Customer: Teva Czech Industries

Details: Isolator workplace for research into HPP synthesis and isolation of semi-finished products or their purification.

Customer: Oncomed Manufacturing (Is. IZV10121)

Details: Isolator workplace with turbulent flow for the preparation of solutions and handling of high API category OEB6 (OEL 0.01 μg/m3). Negative pressure isolator is connected to other manufacturing formulation equipment. The purpose of the isolator is to ensure the safety of the operator when handling hazardous materials and also to protect the handled materials from atmospheric moisture and oxygen. A formulation tank with a volume of 500 L is connected under the isolator using a butterfly valve (Split Valve), which is used to mix products. The boiler is connected to the isolator using a flexible element. After the formulation is completed, the product is pumped into transport tank.

Customer: Merck (IZV11130)

Details: The isolator is used for the preparation of solution and handling of high potency API substances of category OEB4 (OEL 1-10 µg/m3). The purpose of this isolator is to ensure the safety of the operator when handling hazardous materials and also to protect the materials being handled from air moisture, oxygen and organic solvents. Turbulent flow. The device operates in negative pressure mode. Tightness class 3 according to ČSN EN ISO 14 644-7 (ISO 10648-2). Cleanliness class “C” inside the chambers according to EU GMP.

Customer: Bioveta

Details: The YSK024 decontamination pass-through chamber is designed for the transfer of materials between areas with different cleanliness classifications and for their surface decontamination using vaporized H2O2. The equipment prevents cross-contamination while maintaining biological safety. The chamber is connected via a dedicated piping system to an external hydrogen peroxide vapor generator integrated into the IZV11127 isolator. The generator vaporizes the H2O2 solution and delivers the vapor at the required concentration to the chamber using compressed air. The process achieves a 6-log (10-6) reduction in biological contamination. The equipment is fitted with H2O2 concentration, temperature, and humidity sensors. The maximum permissible leakage rate complies with Leakage Class 3 in accordance with ČSN EN ISO 14644-7 (ISO 10648-2). The equipment operates under positive pressure conditions.

Customer: UAB „Thermo Fisher Scientifi c Baltics“

Details: The decontamination pass-through cabin is used for the transfer of material between rooms and for the decontamination of packaging using H2O2 vapours. This device prevents cross-contamination or the spread of infection while maintaining biosafety. The device is connected to a vapourized hydrogen peroxide generator, which is used to evaporate the liquid H2O2 solution and then transport the vapours by means of pressurized air of the required concentration to the pass-through cabin.

Customer: Bioveta (Isolator IZV11127)

Details: The IZV11127 isolator with laminar airflow is used for product transfer using a peristaltic pump, connecting loops via tri-clamp fittings, and filling bottles. The purpose of the isolator is to ensure operator safety during the handling of hazardous materials. The isolator operates under standard atmospheric conditions. The equipment is fitted with an integrated hydrogen peroxide vapor generator designed to evaporate a liquid H₂O₂ solution and subsequently deliver hydrogen peroxide vapor at the required concentration into the isolator chambers using compressed air. This process provides surface decontamination of the loaded material and achieves a 6-log reduction (10⁻⁶) in biological contamination. The isolator cannot be opened during the decontamination process. The equipment is equipped with a hydrogen peroxide concentration sensor, as well as humidity and temperature sensors. The system is designed as a dual-chamber unit. The maximum permissible leakage rate complies with Leakage Class 3 requirements for containment devices in accordance with ČSN EN ISO 14644-7 (ISO 10648-2). The equipment operates under negative pressure. Control of the pressure differential and internal atmosphere exchange modes is performed electronically via an HMI control panel located on the upper cover on the right-hand side of the isolator. A status beacon providing the user with a quick overview of operating and fault conditions is mounted on the upper structure of chamber C1. Room air is supplied to the isolator through a pre-filter, an inlet fan, and HEPA filters located inside the isolator chambers. Neither air temperature nor relative humidity is controlled. Air from the isolator is exhausted through a pair of HEPA filters to a dedicated HVAC exhaust system.