UA-44035381-1
  • AseptiSure HS 5", 10" 20", 30"

AseptiSure HS 5", 10" 20", 30"

mdi AseptiSure HS PES Membrane 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 Throughputs
  • Long Service life
  • 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 Brevundimonas diminuta (ATCC 19146) per cm² LRV >7 for Serratia marcescens (ATCC 14756) per cm²
Air Diffusion Flow (10")
< 30ml/min @ 37 psi (2.6Kg/cm²) with Water < 35ml/min @ 22 psi (1.54Kg/cm²) with Water
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
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
Typical Water Flow Rates (10" Cartridge filters)
44 lpm @ 0.70 Kg/cm² @ 27 °C 55 lpm @ 0.70 Kg/cm² @ 27 °C
Sterilization Autoclavable/In-line steam sterilizable at 135 ° C for 30 minutes, 25 cycles @ ∆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 The filtrate Complies with USP <788> test for particulate matter 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 (with 0.45µm Upstream Layer) CPHX
AseptiSure HS (with 0.65µm Upstream Layer) CPH3
AseptiSure HS (with 0.8µm Upstream Layer) CPH5
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size
Code
0.2µm 01
0.45µm*** 02
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 with 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

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

     Example :

CPH5 55 01 A0 SS 1 01
Example for Non Sterile: CPH55501A0SS101
Datasheet Download
Certificate of Quality Download

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