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PARKER FILTER

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              Pharmacetical Filter

Parker Pharmacetical Filter

PROPOR HC Filter Cartridges

liquid filters

polyethersulphone

PROPOR HC sterilizing grade filters have been specifically
designed for the effective and economical processing of
difficult to filter solutions.

The optimised PROPOR HC PES membrane configuration
features a highly asymmetric membrane prefilter layer, which
significantly extends throughput and prevents the problems
associated with premature filter blockage with complex
solutions.

PROPOR HC filters are high capacity and fast flowing. The PES
membrane is inherently low binding, which minimizes product
loss due to protein or preservative adsorption. The filters have
low extractable levels and broad chemical compatibility.

Features and Benefits

Optimized membrane configuration allows up to ten times the
throughput compared to single layer membrane products

Integral prefilter layer can condense filter trains for greater
processing economy

Incorporates a fully validated and integrity testable 0.2 micron
membrane for assurance of sterility

Low binding for minimal product loss

Performance Characteristics

Specifications

Materials of construction

- Filtration Membrane :
- Prefilter Membrane :
- Upstream Support :
- Downstream Support :

Polyethersulphone
Polyethersulphone
Polyester
Polyester

Filter Cartridges

- Inner Support Core :
- Outer Protection Cage :
- End Caps :
- End Caps Insert :

Polypropylene
Polypropylene
Nylon
316L Stainless Steel

MURUS Disposable Filter Capsules

- Core :
- Sleeve :
- End Caps Insert :
- Standard o-rings/gaskets :
- Capsule Body :
- Capsules Vent Seals :

Polypropylene
Polypropylene
316L Stainless Steel
Silicone
Polypropylene
Silicone

DEMICAP Filter Capsules

- Core :
- Sleeve :
- End Caps :
- Capsule Body :
- Capsules Vent Seals :
- Filling Bel l:

Polypropylene
Polypropylene
Nylon
Nylon
Silicone
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 European Council Pressure Equipment Directive (PED) 97/23/ EC Article 3, Paragraph 3 - 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 : In compliance with PED Article 3, Paragraph 3, SEP, this product does not 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) :
K Size :
A Size :
B Size :
E Size :
Syringe ┆50 mm :

0.55 m²
0.26 m²
0.20 m²
0.10 m²
0.05 m²
14.50 cm²

(5.92 ft²)
(2.79 ft²)
(2.15 ft²)
(1.07 ft²)
(0.53 ft2)
(2.25 in²)

Sterilization

PROPOR HC 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.

Food and 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 despatch. 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

TOC / Conductivity

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

Endotoxins

Aqueous extracts from the 10¨ (250 mm) PROPOR SG 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 litre flush of purified water for a 10¨ (250 mm) cartridge are <10 mg.

Total NVEs extracted in the first 5 litre 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 HC filter cartridges meet current USP and EP quality standards for sterile purified water for oxidizable substances following a <1 litre water flush.

Integrity Test Data

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

*Bubble point for 0.1 レm product is in 60/40 v/v IPA/Water.

Retention Characteristics

PROPOR HC filter cartridges are validated 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) filter cartridge.

Ordering Information