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.颇尔® 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
材料成分
过滤介质 | 聚丙烯 |
硬件 | 聚丙烯 |
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 |
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) |