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Merck
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Key Documents

KWLCA04FF3

Millipore

Milligard® LPB 1.2/0.5 µm nominal, Opticap® XL Capsule

Opticap® XL 4, inlet connection diam. 3/4 in., pore size 1.2/0.5 μm, cartridge nominal length 4 in. (10 cm)

동의어(들):

Opticap XL4 Milligard Low Protein Binding 1.2/0.5 μm 3/4 in. TC/TC

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About This Item

UNSPSC 코드:
23151806
eCl@ss:
32031610

material

mixed cellulose esters (MCE) membrane
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

0.16 m2

입구 연결 직경

3/4 in.

입구에서 출구 너비(W)

19.6 cm (7.7 in.)

출구 연결 직경

3/4 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

≤110 mg/capsule

기질

Milligard® LPB

pore size

1.2/0.5 μm nominal pore size
1.2/0.5 μm pore size

입력

sample type liquid

피팅

inlet sanitary flange
outlet sanitary flange
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

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일반 설명

Device Configuration: Capsule

특징 및 장점

Format: Double 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: KWSCL4FF3

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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