Path: Micronisers / SuperJet -Bottom discharge / Isopak series

SuperJet microniser 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, I2EP, I2FP2S, I2GP2S, I2GP2SN, I2KP4S, I2MP2S, 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.

PROCESS EQUIPMENT
For all the versions, the process equipment are entirely 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-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 products.

CAREFUL ERGONOMICS

The isolator 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 GMPs.
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 all GMPs.

I2KP4S model
WORLD's BIGGEST ISOLATOR



This model has FOUR half-suits and working stations located at 3 different floors in this 6.5 m tall machine
The detail shows the secondary, product dispensing section that offers plenty of space for dispensing and labelling.
The machine is ergonomically designed to allow full access of the operator to the most remote corners, for disassembling the components, servicing and cleaning without break of containment.
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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-2GP2SN
Nominal size

8-inch (200mm)
Expected output

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)
Dimensions (effective)

2.4 x 2.4 x2.3 (H) mt
Shipping: 1750 kgs

17m3

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