Product/Service
Nexis A Filter Cartridges
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 products 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.
Product Description
Nexis A filter cartridges 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 traceable
- Manufactured from FDA listed materials per 21 CFR
- Components meet the specifications for biological safety as per the USP for Class VI-121 °C plastics (gaskets/O-rings excluded)
- Nexis A filter cartridges are 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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