Nexis® A Filter Cartridge (Q Grade) product photo Primary L

Nexis® A Filter Cartridge (Q Grade)

High efficiency, all-polypropylene depth filters for use in Active Pharmaceutical Ingredients (API) processes

An Introduction to Q Grade

The application of Good Manufacturing Practices (GMP) within Active Pharmaceutical Ingredients (API) processes as described in the ICHQ7A guidance document is becoming increasingly important. Pall® Q Grade cartridges are high quality, economical filters aimed specifically at applications within API processes. These products are supplied with a’Q’ certificate of quality, incorporating essential product and manufacturing quality details.

Nexis A filter cartridges (Q Grade) are high efficiency, all-polypropylene depth filters produced by advanced melt blowing technology. Products in this range have an exceptionally stable matrix comprised of a continuous pore gradient of microthin fibers intermingled with large diameter support fibers. This proprietary CoLD (Co Located Large Diameter) structure results in highly effective contaminant removal combined with long on-stream life, particularly when a wide distribution of particle sizes may be present.

GMP Features

  • Manufactured for use under GMP
  • Supplied with a “Q” Certificate of Quality
  • Lot traceableManufactured from FDA listed materials per 21 CFR
    Components meet the specifications for biological safety as per the USP for ClassVI-121 °C plastics (gaskets/O-rings excluded)
  • Free from adhesives, binders and resins

Packaging

  • Bulk-packaged in quantity of 12 filter cartridges per box. Each filter cartridge is individually wrapped in a labeled bag
  • One ‘Q’ certificate per box


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Description

High efficiency, all-polypropylene depth filters for use in Active Pharmaceutical Ingredients (API) processes

An Introduction to Q Grade

The application of Good Manufacturing Practices (GMP) within Active Pharmaceutical Ingredients (API) processes as described in the ICHQ7A guidance document is becoming increasingly important. Pall® Q Grade cartridges are high quality, economical filters aimed specifically at applications within API processes. These products are supplied with a’Q’ certificate of quality, incorporating essential product and manufacturing quality details.

Nexis A filter cartridges (Q Grade) are high efficiency, all-polypropylene depth filters produced by advanced melt blowing technology. Products in this range have an exceptionally stable matrix comprised of a continuous pore gradient of microthin fibers intermingled with large diameter support fibers. This proprietary CoLD (Co Located Large Diameter) structure results in highly effective contaminant removal combined with long on-stream life, particularly when a wide distribution of particle sizes may be present.

GMP Features

  • Manufactured for use under GMP
  • Supplied with a “Q” Certificate of Quality
  • Lot traceableManufactured from FDA listed materials per 21 CFR
    Components meet the specifications for biological safety as per the USP for ClassVI-121 °C plastics (gaskets/O-rings excluded)
  • Free from adhesives, binders and resins

Packaging

  • Bulk-packaged in quantity of 12 filter cartridges per box. Each filter cartridge is individually wrapped in a labeled bag
  • One ‘Q’ certificate per box
Specifications

Materials of Construction

Filter Media Polypropylene
Hardware Polypropylene
Gaskets/O-rings Ethylene propylene (EPDM)/FEP Encapsulated Silicone

Dimensions (Nominal)

Outside Diameter  64 mm (2½ in.)
Length 254 mm (10 in.)
508 mm (20 in.)

Removal Ratings (μm) (by ASTM F-795 Test)¹

Cartridge Designation 99.9% Efficiency 90% Efficiency
NXA 1 1.0 0.7
NXA 5 4.1 3.4
NXA 10 9.5 4.7
¹ Additional information can be obtained by contacting Pall

Maximum Differential Pressure

1.0 bard (15 psid) at 82 °C (180 °F) 
1.7 bard (25 psid) at 66 °C (150 °F)
4.2 bard (60 psid) at 30 °C (86 °F)

Application
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