/ SuperJet -Bottom discharge
/ Isopak series
Isopak-2 is the typical machine for the production of 10-80
kgs batches of toxic or sterile APIs (Active Pharmaceutical
Ingredients) that features sophisticated, USDA-accepted design,
in line with Good Manufacturing Practice and the most demanding
pharma specifications worldwide.
The same machine is used for other applications, with argon
or nitrogen-inerted glove-boxes, to prevent the risk of oxidation
or explosion of highly reactive chemicals.
In production since 1991, SuperJet Isopak-2 has been continuously
improved with several, customised versions ( see I2DP,
I2MP3S ( Millenium), etc.).
The modular design allows customization and inter-changeability
of different components such as the product feeding system,
the microniser's components, the product collecting bin and
the process controls.
For all the versions, the process equipment are entirely located
in the safe, totally contained environment:
microniser with direct collection of the product from the
grinding chamber, without risk of fiber contamination. It
has a nozzle ring with optimized grinding angles, a horizontal
venturi feeding system that avoids metal contamination and
built-in, static classifying system that assures very narrow,
particle size distribution
Twin-shaft feeder, volumetric type, with concave-profile,
self-cleaning, screws, able to break the agglomerates and
to assure an accurate feeding of poor flowing products, for
the whole batch.
The feedrate is controlled by a stepless, speed variator.
High-efficiency, dust separator combining inertial and static
effects, equipped with a membrane filter cartridge, reverse-pulse,
automatic cleaning and final, safety HEPA that exhausts breathing
air quality to the atmosphere.
Standard controls, integrated in the front panel, include
process pressure regulators, pressure gages and differential
gages to monitor the filters.
stainless steel construction, bright finish, with all product
contact parts made of AISI316L, hand polished to pharmaceutical,
super-mirror finish 400-600 grit, Ra 0.15-0.20 microns
The new concept
of total containment technology is applied to Isopak-2 that
features a modular design isolator, class 2. It holds all the
process equipment and is kept negative or positive pressure,
to avoid contamination of the product or of the environment.
Inside the isolator, the working areas are Class 1000 or better,
with laminar flows and high-speed, air recirculation through
HEPA filters to capture the ultra-fine dust released during
the disassembling and cleaning operations.
Purified water shower, washing sink, vacuum and ultrasonic cleaners
and trapped drains allow perfect cleaning of all components,
inside the contained environment, without risk of cross-contamination.
The dialogue with the external room is made through airlocks
that are kept at a different pressure in respect to the working
environment and to the room.
Clean-in-place, on and off-line steam sterilized equipment along
with sterile, contained environments are used for highly sensitive
design is subject of a particular ergonomic study to assure
that all the process equipment and air filtration systems can
be serviced without breaking the containment
The isolator's design is subject of a particular ergonomic study
to assure that all the process equipment and air filtration
systems can be serviced without breaking the containment.
The working areas are easily accessible through half-suits and
feature service and stand-by lights that are built into the
ceiling to assure perfect working conditions according to all
The double-walled half-suit allows natural breathing and permits
heat discharge. Breathing air supply, located inside the isolator,
has independent air flow controls and HEPA filters. By virtue
of a pressure-equilibrium phenomenon, the half-suit is suspended
by a cushion of air around the operator, thereby facilitating
the operator's movements. Vision is very wide through the fully
transparent helmet, welded on the half-suit.
Many process and auxiliary controls are duplicated inside the
isolator, to allow operation from the half-suit and from the
esternal, room environment as well.
The working areas are easily accessible from the half-suit(s)
and feature service and stand-by lights that are built into
the ceiling to assure perfect working conditions according to
With this modular design, all versions can be equipped with the
- automatic controls
and sound alarm that monitor continuously the factory air supply
and the process lines and stop the operation in case of failure
electronic pressure controls that monitor the microniser with
proportional pressure regulators, specifically dimentioned for
very quick response and steady operation
- synoptic and
LCD-alarm display with fault messages in plain english, to signal
pressure drops on the microniser lines and across the filters
- electronic motor
controller allowing stepless regulation of feed speeds across
the specified range and features current limiting to prevent overloading
air filters for each process line, USDA-approved and certified
- batch validation
equipment including 4-20mA loop signals from pressure transducers
and process recorder to document each event and alarm.
- vacuum compensation
system that avoids environment contamination in case of blow-backs.
internal linings include PTFE and hard-metal alloys, etc.
SuperJet Micronisers can be customized according to the purchase
and the product specification.
0.4 - 38 kgs/hr
0.9 - 85 lbs/hr
Air consumption @ 7 barg
3 m3/min (110 scfm)
Compressed air supply
6-10 barg (85-145 psi)
Power supply 380/400V
5.0 kW (4 HP)
4.0 x 3.4 x2.3 (H) mt
Shipping: 1750 kgs
updated 09-Oct-2002. Copyright
� 2002 APTM SA Switzerland. All rights reserved