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

AseptiSure® TH Mini 2.5", 5"

mdi AseptiSure® TH PTFE mini 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.

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
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
Final Filter Pore Size
0.2µm0.45µm
Support Layers Polypropylene
Body and Core Polypropylene
Size
Effective Filtration Area
1000cm² 2000cm²
Length
2.5" 5"
Integrity Testing / Retention
Microbial Retention
Brevundimonas diminuta (ATCC 19146) per cm² Serratia marcescens (ATCC 14756) per cm²
Bubble Point (70% IPA/Water)
>22psi (1.54 kg/cm²)>10psi (0.7 kg/cm²)
Water Intrusion Rate
2.5"< 0.3 ml/min @ 2.0kg/cm²
5"< 0.6 ml/min @ 2.0kg/cm²
Operational
Max. Operating Temperature 95 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure < 3.5 Kg/cm² (50 psi ) @ 25 °C
Reverse Pressure < 0.7 Kg/cm² (10psi) @ 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
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 ISO 11737-1 : 2018
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 Mini
 CPTH
Size
Size Code
2.5" 50
5" 53
Pore Size
Pore Size
 Code
0.2µm 01
0.45µm 02
Adapter
Code
4463 E0
4463B H0
4440 U0
½” MNPT
 K0*
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

*G0 and K0 adapter codes are 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:

CPTH 50 01 E0 SS 1 01
Example for Non Sterile: CPTH5001E0SS101

Datasheet Download
Certificate of Quality Download