Material Qualification Dossier
|Milligard® PES Filters - Process Efficiency Made Easy (MilliporeSigma)|
|Milligard® Sanitary Cartridge Housings|
|Reinforced Membrane Prefilters -- Non-fibrous prefilters for submicron clarification or prefiltration|
|Filters with Milligard® PES Membrane - Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines|
Milligard® PES filters are designed for effective bioburden control and reliable removal of particles from a broad range of fluid streams. These membrane based filters can provide validated bioburden reduction in applications where sterilizing filtration is not required. They can be used at different stages in a bioprocess production train enabling more efficient performance of sterile filters and protection of other unit operations.
- Fast flow and high throughput
- Validated bioburden reduction (1.2/0.2 μm nominal and 1.2/0.45 μm pore sizes only)
- Predictable scalability from small to production scale devices
- High thermal stability: compatible with steam-in place and autoclave sterilization methods
- Caustic stable
- Gamma stable and available in single use assemblies
Milligard® PES filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9001 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is supported by documentation to comply with regulatory requirements. For traceability and easy identification, each filter is marked with
Available Pore Sizes for Bioburden
- 1.2/0.2 μm nominal
- 1.2/0.45 μm
Available Pore Sizes for Particulate Reduction
- 1.2/0.8 μm
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.
Single-use, Small-Scale Tool for Process Screening and Scaling
OptiScale® single-use capsule filters are ideal for quickly evaluating performance of different prefilters with various process streams.
For Pilot and Production Scale Processing
Our cartridge filters are designed for use in stainless steel housings and provide high throughput and minimal differential pressure. These cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. A full range of filtration areas and connection options are available for maximum flexibility.
Opticap® XL Capsules
For Bench to Production Scale Processing
Opticap® XL single-use capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. Capsules may be sterilized by autoclaving or gamma irradiation. Capsules are available with a variety of inlet and outlet connections.
|OptiScale® 25 Capsules||Per 10-inch Cartridge||Opticap® XL 5 Capsules||Opticap® XL 10 Capsules|
|Diameter:||3.1 cm (1.2 in.)||6.9 cm (2.7 in.)||10.7 cm (4.2 in.)||10.7 cm (4.2 in.)|
|Length:||3.9 cm (1.5 in.)||31.8 cm (12.5 in.)||21.6 cm (8.5 in.)||33.5 cm (13.2 in.)|
|Approximate Filtration area||3.5 cm2|
|1.2/0.2 µm nominal (m2/ft2)||-||0.60 m2 (6.4 ft2)||0.30 m2 (3.2 ft2)||0.60 m2 (6.4 ft2)|
|1.2/0.45 µm (m2/ft2)||-||0.60 m2 (6.4 ft2)||0.30 m2 (3.2 ft2)||0.60 m2 (6.4 ft2)|
|1.2/0.8 µm (m2/ft2)||-||0.53 m2 (5.7 ft2)||0.29 m2 (3.1 ft2)||0.57 m2 (6.1 ft2)|
|Materials of Construction|
|Upstream Membrane||Hydrophillic polyethersulfone|
|Downstream Membrane||Hydrophillic polyethersulfone|
|Core||-||Polypropylene||Gamma stable polypropylene|
|Cage||-||Polypropylene||Gamma stable polypropylene|
|Endcaps||-||Polypropylene||Gamma stable polypropylene|
|Capsule Housing||-||-||Gamma stable polypropylene|
|Housing Vent||Capped vent with female Luer connection on inlet side of device||-||-||-|
|Maximum Inlet Pressure||4.1 bar (60 psi) at 25°C||-||5.5 bar (80 psi) at 25°C|
|Maximum Differential Pressure|
|Forward:||4.1 bar (60 psi) at 25°C||5.5 bar (80 psi) at 4-25°C|
|1.7 bar (25) psi at 80°C|
|0,3 bar (4 psi) at 135°C||-||-|
|Reverse:||0 bar||1.4 bar (20 psi) at 4-25°C|
|70 mbar (1 psi) at 135°C||-||-|
|Bubble Point at 25° C|
|1.2/0.2 µm nominal||-||≥ 2700 mbar (39.2 psi) air with water|
|1.2/0.45 µm||-||≥ 2290 mbar (33.3 psi) air with water|
|1.2/0.8 µm||-||≥ 990 mbar (14.3 psi) air with water|
|Bioburden Reduction||-||The 1.2/0.2 µm nominal filter typically provides ≥ 6 log removal of Brevundimonas diminuta based on ASTM® F838 methodology. The 1.2/0.45 µm filter typically provides ≥ 6 log removal of Serratia marcescens based on ASTM® D3863 and F838 methodology.|
|Bacterial Endotoxins||Aqueous extraction from a sample contains <0.25 EU/mL as determined using the Limulus Amebocyte Lysate (LAL) bacterial endotoxins test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.|
|TOC/Conductivity at 25° C||This product exhibits less than 500 ppb TOC per USP <643>and less than 1.3 µS/cm at 25°C per USP <645> after autoclaving and purified water flush of 15 mL.||After sterilization and a controlled water flush of 20 L per 10-inch device, sample exhibited ≤500 ppb TOC per USP <643> and ≤1.3 μS/cm per USP <645> at 25°C.|
|Sterilization||May be autoclaved for 1 cycle at 123° C for 60 min.||Device integrity was maintained after 25 autoclave cycles of 60 minutes at 128° C. Device integrity was maintained after in-line steam of 10 forward and 5 reverse cycles of 30 minutes at 135° C.||Device integrity was maintained after gamma irradiation up to 40 kGy and 3 wet autoclave cycles of 60 minutes at 123° C.|
|Non-Fiber Releasing||Devices tested and meet requirements of USP <788> for large volume parenterals.|
|Component Material Toxicity||Component Materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. This product is non-cytotoxic per USP <87> Cytotoxicity MEM Elution Test.||Component materials meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo. This product meets the specifications of ISO 10993-5 Tests for in vitro cytotoxicity and USP <87> Biological Reactivity, in vitro. This product also meets physicochemical specifications, as described in USP <661> Containers-Plastics.|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 - 182 based on information provided by raw material suppliers.|
|Quality Management System||This product was manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO® 9001 Quality Management Systems Standard.|
|Description||OptiScale® 25 Capsules||Per 10-inch Cartridge|
|Diameter||3.1 cm (1.2 in.)||6.9 cm (2.7 in.)|
|Length||3.9 cm (1.5 in.)||31.8 cm (12.5 in.)|
|Approximate Filtration Area||3.5 cm2|
|Materials of Construction|
|Filter membrane||Hydrophilic polyethersulfone||Hydrophilic polyethersulfone|
|Cage and end caps||-||polypropylene|
|Housing Vent||Capped vent with female Luer conection on inlet side of device||-|
|Maximum Inlet Pressure||4.14 bar (60 psi) at 25°C||-|
|Maximum Differential Pressure|
|Forward||4.14 bar (60 psi) at 25°C||5.52 bar (80 psid) at 4-25 °C
1.72 bar (25 psig at 80 °C
0.34 bar (4 psid) at 135 °C
|Reverse||0 bar||1.38 bar (20 psid) at 4-25 °C
0.07 bar (1 psid) at 135 °C
|Bubble Point at 25 °C||-||1.2/0.2 μm nominal: ≥ 2700 mbar (39.2 psi) air with water
1.2/0.45 μm ≥ 2290 mbar (33.2 psi) air with water
1.2/0.8 μm ≥ 990 mbar (14.3 psi) air with water
|Bioburden Reduction||-<>||The 1.2/0.2 μm nominal filter typically provides ≥6 log removal of Brevundimonas diminuta based on ASTM® D3863 and F838 methodology.
The 1.2/0.45 μm filter typically provide ≥6 log removal of Serratia marcescens based on ASTM® F838 methodology.
|Bacterial Endotoxin||Aqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.|
|TOC/Conductivity at 25 °C||This product exhibits less than 500 ppb TOC per USP <643> and less than 1.3 μS/cm at 25 °C per USP <645> after autoclaving and purified water flush of 15 mL.||This product exhibits less than 500 ppb TOC per USP <643> and less than 1.3 μS/cm per USP <645> after autoclaving and purified water flush of ≤20 L per 10-inch cartridge (33.3 L/m2).|
|Sterilization||May be autoclaved for 1 cycle at 123°C for 60 min.||Device integrity was maintained after 25 autoclave cycles of 60 minutes at 128 °C.
Device integrity was maintained after in-line steam of 10 forward and 5 reverse cycles of 30 minutes at 135°C.
|Non-Fiber Releasing||Devices tested and meet requirements of USP <788> for large volume parenterals|
|Component Material Toxicity||Component Materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics.
This product is non-cytotoxic per USP <87> Cytotoxicity MEM Elution Test.
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|