K003A05HH1

Opticap^® XL5 Clarigard^®

inlet connection diam. 9/16 in., pore size 0.3 μm, cartridge nominal length 5 in. (12.5 cm)

• Sinônimo(s): Opticap XL5 Clarigard 0.3 μm 9/16 in. HB/HB
• Código UNSPSC: 23151806
• eCl@ss: 32031690

Propriedades

• Materiais: polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Nível de qualidade: 400
• conformidade reg.: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• fabricante/nome comercial: Opticap^®
• Parâmetros: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Comprimento: 21.6 cm (8.5 in.)
• comprimento nominal do cartucho: 5 in. (12.5 cm)
• Diâmetro: 10.7 cm (4.2 in.)
• diâm. conexão de entrada: 9/16 in.
• L entrada para a saída: 21.6 cm (8.5 in.)
• diam. conexão de saída: 9/16 in.
• Impurezas: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• extraíveis gravimétricos: ≤10 mg/capsule
• matriz: Clarigard^®
• tamanho de poro: 0.3 μm nominal pore size; 0.3 μm pore size
• entrada: sample type liquid
• conector: inlet hose barb; 14 mm (9/16 in.) inlet/outlet hose barb; outlet hose barb

Descrição

Descrição geral

Device Configuration: Capsule

Embalagem

Double Easy-Open bag

Outras notas

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules user guide
• Storage Statement: Store in dry location.
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Nota de preparo

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Nota de análise

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Informações legais

CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Exoneração de responsabilidade

EMD 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.