Closure Moisture Analyzer (CMA)
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The Closure Moisture Analyzer (CMA) is Phase Technologies'
unique system for determining the effects of absorbed moisture on elastomer
closures by rapidly (about 1 sec.) and non-destructively measuring its
dielectric properties*. A change in the dielectric properties will be related
to a change in the moisture content of the closure. No more wasted time waiting
for a closure to dry (Loss on Drying) or the need to cut closures into many
pieces (Karl Fischer Analysis). Now you can perform non-destructive statistical
measurements (Tutorial on CMA Statistical
Measurements) on as many closures as you wish on a real time basis.
* US Patent 7,205,779.
Free Interactive Demonstration Disk CD
In order to demonstrate the capabilities of the CMA we have created a CD
that will allow you to see for yourself just how his instrument works. The CMA
will come supplied with a high quality touch screen monitor. This CD will
simulate the touch screen features by allowing you to use your mouse instead of
your finger. You can go through the operations for new test data or could
continue testing of a previous run using real test data. We have simulated the
operation of the instrument not the data being used. In addition, you can see
how easy it is to compare previous runs to ascertain the effect of steam
sterilization or drying. If you have ever done a frequency distribution using
Excel you will appreciate the CMA's real time plotting feature. You will be
able to see how the arithmetic mean and standard deviation will change as more
and more data is displayed. To obtain a free Interactive Demonstration Disk CD
just complete the simple Order Form for Free CMA
Demonstration CD
Description and Application CMA
Basic theory up which the operation of the instrument is based.
Sources of absobed moisture in closures
Effect of closure moisture on the stability of lyophilized products
Frequency distribution of the dielectric properties of the closures
How to use the CMA to develop and validate the drying process for
closures
CMA Performance Specifications and Frequently Asked
Questions
CMA
Performance Specifications The document is in a .pdf format and will open
up in Adobe Acrobat, if installed.
Answers
The CMA is supplied to measure closures having diameters of either 13 mm, 20 mm or 48 mm closures,
however, the instrument can be supplied to accommodate any other size closure.
The performance of the CMA is not affected by any
of the closure manufacturers.
The CMA will NOT give you the percentage moisture in the
closure. The reason for this are two fold:
1. In order to determine the percent moisture one would need to need to know
the mass of the closure. One cannot ascertain the mass of the closure from a
measure of the dielectric properties.
2. Because there is a frequency distribution of the mass of the closures and,
as a result, there will be a frequency distribution of dielectric properties
even if the moisture content of the closures were zero.
As a result of the above, there is no standard reference closure against which
one use to ascertain the moisture in the closure directly from either
dielectric, Karl Fischer or LOD measurements. Therefore, the use of the term
percent moisture in a closure is really a meaningless term. In other words
knowing the percent moisture does not mean you know the moisture content in
each closure.
Yes, the CMA can be used in a clean room environment.
Please let us know if this one of your requirements so we can make special
arrangements prior to shipping of the instrument to you.
The dielectric constant for
elastomer closures will generally range from 2 - 3.
Since the dielectric constant for water is 78.5, the observed change in the
dielectric properties of the closure will be more sensitive to changes in the
moisture content than any variation in the composition of the closure.
The actual measurement of the dielectric
properties of the closures takes but about 1 sec. The time to open and closure
the door will require between 1-2 sec. Allowing about 4 sec. to replace the
closure with a new closure, the total time of the measurement can be a mere 6
sec. or 10 closures a minute. The estimated time to measure 1,000 closures
would be less than 2 hours or about the same time that would be required to cut
up a single closure and measure the moisture content by the Karl Fischer
method.
One of the key features of the CMA is that it gives the
operator great flexibility to set both upper and lower limits of the dielectric
properties for the histogram. As a result closures having a select range of
dielectric properties can be sorted from the a given lot (e.g. bag) of
closures. One can then determine the effect that these closures will have on
the stability of a lyophilized product. Such results enable management to make
a rational decision on whether to extend the drying process or simply prevent
those closures from being used in the manufacture of a lyophilized product. The
ability of management to make such a rational decision is a basic tenant of the
PAT Guidelines.
All test data regarding the dielectric properties of the
will not be stored on the CMA. The test data will we stored on a USB device
which is located on the front of the instrument. However, diagnostic data
concerning the performance of the CMA will be stored and the operator will be
advised when the instrument should be returned for service.
The touch screen has a Lock-Out feature that will
prevent the operation of the CMA by any personnel not having a valid Username
and password. During the lock-out, the door to the instrument will remain in a
closed position.
Prior to the start and at the end of each test of
measuring the dielectric properties of a sample lot of closures, the CMA will
go through a diagnostic test to ensure the instrument is functioning within
specifications. The results of such a diagnostic test will be recorded in the
tabular data.
Although the CMA performs a series of complex
operations during each test, the actual operation of the instrument does not
not require highly trained personal that are often required for other test
methods. The user friendly software makes operation simple and easy to use. A
built-in help screen is always available should any assistance be needed.
The Phase technical staff is always available during
the normal or extended warranty period to assist users in the interpretation of
their data
If you have a question not covered by the above FAQ please let us know by
e-mail.
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