BioLumix Nutraceutical Info
2
FDA Regulation and Need for Testing The System Simplified, Rapid, Automated Microbiology Add Value and Efficiency to Your Company Three Elements of The BioLumix System BioLumix instrument in which test vials are incubated and the assays are monitored. Each instrument is capable of simultaneously running 32 test vials at one temperature with an operating range of 18-65°C. The modular structure of the BioLumix System enables flexible growth as needed; up to 1,024 samples can be tested simultaneously with up to 32 instruments connected to a single PC. There is random access to all instrument vial positions at any time. Therefore, no batching is required. Test vials containing growth media and indicators. Samples are introduced to the disposable vials directly, eliminating the need for decimal dilutions. The BioLumix system is the most versatile method for the detection of microorganisms. Based upon state-of- the-art knowledge of the microbial metabolic process, the ready-to-use vials are designed to rapidly detect color or fluorescent change as a result of metabolic activity in a liquid medium. The vials come with a Certificate of Analysis and can be stored at room temperature. A single organism can be detected in a vial. Windows ® - based software with built in compliance. The application shows assay results as soon as detections occur, with no need for operator involve- ment. Any out-of-spec samples are flagged in red, demanding attention. The greater the contamination level, the faster the result; ensuring rapid corrective action. The software contains an audit trail to comply with 21 CFR Part 11. The software contains an audit trail and full data management system. The greater the contamination level, the faster the result, ensuring rapid warning of poor-quality raw material, finished product or any equipment line issues. Contact Neogen today 800/234-5333 • 517/372-9200 Dietary supplement cGMPs require that all manufacturers take steps to ensure that products are free of microbial contamination. Neogen offers innovative microbiological testing solutions designed specifically for the Nutraceutical and Dietary Supplement industries. The BioLumix System can help internalize microbiological testing or make the existing microbial testing simpler, faster, and automated – saving your company significant time, labor and money. We offer a comprehensive range of microbiological tests for raw materials, in-process and finished products as well as processing water and environmental testing. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference. The software offers an Automated Certificate of Analysis within 48 hours.
description
Microbiology Instrumentation for nutritional supplements
Transcript of BioLumix Nutraceutical Info
FDA Regulation and Need for TestingTheSystemSimplied, Rapid,Automated MicrobiologyAdd Value and Efciencyto Your CompanyThree Elements of The BioLumix SystemBioLumix instrument in which test vials are incubated and the assays aremonitored. Each instrument is capable of simultaneously running 32 test vials at one temperature with an operating range of18-65C. The modular structure of theBioLumix System enables exible growth as needed; up to 1,024 samples can be tested simultaneously with up to 32 instruments connected to a single PC. There is random access to all instrument vial positions atany time. Therefore, no batching is required.Test vials containing growth media and indicators. Samples are introduced to the disposable vials directly, eliminating the need for decimal dilutions. The BioLumix system is the most versatile method for the detection of microorganisms. Based upon state-of-the-art knowledge of the microbial metabolic process, the ready-to-use vials are designed to rapidly detect color or uorescent change as a result of metabolic activity in a liquid medium. The vials come with a Certicate of Analysis and can be stored at room temperature. A single organism can be detected in a vial.Windows- based software with built in compliance. The application shows assay results as soon as detections occur, with no need for operator involve-ment.Any out-of-spec samples are agged in red, demanding attention. The greater the contamination level, the faster the result; ensuring rapid corrective action. The software contains an audit trail to comply with 21 CFR Part 11.The software contains an audit trail and full data management system. The greater the contamination level, the faster the result, ensuring rapid warning of poor-quality raw material, nished product or any equipment line issues.Contact Neogen today800/234-5333 517/372-9200Dietary supplement cGMPs require that all manufacturers take steps to ensure that products are free ofmicrobial contamination. Neogen offers innovative microbiological testing solutions designed specically for the Nutraceutical and Dietary Supplement industries. The BioLumix System can help internalize microbiological testing or make the existing microbial testing simpler, faster, and automated saving your company signicant time, labor and money.We offer a comprehensive range of microbiological tests for raw materials, in-process and nished products as well as processing water and environmental testing. The system can analyze tablets, capsules, powder,liquid and viscous material without any product interference. The software offers an Automated Certicate of Analysis within 48 hours.The BioLumix Systemis designed to accelerate product release with a simplied, automated approach. This yields fast, accurate results while reducing costs. No more waiting days for completed assays. The BioLumix System brings automated microbiological testing in house with most assay results achieved over night.It is simple enough to be operated by non-microbiologists, providing accurate data of raw materials, environmental samples, and nished products.The developed method is streamlined and allowsfor easy compliance with cGMP.The BioLumix System AdvantageSimplied testing procedures - can be operated bynon microbiologists Ready to use vials-shorter sample preparation Vial design prevents product interference Real-time communication for immediate action Early warning of contaminated samples An automated Certicate of Analysis within 48 hoursincluding all organisms required by USP Validation package against USP methodology including IQ, OQ and PQ Allows for cost effective internalization of microbiological assays 21 CFR part 11 compliant with audit trail and log in/ log out Centralized test data automatically stored and protected Cost reduction of microbiological assays Automation and connectivity faster product release Allows internalization of microbiological testingAssaysMultiple microbiological assays have been developed specically for the Nutraceutical and Dietary Supplement Market including: Total Aerobic Microbial Count Total Combined Mold andYeast Count Enterobacterial Count (Bile-Tolerant Gram Negative Bacteria) Coliform E. coli Pseudomonas aeruginosa Staphylococcus aureus Salmonella ProbioticNo ProductInterferenceThe vial design is separated into two zones: the incubation zone where the sample is present, and the detection zone where the readings take place.Therefore, the system prevents any product interference.Producers require faster and more cost effective methods of testing to remain competitive while meeting these new regulations.The BioLumix System has been specically designed to meetthis challenge.Quality Assurancewith a Competitive AdvantageThe BioLumix System Saves Time and Money and Allows Greater ProductivityFor additional information regarding the BioLumix System, please contact us:620 Lesher Place Lansing, MI 48912 USA800/234-5333 (USA) 517/372-9200 Fax: 517/[email protected] www.mybiolumix.comFD557-1214 Neogen Corporation, 2014. Neogen and BioLumix are registered trademarks of Neogen Corporation, Lansing, MI 48912 USA.
