Millipore Sigma Vibrant Logo
Attention: We have moved. Merck Millipore products are no longer available for purchase on MerckMillipore.com.Learn More

KHGLS10FH1 Sterile Multilayer Durapore® Opticap® XL 10 in. 0.45 / 0.22 µm

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KHGLS10FH1
1  
Purchase on Sigma-Aldrich

Aperçu

Replacement Information
Description
Catalogue NumberKHGLS10FH1
Trade Name
  • Opticap®
DescriptionSterile Multilayer Durapore® Opticap® XL 10 in. 0.45 / 0.22 µm
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/OutletSanitary Flange/Hose Barb
European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Biological Information
MediaMultilayer Durapore®
SterilitySterile
Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 / 0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionHose Barb
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig)80 psig
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
TOC/ConductivityAfter sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length10 in. (25 cm)
Device Size10 in.
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Référence GTIN
KHGLS10FH1 04053252379482

Produits & Applications associés

Produits associés classés par : Brand Facete

Opticap®

Catégories

Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Durapore
Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Durapore > Multilayer Durapore 0.45 - 0.22 > Multilayer Durapore 0.45 - 0.22 Capsule
Biopharmaceutical Manufacturing > Harvest > Sterile Filtration > Sterile Liquid > Durapore
Small Molecule Pharmaceuticals > API Synthesis > Sterile Filtration > Sterile Liquid > Durapore
Biopharmaceutical Manufacturing > Upstream Processing > Sterile Filtration > Sterile Liquid > Durapore
Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore
Biopharmaceutical Manufacturing > Drug Substance > Sterile Filtration > Sterile Liquid > Durapore
Small Molecule Pharmaceuticals > Bulk API > Sterile Filtration > Sterile Liquid > Durapore
Biopharmaceutical Manufacturing > Formulation > Sterile Filtration > Sterile Liquid > Durapore