Navigation Links
Celsis Rapid Detection's Updated Drug Master Files (DMFs) Accepted by FDA
Date:5/27/2010

CHICAGO, May 27 /PRNewswire/ -- Celsis International, the global leader in rapid microbial detection, announced it has recently updated its Drug Master Files with the U.S. Food & Drug Administration (FDA) to include information on testing both non-sterile and sterile raw materials, in-process solutions and finished goods on the Celsis system.

"A growing number of our Rapid Detection customers are using their Celsis systems to confirm sterility," said Judy Madden, Vice President of Celsis International. "By updating and expanding the information available in our DMFs regarding micro limits and sterility testing, we are helping to simplify and, ideally, speed the regulatory review process," she explained.

Celsis offers a variety of resources to help customers with their filings, including the assistance of an experienced regulatory compliance manager. "We understand the economic value to our customers in getting their products to market faster," said Madden. "Companies won't realize the full financial benefits of rapid detection unless their systems are successfully validated. For this reason we have always delivered outstanding global scientific, technical and customer support as an integral and important part of every Celsis system."

The FDA accepts DMFs from suppliers like Celsis that can be referenced by pharmaceutical companies submitting new, supplemental or amended drug applications. The DMF is a technical document that contains reference support data as well as proprietary information about manufacturing and formulation.  Celsis has two DMFs, the originals dating back to 2006, for the RapiScreen™ and AKuScreen™ assay families. The newly updated DMFs include data for specificity, limit of detection, robustness, ruggedness and equivalence, for use with both microbial limits and sterility testing. They can be used to supplement or streamline the validation of a Celsis system, saving companies' time in preparation and saving the FDA time in review and approval.

For more information, contact Celsis Rapid Detection at +1 312 476 1282 or visit celsis.com/rapid.

About Celsis International

Celsis International is a leading global provider of innovative life science products and laboratory services to the pharmaceutical and consumer products industries. Each Celsis division delivers substantial time and cost savings to its customers while ensuring product quality and safety for consumers. Celsis' extensive client base includes leading pharmaceutical and consumer products companies, as well as all of the top 25 pharmaceutical companies worldwide. Visit www.celsis.com for more information.


'/>"/>
SOURCE Celsis International
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Celsis Receives Frost & Sullivan 2008 Best Practices Award
2. Celsis Launches RapiScreen(TM) Beverage Microbial Screening System
3. Celsis In Vitro Technologies and Promega to Offer Fast, Reliable Solutions for ADME-Tox Testing With Primary Hepatocytes
4. Celsis Introduces ReACT(TM) RNA-Based Microbial Detection Assays
5. Celsis Outlines the Top Five Advantages of Cryo-plateable Hepatocytes
6. Chicago-Based Celsis International Goes Private
7. Celsis IVT Granted U.S. Patent for LiverPool(TM) Hepatocytes
8. Celsis IVT Settles LiverPool Patent Infringement Suit With XenoTech, LLC
9. Pathway Medical Technologies Adds Joe Rafferty as VP, Sales, and Moves To Larger Facility to Accommodate Rapid Growth
10. NanoLogix Inc. Appoints Director of IP and Makes Progress on Rapid Anthrax Detection
11. Spectral partner launches EAA(TM) Rapid Sepsis Diagnostic in Germany
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2016)... ... May 02, 2016 , ... Meister Media Worldwide launches its ... and added functionality give the agricultural world a taste of Meister Media Worldwide’s ... agriculture – from precision farming via satellites and Unmanned Aerial Vehicles (UAVs) to ...
(Date:5/2/2016)... , ... May 02, 2016 , ... ... report on the pre-launch success of their revolutionary, veterinarian-designed product for indoor cats. ... stalk, trap, and play with their food the way nature intended. NoBowls make ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... is excited to announce the launch of the Proove Health Foundation . ... and education to promote the use of personalized medicine for tackling the nation’s ...
(Date:4/29/2016)... , April 29, 2016 ... by Transparency Market Research "Separation Systems for Commercial ... Growth, Trends, and Forecast 2015 - 2023", the ... at US$ 10,665.5 Mn in 2014 and is ... from 2015 to 2023 to reach US$ 19,227.8 ...
Breaking Biology Technology:
(Date:4/26/2016)... LONDON , April 26, 2016 /PRNewswire/ ... Systems, a product subsidiary of Infosys (NYSE: ... partnership to integrate the Onegini mobile security platform ... http://photos.prnewswire.com/prnh/20151104/283829LOGO ) The integration ... security to access and transact across channels. Using ...
(Date:4/19/2016)... , UAE, April 20, 2016 ... be implemented as a compact web-based "all-in-one" system solution ... the biometric fingerprint reader or the door interface with ... of modern access control systems. The minimal dimensions of ... ID readers into the building installations offer considerable freedom ...
(Date:4/15/2016)... , April 15, 2016 ... "Global Gait Biometrics Market 2016-2020,"  report to their ... ) , ,The global gait biometrics market ... 13.98% during the period 2016-2020. Gait ... which can be used to compute factors that ...
Breaking Biology News(10 mins):