설명
HDC II filter cartridges are well suited for a broad range of fine particle and prefiltration applications where purity, economy, and reliability are critical. Typical biopharmaceutical applications include biologicals, pharmaceuticals, fermentation feeds and intermediates, and vaccines.
Features and Benefits
- All-polypropylene construction
- Resin-free, melt-sealed
- Constant density tapered pores
- High-capacity for long-life
- Fixed pore, non-shedding
- Low protein binding
- Low extractables
- Broad chemical compatibilities
- Autoclavable and steamable in situ
- Manufactured for use in conformance with cGMP
- ISO 9000 Certified Quality System
- Pharmaceutical P optimized grades with Certificate of Test provided
- FDA-listed materials per 21 CFR
Note: These filters are also available in Kleenpak Nova capsule format.
Quality and Bio-Safety
Biological Tests
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing Non-Pyrogenic per USP
- Bacterial Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
규격사양
Operating Limits1
Operating Temperature | Maximum Differential Pressure |
50 °C | 5.5 bard (80 psid) |
80 °C (Maximum) | 4.1 bard (60 psid) |
1 In compatible fluids which do not soften, swell or adversely affect the filter medium or materials of construction Steam Sterilization
Maximum Cumulative Steam Sterilization
Steam Sterilizing Temperature of AB Steaming Exposure (In situ or Autoclave)50 hours | Up to 140 °C |
Retention Ratings
Media Code | Liquid Absolute Rating | Liquid Retention (90%) | Gas Efficiency3 for 0.3 µm Aerosols | Nominal Filter Area4 | Gas Flow Rates per 254mm Cartridge2 for Air m3/h, P = 10 mbar (0.15 psi)4 |
J006 | 0.6 µm 3 | < 1.0 µm 3 | 100.00 % | 0.62 m2 (6.67 ft2) |
4 |
J012 | 1.2 µm | < 1.0 µm 3 | 99.996 % | 0.69 m2 (7.43 ft2) |
10 |
J025 | 2.5 µm | < 1.0 µm 3 | 99.95 % | 0.86 m2 (9.26 ft2) |
14 |
J045 | 4.5 µm | 1.2 µm | 99.75 % | 0.86 m2 (9.26 ft2) |
17 |
J060 | 6.0 µm | 3.0 µm | 99 % | 0.40 m2 (4.31 ft2) |
24 |
J100 | 10.0 µm | 5.4 µm | 93 % | 0.52 m2 (5.6 ft2) |
39 |
J200 | 20.0 µm | 10.0 µm | - | 0.53 m2 (5.7 ft2) |
- |
J400 | 40.0 µm | 22.0 µm | - | 0.37 m2 (3.98 ft2) |
- |
2 For fluids of 1 cP viscosity. As a general guide for viscosities multiply pressure drop by viscosity in cP. For cartridges of 508, 762 and 1016 mm nominal length, divide differential pressure by 2, 3, and 4 respectively.
3 Based on mineral oil test.
4 For 254 mm (10 in.) nominal length cartridge
5 Extrapolated value.
종류
사용
관련 문서
Regulatory/Quality Documentation
적용분야
영역
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