The Dispensing Isolator is a GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for production activities.
The isolator system is equipped with a turbulent air flow system, and constantly guarantees a 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.
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). The Dispensing Isolator is the perfect solution for Manual Sampling, Weighing and Dispensing operations of High Potent Active Pharmaceutical Ingredients (HPAPI).
The isolator configuration is composed of a 4-glove working chamber and an inlet/outlet transfer chamber. An Elevated Platform is integrated into the isolator for a safe and efficient operation.
The Dispensing Isolator 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 10648-2:1994(E).
The Dispensing Isolator 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 50μm diameter.
The Dispensing Isolator 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.
An integrated compact control module made of AISI 304 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 weighing scale with operator interface, a manually operated High Containment Split Butterfly Valve (HCSBV) and an Intermediate Bulk Container (IBC) are integrated into the isolator for a fully contained weighing and dispensing process.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.