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#modularity

A move closer to perfection

“Modular facility design” is a hot topic in modern pharma and bio-pharma manufacturing. Such an approach involves designing the process systems as single production units (washing, depyrogenation, handling equipment, filling, stoppering, etc.). These units are generally built and assembled on a parallel timeline with on-site civil and facilities construction. This shortens project time and ensures major advantages such as reduced costs, faster time-to-market and higher quality assembly and fabrication. The modular units are always rearranged with different layouts to add to or form entire plants. To combine intelligent facility layout with innovative processes and technologies, IMA Life not only safeguards set-up modularity (i.e. flexible use of the plant space) but, thanks to our state-of-the-art robotic technologies, also maximises operational modularity.

Modularity is an inherent part of INJECTA’s concept. INJECTA’s integrated “combi” configuration guarantees a complete, contained, integrated production system, with no use of interchangeable production modules to adjust production processes. INJECTA’s design is intrinsically modular and instinctively meets multiple requirements: machine functions can be assembled in different configurations to fit an unlimited number of layout solutions, starting from the handling of primary packaging components.

#Modularity is a High Degree of Automation in Sterile Primary Package Opening.

To preserve the sterile state of the tub/tray, dedicated six-axis robots automatically open the sterile RTU packages and handle all critical aseptic operations. The primary packaging feeding area is usually surrounded by a cRABS area, separating it from the nearby isolated processing area.

Robotic technology ensures great efficiency in handling sterile primary packages also in conventional filling lines.

The tub/tray outer/inner bag opening modules have been designed not only for INJECTA:  they can also be integrated with conventional aseptic lines handling RTU vials pre-arranged in trays. This means that small volume RTU vials can also be efficiently fed and processed in traditional aseptic lines, using the same robotic handling system. Forward-looking facilities will consider it an important benefit to best utilize space layout and existing plant conditions to plan for the implementation of a new/future production process. In addition to the given opportunity of scaling existing lines up or down, this would save considerable investment.

#Modularity is Unlimited Smart Solutions for Layout Design Optimisation.

INJECTA allows the optimisation of space design for new parenteral manufacturing and/or for newly designed plants.

Furthermore, in the case of existing plants, thanks to its superior adaptability, INJECTA perfectly fits into an unlimited number of layout configurations with upstream de-pyrogenating tunnel and downstream alu-capping, external washing, up to freeze-drying and complete high potent lines under isolation. In addition, the RTU containers can be accurately and efficiently filled and closed  in a nest or with de-nesting. By implementing a modular approach, INJECTA models itself to any kind of production context requirement. 

INJECTA can achieve unlimited best-in-class modular layout solutions.

Here are some examples of possible layout configurations:

  • Customised solutions to process RTU components (syringes, vials and cartridges) pre-arranged in nest and tub;
  • Dedicated solutions to process RTU vials from bulk with de-nesting;
  • Dedicated solutions to process RTU vials upside down from trays with de-nesting;
  • Dedicated solutions to process RTU vials lyophilised in a nest;
  • Dedicated solutions for handling plastic press-fit vial closures (snap caps) for lyo vials.

#Modularity is Custom-built Lyo Configurations to Maximise Space Flexibility.

To help them reduce costs emanating from their supply chain, today’s innovative pharma and biotech companies retain flexibility and have the agility to react quickly to changing circumstances within the development, manufacturing and packaging process. The final aim is to combine intelligent facility layout, cutting-edge technologies and innovative processes.

Facilities should allow for flexibility in terms of process development and technical equipment, while maintaining high quality standards. INJECTA helps enhance space flexibility thanks to its own unique intrinsic modular approach. 

INJECTA’s intrinsic modularity is fit for lyo process integration.

INJECTA can be easily integrated with an in-line lyophilisation process, where an automated vial loading/unloading system handles products into and out of the freeze dryer. INJECTA’s robotic arm helps place the nested vials into the lyo process ensuring no product losses, no vial falls and no glass breakages. At the end of the lyophilisation process, the pressure applied by the freeze dryer shelves closes the vials. All stoppered vials are then moved to capping operations, relying on conventional standard primary packing components (alu caps).

A few examples of the most frequently required lyo configurations:

  • IN-LINE lyo configurations ;
  • T-SHAPE lyo configurations;
  • All-in-one integrated fill-finish solutions with combined (double lane) lyo process and capping operations.