|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters|
|Filter Integrity Test Methods|
|Sterile and Gamma Compatible Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Filters (MilliporeSigma)|
|What are the most common causes of filter clogging (air bubbles, particulates, surface tension, inappropriate filter size etc.)?||Trapped bubbles, particulates and improper sizing are all common causes of fitration issues. True filter clogging is caused by particulates. Hard particles will form a cake on the filter surface. This will generally slow the filtration but not necessarily block filtration becuase fluid can flow through the layer of hard particles and then through the filter.
Deformable particles can compress across the filter pores, forming impermeable barriers to filtration. This type of problem is common with solutions containing proteins or lipids.
|Hydrophilic Durapore® Cartridges and Capsules User Guide|
|Opticap® XL Capsules and Opticap® XLT Capsules|
Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.
Learn More >>
Durapore® 0.1 µm and 0.22 µm Gamma Compatible Capsule FiltersEnhanced process efficiency and cost-effectiveness from reduced cleaning and validation requirements
Learn More >>
Durapore® 0.1 µm and 0.22 µm Cartridge FiltersA trusted name in the industry for over 25 years, The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.
Learn More >>
Related Products By: Application Facete
|Dialysis and Filtration|
Related Products By: Brand Facete
|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore|
Sterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF membrane. The filters are sterilized by gamma irradiation prior to shipment, eliminating the need for autoclaving prior to use. They are available with a variety of inlet and outlet fittings to suit any sterile filtration application from ten to thousands of liters.
Overall process efficiency and cost effectiveness is enhanced due to the elimination of sterilization and associated validation issues.
The hydrophilic Durapore membrane provides high flow rate and throughput, low extractables and particle shedding, low protein adsorption, and broad chemical compatibility.
Sterile Opticap filters are supplied double bagged. The outer bag is designed with an easy-open feature to facilitate handling in a prep area. The inner bag is designed with a “header” to facilitate aseptic handling and connections.
For traceability and easy identification, each sterile Opticap filter is labeled with its catalogue number, lot number, serial number, and pore size. A gamma radiation indicator label, which turns red upon exposure, is provided with each unit as evidence of sterilization.
Sterile Opticap capsules are suitable for sterile filtration of aqueous feed streams such as:
Sterile Opticap filters are manufactured with sterilizing grade Durapore membrane. Membrane samples are tested for bacterial retention prior to device manufacture. Samples of final devices are tested for retention per ASTM F838-83. Each filter is integrity tested during manufacturing with a test correlated to bacterial retention.
Product sterility is assured by gamma irradiation at ≥ 25 kGray, a minimum dose confirmed effective per AAMI guidelines.
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
|10" Disposable Capsules|
|Materials of Construction|
|Filter||Polyvinylidene Fluoride (PVDF) Hydrophilic|
|Filtration Area||0.73 m²|
|Maximum Inlet Pressure, bar (psi)||5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C|
|Bacterial Retention||Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|NVR Gravimetric Extractables||The extractables level was equal to or less than 25 mg after a 1 L flush and 24 hours in water at controlled room temperature.|
|Oxidizable Substances||Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L|
|Toxicity||Component materials meet the requirements of the USP Class VI Biological Test for Plastics. The cartridges also meet the requirements of the USP General (Mouse) Safety Test.|
|Sterilization||Shipped sterile by gamma irradiation @ >25 kGray gamma exposure|
|Integrity Test - 0.22 µm Units|
|Bubble Point||≥3450 mbar (50 psig) air with water|
|Air Diffusion||≤14 mL/min @ 2.75 bar (40 psig) in water|
Coming Soon - Opticap XL
An Industry Standard is Made Even Better
- New sizes in a single uniform design; Opticap XL 2, 4, 5 and 10 inch
- A more durable and robust housing structure
- Unparalleled thermal and hydraulic stress resistance
- Improved vent design for ease of use