/ SuperJet -Bottom discharge
/ Isopak series
Isopak-1 is the typical machine for R&D and small production
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
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-1 has been continuously
improved in terms of versatility and compactness ( like, for
instance, the models I1F, I1H
and up to the newest I1P/ 2003-version).
The modular design allows customization and interchangeability
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 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-1F that
features a modular design glove-box, 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 glove-box, 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 differential 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 working areas are easily accessible through gloves and feature
service and stand-by lights that are built into the ceiling
to assure perfect working conditions according to all GMPs.
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.
0.2 - 1.5 kgs/hr
Air consumption @ 7 barg
800 Nlt/min (28scfm)
Compressed air supply
6-10 barg (85-145 psi)
Power supply 380/400V
1.6 kW (1.2 HP)
1.2 x 1.0 x1.7 (H) mt
Shipping: 350 kgs
updated 09-Oct-2002. Copyright
© 2002 APTM SA Switzerland. All rights reserved