SteriDisc- EHCN
 

SteriDisc- EHCN membrane Edge Hydrophobic Membrane Disc Filters are used for sterility testing of antibiotics and drugs containing bacteriostats. 6mm rim is hydrophobic and rest of the membrane is hydrophilic. The hydrophobic edge does not allow the drug to seep under the rim of the filter holder.

This ensures complete removal of the drug during flushing so that growth of any microorganisms which have been retained on the membrane is not inhibited due to the residual drug, improving the sensitivity and reliability of the test.

Cost reduction is possible by reducing or eliminating antibiotic breaking enzymes.

  SteriDisc- EHCN
 
 
 
  • Applications
  • Specifications
  • Ordering Information
  • Sterility testing of antibiotics and drugs containing bacteriostats
  • Product Microbiology of antibiotics and drugs containing bacteriostats

 

Construction
Pore size 0.45μm
Membrane Cellulose Nitrate membrane with 6mm Hydrophobic Rim
Size 47mm
Operational
Bubble Point >32psi (2.25Kg/cm²) with water
Water Flow Rate > 45ml/min/cm² @ 0.70 Kg/cm² @ 27 °C
Retention Efficiency LRV > 7 for Sr. marcescens

Sterilization

EHCN Autoclavable at 121 °C for 30 minutes
EHCN-S Pre-sterilized with EO
Assurance
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001:2008 Certified
CE Certification Comply with the requirements of Medical Device Directive, 93/42/95 (MDD) for Medical Device Class-1
USFDA DMF Type V No. 15554
 
Type
EHCN
EHCN
 
Size
Dia
Code
47mm
09
 
Pore Size
Pore Size
Code
0.45µm
02
 
XX
 
XX
 
Sterile/ Non Sterile
Code
Non Sterile
1
EO Sterilized 2
 
Pack Size
Pack Size
Code
100
04
 
 
EHCN
09
02
XX
XX
1
04

 

 
 
 
 
 
 
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Related Documents
-  Data Sheet
-  Certificate of Quality
MSDS
Validation Guide

Related Products
-  Stericheck
-  SteriDisc CN
-  SteriDisc GCN
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-  SteriDisc RGCN
-  SteriDisc Dispenser
 
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