GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for compounding activities.
Maximizing operator protection is the primary characteristic of a containment isolator. Tema Sinergie assures very stringent containment levels thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and/or static seals made of FDA approved EPDM (Ethylene Propylene Diene Monomer) to guarantee air tightness Class II (ISO 10648:2). Turbulent air flow system, negative pressure gradient between the chambers and the lab environment. The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) filters.
The isolator configuration is composed of a 4-glove working chamber and an inlet/outlet transfer chamber.
The Compounding Isolator (Production) is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2 (E).
The Compounding Isolator (Production) can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm diameter.
The Compounding Isolator (Production) is provided with integrated manual Wash-In-Place (WIP) for cleaning processes, thus improving safety for the operators involved in the production of potentially hazardous compounds and reducing the risk of possible cross contamination.
The Compounding Isolator (Production) is equipped with an integrated inert gas distribution system (i.e. Nitrogen, supplied by the customer), as an alternative to compressed air or laboratory air ventilation, which allows to both blanket the chambers and maintain the oxygen concentration within the enclosures below 2%, so to preserve particular products from oxidation phenomena.
An integrated compact control module made of AISI 316L stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations. A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.
A continuous liner and a suitable welder are integrated into the isolator for a fully contained material and samples transfer.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.
Jacketed Preparation Vessel integrated into the isolator for a fully contained production process. Mechanical integration via EPDM membrane to allow weighing procedures through integrated load cells. The isolator’s PLC manages the integrated WFI and Nitrogen circuits, and allows pre-loaded recipies for a full automated process.