UA-44035381-1
  • ClariCap GS 25mm,50mm

ClariCap GS 25mm,50mm

mdi ClariCap GS lab scale capsule filters are ready to use, disposable filtration devices. These are specially designed filters incorporating a microglass fiber and a downstream Polypropylene membrane final layer and are used as pre-filters in biopharmaceuticals process development for difficult to filter solutions.

The microglass fiber layer offers high dirt holding capacity and efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions. The downstream Polypropylene layer prevents fiber release into the downstream.

  • High Flow Rates
  • High Throughput
  • Very High Retention
  • Compact Design
  • Pre-filtration of cell culture media
  • Pre-filtration of serum solutions
  • Clarification of cell harvest supernatants
  • Pre-filtration of protein solutions
  • Pre-filtration of high value difficult to filter drug solutions
  • Pre-filtration of difficult to filter small volume parenterals
  • Polishing of turbid solutions
Construction
Pore size 0.7µm, 1µm, 1.5µm,2µm
Filter Media Multilayered Microglassfiber
Downstream Layer Polypropylene
Body and Core Polypropylene
Size
Size
25 mm50 mm
Effective Filtration Area (Nominal)
5cm²20cm²
Operational
Max. Operating Temperature 60 °C
Max. Differential Pressure 3Kg/cm² (42 psi) @ 30 °C
Burst Pressure >8Kg/cm²
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30minutes, 30 cycles and it cannot be in-line steam sterilized
Shelf Life 3 years after EO sterilization
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3 (b)(6) for fiber release
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
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 injections
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554



ClariCap GS- 25mm

Type
ClariCap GS IGSX
Size
Dia
Code
25mm 06
Pore Size
Pore Size Code
0.7µm 41
1µm 05
1.5µm 14
2µm 15
I/O Connection
Connection Code
Female Luer Lock M
Male Luer Slip N
⅛" Hose Barb H
¼" Hose Barb B
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

Example :

IGKX 06 05 MN X X 1 04

Example for Non Sterile: IGSX0605MNXX104                                                            Example for EO Sterile: IGSX0605MNXX204

ClariCap GS- 50mm

Type
ClariCap GS VGSX
Size
Dia
Code
50mm 10
Pore Size
Pore Size Code
0.7µm 41
1µm 05
1.5µm 14
2µm 15
I/O Connection
Connection Code
¼” SHB B
¾" Sanitary Flange* S
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 02
* ¾" Sanitary Flange is available as Outlet only

Example :

VGSX 10 05 BB X X 1 02
Example for Non Sterile: VGSX1005BBXX102                                                            Example for EO Sterile: VGSX1005BBXX202

Datasheet Download
Certificate of Quality Download

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