Pharmsteri™ PES Disposable Filter
Specify Your Part
Part Number:
Interested in an Entegris Product?
To discuss your specific needs, contact your local Entegris representative.
Don't have an Entegris representative?
Contact Us
Request a Quote
Quote Requested
Thank you for requesting a quote. Someone from Entegris will contact you shortly.
Your quote number is {0}.
Top of page
Reference Materials
CAD
CAD drawings may be available for this product. Please use the Part Selector to select a part number to see if they are available.
Applications
- Bioburden reduction or sterile filtration for injections
- Upstream/downstream processing steps
- Buffers
- Culture media
- Intermediates
Specifications
| Retention rating | Single-layer | 0.22, 0.45 µm |
| Dual-layer | 0.45 / 0.22 µm | |
| Materials | Membrane | Polyethersulfone (PES) |
| Housing, support | Polypropylene | |
| Sleeve, core, top, end caps | Polypropylene | |
| O-ring | Silicone | |
| Sealing technology | Thermal bonding without adhesives | |
| Filtration area | 10" Single-layer | 0.6 m2 |
| 10" Dual-layer | 0.53 m2 | |
| 5" Single-layer | 0.3 m2 | |
| 5" Dual-layer | 0.25 m2 | |
| Integrity test (0.22 µm) | Minimum bubble point at 25°C (77°F) | ≥50.7 psi (3500 mbar) |
| Maximum diffusion flow at 40.6 psi (2800 mbar) @ 25°C (77°F) | 5": ≤15 mL/min | |
| 10": ≤30 mL/min | ||
| Maximum operating conditions | Maximum forward differential pressure | 70.5 psi (5.0 bar) @ 25° ±2°C (77°F), 43.5 psi (3.0 bar) @ 60° ±2°C (140°F) |
| Sterilization cycles | Maximum 5 cycles of autoclave @ 127°C (261°F), 30 min | |
| Endotoxin releasing | <0.25 EU/mL according to the USP test methodology | |
| TOC | <0.5 mg/L after a water flush of 11 L/10" filter | |
| Conductivity | ≤1.3 µS/cm after water flush of 11 L/10" filter | |
| Particle release | Meets the requirements of WFI set by USP | |
| Non-fiber releasing | Meets the criteria for a non-fiber releasing filter defined in 21 CFR 210.3(b)(6) | |
| Extractables | Tested according to USP<665>. Report is available upon request. | |
| Material toxicity | All components meet the requirements of the USP <88> Reactivity Test for Class VI Plastics | |
| Filters meet the requirements of USP <87> Biological Reactivity Tests In Vitro Cytotoxicity | ||
| Bacterial challenge test | Filters with the claim passed the bacterial challenge testing using Brevundimonas diminuta (ATCC 19146) at a minimum challenge concentration 1x107 CFU/cm2 (0.22 µm) per ASTM F838 methodology | |
| Indirect food additive | Meets the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 | |
| Food contact material | (EU) No. 1935/2004, (EU) No. 10/2011 | |
| Quality | Manufactured in accordance with ISO 9001 and ISO 13485 certified quality management system | |
Successfully Opted for software Updates
Part Numbers
| Part Number | Retention Rating | Length |
|---|---|---|
| PSTSUS022FS10-A2 | 0.22 µm | 10" |
| PSTSUS022FS5-A2 | 0.22 µm | 5" |
| PSTSUS045FS10-A2 | 0.45 µm | 10" |
| PSTSUS045FS5-A2 | 0.45 µm | 5" |
| PSTSUSD42FS10-A2 | 0.45 + 0.22 µm | 10" |
| PSTSUSD42FS5-A2 | 0.45 + 0.22 µm | 5" |