Proclear PP | Filter Cartridges

Description

PROCLEAR PP filters are designed for a wide range of prefiltration duties within the production of pharmaceuticals and are particularly suited to applications where chemical compatibility is an issue.

The optimum pleat configuration and graded density polypropylene media used in PROCLEAR PP filters ensure the filters have the highest possible throughput to blockage resulting in long service life.

The PROCLEAR PP range of filters are fully supported by a comprehensive validation guide to simplify its specification into new and existing processes.

Features/ Benefits

• Graded density polypropylene media for high capacity
• Extremely robust to withstand aggressive conditions
• All polypropylene construction
• MURUS and DEMICAPs can be gamma-irradiated and autoclaved

Performance Characteristics

Specifications

Materials of Construction

• Filtration Media: Polypropylene
• Upstream Support: Polypropylene
• Downstream Support: Polypropylene

Filter Cartridges

• Inner Support Core: Polypropylene
• Outer Protection Cage: Polypropylene
• End Caps: Polypropylene
• End Caps Insert: 316L Stainless Steel
  *Not available in B & L endcap variants

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
• Capsule Body: Polypropylene
• 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) up to 0.79 m2 (8.5 ft2)

Cleaning and Sterilization

PROCLEAR PP 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

Gamma-Irradiation

PROCLEAR PP 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) PROCLEAR PP 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) PROCLEAR PP 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

PROCLEAR PP filter cartridges meet current USP and EP quality standards for sterile purified water for oxidizable substances following a <1 litre water flush.

Ordering information