Validated and used worldwide - Pharmaceuticals

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Complimentary Report:
Validating a Celsis System

Download the white paper and learn how much easier it can be to validate an absence/presence system, especially with all the support you receive from Celsis.

Product validations using the Celsis system have been approved by regulatory agencies worldwide

Celsis has a strong track record of successful worldwide implementations:

  • First rapid microbial method (RMM) ever to receive regulatory approval was for a company using Celsis - 1997, Wyeth (Pfizer)
  • Multiple agency approvals including: FDA, EMEA, ANVISA, COFEPRIS
  • For multiple pharmaceutical companies including: Abbott Labs, AstraZeneca, EMS, GSK, Hoffman-La Roche, J&J CPSG, Novartis, Sanofi Aventis, Pfizer
  • Two active Drug Master Files (DMFs) on file with the US FDA
  • Comprehensive Technical Reports to supplement validation and regulatory submission consistent with guidance outlined in PDA TR33, EP 5.1.6, USP<1223>.
  • System software allows full compliance with the FDA's 21 CFR Part 11

Validation support: included with every Celsis system

As a growth-based, absence/presence and therefore qualitative screen, the Celsis system is easier to validate than other types of rapid methods. Plus, with more than 100 million assays already run on our system, technical reports and two drug master files (DMFs) on record with the U.S. FDA, there is a wealth of data to support your submission process.

Our validation support options include:

  • Instrument and software installation qualification and operation qualification (IQ/OQ)
  • A step-by-step validation guide specific to your new Celsis system and your industry
  • Access to My Celsis, your 24/7 online customer portal for technical documentation, manuals, MSDS, training tools and customer FAQs
  • Instruction for you and your lab staff, including the initiation of validation, with a focus on:

Sample Effects: An initial study to determine product suitability.

  • Does the product contain background Adenosine Triphosphate (ATP)?
  • Does the product interfere with the ATP bioluminescence reaction?

Spiking Studies: Inoculation studies to document the detection of a panel of appropriate organisms using the Celsis method.

Parallel Testing/Equivalency Study: Demonstration that the Celsis method is equal to or better than the compendial method.

Join the global companies who are getting products to market faster

In an industry where time-to-market matters and every day counts, you can't afford to continue waiting for traditional test results. Forward-looking pharmaceutical companies have already seen the value and the benefits a Celsis rapid system brings. You can, too.

Take the next step and contact us today. We look forward to working with you.

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