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

AseptiSure TF Mini 2.5", 5"

mdi Aseptisure TF PTFE membrane mini cartridge filters are hydrophobic filters offering absolute retention. These filters are designed for sterilizing filtration of gases. The high quality of membrane and design of cartridge assures long life and ability to withstand adverse process conditions experienced during use.

These filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractable, heat stability, flow rates and blow through.

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
Construction
Membrane Hydrophobic PTFE
Final Filter Pore Size
0.2µm 0.45µm
Support Layers Polypropylene
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point
>22psi (1.52 Bar) with 70% IPA/Water Solution>10psi (0.69 Bar) with 70% IPA/Water Solution
Microbial Retention
Brevundimonas diminuta (ATCC 19146) per cm² Serratia marcescens (ATCC 14756) per cm²
Size
Effective Filtration Area
1000cm² 2000cm²
Length
2.5" 5"
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 (10psi) @ 25 °C
Sterilization Autoclavable/In-line steam sterilizable at 121° C for 30 minutes, 100 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 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
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
pH Compatibility Compatible with pH range of 1 - 10
Type
AseptiSure TF Mini
CPTF
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 :

CPTF 50 01 E0 SS 1 01
Example for Non Sterile: CPTF5001E0SS101

Datasheet Download
Certificate of Quality Download

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