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Merck
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Key Documents

KWL9A04HH3

Millipore

Milligard® LPB 1.2 µm, Opticap® XL Capsule

Opticap® XL 4, inlet connection diam. 9/16 in., pore size 1.2 μm, cartridge nominal length 4 in. (10 cm)

동의어(들):

Opticap XL4 Milligard Low Protein Binding 1.2 μm 9/16 in. HB/HB

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About This Item

UNSPSC 코드:
23151806
eCl@ss:
32031610

material

mixed cellulose esters (MCE) (low protein-binding)
polyester support
polypropylene
polypropylene housing
polypropylene vent cap
silicone seal

Quality Level

규정 준수

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

무균

non-sterile

멸균 적합성

autoclavable compatible

제품 라인

Opticap® XL 4

특징

hydrophilic

제조업체/상표

Opticap®

파라미터

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.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

기술

prefiltration: suitable

길이

19.6 cm (7.7 in.)

너비

3.3 in.

카트리지 공칭 길이

4 in. (10 cm)

직경

12.5 cm (4.9 in.)

여과 면적

0.2 m2

입구 연결 직경

9/16 in.

입구에서 출구 너비(W)

19.6 cm (7.7 in.)

출구 연결 직경

9/16 in.

불순물

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

중량 추출물

≤105 mg/capsule

기질

Milligard® LPB

공극 크기

1.2 μm nominal pore size
1.2 μm pore size

입력

sample type liquid

피팅

inlet hose barb
outlet hose barb
(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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일반 설명

Device Configuration: Capsule

특징 및 장점

Format: Single Layer

포장

Double Easy-Open bag

기타 정보

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.

규격

Filter Grade: Low Protein Binding Milligard® Media

결합

Replaces: KW19L4HB3

제조 메모

Sterilization Method
3 autoclave cycles of 30 min @ 121 °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).

분석 메모

Gravimetric Extractables: after a 2 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

법적 정보

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

면책조항

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.

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Storage Class Code

4.1B - Flammable solid hazardous materials

WGK

WGK 3


시험 성적서(COA)

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