified water for a 10¨ (250 mm) cartridge are <10 mg.
Total NVEs extracted in the first 5 liter flush of purified water for an A size 7.9¨ (200 mm) DEMICAP capsule are <5 mg.

Pharmaceutical Validation

A full validation guide is available upon request from Laboratory Services Group (LSG).

Oxidizable Substances

PROPOR BR filter cartridges meet current USP and EP quality standards for sterile purified water for oxidizable substances following a <1 liter water flush.