Home » Pall Launches New Rapid Microbiology System
Pall Launches New Rapid Microbiology System
Pall Corp., a global leader in filtration, separation and purification, today announced the introduction of the GeneDisc Rapid Microbiology System for advanced microbial quality monitoring. This system represents Pall’s latest quality assurance innovation for the pharmaceutical manufacturing industry.
“The GeneDisc Rapid Microbiology System represents a leap forward for applications of rapid microbiological analysis in the pharmaceutical manufacturing setting,” says Ken Frank, President of Pall Life Sciences Biopharmaceuticals division. “This reliable, simple to use, and robust platform represents a significant time savings over traditional incubation sampling methods and can allow materials and final products to be released more quickly, improving production efficiency and reducing inventories.”
Typical culture-based methods may need at least five days to produce results. Pall’s GeneDisc System generates comparable results for most microbiological applications in just a few hours. The advantage provided by the GeneDisc System shortens the manufacturing cycle for pharmaceutical manufacturers, reducing warehousing costs, improving product time to market, and increasing ROI throughout the production process. The GeneDisc Rapid Microbiology System represents Pall’s first step in providing a complete qPCR platform for rapid microbiology analysis.
The GeneDisc Rapid Microbiology System is efficient and easy to use. Its novel, highly simplified technology, based on bar-coded data input and fewer operator-dependent steps, ensures reliable results that significantly reduce the risk of user error. The economic design of the GeneDisc System also offers the unique advantage of moving assays to an operator with relatively modest training, freeing up technically skilled staff for more demanding duties.
This new application in Pall’s GeneDisc product group is based on established quantitative polymerase chain reaction (qPCR) technology, which provides a simple, rapid tool for microbiological analysis. This single-protocol solution yields highly reproducible results with simplicity, speed and security, enabling quality control testing to be executed on a much shorter timetable than by using traditional methods.
The first of these assays is a Specified Microorganism Test, which simultaneously detects indicator pathogens as required by Pharmacopeia. Results are obtained within hours and not the several days required by traditional microbiology methods. Additional assays are planned that will further expand the GeneDisc System to perform accelerated microbiological testing during various stages of pharmaceutical and biotech production.
By improving internal quality assurance methods, Pall’s GeneDisc System also adds an increased level of security to the pharmaceutical manufacturing process.
“Typical methods of sample analysis often require three to five days to detect contamination,” says Dr. Peter Ball, Technical Marketing Director for Pall Life Sciences. “That can mean scrapped or reworked product, which represents considerable risk and cost. With the GeneDisc System, we can reliably eliminate those production risks in just a few hours,” Ball says.
Amelia G. Tait-Kamradt, a Scientist at Pfizer, Inc., will present, “Using a Novel qPCR Platform to Accelerate Pharmaceutical Microbiology Testing,” a whitepaper highlighting the advantages of the GeneDisc System at the Parenteral Drug Association’s 5th Annual Global Conference on Pharmaceutical Microbiology, October 26, in Washington, D.C. For more information on the GeneDisc Rapid Microbiology System or any of the other Pall Corporation life sciences solutions, visit www.pall.com/biopharm.
Merck Stops Development of Parkinsonís DrugFrom Bloomberg
Merck & Co. will end development of preladenant because a preliminary review of late-stage clinical trials suggests it doesnít work
French Drugmaker on Trial for Suspected DeathsFrom Yahoo! News
Servier Laboratories, French drugmaker responsible for producing diabetes and weight loss drug Mediator, faces charges for deception in relation to the suspected deaths of hundreds of people.
Novo Acquires Xellia Pharmaceuticals for $700 MillionFrom PharmaTimes Online
Novo A/S has acquired Xellia Pharmaceuticals of Norway
Royalty Increases Bid as Elan Unveils AcquisitionsFrom PharmaTimes Online
Royalty Pharma has resurfaced to raise its bid to acquire the Irish drugmaker Elan
New Asthma Drug Offers Hope for PatientsFrom Forbes
An experimental asthma drug could give new hope to patients for whom existing medicines are not enough
Syrian Pharma Production Nearly Halted by WarFrom AFP
A shortage of foreign currency has brought production to a near halt in Syria
Camfil APC Opens Manufacturing Plant in the UKFrom Camfil
Camfil announced the grand opening of its new 40,000-sq.-ft. facility
Actavis Acquiring Warner Chilcott for $8.5BFrom AP
Actavis to buy Warner Chilcott in an all-stock transaction
Northwest Analytics Launches Next Generation Enterprise Manufacturing Intelligence SolutionFrom Northwest Analytics
NWA Focus EMI Delivers Real Time Process Intelligence and Unique Accelerating Modules - a Shared Knowledge Base and Manufacturing-Centric Collaboration
Innovative Clinical Development Partnership Announced By Quintiles and Merck SeronoFrom MarketWatch.com
Agreement creates unique strategic collaboration for development and clinical trial execution
- All news »