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Key Documents

KR05A05HH1

Millipore

Opticap® XL5 Polygard® CR

inlet connection diam. 9/16 in., pore size 5.0 μm, cartridge nominal length 5 in. (12.5 cm)

Sinonimo/i:

Opticap XL5 Polygard-CR 5.0 μm 9/16 in. HB/HB

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About This Item

Codice UNSPSC:
23151806

Materiali

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Livello qualitativo

Conformità normativa

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

Produttore/marchio commerciale

Opticap®

Parametri

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 25 °C
80 psig max. inlet pressure

Lunghezza

21.6 cm (8.5 in.)

Lunghezza nominale della cartuccia

5 in. (12.5 cm)

Diametro

10.7 cm (4.2 in.)

Diam. connessione ingresso

9/16 in.

Amp. ingresso/ uscita

21.6 cm (8.5 in.)

Diam. connessione uscita

9/16 in.

Impurezze

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

Estraibili (gravimetria)

≤30 mg/capsule

Matrice

Polygard®-CR

Dimensione pori

5.0 μm nominal pore size
5.0 μm pore size

input

sample type liquid

Raccordi

inlet hose barb
14 mm (9/16 in.) inlet/outlet hose barb
outlet hose barb

Descrizione generale

Polygard® CR products are nominally rated filters designed for particle removal applications in liquids and gases. The graded-density depth structure of Polygard® CR filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.

The KR05A05HH1 Opticap® XL5Polygard® CR features a pore size of 5.0 μm. This single layer capsule filter has a hose barb inlet/outlet connection measuring 9/16 in. in diameter.

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with Polygard® CR media minimizes hold-up volume and reduces production losses.

Caratteristiche e vantaggi

Format: Single Layer

Confezionamento

Double Easy-Open bag

Altre note

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Nota sulla preparazione

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

Risultati analitici

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2.5 L

Note legali

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

Esclusione di responsabilità

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.

Certificati d'analisi (COA)

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