UA-44035381-1
  • AseptiSure HS Mini 2.5", 5"

AseptiSure HS Mini 2.5", 5"

mdi AseptiSure HS PES membrane mini cartridge filters are high temperature resistant filtration devices. These are designed to withstand high pressure differential at high temperature steam sterilization upto 135°C.

AseptiSure HS cartridge filters with polyethersulfone membrane serial layers offer enhanced throughputs, thus ensuring better economics.These are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.

  • High heat Stability
  • Non-toxic material of construction
  • Heat sealed, no glues or adhesives
  • Each filter comes with an individual certificate of quality
Consistent and Reliable Quality:AseptiSure 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
Low Protein Binding:
Results in increased overall product yield and higher throughputs with biological streams
High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Total Traceability
Unique identification number is laser etched on each other.

Sterile filtration of:

  • Proteinaceous liquids where minimum protein loss is desired, such as sera, culture soups and recombinant proteins, antibodies etc
  • Cell culture media
  • Buffers
  • Small volume parenterals
  • Large volume parenterals
Construction
Membrane Polyethersulfone
Final Filter Pore Size
0.2 µm 0.45 µm
Prefilter Pore Size
0.8 µm, 0.65 µm, 0.45 µm 0.65 µm, 0.8 µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point
> 50psi (3.51Kg/cm²) with Water > 30psi (2.11Kg/cm²) with Water
Microbial Retention
LRV>7 for B.diminuta(ATCC 19146) per cm²LRV>7 for S.marcescens (ATCC 19146) per cm²
Size
Size
2.5" 5"
Effective Filtration Area (Nominal)
1000cm² 2000cm²
Operational
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure 3.5 Kg/cm² (50 psi) @ 25 °C
Reverse Pressure < 0.7 Kg/cm² (10 psi) @ 25 °C
Sterilization 5 Autoclave/In-line steam sterilization cycles at 135°C for 30 min., ∆p=5 psi (0.3kg/cm²
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity
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
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.
TOC/Conductivity at 25 °C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiSure HS Mini
(with 0.45µm Upstream Layer)
CPHX
AseptiSure HS Mini
(with 0.65µm Upstream Layer)
CPH3
AseptiSure HS Mini
(with 0.8µm Upstream Layer)
CPH5
Size
Code
2.5" 50
5" 53
Pore Size
Code
0.2µm 01
0.45µm* 02
Adapter
Code
4463 E0
4463B H0
4440 U0
Seal-K
G0**
Seal-O
F0***
Seal-M
J0
Elastomer
Code
Silicone SS
Without 'O' ring XX
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01

     * 0.45µm cartridge filter are available with 0.65µm or 0.8µm upstream layer only

    **Adapter code “G0” does not come with Elastomer

    ***Adapter code F0 is available only in 5” cartridge filters

      Example :

CPH5 50 01 E0 SS 1 01
Example for Non Sterile: CPH55001E0SS101

Datasheet Download
Certificate of Quality Download

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