Battelle REBS™: Production & Manufacturing

Battelle’s Rapid, Enumerated Bioidentification System (REBS), provides a rapid and flexible next-generation microbial detection, identification and enumeration capability for industrial microbiology and sterile operations. REBS non-destructively detects and identifies microbial contamination in the air, in raw materials, in-process fluids or finished products within minutes from a single test sample. It increases manufacturing productivity, reduces inventory expenses and generates working capital.

Capabilities

REBS rapidly and accurately detects, identifies and enumerates particulates and microbiological contaminants without the need for expensive reagents and other consumables. It permits secondary identification confirmation using the original test sample due to the fact that it is non-destructive.

REBS can be configured to identify environmental or liquid samples, providing a highly flexible contaminant microbial detection and identification platform. It has demonstrated identification performance with contaminants such as bacteria, fungus, molds, yeasts and endotoxins. REBS offers an integrated quality assurance solution for your operations.

Perform rapid detection, identification, and enumeration without the need to culture
Detect single microbiological contaminants with spectroscopic identification
Phenotypically identify contaminants by analyzing molecular bonding within materials
Provide compatibility with many viability stain protocols
Provide non-destructive results, enabling secondary identification confirmation
Deliver automated detection, identification, and enumeration results reporting
Mean time between failures ~ 10,000 hours

Get integrated biodetection and bioidentification in minutes.*
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Features

Hardware

Detects, identifies and enumerates in minutes
- Yeasts, fungi, gram-positive and gram-negative cells, spores, molds
- Determine objectionable limits within minutes, including chemical additives, composition and concentration
Single cell sensitivity
Non-destructive detection method permits secondary confirmation
Minimal sample preparation
- Staining for viability only
- No amplification of lysing
Sample traceability
- Open Database Connectivity (ODBC) and Laboratory Information Management System (LIMS) compatibility
Size
- Detection and identification engine: 46 cm × 46 cm × 61 cm (1.5’ × 1.5’ × 2’)
- Detection and identification engine weight: < 45 Kg (100 lbs.)

Software

Modular system with easily upgradable library for emerging contaminants
- Software validation
- Periodic library updates
- Facility-specific library expansion services
- Compliant to the requirements of 21 CFR Part 11

Extended Support

Technology validation services
Extended maintenance warranty and service contract
Leasing options available
Facility contamination tracking service
Facility risk assessment modeling
Complementary analytical methods development
In-line near real-time contamination control

Benefits

Increase efficiency and avoid costly recall events with fast integrated biodetection and bioidenitification.

Select particulate identity at biological, genus, species, and, in some cases, strain levels
Microbial identification library is easily upgraded for emerging contaminants
Identify contaminants within minutes and initiate mitigation within hours
Identify stressed or stained cells, including viable but non-culturable
Reduce product losses
Increase product surety without increasing labor costs
Low total-cost-of-ownership because consumables such as reagents are not required
Non-destructive detection allows secondary confirmation

REBS provides exceptionally low operating cost, high sensitivity and superior accuracy–-effectively increasing manufacturing productivity, reducing inventory expenses, and generating working capital.

*Demonstrated in laboratory tests with the top 10 microbes that caused product recalls over the last 10 years (L. Jimenez, “Microbial Diversity in Pharmaceutical Product Recalls and Environments,” PDA Journal of Pharmaceutical Science and Technology, Vol. 61, Issue 5, pp. 383–399 (2007).)

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