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Sterile Grade Performance


· Sanitary filtration is a process that to remove bacterial from fluid under the condition that no bad effect on product itself.
· ASTMF 838-05 is a standard insert TM, can be used in all sanitary grade membrane.
· It proves that can removal a standard laboratory bacterial, minimum concentration is 107cfu/cm2.

 

 

 

 

■ Bacterial Challenge Test

 

 

 

■ Third Part Bacterial Challenge Test Report

 

 

 

 

 


Validation Guide for SPS 0.22 Pharmaceutical Grade Cartridge Filter

 

 

 

2.0 Product Summary

   2.1 Product Description

   2.2 Catalogue Number Guide

   2.3 Product Traceability

   2.4 Endcap Configuration Diagrams

   2.5 Product Specification

   2.6 Certification

   2.7 Chemical Compatibility

 

3.0 Test Methods and Results Summary

   3.1 Organism Retention

      3.1 .1Organism Retention for Membrane

      3.1.2 Organism Retention for Cartridge Filter

   3.2 Integrity Test

   3.3 Water Flow Rate

   3.4 Hydraulic Stress Resistance

      3.4.1 Hydraulic Stress at 25℃

      3.4.2 Hydraulic Stress at 90℃

   3.5 Thermal Stress Resistance

      3.5.1 30 Autoclave Cycles at 121℃ for 30 minutes

   3.6 USP Biological Safety

      3.6.1 USP Class VI Biological: Tests for Plastics

      3.6.2 USP Bacterial Endotoxin: LAL Test

   3.7 Cleanliness 

      3.7.1 Gravimetric Extractables in Water

      3.7.2 USP Oxidizable Substances

      3.7.3 Particle Releasing

      3.7.4 Fiber Shedding

      3.7.5 Total Organic Carbon & Conductivity

 

 

1.0 Introduction

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