R&D Containment Isolator Designed For Containment Of Potent Powdered Compounds

The Walker Barrier Systems R&D Containment Isolator is designed for the containment of potent powdered compounds during various functions and process steps involved with injectable formulations and filling. Our experience with such projects would show that operator protection significantly below 1?/m3 TWA can be achieved when defined SOP's are followed.

Process Description:
This multi functional Lab Scale Development Isolator provides integrated zones within one single negatively pressurized chamber to allow processes including mixing, magnetic stirring, weighing, homogenization, drying and filling under a strict temperature and pressure control system.

In order to provide a unidirectional zone for hand filling of vials, the area to the right hand side of the Isolator is fitted with a terminal HEPA filter for constant 45ft/min downflow of clean air. Raw material is introduced into theIsolator through a Rapid Transfer Port. Depending on requirements, the operator moves the product through the various stations for processing.

Design Advantages:

• Ergonomically designed oval gloveports are specified as standard, with Hypalon gloves.
• Fully welded 7 gauge 316L stainless steel construction, with laminated safety glass, and 5/8 inch corner radiuses.
• The PLC allows the Isolator to maintain a constant pressure within high and low set points, with a visual alarm back-up.
• Cam-lock connections for inlet and outlet of gas sterilant.
• Temperature control to maintain the Isolator at a constant temperature with high/low set points.
• Negative pressure System with safe change supply & exhaust HEPA filtration.
• Designed as a complete development laboratory containing the balance, magnetic stirrer, mixer, homogenizer, centrifuge and area for hand filling.
• Automatic pressure control for ammonia leak testing.
• Automatic oxygen and humidity control systems.

Options:

• PLC based control systems with automated valves.
• Full validation services available including IQ/OQ protocols and dust in air/containment testing.

Our Sales and Engineering staff will work closely with you to design the optimum system to meet your needs. Walker Barrier Systems offers complete in-house design, mock-ups, engineering, fabrication, installation and onsite start up services.

SOURCE: Extract Technology