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Modular sterility test isolator to inspect cleanliness and sterility of filled batches and to increase safety
September 5, 2018
By: Kristin Brooks
Managing Editor, Contract Pharma
Metall+Plastic has introduced the STISO, a modular, ergonomic and fast sterility test isolator to inspect cleanliness and sterility of filled batches and to increase safety. Metall+Plastic deigned the STISO as a plug & play isolator for aseptic (STISO), and toxic (STISOtox) applications. The sterility test isolators from Metall+Plastic are adjustable to customer requirements. The standard version includes four glove ports in the isolator chamber. Isolator chambers with two or three glove ports are also available. The MTC (Material Transfer Chamber) can be installed to the left or the right of the chamber or on both sides, and can also be retrofitted later. It comes in two different sizes in the standard version. The STISO can be operated from one side and is suitable for installation against the wall, allowing the STISO to be used for small batches. The STISO features an anti-fatigue design to minimize physical stress for operators. The operator panel height can be adjusted, and has an adjustable pivot angle, and allows for sufficient legroom. It is also possible to work in a sitting position with a pivoting chair. It also features a loading cart and trolley. Additional options include: particle monitoring, air sampler, sterility test pumps and scales. The STISO accommodates highly active agents like cytotoxics for live vaccines, viruses and bacteria by utilizing HPT filters from Metall+Plastic to ensure operator and product safety while processing toxic substances. 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 optional in H14 quality. The filters also offer the opportunity to perform an integrated filter integrity test and the plastic paneling can be burned without any residue. According to the company, the STISO offers shortened cycle times that result from catalytic ventilation that ensures the H2O2 used for the isolator decontamination is removed quickly. According to the company, the system can obtain time-savings of several hours, depending on the expected remaining H2O2 concentration, which is achieved by a constant air circulation with a catalytic converter that absorbs H2O2 and removes it continuously during the operation.
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