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Merck
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주요 문서

CPGE73TF3

Millipore

Millipore Express® PHF 0.2µm Cartridge 30

Code 7 Fluorocarbon, Autoclavable and SIP

동의어(들):

Millipore Express PHF Cartridge Filter 30 in. 0.2 μm Code 7 Fluorocarbon

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About This Item

UNSPSC 코드:
23151806
eCl@ss:
32031690

제품명

Millipore Express® PHF, Cartridge, pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 7, fluoroelastomer seal

material

fluoroelastomer seal
polyethersulfone
polypropylene
polypropylene support
polysulfone

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

Millipore Express®

특징

hydrophilic

제조업체/상표

Millipore Express®

파라미터

≤90 mL/min air diffusion at 2.76 bar (40 psig) and 23 °C (in water)
0.07 bar max. differential pressure (1 psid) at 135 °C (Reverse)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
1.0 psi max. differential pressure (69 mbar) at 135 °C (Reverse)
1.4 bar max. differential pressure (20 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
20 psi max. differential pressure (1.4 bar) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 80 °C (Forward)
5.0 psi max. differential pressure (340 mbar) at 135 °C (Forward)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

기술

bioburden reduction: suitable

길이

30 in.

너비

2.7 in.

카트리지 공칭 길이

30 in. (75 cm)

직경

6.9 cm (2.7 in.)

여과 면적

1.62 m2

불순물

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

Matrix

Millipore Express® PHF

공극 크기

0.2 μm pore size

입력

sample type liquid

카트리지 코드

Code 7

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 of Filters with MILLIPORE EXPRESS® Membrane user guide
  • Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

제조 메모

Sterilization Method
12 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 15 autoclave cycles of 60 min @ 126 °C
This product was manufactured with a Millipore Express® 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 of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 30 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

법적 정보

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

시험 성적서(COA)

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