Filling System Integrates Aseptic Fill/Finish Systems with Isolator Technology

Dara Moduline filling system for vials, syringes, and cartridges from NJM Packaging integrates aseptic fill-and-finish systems with Getinge La Calhene’s isolator technology to achieve a class 100 cleanroom working environment when operating the system in a class 100,000 cleanroom.

Moduline is a compact and modular solution for filling liquids and powders at speeds of up to 100 units per minute in a footprint only 1150 mm (45 inches) wide and 3200 mm (126 inches) long. It doses volumes from 0.1 to 100 ml for liquids, and from 2 to 1500 mg for powders while maintaining an accuracy of +/- 0.5%.

A single HMI (human machine interface), which can be accessed locally on the unit and remotely from the customer’s SCADA system, controls both the fill-finish system and the isolator. The GAMP-compliant software monitors air velocity, differential pressure, relative humidity, temperature, non-viable particulate, microbes, and more. It can be equipped with data acquisition software that complies with FDA 21CFR Part 11.

Moduline features an isolator shell that surrounds the fill-finish machine frame with a continuous, jointless base. Ready-to-use materials can be supplied in nests or tubs, or materials can be supplied in bulk. Transfers are achieved without violating the system’s sterility using mouse holes, transfer modules with rapid bio-contamination, a sterilization tunnel, and a bag-out system.

The system can be equipped with stainless steel or ceramic rotary piston pumps and peristaltic pumps for liquids and vacuum pressure fill for powders. Both vapor hydrogen peroxide and nitrogen dioxide sterilization methods are available. For statistical process control, the system can be equipped with a micro-scale for 100% weight control.

The system includes 304 stainless steel and glass on all external materials and 316 stainless steel and polymers on all internal materials; Moduline has been designed in compliance with cGMP. The isolator and bio-decontamination cycle are prevalidated. The company will introduce the new system at INTERPHEX 2016, in New York, NY.

Source: NJM Packaging