Brisip™ SP3 Capsule Filter
Hydrophobic PTFE Membraen· Sterile Gas Filter
Brisip™ SP3 Capsule Filter with Cobetter Aegivast™ AFL Membrane is designed for use in sterile air and gas filtration in biopharmaceutical applications. Composed of a hydrophobic PTFE membrane and polyetherimide housing, these capsule filters provide an alternative to filter and stainless steel housing combination and thus reduce operating costs and maintenance time. Polyetherimide housing allows for multiple SIP (steam-in-place) cycles at high pressures and temperatures.
Features and Benefits
- Integrity Tested with WIT (Water Intrusion Test)
- Low operating cost when compared to filter and stainless steel housing components
- Steam sterilizable with long service life
- Able to operate at high pressures with temperatures up to 40°C
Quality Standards
- Integrity Test correlates to ASTM F838-05 Bacterial Challenge Test (BCT)
- Each filter is individually Integrity Tested prior to leaving the factory
- Each filter is fully traceable with a unique serial number
- Each filter is supplied with Certificate of Analysis
- Validation Guide available upon request
- Designed, developed and manufactured in compliance with ISO9001
- Full Regulatory Compliance with the following:
- 21CFR.210.3(b)(5)(6), 211.72 for Non-Fiber Release
- Endotoxins: <0.25EU/ml/10inch filter
- USP <88> Plastic Class VI-121°C
- FDA 21 CFR177-182 & EU 1935/2004/EC
