New INTISO:
Smart isolator technology for aseptic processes

New INTISO

New INTISO:
Smart isolator technology for aseptic processes


A new design for isolator technology: Metall+Plastic's INTISO is distinguished by the absence of an HVAC unit and the relocation of cooling and ventilation units from the mechanical floor to the isolator plenum. Even its modular construction is innovative. This article shows the advantages and practical application scenarios that result from this.
Photographs of isolators in cleanrooms are only able to show part of the overall complex isolator technology. The HVAC unit (HVAC: Heating, Ventilation and Air Conditioning) is located, almost invisibly, above the isolator on the technical floor. If it were possible to dispense with the large HVAC unit and extensive piping, it would be feasible to significantly reduce the amount of work involved in isolator construction, as well as the time and effort required for installation and commissioning. Metall+Plastic has succeeded in relocating essential HVAC functions to the isolator plenum. The isolator plenum is the area located above the machine enclosure or the manipulation unit with the glove interfaces, and it is usually located flush with the cleanroom ceiling. The ventilation and cooling units are the newly repositioned technology. This design makes the INTISO suitable for standard applications carried out under the climatic conditions typically found in clean rooms, which roughly corresponds to a room temperature of about 20°C with a humidity level of about 40 to 50%. This is because INTISO uses the pre-conditioned air from the clean room and releases it back into the clean room (or even through the roof ).
A new generation of isolators
What differentiates the INTISO and sets it completely apart from similar concepts available on the market is a supportive temperature control system. A temperature adjustment of around +/- 6° C can be carried out with a cooling unit that is integrated into the isolator plenum. In practice, this makes it possible, for example, to compensate for waste heat from fans or other isolator components and to create consistent temperature conditions, regardless of the batch size. The INTISO also compensates for the temperature fluctuations that occur in the clean room with its integrated cooling and ventilation technology. Interim conclusion: This means that this type of isolator is just as safe for standard applications, but is also more costeffective and available more quickly than customized designs. In scenarios that differ from standard applications, such as when pharmaceuticals require cold loading or highly active ingredients are being processed that require a very high air exchange rate, a tailor-made isolator from Metall+Plastic remains the better choice. But for almost all standard sterile fillings, from now on the INTISO will not just be an interesting alternative, it will be the first choice. Matthias Aster, Team Leader Sales at Metall+Plastic, is convinced of this.
INTISO
With INTISO, the ventilation and cooling technology is reduced to the basics. It offers the highest pharmaceutical safety, cost and time benefits for standard applications.
A new generation of isolators
What differentiates the INTISO and sets it completely apart from similar concepts available on the market is a supportive temperature control system. A temperature adjustment of around +/- 6° C can be carried out with a cooling unit that is integrated into the isolator plenum. In practice, this makes it possible, for example, to compensate for waste heat from fans or other isolator components and to create consistent temperature conditions, regardless of the batch size. The INTISO also compensates for the temperature fluctuations that occur in the clean room with its integrated cooling and ventilation technology. Interim conclusion: This means that this type of isolator is just as safe for standard applications, but is also more costeffective and available more quickly than customized designs. In scenarios that differ from standard applications, such as when pharmaceuticals require cold loading or highly active ingredients are being processed that require a very high air exchange rate, a tailor-made isolator from Metall+Plastic remains the better choice. But for almost all standard sterile fillings, from now on the INTISO will not just be an interesting alternative, it will be the first choice. Matthias Aster, Team Leader Sales at Metall+Plastic, is convinced of this.
INTISO
With INTISO, the ventilation and cooling technology is reduced to the basics. It offers the highest pharmaceutical safety, cost and time benefits for standard applications.

"This type of isolator is just as safe for standard applications, but is also more cost-effective and available more quickly than customized designs."

Matthias Aster, Team Leader Sales, Metall+Plastic

INTISO is equipped with a DECOpulse® decontamination unit. Consequently, compared to custom isolators, there is no difference in the decontamination times that can be achieved and the H₂O₂ residual concentration values. In a market comparison, the values achieved by Metall+Plastic are also at a very low level. The INTISO also conforms to all requirements according to cGMP Annex 1. For example, this includes individual filter integrity tests in accordance with DEHS/DOP. Likewise, the monitoring units are identical to customized systems in terms of their design. Furthermore, the INTISO's SCADA system corresponds to the earlier design, and can be combined with the HMI of filling and closing systems.
Modularity assists with time and cost savings
INTISO
For example, inactivated vaccines or insulin usually do not require special climatic requirements in aseptic processing – ideal areas of application for the new isolator type INTISO.
he thing that also sets the INTISO apart is its modular construction. To achieve this, Metall+Plastic has introduced a modular system for the INTISO manipulation unit, so that the frames are now pre-engineered. The resulting simplified engineering contributes to reducing costs, while at the same time, the system remains so flexible that adjustments to meet customer requirements can be made at any time. Similarly, connection to Optima and other manufacturers' filling and closing machines is unaffected.
Last but not least, INTISO improves access to technology, because filters or hoses, for instance, can be reached via the access panels on the plenum. Metall+Plastic performs all the engineering in this area without the need for tools, for example with crimp closures, so avoiding potential particle contamination in the clean room.
The new INTISO delivers persuasive benefits for standard applications in sterile filling. This is underlined by the range of orders Metall+Plastic has already received for the INTISO. The first project is about to go into operation.
Modularity assists with time and cost savings
INTISO
For example, inactivated vaccines or insulin usually do not require special climatic requirements in aseptic processing – ideal areas of application for the new isolator type INTISO.
Was den INTISO darüber hinaus kennzeichnet, ist sein modularer Aufbau. Dazu hat Metall+Plastic für den INTISO ein Baukastensystem für die Manipulationseinheit eingeführt, sodass die Zargen nun vorkonstruiert sind. Das damit vereinfachte Engineering trägt dazu bei, den Kostenaufwand zu reduzieren. Gleichzeitig bleibt das System so flexibel, dass Anpassungen an Kundenwünsche jederzeit durchführbar sind. Genauso bleibt der Anschluss an die Füll- und Verschließmaschinen von Optima und anderen Herstellern davon unberührt.
Nicht zuletzt verbessert sich beim INTISO die Zugänglichkeit der Technik, da beispielsweise Filter oder Schläuche über die Revisionsklappen am Plenum erreichbar sind. Die gesamte Technik führt Metall+Plastic in diesem Bereich werkzeuglos aus, beispielsweise mit Crimp-Verschlüssen, damit eine potenzielle Partikelbelastung im Reinraum vermieden wird.
Die Vorteile, die der neue INTISO für Standardanwendungen in der Sterilabfüllung bietet, sind überzeugend. Diverse Aufträge, die Metall+Plastic für den INTISO bereits erhalten hat, können dies unterstreichen. Ein erstes Projekt steht kurz vor der Inbetriebnahme.
Information
IMPORTANT FOR YOU
  • New type of isolator: The INTISO from Metall+Plastic does not need an HVAC unit on the technical floor.

  • Ventilation and cooling units are installed in the isolator plenum. The INTISO receives pre-conditioned air from the clean room.

  • Significant time and cost savings

  • Ideal for standard applications

  • Improved accessibility

  • The modular construction of the INTISO assists with time and cost savings

  This report has been published in the O-COM Magazin Pharma July | 2021.

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