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Rapid Sterility Testing Solutions
Dr. Daniel Prince
Proprietary and Confidential © Gibraltar Laboratories, Inc.
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MEETING AGENDA Rapid Sterility Testing Solutions
• Principle of Rapid Sterility Testing
• Benefits
• Applications
• Rapid Sterilty Test v/s Steritest
• Question and Answers
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Principle- ATP Bioluminscence Technology
ATP+ D-luciferin + Oxygen (O2)
ATP Molecule AMP + PPi + Oxyluciferin + CO2 Photuris lucicrescens
LIGHT
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Benefits Better process control
Increased confidence in product quality
Reduced risk of product contamination
improved operation efficiency Reduce manufacturing
cycle time
Faster release of water, raw materials, in-process
samples, and final products
Faster detection of process problems
Earlier implementation of corrective actions
Faster resolution of problems
Reduced storage cost
Increase capacity/yields
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Milliflex® Rapid Sterility System
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Fast, reproducible test results in three steps:
Step 1: Sample Prep
• Filter the desired sample volume through
presterilized, disposable Milliflex® filter units.
• Filter a rinse solution to wash away any growth
inhibitors (if necessary).
• Place filter base onto a media cassette and
incubate
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Fast, reproducible test results in three steps:
Step 2: Apply Reagents
• Release filter base from the Milliflex®
prefilled media cassette and place filter
unit on the Milliflex® AutoSpray Station
for application of reagents.
• Reagents are automatically sprayed
across the membrane in quick
succession.
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Fast, reproducible test results in three steps:
Step 3: Enumerate Microorganisms
• Transfer the filter unit to the Milliflex®
Rapid Detection Tower for enumeration of
colonies.
• From the PC, enter information about the
sample and click the Run Test button to
enumerate the micro colonies.
• The colony count in CFUs and an image of
the filter/organisms are automatically
recorded, displayed, and archived.
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Applications of Milliflex® Rapid Sterilty System Raw Materials
Water Media preparations
In-Process Bioburden
Intermediate products Bioburden prior to sterilization
Final Product Bioburden
Sterile preparations Non-sterile preparations
Environmental Monitoring Liquid samples Final Product Sterility
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Steritest vs. Milliflex Rapid for Sterility Testing
STERITEST
Compendial method EP/USP
Closed device
Test in liquid medium (2 media)
Incubation: 14 days
Reading: visual turbidity
observation
Result: qualitative (turbidity)
MILLIFLEX RAPID
Alternative method
Device not closed
Test on solid agar medium
(Schaedler Blood Agar)
Incubation: target = 5 days
Reading: Visual or Milliflex Rapid system
Result: quantitative (CFU)
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CONTACT US Gibraltar Laboratories is conveniently located
GIBRALTAR
LABORATORIES
122 Fairfield Road
16 Montesano Road (Shipping/Receiving)
Fairfield, New Jersey 07004
(973) 227-6882
www.gibraltarlabsinc.com
Facebook.com/GBLinc
Twitter.com/GBLinc
THANK YOU!
Proprietary and Confidential © Gibraltar Laboratories, Inc.
www.gibraltarlabsinc.com / (973) 227-6882
