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Simple and Direct
Microbial Detection
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Demonstrated BacT/ALERT 3D Performance
Upon customer validation BacT/ALERT 3D is anestablished Rapid
Microbial Method with uniquebenefits for sterility testing.Some
current applications include:
Eukaryotic Cell Culture
Viscous / High CFU products can easily be tested forsterility
since membrane filtration is not required.
Tissue Banks
Sterility testing can be conducted for soft tissueproducts where
irradiation is not an option.
Autologous Cell Therapy
Contaminated samples can be detected for shortshelf-life
products; within 24-72 hours*.
Regulatory Agencies and ProfessionalOrganizations enable the use
of BacT/ALERT 3Das an alternative to 14-day compendia methodsfor
sterility testing.
The United States and European Pharmacopoeiascontain chapters
that are specific for the use of Alternative Microbiological
Methods.
USP Validation of Alternative
MicrobiologicalMethods
EP 5.1.6Alternative Methods for
Control of MicrobiologicalQuality
EP 2.6.27Microbiological Control
of Cellular Products
BacT/ALERT® 3D if a fully automated,non-destructive,
FDA-cleared, rapidmicrobiology method (RMM) forin-process quality
control that eliminatesthe need for lengthy compendia
methods.
Faster detection of contaminatedproduct with BacT/ALERT 3D
reducescost and the chance for further productor environmental
contamination.
The only choice you will never regret
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FDA Chapter 21 CFR 610.9
“Equivalent Methods andProcesses” covers the
modification of compendialtechniques with
AlternativeMicrobiological Methods
FDA Guidancefor Industry :
Validation of Growth-BasedRapid MicrobiologicalMethods for
Sterility
Testing of Cellular and
Gene Therapy Products
PDA Technical Report #33contains a section “Growth
Based Methods” that specificallyexplains the Colorimetric
Detection of CO2 which is thetechnology utilized in
BacT/ALERT 3D
The use of BacT/ALERT 3D
as an in-process qualitycontrol also supports the
Process AnalyticalTechnology (PAT)
initiative from the FDA
Users considering the BacT/ALERT 3Dsystem and culture bottles
for releaseof medical products, including humanbiological
substances, should firstconsult their appropriate regulatoryagency
for requirements.
* Kielpinski, G. et al. Roadmap to approval: use of an
automated sterility test method as a lot release testfor
Carticel, autologous cultured
chondrocytes.Cytotherapy 2005;7(6):531-541
Benefits provided by BacT/ALERT® 3D include:
Continuous monitoring that ensures positivebottles are detected
immediately regardlessof date or time.
Detection of positive bottles doesn’t rely
upon manual interpretation of turbidity.
Subcultures may be taken directly from positivebottles; this
reduces sample manipulation.
Fully automated testing reduceshands-on time and labor
costs.
Plastic BacT/ALERT 3D bottles reduce the chancefor 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 CFRPart 11
compliance.
Device Master File (DMF) filed with the UnitedStates Food and
Drug Administration (FDA).
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bioMérieux Support
To assist in the validation of BacT/ALERT® 3D as an alternative
to 14-day compendia testing bioMérieuxprovides the BacT/ALERT 3D
Implementation Guide (BIG). The BIG document contains the
following:
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Validation Report
bioMérieux also has dedicated technical support that works
specifically with BacT/ALERT 3D forthe Industrial market. Our
scientists enable your use of BacT/ALERT 3D for sterility testing
by conductingfeasibility studies and providing protocol support
upon request. They also provide continuous productsupport for all
BacT/ALERT 3D Industry customers worldwide.
To learn more about BacT/ALERT 3D and all other bioMérieux
Industrial applications please
visit:http://www.biomerieux-industry.com
bioMérieux SA69280 Marcy l’EtoileFrance
Tel: (33) 04 78 87 20 00Fax: (33) 04 78 87 20 90
www.biomerieux.com www.biomerieux-industry.com
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