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Merck
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Key Documents

KGW3A2THH1

Millipore

Polysep II 1.0/0.2 µm nominal, Opticap® XLT Capsule

inlet connection diam. 5/8 in., Opticap® XLT 20, pore size 1.0/0.2 μm, cartridge nominal length 20 in. (50 cm)

동의어(들):

Opticap XLT20 Polysep II 1.0/0.2 μm 5/8 in. HB

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About This Item

UNSPSC 코드:
23151806
eCl@ss:
32031610

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
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)

무균

non-sterile

멸균 적합성

autoclavable compatible

제품 라인

Opticap® XLT 20

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

62.5 cm (24.6 in.)

너비

7.8 in.

카트리지 공칭 길이

20 in. (50 cm)

여과 면적

0.93 m2

입구 연결 직경

5/8 in.

입구에서 출구 너비(W)

19.8 cm (7.8 in.)

출구 연결 직경

5/8 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

≤290 mg/capsule

기질

Polysep II

pore size

1.0/0.2 μm nominal pore size
1.0/0.2 μm pore size

입력

sample type liquid

피팅

inlet hose barb
outlet hose barb
(16 mm (5?8 in.) Hose Barb Inlet and Outlet)

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일반 설명

Device Configuration: Capsule
T-line/Gauge Port: T-line

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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 10 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥10 L

법적 정보

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

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

11 - Combustible Solids

WGK

WGK 2


시험 성적서(COA)

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