The

System

Simplified, Rapid,
Automated Microbiology
Add Value and Efficiency
to Your Company

FDA Regulation and Need for Testing

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.

Three Elements of The BioLumix System

BioLumix instrument in which

Windows- based software

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
18-65C. 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.

with built in compliance. The application

shows assay results as soon as detections
occur, with no need for operator involvement. 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

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-ofthe-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.

equipment line issues.

Contact Neogen today

800/234-5333 517/372-9200

Quality Assurance
with a Competitive Advantage
The BioLumix System Saves Time and Money and Allows Greater Productivity
The BioLumix System

The BioLumix System Advantage

is designed to accelerate product release with a simplified,

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 finished products.

The developed method is streamlined and allows

for easy compliance with cGMP.

Simplified testing procedures - can be operated by

non 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 Certificate of Analysis within 48 hours
including 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 testing

Assays
Multiple microbiological assays have been developed specifically for
the Nutraceutical and Dietary Supplement Market including:
Total Aerobic Microbial Count
Total Combined Mold and
Yeast Count
Enterobacterial Count (Bile-Tolerant
Gram Negative Bacteria)
Coliform

E. coli
Pseudomonas aeruginosa
Staphylococcus aureus
Salmonella
Probiotic

No 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 specifically designed to meet
this challenge.

The 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.

For additional information regarding the BioLumix System, please contact us:
620 Lesher Place Lansing, MI 48912 USA
800/234-5333 (USA) 517/372-9200 Fax: 517/372-2006
foodsafety@neogen.com www.mybiolumix.com
Neogen Corporation, 2014. Neogen and BioLumix are registered trademarks of Neogen Corporation, Lansing, MI 48912 USA.

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