Technical rundown: new isolator technology for aseptic processes

As the trends in pharmaceuticals progress they require new ideal conditions. A new design for isolator technology, Metall+Plastic’s INTISO, is distinguished by the absence of a HVAC unit and the relocation of cooling and ventilation units from the mechanical floor to the isolator plenum. This can create the ideal conditions for the biotechnology of the day; inactivated vaccines or insulin

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 and 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 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 cleanrooms, 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 cleanroom and releases it back into the cleanroom (or even through the roof).

The HVAC unit is located, almost invisibly, above the isolator on the technical floor

A new generation of isolators

What differentiates the INTISO and sets it 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 cost-effective 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 INTISO will not just be an interesting alternative, it will be the first choice. Matthias Aster, Team Leader of Sales at Metall+Plastic, is convinced of this.

INTISO uses the pre-conditioned air from the cleanroom and releases it back

INTISO is equipped with the 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 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 customised 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 benefits

The 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.

The simplified engineering contributes to reducing costs

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 cleanroom.

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.

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