Millipore Sigma Vibrant Logo

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.
View Products on Sigmaaldrich.com
KHGLS10FH1
1  
Prix en cours de récupération
Le prix n'a pas pu être récupéré
La quantité minimale doit être un multiple de
Maximum Quantity is
À la validation de la commande Plus d'informations
Vous avez sauvegardé ()
 
—
Demander le prix
—
Disponibilité limitée Disponibilité limitée
En stock 
Interrompu(e)
Disponible en quantités limitées
Disponibilité à confirmer
    Pour le restant : Nous vous tiendrons informé
      Pour le restant : Nous vous tiendrons informé
      Nous vous tiendrons informé
      Contacter le Service Clients
      Contact Customer Service

       

      Contacter le Service Clients

      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

      Documentation

      Material Qualification Dossier

      TitreVersion
      3.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Certificats de qualité

      Titre
      Opticap XL 10 Capsule Multilayer Durapore Membrane C7JA39840
      Opticap XL 10 Capsule Multilayer Durapore Membrane C3KB37103

      Manuels d'utilisation

      Titre
      Opticap® XL Capsules and Opticap® XLT Capsules

      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