Rapid sterility testing system is an automated solution for the rapid detection, response, and resolution of microbial contamination in filterable samples throughout the manufacturing process. Accurate, rapid sterility testing is not only critical for patient safety it also makes great sense for the compounders and other pharmaceutical manufacturers.

1. 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
Kkohan@gibraltarlabsinc.com
www.gibraltarlabsinc.com
Facebook.com/GBLinc
Twitter.com/GBLinc

12. THANK YOU!
Proprietary and Confidential © Gibraltar Laboratories, Inc.
www.gibraltarlabsinc.com / (973) 227-6882