Description
PROPOR SG sterilizing grade filters feature a microbially retentive polyether sulphone membrane for fast, reliable and cost-effective sterile filtration of pharmaceutical fluids.
The asymmetric pore structure and high voids volume of the PROPOR SG membrane allow high throughputs and exceptionally high flow rates compared with competitive PES and alternative membranes. Low protein and preservative binding properties minimize product loss due to adsorption.
PROPOR SG filters are optimized for pharmaceutical processing. They have low extractable levels and broad chemical compatibility across the full pH range including organic solvents.
Features/ Benefits
- Up to 3.5 times higher flow rates than competitive sterilizing grade filters
- Fully validated and integrity testable membrane for assurance of sterility
- Low binding for minimal product loss
- MURUS and DEMICAPs can be gamma-irradiated and autoclaved
Performance Characteristics
Specifications
Materials of Construction
- Filtration 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)
Cleaning and Sterilization
PROPOR SG 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 SG MURUS & DEMICAP disposable filters can be gamma-irradiated up to a maximum dosage of 40 kGy
Performance Characteristics
Retention Characteristics
PROPOR SG filter cartridges are validated by bacterial challenge testing with Brevundimonas diminuta to current ASTM F838 methodology (10^7 organisms / cm2 EFA minimum) with typical in-house challenge levels being 10^11 organisms per 10¨ (250 mm) filter cartridge.
*Protein binding on membrane materials
*Differential pressure comparison of 10¨ (250 mm) sterilizing grade filters
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 µm product is in 60/40 v/v IPA/Water
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 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 SG filter cartridges meet current USP and EP quality standards for sterile purified water for oxidizable substances following a <1 liter water flush.