new isolator technology for aseptic processes
As drug trends progress, they require new ideal conditions. A new design for insulator technology, the INTISO from Metall+Plastic 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. This can create the ideal conditions for today’s biotechnology; inactivated vaccines or insulin
A new design for insulator 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 the modular construction is innovative and this article shows the benefits and practical application scenarios that result.
Photos of insulators in cleanrooms can only show part of the overall complex insulator technology. The HVAC unit is located, almost invisibly, above the isolator on the technical floor. If it were possible to forego the large HVAC unit and extensive piping, it would be feasible to significantly reduce the amount of work involved in the construction of the insulator as well as the time and effort required for installation and commissioning.
Metall+Plastic has succeeded in moving essential HVAC functions to the isolator plenum. The isolator plenum is the area located above the machine housing or the manipulation unit containing the glove interfaces and is usually flush with the ceiling of the cleanroom. The ventilation and cooling units are the newly repositioned technology.
This design makes the INTISO suitable for standard applications performed under the climatic conditions typical of cleanrooms, which corresponds approximately to a room temperature of approximately 20°C with a humidity level of approximately 40 to 50%. This is because INTISO uses the preconditioned 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 insulators
What sets the INTISO apart and sets it apart from similar concepts available on the market is a supportive temperature control system.
With a cooling unit integrated in the isolator plenum, a temperature control of approximately +/- 6°C is possible. In practice, this makes it possible, for example, to compensate for residual heat from fans or other insulator components and to create consistent temperature conditions, regardless of batch size. The INTISO also compensates for the temperature fluctuations that occur in the cleanroom with its integrated cooling and ventilation technology.
Interim conclusion: This means that this type of insulator is just as safe for standard applications, but also more cost-effective and more readily available than custom designs. In scenarios that deviate from standard applications, such as when medicines are cold-loaded or highly active ingredients are processed that require very high air exchange, a custom insulator from Metall+Plastic remains the better choice. But for almost all standard sterile fillings, INTISO is now not only an interesting alternative, but the first choice. Matthias Aster, Team Leader of Sales at Metall+Plastic, is convinced of this.
INTISO uses the preconditioned air from the cleanroom and releases it again
INTISO is equipped with the DECOpulse decontamination unit. As a result, there is no difference in the decontamination times to be achieved and the H2O2 residual concentration values compared to custom-made insulators. Even in a market comparison, the values achieved are at a very low level. The INTISO also complies with all requirements according to cGMP Annex 1. This includes, for example, individual filter integrity tests according to DEHS/DOP. Likewise, the monitoring units are identical in design to customer-specific systems. Furthermore, the INTISO’s SCADA system corresponds to the previous design and can be combined with the HMI of filling and closing systems.
What also distinguishes the INTISO 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-assembled. The resulting simplified engineering contributes to cost reduction, while at the same time keeping the system flexible so that adjustments can be made at any time to meet customer requirements. Likewise, the connection with Optima and the filling and sealing machines of other manufacturers remains unaffected.
The simplified engineering helps to reduce costs
Last but not least, INTISO improves access to technology because, for example, filters or hoses can be reached via the access panels on the plenum. Metall+Plastic carries out all engineering in this area without tools, e.g. with crimp closures, thus avoiding possible particle contamination in the cleanroom.
The new INTISO offers convincing advantages for standard applications in sterile filling. This is underlined by the series of orders that Metall+Plastic has already received for the INTISO. The first project is about to start.