Fluid
Jet Mill MC ONE® Laboratory R&D Unit
This, the smallest R&D mill offered by the JETPHARMA GROUP,
is able to micronize and produce scalable Particle Size Distributions
(PSD) from extremely small batches/samples of 0.2-0.3 grams up
to 50-100 grams. For the typical sample of batch size of new molecules,
this value is extremely important.
A significant example of yield performance micronizing lactose
is:
 Quantity
of product fed 0.3 grams;
Quantity
of product micronized 0.22 grams.
This kind of Jet Mill is applicable over the whole drug’s
life cycle from clinical development to product launch and/or
discontinuation.
The MCONE® is able to test each compound, as well as offering
other value-added benefits such as the Adis Rating of Therapeutic
Value, the chemical structure, product compounds, pharmacokinetics,
pharmacodynamics, drug interactions, and mechanism of action in
order to focalise the product bioavailability.
Simplicity of design also means that assembly and the disassembly
of the whole unit can now be accomplished without tools, while
the whole working area can quickly be emptied and cleaned for
validation and cleaning validation purposes, which minimises the
likelihood of cross-contamination.
There are three main configurations:
STANDARD
VERSION
Assembled on a portable skid utilizing a pneumatic manifold
to control the process gas parameter.
ENCLOSED IN LAMINAR FLOW BOOTH
Proves a high level of operator safety.
ENCLOSED
IN GLOVE BOX
At NEGATIVE PRESSURE offering the highest level of protection
from toxic products; or at POSITIVE PRESSURE, to protect the product
from external contaminants (typical for sterile applications).
The MCONE® is based on jet mill technology optimised from the
daily use (from over 40 years) in its micronization sites (in Switzerland
and in Italy – both regularly FDA inspected and ISO 9001 certified).
CONTRACT MICRONIZATION SERVICE
This service is for highly potent active pharmaceutical ingredients
and uses the new JETPHARMA Glove Box Isolator.
The technology used for the new JETPHARMA GLOVE BOX ISOLATOR
comes from the nuclear industry and it has been studied to optimise
operator safety from the two primary means of exposure: namely
inhalation during the work process, and secondly, but potentially
more likely, inhalation during the disassembling and cleaning
phases of the equipment between trials.
To combat these shortcomings, JETPHARMA GLOVE BOX ISOLATOR can
operate at a constant negative pressure. The airflow from exterior
to interior is regulated to create the constant negative pressure
within the range of 5-25 mmH2OC in the working area, and small
DP of a few mmH2OC to create an airlock in the transfer area.
Horizontal and vertical currents draw any released particles
within the working area to the filtration unit comprised of pre-filtration
and absolute (HEPA) filters. Once filtered, the air is partially
recycled to the working area, with make-up air supplied externally
to avoid build-up of impurities and/or humidity. All components
in contact with the product can be washed inside the isolator.
It is possible to work, depending upon the requirements to protect
the operator from the product, or to protect the product from
the external contamination. To protect the product from contaminates,
the JETPHARMA GLOVE BOX ISOLATOR can work at positive pressure
to maintain a class 100 working environment for sterile applications.
This new contract micronization service with the new JETPHARMA
GLOVE BOX ISOLATOR has been developed to satisfy the increasing
needs of the global pharmaceutical market. |