Sterility assurance solutions

ChargePoint Technology has been providing solutions that combine the need for containment and sterility assurance for over a decade.

Our AseptiSafe® product range for sterility assurance has been purposely developed to perform aseptic transfers that: 

  • Protect process operators  
  • Maintain critical area integrity 
  • Reduce risk of contamination via closed transfers providing containment performance of up to <1 μg/m3 (OEB4) 
  • Meet GMP and product quality requirements.  
  • Perform enhanced sterility assurance through H202 Bio decontamination providing a validated 6 log reduction. 

The range removes the requirement for large, high-grade control areas by maintaining the critical area with the split butterfly valve and the single use bag system eliminates cleaning and sterilization associated with rigid containers. 

All products suitable for aseptic manufacturing are independently validated by third parties according to ISPE containment performance measurement (SMEPAC) guidelines providing unrivalled, validated levels of containment performance alongside sterility assurance. 

The solutions offered by ChargePoint to provide sterility assurance include: 

You can be sure that your product, people and process are in safe hands with ChargePoint’s sterility assurance solutions. Our solutions are manufactured using FDA compliant materials with full material certification and batch traceability and are manufactured in facilities that conform to ATEX (European Hazardous Area Directive) HazLoc (North America Hazardous Area Directive) and PED (European Pressure Equipment Directive).