UA-44035381-1
  • ClariSure<sup>®</sup> PP 5", 10", 20", 30"

ClariSure® PP 5", 10", 20", 30"

mdi ClariSure® PP cartridge filters are 100% polypropylene construction precision filtration devices. These are very high retention efficiency pleated cartridge filters offering large filtration area. These filters are used as terminal filters in applications requiring highly efficient particulate removal.

  • High Flow Rates
  • Wide Chemical Compatibility
  • Non Media Migrating
Very High Retention Efficiency:
99.999%
Consistent and Reliable Quality:
ClariSure® cartridge filters are produced with ISO 9001-2008 certified quality management systems.
Regulatory Compliance:
Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
Total Traceability
Unique identification number is laser etched on each other.
  • Polishing filtration of Non Sterile API
  • Filtration of precipitating agents
  • Filtration of wash solvents for final non sterile API
  • Filtration of air to dryers and micronizers
  • DM water tank venting
  • Final wash water for Ampoule/Vial washing and Bung washing
Construction
Pore size 0.2μm, 0.5μm, 1μm, 1.2μm, 2μm, 2.5μm, 5μm,10μm, 20μm, 30μm
Filter Media Polypropylene
Support Layers Polypropylene
Other Components Polypropylene
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
2500cm²5000cm²10000cm²15000cm²
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 50 psi (3.5 Kg/cm²) @ 25 °C
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes test as per USP
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
ClariSure® PP
CPPP
Size
Length
Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.2 µm 01
0.5 µm 04
1 µm 05
1.2 µm 10
2 µm 15
2.5 µm 06
5 µm 07
10 µm 08
20 µm 11
30 µm 19
Adapter
Code
7P A0
BEO B0
28 with fin C0
'O' D0
7P without finA1
Elastomer
Code
Silicone SS
Viton SV
EPDM SE
PTFE ST***
FEP Encapsulated Viton FV*
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01

*FV is available in Adapter Code A0 (7P) and A1 (7P without fin) only

**Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only

***PTFE (ST) gasket seals are available with 'B0' adapter code only

Example :

CPPP 55 19 A0 SV 1 01
Example for Non Sterile: CPPP5519A0SV101

Datasheet Download
Certificate of Quality Download

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