PAT Closure Drying Ovens
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These ovens are specifically designed for
PAT drying of closures in bags prior
to their being use as seals for lyophilized or freeze dried products. This new
oven design, equipped with its own analytical technology, is used in
combination with the Closure Moisture Analyzer (CMA).
Such a combination can provide a means by which the number of defective
closures in the bags approaches six sigma. That means that the number of
defective closures having a moisture content that can affect the stability of
lyophilized product at its defined range of storage temperatures will only 3.4
closures per million closures dried. In order to accomplish this the oven must
closures in which amount of outgassing
of moisture from the closures will not have an adverse affect on the
product over its entire shelf life. The latter can only be accomplished if the
oven has a built in analytical system that will ensure the closures in the bags
are properly dried before they are removed from the oven
Clean Room Compatible Ovens
These ovens are specially designed to operate completely in any Class 100
or Class B environment and occupy a very little clean room floor space. Once
the utilities are connected to the oven it is ready to be used so there is
NO need to make any major alternations to the clean room. As a result
you need not remove your current ineffective pass through drying oven to make
room for the PAT Closure Drying Oven.
To obtain a general description on the construction of the Ovens, their
technical specifications and their compatibility to operate effectively and
safely in a Class 100 or Class B environment just click on
PAT
Closure Drying Ovens. The document will open up in Adobe Acrobat, if
installed.
If you have a question that is not covered by the above, please send them
to this e-mail address.
Answers
The oven is designed to fit through a standard 32 inch
(813 mm) door way.
The CMA provides a rapid and nondestructive means for
providing the frequency distribution of the effect that the moisture will have
on the dielectric properties of the closures. For a given drying processes an
entire bag of closures can be examined and those closures with higher moisture
can be checked to determine if they are dry enough that they will not affect
the stability of the lyophilized product. If the drying processes is found to
be adequate, one can determine from the statistical CMA data the chances that
the number of defective closures (excessive moisture) dried in the oven will
meet the six sigma criteria.
Phase will provide a drying process for the closures.
However, it shall be the responsibility of the end user of the oven to validate
the drying process on their lyophilized or freeze dried product based using the
CMA statistical data.
There is a safety feature built into the design of the
oven. The outer door will automatically lock when the temperature of oven is
equal to or greater than 50 oC. and automatically unlock when the
oven temperature is lower than 50 oC. Such a feature will prevent
the operator from being accidently burned by a hot metal surface.
Special tests will be build into the drying protocol to
ensure that not only all the closures are sufficiently dried but also that over
drying of the closures does not take place should that be a problem for the
stability of the lyophilized product.
The data will be displayed on a monitor and, if desired
as a hard copy from a printer. The complete data from the drying process will
be stored on a USB device in a graphic (gif or jpeg) and tabular (pdf) formats.
No process data will be stored in the dryer; however, the computer will alert
the operator when it is necessary to perform any scheduled maintenance on the
dryer.
The oven is equipped with moisture and temperature sensors to continuously monitor the entire drying process to
ensure that the moisture content of the closures throughout each of the bags is
within a defined limits as defined by the CMA.
The oven comes equipped with two levels of alarms.
There is a set of alarms to alert the operator that the drying process is not
within defined specifications. The second set of alarms will indicate when
indicate when a key operating component of the oven requires replacement or
servicing.
The oven will occupy a space 32 inches wide (813 mm)
and 52 inches (1320 mm) long for a floor area of 1664 in2 (1.07
m2).
Since there will be a frequency distribution of
moisture in the closures (see Managing the Risk of Residual
Moisture...)), at a given temperature and partial pressure of water vapor
in the bag the rate of outgassing
will vary and therefore so will the drying rate of the closures until the
rate of outgassing of the closures approaches zero.
The oven is constructed in such a manner that it
can be easily disassembled by an operator and sanitized prior to being put into
service. The oven is designed with the user in mind.
If you have a question not covered by the above FAQ please let us know by
e-mail.