Hydrophobic Millipore Express® SPG Gamma Stable Capsule Filters
Produits recommandés
-
679100 Millipore Vitamin D₂, 1α-Hydroxy- - CAS 54573-75-0 - Calbiochem -
72085 Breast Cancer Panel I, 6-Plex -
AP181R Sigma-Aldrich Goat Anti-Mouse IgG Antibody, Rhodamine conjugate, Species Adsorbed -
C257521 Mobius® Essential Assemblies -
MAB8262B-5 Sigma-Aldrich Anti-RSV Antibody, fusion protein, all type A, B strains, clone 133-1H -
SLHVMZ5NZ Millipore Filtre Millex compatible avec les applications automatisées, HPF, 0,45 µm, PVDF, avec préfiltre en fibre de verre gradué, non stérile -
ZRXQ005US Milli-Q ZRXQ005US -
KN03A05FF1 Millipore Opticap XL5 Polygard-CN 0,3 µm, raccords sanitaires TC 3/4" entrée/sortie -
C134840 Non-Sterile Millex® Syringe Filters with Durapore® Membrane
Aperçu
Caractéristiques
Guide d'achat
Documentation
Produits & Applications associés
Produits associés classés par : Application Facete
| Sterility Testing |
| Fermentation Solutions |
| Dialysis and Filtration |
Produits associés classés par : Brand Facete
| Opticap® |
Catégories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Millipore Express SPG |
Gamma Stable Opticap® XL Capsule Filters with Millipore Express® SPG (Sterile Phobic Gamma) hydrophobic membrane are the ultimate choice for optimal gas filtration and venting in single-use applications. The 0.2 μm sterilizing-grade membrane provides sterility assurance and high flow rates. Its ability to maintain flow rates during extended batch durations contributes to higher process confidence.
Features
The polyethersulfone membrane based gas filter:
- Can be sterilized by gamma irradiation or autoclaving
- Can be integrity tested using HydroCorr™ test
- Is validated for liquid bacterial retention
- Maintains superior flow rate over extended process duration
Typical Applications
Gamma Stable Opticap® XL Capsule Filters with Millipore Express® SPG Hydrophobic membrane are validated for retention using a liquid bacterial challenge test ensuring retention even in humid process conditions. These filters will sterilize air or gas streams in:
- Single-use bioreactors
- Filtration and bag assemblies
- Carboys
- Filling vessels
- Transfer vessels
- Fill-finish applications
- Holding/storage bags
- Mixers
- Bottle assemblies
| Gamma Stable Opticap® XL 50 Capsule Filters with Millipore Express® SPG Hydrophobic membrane | |
| Filtration Area, m2 | 0.00196 (19.6 cm2) |
| Materials of Construction | |
| Filter Structural Components | Hydrophobic Polyethersulfone Gamma Stable Polybutylene terephthalate based blend |
| Inlet/Outlet | Stepped Hosebarb Inlet and Outlet for silicone flexible tubing with 6.5 to 9.5 mm internal diameter; female Luer slip interior |
| Maximum Pressure, bar (psid) | Forward: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent |
| Hydrocorr Test | ≤ 0.03 mL/min @ 38 psi |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-05 (2005) methodology |
| Bacterial Endotoxin | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Gamma/Autoclave Stability | Gamma compatible to 45 kGy; OR up to 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| USP Toxicity | Non-toxic per MEM elution ISO 10993-5 |
| Good Manufacturing Practices | These products are manufactured in a facility, which adheres to FDA Good Manufacturing Practices. |
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirementscited in 21 CFR 177–182 and the European food contact regulation EC Directive 2002/72/EC. |