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Merck

KVGLA02TT3

Millipore

Durapore® 0.22 µm, Opticap® XL Capsule

Opticap® XL 2, inlet connection diam. 1.5 in., cartridge nominal length 2 in. (5 cm)

동의어(들):

Opticap XL2 Durapore 0.22 μm 1-1/2 in. TC/TC

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About This Item

UNSPSC 코드:
23151806

material

PVDF
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® XL 2

특징

hydrophilic

제조업체/상표

Opticap®

파라미터

1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

기술

sterile filtration: suitable

길이

14.2 cm (5.6 in.)

카트리지 공칭 길이

2 in. (5 cm)

직경

12.5 cm (4.9 in.)

여과 면적

0.09 m2

입구 연결 직경

1.5 in.

입구에서 출구 너비(W)

14.2 cm (5.6 in.)

출구 연결 직경

1.5 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

≤10 mg/capsule

기질

Durapore®

공극 크기

0.22 μm

입력

sample type liquid

버블 포인트(bubble point)

≥3450 mbar (50 psig), air with water at 23 °C

피팅

1/4 in. drain/vent hose barb (with double O-ring Seal)
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

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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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

결합

Replaces: KVGL04TC3

제조 메모

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

분석 메모

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

법적 정보

ASTM is a registered trademark of American Society for Testing and Materials
Durapore 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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