PTFE 0.2μm Sterilizing-Grade Capsule Filters
基本情報
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製品名
PTFE 0.2μm Sterilizing-Grade Capsule Filters
仕様
- Product Specification: Alicap® L300
- Filtration Area: 380 cm2
- Pore Size: 0.2 μm
- Bacterial Retention: ＞107 cfu/cm2 B. diminuta ( ATCC® 19146TM )
- Maximum Differential Pressure: Forward: 5.0 bar（72.5 psi）@ 25 °C / 3.0 bar（43.5 psi）@ 80 °CReverse: 2.0 bar（29.0 psi）@ 25 °C
- Bubble Point: ≥1200 mbar（17.4 psi）(wetted with 60% IPA, 20℃, compressed air)
- -: ≤ 1.2 mL/min
- Sterilization: Autoclave(A): 131℃, 30min, 10 cycles
- Biological Safety: All the construction components of this filter comply with the requirements for biological safety of Class VI plastics in current USP <88>
- Indirect Food Additive: The primary construction components of this filter comply with the requirements for food contact materials as stipulated in EU 1935 / 2004 / EC and FDA 21 CFR 177-182
- Cleanliness: Cleanliness meets the requirements for nonfiber releasing filter as specified in FDA 21 CFR211.72 and 210.3 (b) (5) (6), and the level of insoluble particles in rinsing liquid meets the requirements of USP <788>
- Endotoxin: The endotoxin level of cartridge rinsing liquid is <0.25 EU/mL as indicated by gel method, which complies with the requirements of USP <85>
- Integrity: Filters are 100% integrity tested
- Manufacturing Environment: Manufactured in conformance with cGMP
書類
ISO 90001
CNAS
RoHS
FDA DMF Type II
ISO9001 quality system and adheres to GMP guidelines
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