Our Capsule filters are cGMP compliant single-use items and commonly used for sterile filtration applications in biopharmaceutical manufacturing. GMPTEC offers many different types and sizes 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.
Capsule Filters
Description
Information about Capsule Filters
The GMPTEC capsule filters 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 for research and development environments but also items which are designed for larger GMP batches.
All capsule filters are made of high-quality materials only. These materieal are FDA compliant for usage in the pharmaceutical and food industry. The 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 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, for example with our Sanitary Fittings, Clamps and Gaskets!
GMPTEC also offers single-use 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 and help to chose the right components for your process.
PUPSIT Sterile Filtration
The actual GMP Annex 1 requirement of implementing a pre use and post sterilization intergrity testing creates many issues in excisting sterile filtrations. Often biopharma companies do not have an filtration assembly implemented, which enable the users do execute this new testing procedure. Besides this, it is not an easy adjustment on current single-use assemblies, because multiple aspects have to be considered. GMPTEC is well experienced with single-use PUPSIT Assemblies and we gladly help you to design a robust and safe PUPSIT Assembly. Just Contact us!
Features and Properties
- 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 compliant
- Cleanroom Manufactured
- Available pre-sterilized
Processes and Applications
- Sterile Filtration
- PUPSIT (Pre Use Post Sterilization Intergrity Testing)
- 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 | Â 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
|
|||
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
