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

ClariSure® GS 5", 10", 20", 30"

mdi ClariSure® GS cartridge filters are multilayered, high throughput filters, specially designed for difficult to filter solutions.It is a very high efficiency pre-filter combining the unique abilities of microglassfiber filter media to retain colloidal particles and heat calendered polypropylene filter media to ensure non media migration.

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
  • Precipitate removal post viral inactivation
  • Pre-filtration of cell culture media
  • Pre-filtration of serum and other viscous biologicals
  • Pre-filtration of serum solutions
  • Clarification of cell harvest supernatant
  • Pre-filtration of protein Solutions
  • Pre-filtration of high value difficult to filter drug solutions
  • Polishing of turbid solutions
Construction
Pore size 0.7µm, 1µm
Filter Media Microglassfiber
Body and Core Polypropylene
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
1700cm² 3400cm² 6800cm² 10200cm²
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 50 psi (3.5 Kg/cm²) @ 30 °C
Sterilization Autoclavable/In-line steam sterilizable at 121 °C for 30minutes, 30 cycles
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) 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® GS
CPGS
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.7µm 41
1µm 05
Adapter
Code
7P A0
7P without fin A1
28 with fin C0
'O' D0
Elastomer
Code
Silicone SS
Viton SV
EPDM SE
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

Example :

CPGS 56 41
A0 SS 1 01
Example for Non Sterile: CPGS5641A0SS101

Datasheet Download
Certificate of Quality Download

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