UA-44035381-1
  • AseptiSure<sup>®</sup> HSR Mini 2.5", 5"

AseptiSure® HSR Mini 2.5", 5"

mdi AseptiSure® HSR Polyethersulfone (PES) membrane mini cartridge filters type AseptiSure® HSR are designed to withstand high pressure differential upto 0.3 Kg/cm² (5 psi) at high steam sterilization temperatures of up to135 °C.

These filters with Polyethersulfone membrane and Polypropylene support layers offer pH compatibility from 1 to14, and are thus ideal for use with acidic as well as alkaline solutions.

mdi AseptiSure® HSR Mini Cartridge filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.

  • Low protein binding
  • High throughputs
  • Long service life
  • Non-toxic material of construction
  • Heat sealed, no glues or adhesives
  • Each filter comes with an individualcertificate of quality
  • Total traceability: Unique Identification number is laseretched on each filter
  • Sterile Filtration of Culture media for mammalian cell culture
Construction
Membrane Polyethersulfone
Final Filter Pore Size
0.2µm 0.45µm
Prefilter Pore Size
0.8 µm, 0.65 µm, 0.45 µm 0.65 µm, 0.8 µm
Support Layers Polypropylene
Body and Core Polypropylene
Size
Size
2.5" 5"
Effective Filtration Area (Nominal)
1000cm² 2000cm²
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
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 Autoclave/In-line steam sterilization cycles at 135°C for 30 min., ∆p=5 psi (0.3kg/cm²), 25 cycles
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 ISO 11737-1 : 2018
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® HSR Mini Cartridge
(with 0.45µm Upstream Layer)
CHRX
AseptiSure® HSR Mini Cartridge
(with 0.65µm Upstream Layer)
CHR3
AseptiSure® HSR Mini Cartridge
(with 0.8µm Upstream Layer)
CHR5
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
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

     **G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering

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

      Example :

CHRX 50 01 E0 SS 1 01
Datasheet Download

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