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Merck
모든 사진(1)

Key Documents

K002A51FF1

Millipore

Opticap® XL1 Clarigard®

inlet connection diam. 3/4 in., pore size 0.2 μm, cartridge nominal length 1 in. (2.5 cm)

동의어(들):

Opticap XL1 Clarigard 0.2 m 3/4 in. TC/TC

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About This Item

UNSPSC 코드:
23151806
eCl@ss:
32031690

material

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Quality Level

규정 준수

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

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.
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

길이

21.6 cm (8.5 in.)

카트리지 공칭 길이

1 in. (2.5 cm)

직경

10.7 cm (4.2 in.)

입구 연결 직경

3/4 in.

입구에서 출구 너비(W)

21.6 cm (8.5 in.)

출구 연결 직경

3/4 in.

불순물

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

중량 추출물

≤10 mg/capsule

기질

Clarigard®

공극 크기

0.2 μm nominal pore size
0.2 μm pore size

입력

sample type liquid

피팅

inlet sanitary flange
19 mm (3/4 in.) inlet/outlet sanitary flange
outlet sanitary flange

관련 카테고리

일반 설명

Device Configuration: Capsule

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.

제조 메모

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).

분석 메모

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

법적 정보

CLARIGARD 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.

시험 성적서(COA)

제품의 로트/배치 번호를 입력하여 시험 성적서(COA)을 검색하십시오. 로트 및 배치 번호는 제품 라벨에 있는 ‘로트’ 또는 ‘배치’라는 용어 뒤에서 찾을 수 있습니다.

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