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Simple and Direct

Microbial Detection

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The only choice you will never regret

Demonstrated BacT/ALERT 3D Performance

BacT/ALERT 3D if a fully automated,
non-destructive, FDA-cleared, rapid
microbiology method (RMM) for
in-process quality control that eliminates
the need for lengthy compendia
methods.
Faster detection of contaminated
product with BacT/ALERT 3D reduces
cost and the chance for further product
or environmental contamination.

Upon customer validation BacT/ALERT 3D is an

established Rapid Microbial Method with unique
benefits for sterility testing.
Some current applications include:
Eukaryotic Cell Culture
Viscous / High CFU products can easily be tested for
sterility since membrane filtration is not required.
Tissue Banks
Sterility testing can be conducted for soft tissue
products where irradiation is not an option.
Autologous Cell Therapy
Contaminated samples can be detected for short
shelf-life products; within 24-72 hours*.

Regulatory Agencies and Professional

Organizations enable the use of BacT/ALERT 3D
as an alternative to 14-day compendia methods
for sterility testing.
The United States and European Pharmacopoeias
contain chapters that are specific for the use of
Alternative Microbiological Methods.

EP 5.1.6
Alternative Methods for
Control of Microbiological
Quality

USP <1223>
Validation of
Alternative
Microbiological
Methods
EP 2.6.27
Microbiological Control
of Cellular Products

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Benefits provided by
BacT/ALERT 3D include:
Continuous monitoring that ensures positive
bottles are detected immediately regardless
of date or time.
Detection of positive bottles doesnt rely
upon manual interpretation of turbidity.
Subcultures may be taken directly from positive
bottles; this reduces sample manipulation.
Fully automated testing reduces
hands-on time and labor costs.
Plastic BacT/ALERT 3D bottles reduce the chance
for leakage or breakage.
Regulatory agencies have accepted BacT/ALERT
3D as an alternative to the compendia methods.
Contains all of the technical controls for 21 CFR
Part 11 compliance.

Users considering the BacT/ALERT 3D

system and culture bottles for release
of medical products, including human
biological substances, should first
consult their appropriate regulatory
agency for requirements.
* Kielpinski, G. et al. Roadmap to approval: use of an
automated sterility test method as a lot release test
for Carticel, autologous cultured chondrocytes.
Cytotherapy 2005;7(6):531-541

Device Master File (DMF) filed with the United

States Food and Drug Administration (FDA).

FDA Guidance
for Industry :
Validation of Growth-Based
Rapid Microbiological
Methods for Sterility
Testing of Cellular and
Gene Therapy Products

FDA Chapter
21 CFR 610.9
Equivalent Methods and
Processes covers the
modification of compendial
techniques with Alternative
Microbiological Methods

The use of BacT/ALERT 3D

as an in-process quality
control also supports the
Process Analytical
Technology (PAT)
initiative from the FDA
PDA Technical Report #33
contains a section Growth
Based Methods that specifically
explains the Colorimetric
Detection of CO2 which is the
technology utilized in
BacT/ALERT 3D

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01/2009 / 006US99162A / This document is not legally binding, bioMrieux reserves the right to modify specifications without notice / BIOMERIEUX, the blue logo
and BACT/ALERT 3D are used, pending and /or registered trademarks belonging to bioMrieux SA or one of its subsidiaries. Any other name or trademark is the property
of its respective owner / Printed in France / bioMrieux SA - RCS Lyon 673 620 399 / Layout and design: Actitudes RCS Lyon 394 805 113. actitudes.com

bioMrieux Support
To assist in the validation of BacT/ALERT 3D as an alternative to 14-day compendia testing bioMrieux
provides the BacT/ALERT 3D Implementation Guide (BIG). The BIG document contains the following:

Installation Qualification
Operational Qualification
Performance Qualification
Validation Report

bioMrieux also has dedicated technical support that works specifically with BacT/ALERT 3D for
the Industrial market. Our scientists enable your use of BacT/ALERT 3D for sterility testing by conducting
feasibility studies and providing protocol support upon request. They also provide continuous product
support for all BacT/ALERT 3D Industry customers worldwide.

To learn more about BacT/ALERT 3D and all other bioMrieux Industrial applications please visit:
http://www.biomerieux-industry.com

bioMrieux SA
69280 Marcy lEtoile
France
Tel: (33) 04 78 87 20 00
Fax: (33) 04 78 87 20 90
www.biomerieux.com
www.biomerieux-industry.com