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17th April 2018  Content supplied by: Sartorius AG

Need to Revalidate Your Sterility Testing System? Don’t Wait Too Long!

Are you not yet using the Sartorius Sterility Testing Systems? In that case you might face a product re-design in your current sterility testing equipment with a pending discontinuation of existing products as early as July 2018. Although new units are not expected before June, it has been suggested that these may not require revalidation in established test methods.

The current USP and EP 2.6.1. states, “...this method suitability is performed ...... whenever there is a change in the experimental conditions in the test.” Can you afford to wait until June to make this decision?

Gas-tight blister packaging has been available for Sartorius sterility testing systems for more than 15 years. And, we have more innovations see

Revalidate now with the Sartorius Sterisart® sterility testing system.

A product redesign can impact your production timeline in unanticipated ways – especially if revalidation is required:

  • Delivery shortages as other users react to the announced changes by stocking up on existing units
  • Production delays that will impact your customers due to required revalidation

Contact Sartorius now to learn about the Sterisart® sterility testing system. We are happy to support you.

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Date Published: 17th April 2018

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