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Pharmaceutical Industry review/Фармацевтична галузь, 2022, #2 (91) May

A sterility test isolator that is sure to be desired

Product safety is the focal point during the filling of pharmaceutical products. Sterility test isolators are used to check the purity and sterility of filled batches and to increase safety. Metall+Plastic offers an appropriate solution with the new sterility test isolator - or short STISO. The STISO was designed as a plug & play isolator for aseptic (STISO) and aseptic-toxic (STISOtox) applications.

FLEXIBLE MODULAR SYSTEM

The sterility test isolators from Metall+Plastic are easy to adjust to customer requirements due to their modular design. The standard version includes four glove ports in the isolator chamber. However, the isolator chamber is also available with two or three glove ports. The MTC (material transfer chamber) can be installed to the left or the right of the chamber or on both  sides. The MTC can also be retrofitted at a later date. It c omes in two different sizes in the  standard  version. The STISO can be operated from one side and theref ore, is  suitable for space  saving installation against the wall,  allowing the STISO to be used for small batches.

OPTIMAL OPERATOR ERGONOMICS

To ensure health and prevent physical stress of your employees and to create a comfortable work environment, the STISOs are ergonomically designed. An ergonomic study was performed in cooperation with “Scala Design” and the results of the study were incorporated into the design of the sterility test isolator. Therefore, the operator panel is at an optimal height, it is pivotable and angle adjustable. In addition, the machine allows for sufficient legroom. The insertion heights can be adjusted to match the operator’s height. It is also possible to work in a sitting position with an ergonomically designed pivoting chair. Operators also benefit from the loading cart and trolley. Additional options that can be included are: particle monitoring, air sampler, sterility test pumps and scales.

HPT FILTER FOR ASEPTIC-TOXIC REQUIREMENTS

Highly active agents like Cytotoxic for live vaccines, viruses and bacteria are becoming more and more vital. It is critical to guarantee the operator’s and the product’s safety while processing toxic substances. This is accommodated by utilizing HPT filters from Metall+Plastic (upon request). The filters separate the airborne particles from the product. The HPT filters are able to handle a volume flow of approximately 1300 cubic meters per hour in H13 or H14 quality. The filters are light weight and easy to change. They also offer the opportunity to perform an integrated filter integrity test and the plastic housing can be burned without any residue.

INTEGRATED GLOVE TESTING UNITS GTS-WL

The STISO glove testing units are operator friendly and are integrated on the side of the housing to make the operation easy. Inspection covers are integrated on the side of the system, are ready-for-use in a short amount of time and stowed-away fast. The software for the testing unit is also integrated into the HMI.

REDUCTION OF AERATION AND CYCLE TIMES

Another benefit, besides the ergonomic design of the STISTO, for the operator is the short cycle times that are the result of catalytical ventilation. This ventilation ensures that the H2O2 used for the isolator decontamination is removed quickly. The evaporation system RGx enriches the preconditioned carrier air with H2O2 and blows it into the STISO. Due to the catalytical ventilation, the Metall+Plastic system obtains time savings of several hours, depending on the expected remaining H2O2 concentration and is achieved by a constant air circulation with a catalytic converter that absorbs H2O2 and removes it continuously during the operation.

NO RESIDUES IN THE H2O2 EVAPORATOR

The STISO creates a maintenance friendly socalled flash evaporation. With the patented DECOjet process from Metall+Plastic, the liquid H2O2 will be transformed into a gaseous state. The advantage: hardly any maintenance work is needed in the evaporator area. Residues can still be determined within half a year during the recommended maintenance interval.

METALL+PLASTIC GmbH
78315 Radolfzell-Stahringen, Germany
info@metall-plastic.de
www.metall-plastic.com

Валерій Буб
Технічний спеціаліст відділу продажів
Тел.: +49 7738 9280-66
Моб. тел.:  +49 152 09205999
valerij.bub@metall-plastic.de

Офіційний представник в Україні: ТОВ «Михаил Курако»
Україна, 01001, м. Київ,
вул. Лютеранська, 3, оф. 11
Тел.: +380 (44) 279-30-95 (31-04),
факс: +380 (44) 270-56-17
www.kurako.com
kurako@kurako.com