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Capsule Filters

Capsule filters are GMP compliant single-use items and commonly used for filtration applications in biopharmaceutical manufacturing processes. GMPTEC offers many different types of capsule filters, which are suitable for applications like purification, sterile filtration, particle filtration or virus filtration. The filter housing and other components of the capsule filters are made of biocompatible materials, which are either gamma sterilizable or autoclavable.

Category:

Description

Information about Capsule Filters

The GMPTEC capsule filters made by Cobetter are available in many different configurations. Several choices of membrane materials and pore sizes assure that you will always find the ideal product for every process. The series of capsule filters includes products for small batches in laboratory or research environments as well as products designed for large batches in GMP production processes.

All filters are made of high-quality materials only, which are FDA approved for usage in the pharmaceutical and food industry. The capsule filter housings are thermally bonded and free of any additives and adhesives. This assures that the housings are completely sealed and guarantee a sterile barrier to the environment.

Most types of capsule filters have hose barb connections, so they can directly be connected to the used tubing. As an alternative, many of the filters are also available with sanitary flange connections. These options allow to easily integrate the filters into your process.

GMPTEC also offers assemblies with capsule filters, which can be customized and are supplied as ready-to-use. We will gladly provide technical on-site support and drawings based on your individual requirements, help to chose the right components and design the overall process.

Features and Properties of GMP Capsule Filters

  • Autoclavable
  • Gamma Stable
  • High Flow Rates
  • High Process Safety
  • Various Membranes
  • Low Minimum Order Quantity
  • 100% Integrity Tested
  • Many different Materials
  • USP <85> Endotoxin < 0,25 EU/ml (post autoclave)
  • USP <88> Class VI Conformity
  • USP <87> Conformity (Cytotoxicity)
  • FDA 21 CFR 177.182 Conformity
  • Cleanroom Manufactured
  • Available pre-sterilized

Processes and Applications

  • Sterile Filtration
  • Purification
  • Virusfiltration
  • Ultrafiltration
  • Pufferfiltration
  • Gasfiltration
  • Bioburden Reduction
  • Water Sampling
  • Water Purification
  • GMP Fill and Finish
  • Cell Harvest
  • Micro Carrier Separation

The below listed item details like membranes, housing and retention ratings can be used to configurate the required capsule filter.

An example configuration can look as follows:

WSF (Capsule Housing) – SPSHR (Membrane) – 0010 (Retention) – 580 (Capsule Length)

Available membrane materials are listed in the following table:

Membrane Material / Type Retention
SPSHR Symmetric PES Membrane 0022 (0.22 μm), 0045 (0.45 μm)
APSB Asymmetric PES Membrane 0022 (0.22 μm), 0045 (0.45 μm), 0065 (0.65 μm), 0080 (0.8 μm), 0120 (1.2 μm)
DPSDDT Double-layer PES Membrane 2210 (0.22 μm + 0.1 μm), 2222 (0.22 μm + 0.22 μm), 4522 (0.45 μm +

0.22 μm), 4545 (0.45 μm + 0.45 μm), 6545 (0.65 μm + 0.45 μm)

LHPVND PVDF Membrane 0022 (0.22 μm), 0045 (0.45 μm), 0065 (0.65 μm)
LHPVHBR Charged PVDF Membrane 0022 (0.22 μm), 0045 (0.45 μm)
LHPF Hydrophilic PTFE Membrane 0022 (0.22 μm), 0045 (0.45 μm), 0100 (1.0 μm)
GPF-P (for gas) Hydrophobic PTFE Membrane 0010 (0.1 μm), 0022 (0.22 μm)
APP Absolute-Rated Polypropylene (Depth) 0010 (0.1 μm) to 2000 (20 μm)
HPP Nominal-Rated Polypropylene (Depth) 0010 (0.1 μm) to 2000 (20 μm)
PFSA2 Multi-layer Polypropylene (Depth) 0020 (0.2 μm) to 15000 (150μm)
LGFP Glass Fiber (Depth) 0010 (0.1 μm) to 0500 (5 μm)

Available capsule housings are listed in the following table:

Housing Diameter Length Inlet/Outlet Vent/Drain
KZ50 71,9 mm 68,4 mm ½“ Tri-Clamp Luer Lock
PKZ 94,5 mm 119 mm 1“ Tri-Clamp 6 mm HB
STKZ 74,0 mm 163,0 mm 1“ Tri-Clamp M5
WSF 128,0 mm 214 / 335/ 580 / 825 mm 1 ½“ Tri-Clamp 6 mm HB
UCF-T 130,0 mm 310 / 554 / 800 mm 1“ Tri-Clamp 6 mm HB
92WM 70,0 mm 89,8 mm 6-9 mm HB 1/8“ NPT
WM 65,1 mm 139,1 mm 6-9 mm HB 1/8“ NPT
195WM 66,0 mm 196,3 mm 6-9 mm HB 1/8“ NPT
STBT1 74,2 mm 138,0 mm 12 mm HB 1/8“ NPT
STBT2 74,2 mm 188,3 mm 12 mm HB 1/8“ NPT

Total Filtration Surfaces of each Membrane-Housing Combination:

Housing/ Membrane SPSHR SPSHR SPSHR SPSHR SPSHR SPSHR SPSHR
KZ50 33 cm² 33 cm² 33 cm² 33 cm² 33 cm² 33 cm² 33 cm²
PKZ 370 cm² 370 cm² 370 cm² 370 cm² 370 cm² 370 cm² 370 cm²
STKZ 1170 cm² 1170 cm² 1170 cm² 1170 cm² 1170 cm² 1170 cm² 1170 cm²
WSF 5inch 2660 cm² 2660 cm² 2660 cm² 2660 cm² 2660 cm² 2660 cm² 2660 cm²
WSF 10inch 5080 cm² 5080 cm² 5080 cm² 5080 cm² 5080 cm² 5080 cm² 5080 cm²
UCF-T 5inch 2660 cm² 2660 cm² 2660 cm² 2660 cm² 2660 cm² 2660 cm² 2660 cm²
UCF-T 10inch 4970 cm² 4970 cm² 4970 cm² 4970 cm² 4970 cm² 4970 cm² 4970 cm²
92WM 390 cm² 390 cm² 390 cm² 390 cm² 390 cm² 390 cm² 390 cm²
WM 720 cm² 720 cm² 720 cm² 720 cm² 720 cm² 720 cm² 720 cm²
195WM 1320 cm² 1320 cm² 1320 cm² 1320 cm² 1320 cm² 1320 cm² 1320 cm²
STBT1 1140 cm² 1140 cm² 1140 cm² 1140 cm² 1140 cm² 1140 cm² 1140 cm²
STBT2 2060 cm² 2060 cm² 2060 cm² 2060 cm² 2060 cm² 2060 cm² 2060 cm²
Housing/ Membrane LHPF LHPF LHPF LHPF LHPF LHPF LHPF
KZ50 33 cm² 33 cm² 33 cm² 33 cm² 33 cm² 33 cm² 33 cm²
PKZ 580 cm² 580 cm² 580 cm² 580 cm² 580 cm² 580 cm² 580 cm²
STKZ 1790 cm² 1790 cm² 1790 cm² 1790 cm² 1790 cm² 1790 cm² 1790 cm²
WSF 5inch 4110 cm² 4110 cm² 4110 cm² 4110 cm² 4110 cm² 4110 cm² 4110 cm²
WSF 10inch 7690 cm² 7690 cm² 7690 cm² 7690 cm² 7690 cm² 7690 cm² 7690 cm²
UCF-T 5inch 4110 cm² 4110 cm² 4110 cm² 4110 cm² 4110 cm² 4110 cm² 4110 cm²
UCF-T 10inch 7690 cm² 7690 cm² 7690 cm² 7690 cm² 7690 cm² 7690 cm² 7690 cm²
92WM 580 cm² 580 cm² 580 cm² 580 cm² 580 cm² 580 cm² 580 cm²
WM 1070 cm² 1070 cm² 1070 cm² 1070 cm² 1070 cm² 1070 cm² 1070 cm²
195WM 1890 cm² 1890 cm² 1890 cm² 1890 cm² 1890 cm² 1890 cm² 1890 cm²
STBT1 1790 cm² 1790 cm² 1790 cm² 1790 cm² 1790 cm² 1790 cm² 1790 cm²
STBT2 3150 cm² 3150 cm² 3150 cm² 3150 cm² 3150 cm² 3150 cm² 3150 cm²

GMPTEC offers a range of gamma sterilizable capsule filters, especially designed for single-use applications in the biopharmaceutical industry. These filters are used for small- to mid-sized process volumes.

Sizes and details are shown in the table below:

Item  Diameter Filtration surface Vent/Drain
GM200 63,6 mm 0,02 m² ¼“ HB
GM400 63,6 mm 0,04 m² ¼“ HB
GM800 63,6 mm 0,08 m² ¼“ HB
Available Inlets and Outlets

  • ¾“ TC
  • 1 ½“ TC
  • ¼“-1/2“ HB

Features and details of gamma stable single-use capsule filters:

  • 100% Integrity Tested
  • Quality Management System ISO 9001:2015
  • USP Class VI Conformity
  • Meets FDA CFR 21 210.3 (b) (6) „non fiber releasing“ filter
  • Meets Quality Standards of USP „sterile water for injection“
  • Endotoxin Level according LAL Testing < 0,25 EU/ml
  • Gamma Stable at 25-45 kGy
  • Autoclavable at 121°C
  • Filter Membrane Materials: PES / PVDF
  • Filter Housing and Support Material: PP
  • O-Ring: Silicone

 

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