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Merck

K010A51HH1

Opticap® XL1 Clarigard®

inlet connection diam. 9/16 in., pore size 1.0 μm, cartridge nominal length 1 in. (2.5 cm)

동의어(들):

Opticap XL1 Clarigard 1.0 μm 9/16 in. HB/HB

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크기 선택

제품정보 (DICE 배송 시 비용 별도)

eCl@ss:
32031690
UNSPSC Code:
23151806

주요 문서

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제품 이름

Opticap® XL1 Clarigard®, inlet connection diam. 9/16 in., pore size 1.0 μm, cartridge nominal length 1 in. (2.5 cm)

material

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

manufacturer/tradename

Opticap®

parameter

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

L

21.6 cm (8.5 in.)

cartridge nominal length

1 in. (2.5 cm)

diam.

10.7 cm (4.2 in.)

inlet connection diam.

9/16 in.

inlet to outlet W

21.6 cm (8.5 in.)

outlet connection diam.

9/16 in.

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤10 mg/capsule

matrix

Clarigard®

pore size

1.0 μm nominal pore size
1.0 μm pore size

input

sample type liquid

fitting

inlet hose barb
14 mm (9/16 in.) inlet/outlet hose barb
 outlet hose barb

Quality Level

400

관련 카테고리

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Disclaimer

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.

General description

Device Configuration: Capsule

Other Notes

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.

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

Packaging

Double Easy-Open bag

Preparation Note

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).

Legal Information

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

시험 성적서(COA)

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국제 무역 품목 번호

SKUGTIN
K010A51HH104053252347726

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