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Merck
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Key Documents

CV0672TP3

Millipore

Multimedia Durapore® 0.5/0.22 µm, Cartridge

pore size 0.5/0.22 μm, cartridge nominal length 20 in. (50 cm), Code 7 (2-226; O-rings w/locking-tabs)

동의어(들):

Durapore Multimedia Cartridge Filter 20 in. 0.5+0.22 μm Code 7

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About This Item

UNSPSC 코드:
23151806
eCl@ss:
27293007

material

PVDF
mixed cellulose esters (MCE)
mixed cellulose esters (MCE) prefilter
polypropylene
polypropylene support
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
steam-in-place compatible

제품 라인

Durapore®

특징

hydrophilic

제조업체/상표

Durapore®

파라미터

≤26.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
3.5 bar max. inlet pressure (50 psi) 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 25 °C (Forward)

기술

sterile filtration: suitable

길이

20 in.

너비

2.7 in.

카트리지 공칭 길이

20 in. (50 cm)

직경

6.9 cm (2.7 in.)

여과 면적

1.38 m2

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

≤90 mg/cartridge

기질

Multimedia Durapore®

pore size

0.5/0.22 μm pore size

입력

sample type liquid

버블 포인트(bubble point)

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

카트리지 코드

Code 7 (2-226; O-rings w/locking-tabs)

일반 설명

Device Configuration: Cartridge

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.

제조 메모

Sterilization Method
6 autoclave or SIP cycles of 30 min @ 123 °C
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 ≥10 L

법적 정보

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

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Storage Class Code

11 - Combustible Solids

WGK

WGK 2


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