All-polypropylene pleated filters with high flow and high contaminant holding capacity for longer on-stream life

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.

Poly-Fine II filter cartridges (Q Grade) are all-polypropylene pleated filters with high flow and high contaminant holding capacity for longer on-stream life. The filter media is produced by Pall using a proprietary melt-blowing process that delivers exceptional product consistency. Poly-Fine II filter cartridges (Q Grade) are ideally suited to the capture of non-deformable particles from compatible liquid or inert gas feed streams, characterized by a narrow particle size distribution.

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 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