New isolator for containment of pharmaceuticals

Published: 7-Oct-2011

The modular system is ideal for weighing and dispensing potent APIs

The new Modular Isolator System has been conceived by Italian company Comecer for pharmaceutical companies that require high containment level during manipulation of potentially dangerous products.

The containment conditions achievable within the system (OEB5) enable the manual sampling, weighing and dispensing of highly active pharmaceutical ingredients (HAPIs).

The base isolator system is composed of one glove chamber and one glove pre-chamber. A glove chamber is also available to join with the other modules in a configuration to address most processing needs. All the chambers are equipped with 10” oval-shaped glove ports made of polypropylene and neoprene long isolator gloves. Other kind of materials can be used upon request.

Available upgrades include rapid transfer ports, liners and an assortment of other systems. Exhausts can be collected in a dedicated piping or returned directly into the lab.

The isolator system is ventilated with turbulent air flow in all the chambers. The chambers operate in negative pressure with respect to the lab environment. The system is designed to take air from a Class D laboratory or from a HVAC system.

Standard HEPA (H14) inlet and outlet filters are mounted within the chambers and it can have a nitrogen /compressed air distribution system, and oxygen sensors available upon request.

The shell structure is made of “mirror-brite” SS 316L, the sheathings are made of “scotch-brite” SS 304. Internal angles are 20mm rounded to facilitate cleaning and sterilisation operations, the welds are ground, smoothed, and polished. Stainless steel components are welded using TIG method (in an argon atmosphere).

All the inflatable and static seals are made of FDA approved EPDM (ethylene propylene diene monomer) for a high resistance with solvents.

The view panels are made of 12 mm tempered glass and may be externally laminated with a safety film and all the chambers are fitted with a sanitary drain system. Manual Wash-In-Place (WIP) and automatic Clean-In-Place (CIP) systems are available upon request.

You may also like