Laboratory Closure Drying Ovens
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During the development of a lyophilization process -
especially if the product cake mass is less than 100 mg - special care should
given to ensure that the closures used will not affect any stability testing of
the new lyophilized product. In the spirit of the new
PAT guidelines it is incumbent that those
developing the lyophilized product inform the production department as to the
required moisture distribution (see CMA) necessary to
ensure the stability of the manufactured product.
The Laboratory Closure Drying Oven is specifically designed for
drying of closures in bags or in trays prior to their being use
as seals for lyophilized or freeze dried products. The Laboratory Closure
Drying Oven is designed with just three shelves but is equipped with its own
analytical technology that is used in the
PAT Closure Drying Ovens. As a
result of this advanced analytical technology the drying time will be dependent
on the relative moisture in the closures rather than some arbitrary temperature
and time criteria.
Laboratory Compatible Ovens
These ovens are specially designed to operate in a laboratory environment
and will occupy a very little laboratory floor space. Once the utilities are
connected to the oven it is ready to be used so there is NO need to make
any other alternations to the laboratory. While the oven is designed
specifically for drying closures it can be use for drying other materials.
To obtain a general description on the construction of the Oven and their
technical specifications just click on
Laboratory
Closure Drying Oven. The document will open up in Adobe Acrobat, if
installed.
For a prompt quoation on how you can obtain a Laboratory Closure Drying
Oven please contact us.
If you have an additional question on the oven or wish a quotation, please
contact us.
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. For
more information on how to determine is the closures meet the six sigma
criteria please take the CMA Tutorial.
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.
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.