IL-CELSIS

Celsis, the global leader in rapid microbial testing systems for industry, today introduced the Celsis Accel System for Pharma, a rapid microbial screening system for Pharmaceutical manufacturing companies with midrange test volumes. The Celsis Accel borrows the robustness and ease-of-use of the large capacity Celsis Advance II , packaged into a compact system specifically designed for midrange test volumes. Both systems allow compliance with regulatory guidance’s and offer full data analysis, report generation and remote user access.

The Celsis Accel System for Pharma together with Celsis’ proprietary reagent technology, decreases time necessary for quality control assessment of microbial contamination. As a result, manufacturing cycle times are shortened, quarantined inventory awaiting release is reduced and working capital requirements are diminished. Faster quality control results also provide an earlier indication of contamination allowing a faster and more effective investigation and corrective action, thereby reducing the economic impact of the event.

Using its Financial Impact Assessment (FIA) , Celsis has worked with hundreds of manufacturing facilities around the world to evaluate the cost savings of implementing a Celsis system. Utilizing company specific information including the value of products and the time and cost comparisons associated with the Celsis method, the FIA projects the 5-year Net Present Value (NPV) of a company’s investment in the Celsis system. The 5-year NPV for a Pharmaceutical manufacturing facility with midrange test volumes is typically in excess of $500,000 with even greater value for larger volume facilities or rapid sterility applications.

Building on more than 20 years of experience, the robust Celsis Accel System for Pharma incorporates data security, remote data access and comprehensive data analysis tools into a compact system designed for Pharmaceutical manufacturing facilities with midrange testing volumes. Offering the fastest time to results of any ATP bioluminescence system on the market, Celsis has also expanded the kit configuration options for its proprietary Celsis AMPiScreen™ reagent technology to better match varying testing volumes and to optimize reagent utilization.

To read more about the new Celsis Accel System for Pharma online, please visit celsis.com/Pharma-Accel

“Testing requirements and regulatory oversight vary amongst the various industries served by Celsis. We saw the need for a smaller-scaled instrument platform that still provided the full system security, data analysis and reporting tools necessary for the pharmaceutical market,” said Jay LeCoque, CEO. “The Accel System for Pharma provides all the functionality of our high volume Advance II system but in a smaller throughput format.”

From reagent bottle access to sample loading, the ergonomic design of the Celsis Accel system for Pharma puts everything easily at the fingertips of the user. In designing the system, Celsis adapted the familiar sample tube platform of the large capacity Celsis Advance II to a precision movement carousel for easy loading and speedy processing with the ability to run 30 assays per hour. A fourth injector position gives the system flexibility to incorporate new reagent technologies as they are developed.

New software innovations keep multiple systems connected for remote data management and enhanced data security. Sample results can be exported to common file types used by LIM systems while system administration features, an event log and more allow users compliance with the FDA’s 21 CFR Part 11 and the EU’s Annex 11.

Celsis has a strong and continuously growing track record of successful worldwide implementations and approvals. Regulatory support includes multiple Drug Master Files (DMFs) and Technical Reports to reduce validation burden and help simplify the process. Partnering with international cGMP laboratories, Celsis also offers unparalleled support for companies looking to outsource validation resources.

Proven rugged and reliable systems, plus dedicated global support, have made Celsis the industry standard for leading manufacturers around the world. Celsis systems are used to rapidly and effectively screen a variety of Pharmaceutical products — including tablets and ointments, IV solutions and oral drug suspensions — helping companies save time and money while releasing safe products to market.

To read more about the new Celsis Accel System for Pharma online, please visit celsis.com/Pharma-Accel

For more information about Celsis products and services for the Pharmaceutical industry including our full range of instrument options, please visit www.celsis.com/technical-center/pharmaceutical-solutions or call +1 312 476 1282.

Contact:

Media
Celsis, Inc.
Liz Garvey, +1-312-476-1218
lgarvey@celsis.com

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