Path: Micronisers / SuperJet -Bottom discharge / Isopak series

SuperJet microniser 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 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-1 has been continuously improved in terms of versatility and compactness ( like, for instance, the models I1F, I1M ( Millenium), 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.

PROCESS EQUIPMENT
For all the versions, the process equipment are located in the safe, totally contained environment:

  • SuperJet 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.
  • Full 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
TOTALLY SAFE ISOLATOR

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 products.

CAREFUL ERGONOMICS

The glove-box 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.

I1H model


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OPTIONS
With this modular design, all versions can be equipped with the following options:

  • automatic controls and sound alarm that monitor continuously the factory air supply and the process lines and stop the operation in case of failure
  • high-precision, 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
  • sterilizing 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.
  • replaceable internal linings include PTFE and hard-metal alloys, etc.

All SuperJet Micronisers can be customized according to the purchase and the product specification.


MAIN SPECIFICATIONS

SuperJet Microniser
Isopak-1H
Nominal size

4-inch (100mm)
Expected output

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

1.0 kW (0.8 HP)
Dimensions (effective)

2.2 x 1.4 x2.2 (H) mt
Shipping: 460 kgs

5m3

Last updated 09-Oct-2002. Copyright � 2002 APTM SA Switzerland. All rights reserved