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.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.
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 颇尔 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
材料成分
| 过滤介质 | 聚丙烯 |
| Support and Hardware | 聚丙烯 |
| Gaskets/O-rings |
Ethylene propylene (EPDM) FEP encapsulated silicone (O-rings) Expanded PTFE (gaskets) |
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 |
| PFTQ045 | 1.2 | 0.45 |
| PFTQ2 | 5 | 2 |
| PFTQ5 | 12 | 5 |
Maximum Differential Pressure
| 5.1 bard (75 psid) at 20 °C (68 °F) |
| 2.8 bard (40 psid) at 65 °C (150 °F) |
