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14th July 2014  Content supplied by: Charles River

Pfizer Successfully Implements Endosafe® Endotoxin Testing Platforms

Over the last 3 years, Pfizer has assessed the Endosafe® rapid test methods on dozens of applications and gathered extensive data to support comparability to USP<85> and PharmEur 2.6.14 Bacterial Endotoxin.

This poster, which was presented by Pfizer at the 2014 PDA Annual Meeting, provides a summary of the methodology, Endosafe® platform, collected data to support compatibility to traditional methods, examples of implementation and the operational benefits realized.

Summary of Evaluation and Benefits:

  • 47,000+ water and buffer samples tested, by 19 different users, demonstrated the assay performs as designed, results distributed across compendial acceptance of 50% to 200% spike recovery
  • Endosafe platform system aligned with USP<85> and PharmEur 2.6.14
  • Reduced operator error, cost/test, training, metrology, reagent overhead/control and technician test time
  • Reduction of investigations (~$1,800/investigations)
  • Moved upwards of 60% of testing from Lab to Floor
  • Pfizer global implementation: 69 PTS™ units and 20+ MCS™ units

Contact us today to learn how you can improve lab efficiencies and decrease testing times by transitioning from a traditional methods to the Endosafe™ PTS™.

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Date Published: 14th July 2014

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