Are cGMP Regulations driving up your Costs? Find out how to reduce your Microbiological testing Costs

For answers Visit BioLumix at booth 21017 @ SupplySide West 2011 in Las Vegas

Since the completion of implementation of the cGMP’s for Nutraceutical Companies, all manufacturers must test their products for microbiology quality assurance and generate a certificate of analysis for each batch.  The products need to be tested in accordance with the methods described in USP <2021> and <2022>. Products need to be tested for Total Aerobic Microbial Count, Total Combined Mold and Yeast, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organism such as Salmonella, E. coli, and sometimes S. aureus).  The state of the art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP. The System is designed to accelerate product release with a simplified, automated approach. This yields fast, accurate, real-time results while reducing costs.  No more waiting days for completed assays. 

The streamlined all-in-one system is capable of testing raw materials, finished product, environmental swabs and processing water, all on a single platform.  Additionally, the system offers simplified sample preparation, real-time communication and a complete automated Certificate of Analysis, including the completion of all assays in 48 hours.   Dealing with difficult to read plates or manual data transfer is a thing of the past. With automated monitoring of ready-to-use assay vials and automated data processing and archiving (paperless), the microbiologist‘s job got a lot easier with the same accurate results in less than half the time.  Real-time data communication: Early warning of contaminated samples as well as sample release information could be automatically communicated through your intranet, significantly improving your company’s efficiencies.  BioLumix system can be used to test powders, oils, enzymes, botanical material, tablets, capsules, powders and liquids easily and without product interference.

BioLumix trainers will provide each customer with a full and customized Validation book, during the two and a half days of on-site training and installation of the system, including installation qualification, Operation Qualification and Performance qualification.  A sample Validation book will be available for viewing while visiting the BioLumix booth during SupplySide West 2011.

With this internal automated microbiological system, customers have control over their testing, leading to accurate results and accelerated product release while reducing costs.  The BioLumix Advantage: 

-          All assays can be performed on one Automated Microbial testing system

-          Automated Certificate of Analysis within 48 hours including results of all assays

-          Can be operated by non-Microbiologist

-          Complies with FDA cGMP Regulations

-          System is fully Validated during system installation

-          Designed to accelerate product release

-          Fully automated data archiving

You can find BioLumix on social media pages Linked In, Twitter and Facebook.  Follow us, become a Fan or join a discussion on one of our pages.

October 2011 marks the 5th year of BioLumix to exhibit at SupplySide West in Las Vegas, NV.  This yearly convention is held at the Sands Expo Center in The Venetian Hotel & Casino.  The Exhibit show hall will open beginning Wednesday, October 12th from 10am – 5:30pm, and Thursday, October 13th from 10am – 5pm.  BioLumix will be exhibiting in booth #21017.  Be sure to stop by booth #21017 to inquire about our free product trial and current Show Special! Pick up literature or leave your contact information to find out more about how the system can help your company save.

Leave a Reply

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>