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

AseptiSure TH 5", 10", 20", 30"

mdi AseptiSure TH PTFE cartridge filters are specially designed high temperature resistant PTFE filters which are steam sterilizable at upto 135°C. These filters are validated with liquid microbial challenge test as per ASTM F 838-05 to offer absolute retention even under high moisture conditions.

These are also validated for other key performance parameters such as chemical compatibility, extractable, heat stability, flow rates, blow through and ability to withstand accidental reverse pressure. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications for air as well as liquid.

  • Absolute retention
  • Essentially hydrophobic
  • High heat stability
  • Wide chemical compatibility
  • Heat sealed
  • No leaching
  • 100% Integrity tested
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.
  • Fermentors venting and aeration
  • Sterile filtration of API and injectables
  • Sterile compressed air for pharma machineries
  • Sterile air for dry powder injectables filling
  • High temperature WFI tank venting
Construction
Membrane High Temperature Resistant Hydrophobic PTFE
Pore size
0.2µm 0.45µm
Support Layers Polypropylene
Body and Core Polypropylene
Integrity Testing / Retention
Microbial Retention
Brevundimonas diminuta (ATCC 19146) per cm²Serratia marcescens (ATCC 14756) per cm²
Air Diffusion Flow (with 70% IPA Wetted)
< 45 ml/min @ 16 psi (1.12 Kg/cm²) < 45 ml/min @ 8 psi (0.56 Kg/cm²)
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Operational
Max. Operating Temperature 95 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 50 psi (3.5 Kg/cm²) @ 25 °C
Reverse Pressure < 10 psi (0.7 Kg/cm²) @ 25 °C
Sterilization Autoclavable/In-line steam sterilizable at 135 °C for 30minutes, 80 cycles @ Δp= 5psi (0.3kg/cm²)
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity
Bacterial Endotoxin Aqueous extracts exhibit < 0.5 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
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 injectables
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiSure TH CPTH
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 in Adapter Code A0 (7P) and A1 (7P without fin) only

**Size 5" is available in Code A0 (7P) and A1 (7P without fin) only

Example :

CPTH 53 01 A0 SS 1 01
Example for Non Sterile: CPTH5301A0SS101

Datasheet Download
Certificate of Quality Download

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