Micro PRO ™ Microbial Detection System
A D V A N C E D A N A LY T I C A L
Improving Process • Empowering Progress
MICRO PRO™ DETECTION SYSTEM
D E L I V E R I N G O N T H E P R O M I S E O F R A P I D M I C R O B I O L O G Y. . . >
Screen products for bacteria, yeast, and mold in a single assay with overnight results
>
Microbial monitoring of purified water in just 4 minutes… not days
>
Analyze surface swabs for microbial contamination and residual product
>
Accurately enumerate pure cultures; reduce laboratory labor
Key Benefits
Key Markets
> Versatile
The Micro PRO™ system’s analytical speed and sensitivity benefits manufacturers across many industries:
> Automated,
> Personal
system covering the many aspects of microbial testing (qualitative and quantitative modes of operation) high throughput processing (up to 20 samples/hour) with unattended analysis
> Reagents > Easy
stable at room temperature for 7 days
to use and maintain
• Media kit containing all necessary components • Intuitive, 21 CFR compliant software
care and cosmetics
> Over-the-counter
pharmaceuticals
> Pharmaceutical > Biopharmaceutical/biotechnology > Beverage
and nutraceuticals
• Preventive maintenance agreements available > Excellent
technical and validation support
A D V A N C E D A N A LY T I C A L
>
W W W. A A T I - U S . C O M
MICRO PRO™ DETECTION SYSTEM
> PRODUCT SCREENING
B A C T E R I A , Y E A S T, A N D M O L D D E T E C T I O N — O N E T E S T. . . O N E S O L U T I O N The Micro PRO™ system offers significant cost savings over traditional methods. Results are obtained the next day; not next week. > Release
inventory days sooner
> Maintain
lower inventory safety stock levels
> Identify
potential contamination issues earlier
> Reduce
“at risk” product levels
Screen for microbial contamination in – > Finished
products
> In-process > Raw
samples
materials
E F F I C I E N T O P E R A T I O N ; C L E A R A N D O B J E C T I V E R E S U LT S The proprietary Micro PRO™ Media Kit allows for streamlined sample preparation and analysis. The kit provides all of the tubes, substrate, and media required with an easy-to-follow protocol. Customized software provides straightforward operation and reporting of results in an objective pass/fail format. Any bacteria, yeast, and/or mold present are detected with a single assay. Results from the Micro PRO™ system directly correlate with traditional methods across a wide range of product types as shown below. Micro PRO™ Overnight Results vs. Agar Plates Dish Soap
Toothpaste
Shave Gel
MultiVitamin
Micro PRO™
+
+
+
+
Agar Plate
+
+
+
+
Micro PRO™
+
+
+
+
Agar Plate
+
+
+
+
Micro PRO™
+
+
+
+
Agar Plate
+
+
+
+
Micro PRO™
–
–
–
–
Results obtained using the Micro PRO™ versus agar plates for representative product types. Products were spiked with bacteria, yeast, or mold or not spiked to serve as negative controls.
Agar Plate
–
–
–
–
+ = positive result; – = negative result
BACTERIA
YEAST
MOLD
NEGATIVE CONTROL
A D V A N C E D A N A LY T I C A L
>
W W W. A A T I - U S . C O M
MICRO PRO™ DETECTION SYSTEM
> MICROBIAL MONITORING OF PROCES S/PURIFIED WATER
PURIFIED WATER MONITORING IN JUST 4 MINUTES... NOT DAYS Purified water is a primary ingredient in the manufacturing of pharmaceuticals, personal care products, and many other industrial products. The microbial content of that water must be monitored to ensure product quality. The Micro PRO™ system provides – > Direct
enumeration of viable microorganisms
> Quantitative > No
results in 4 minutes
enrichment required
> Micro
PRO™ results trend with traditional plate count method
As shown below, in every instance where the 10-day plate counts were below the 50 cfu/mL Alert Limit, corresponding Micro PRO™ results were obtained in just minutes. Purified Water Monitoring Results Micro PRO™ and R2A Plates Counts
Note: Two samples requiring a 10-day incubation to exceed the Alert Limit were successfully identified by the Micro PRO™— in a fraction of the time.
> S U R F A C E S W A B A N A LY S I S
S W A B , A N A LY Z E , A N D G O . . . N O T I N C U B A T E A N D W A I T An important quality component of manufacturing involves the cleaning and decontamination of surfaces and process equipment followed by subsequent testing using surface swabs. The Micro PRO™ system provides rapid results to keep production on schedule versus traditional methods that require 24 to 48 hours. > Obtain
quantitative results in 4 minutes — no waiting for microbial plate results
> Identify
potential contamination events quickly providing for immediate corrective action
> Reduce
costly equipment downtime after cleaning and decontamination
> Avoid
the premature placing of contaminated equipment into service
> Detect
residual product
A D V A N C E D A N A LY T I C A L
>
W W W. A A T I - U S . C O M
MICRO PRO™ DETECTION SYSTEM
> P U R E C U LT U R E E N U M E R A T I O N
A C C U R A T E LY E N U M E R A T E M I C R O O R G A N I S M S I N P U R E C U LT U R E S ; REDUCE LAB ORATORY LAB OR Microbiologists often need to accurately determine the concentration of microorganisms in a pure culture. Applications for this measurement include fermentation monitoring, spike studies for preservative challenge testing, and microbial growth studies. Traditional methods are laborious, time-consuming, and require multiple steps. The analytical capabilities and benefits of the Micro PRO™ system are – > Wide
dynamic range (101 to 106 cfu/mL)
> Serial
dilutions and plate counts are eliminated
> Accurate
counts per mL are provided in 4 minutes
> Excellent
correlation with traditional methods
Correlation of Micro PRO™ Counts vs. Plate Counts
This graph highlights the analytical capabilities of the Micro PRO™ system. Notably, accurate enumeration was achieved for Mycoplasma bovis, an organism with a cell size down to 0.1 µm as well as for Candida albicans, a yeast with a cell size up to 20 µm. Candida albicans Escherichia coli Mycoplasma bovis Salmonella typhimurium
(n (n (n (n
= = = =
14, 17, 15, 15,
R2 R2 R2 R2
= = = =
0.9982) 0.9959) 0.9891) 0.9952)
From a poster presented at the 2006 Society of Industrial Microbiology Annual Meeting.
The Micro PRO™ system has accurately enumerated the following: > Gram
positive and negative bacteria
> Yeasts
and molds
> Bacterial
and micro-aerophilic bacteria
> Spirochetes
and fungal spores
> Filamentous
> Anaerobic
bacteria and fungi
> Mycoplasmas > Parasite
cysts
> TECHNICAL SUPPORT SERVICES
FROM FEASIBILITY TO ROUTINE USE Advanced Analytical developed strong technical support to complement its innovative technology and to achieve long-term customer satisfaction. We offer – > Completed
feasibility studies with actual customer samples
> Experienced
industrial microbiologists who conduct “hands-on” training and support
> Comprehensive > IQ
validation assistance with a broad range of services
and OQ testing at installation
> Documentation
templates for validation and Standard Operating Procedures
A D V A N C E D A N A LY T I C A L
>
W W W. A A T I - U S . C O M
MICRO PRO™ DETECTION SYSTEM
> MICRO PRO™ INSTRUMENT AND TEST KITS
MP-4000-V1
Micro PRO™ Instrument
MP-4000-70
Micro PRO™ Reagent Kit for 400 Tests
MP-4000-71
Micro PRO™ Media Kit for 50 Tests
RBD-3000-50
FASTEST Total Viable Organisms (TVO) Kit for 800 Tests
> MICRO PRO™ SYSTEM TECHNICAL SPECIFICATIONS
Maximum Sample Throughput:
20 samples/hour
Dynamic Range:
10 1 to 10 6 cfu/mL
Cell Size:
0.1 µm and larger
Electrical:
100–200 VAC, 2A, 60Hz or 200–240 VAC, 0.75A, 50 Hz ETL and CE Certified Battery back-up/UPS system with surge protection required
Instrument Dimensions:
64 cm H x 90 cm W x 57 cm D (25.6 x 36 x 22.8 in)
Instrument Weight:
104 kg (230 lbs)
Water:
Purified (RO, distilled or de-ionized) water
Air:
0.5 MPa (75 psi) or greater dry, instrument-grade compressed air
Software:
Proprietary Micro PRO™ software 21 CFR Part 11 compliant
Data Export Format:
Microsoft® Excel spreadsheet
Environmental Conditions:
Indoor use, normal laboratory environment
Recommended External Temp:
15.5º–26.7º C (60º to 80º F)
Relative Humidity Range:
35% to 80% (no condensation)
Advanced Analytical Technologies, Inc. 2901 South Loop Drive, Suite 3300 Ames, IA 50010 USA Phone: +1-515-296-6600 Fax: +1-515-296-6789 E-mail:
[email protected] www.aati-us.com
Copyright © 2007 Advanced Analytical Technologies, Inc. All Rights Reserved. Reproduction, adaptation or translation without prior written permission is prohibited, except as allowed under copyright laws. Micro PRO™ is a trademark of Advanced Analytical Technologies, Inc. Published September 2007 Pub Lit# Micro-7001.
