The new STISO from Metal+Plastic

(Image rights: Metall + Plastic GmbH)

Modular, ergonomic, and fast

Product safety is the focus when filling pharmaceutical products. To check the purity and sterility of filled batches and to further increase safety, sterilization test isolators are used.

For this purpose, Metall+Plastic offers a suitable solution with the new sterilization test isolator – also called “STISO”.

The STISO was developed as a plug & play isolator that can be used for aseptic (STISO) as well as aseptic-toxic (STISOtox) applications. It features a variety of new features. The new sterilization test isolators from Metall+Plastic can be individually adapted to customer needs thanks to their modular design. In the standard version, the working chamber of the isolator has four glove ports. Alternatively, work chambers with two or three glove ports are also available. The MTC (Material Transfer Lock) can be positioned on the right or left, as well as on both sides of the working chamber. Later upgrades of the MTC are also possible. Two sizes are available as standard.

Since the STISO can be operated from one side, it is also suitable for space-saving installation on a wall. This allows the use of the STISO even in smaller laboratories. Fatigue-free work: users benefit from the ergonomic design to keep health burdens for operators as low as possible. The developers of the STISO paid special attention to ergonomics. The basis was an ergonomic study conducted in collaboration with Scala Design. The results influenced the design of the sterilization test isolator. The control panel is at an optimal height, can be swiveled, and adjusted in angle. Additionally, sufficient legroom is provided. The access height can be adjusted to the operator. Work can also be performed sitting down with the help of an ergonomic standing aid, which is available as an accessory. Operators also benefit from loading carts and transport trolleys.

Accessories include particle monitoring, air microbial samplers, sterilization test pumps, and scales. Highly active substances such as cytotoxic agents for live vaccines, viruses, and bacteria are becoming increasingly important. When processing such products, protecting the operator and ensuring safe product handling are absolute musts. Metall+Plastic addresses this development with the HPTFilter, which can be equipped on request with the STISO. They separate airborne particles from the products and handle a volumetric flow of around 1300 cubic meters per hour in H13 quality, optionally H14. The filters can be easily replaced and are lightweight. They also allow for an integral filter integrity test. The plastic housings can be incinerated without residue. The development of glove testing devices also considered user needs. These are integrated on the side of the housing, facilitating operational practice. Test covers are integrated into the side design and can be ready for use within a short time and quickly stored out of sight again.

The software for the testing device has been integrated into the HMI. Ventilation and cycle times are shortened. The operator benefits not only from the ergonomic design of the STISO but also from short cycle times resulting from catalytic ventilation. This ensures that H2O2 used for decontamination of the isolator is quickly broken down again. The evaporation system RGx is used, which enriches pre-conditioned carrier air with H2O2 and then injects it. Depending on the expected residual concentration, the system from Metall+Plastic achieves a time saving of several hours through catalytic ventilation. This is achieved by continuous air circulation through the catalyst, where H2O2 is absorbed and continuously broken down during operation.

Maintenance-friendly features of the STISO include a so-called flash evaporation. With the patented DECO-jet© process from Metall+Plastic, liquid
H2O2 is converted into a gaseous state. The advantage: virtually no maintenance work is required in the evaporator area. Even within the recommended maintenance intervals of six months, no residues can be detected in the evaporator. Manufacturers of highly active substances can make their sterilization tests particularly safe and save a lot of time by using the STISO. The modular principle allows it to be perfectly adapted to the given space conditions and personnel needs. This guarantees efficient work without exhausting the operators. Ultimately, this also benefits high safety in sterilization tests and quality control.