SubscribeComplete inova line for sterile liquid pharmaceuticals: Higher economic efficiency and safety with robotics and isolator
Since safety and highest quality are of paramount importance in the pharmaceutical industry, innovations in this sector are seldom revolutionary - simply because revolutions overthrow the status quo and inevitably bring about new uncertainties. The new inova syringe processing line improves several technical processes in an evolutionary way. It is based on a joint development process of all parties involved: the customer Solvay Pharmaceuticals and the machine manufacturer inova pharma systems as turn-key supplier together with the manufacturer of the isolator, the supplier of components Becton Dickinson Pharmaceutical Systems and the consulting company working for the customer.
Due to the highly professional preparation and execution it was possible to implement this extensive and ambitious project within 12 months after receipt of the order. A crucial factor for the success was the preceding engineering phase with risk analysis, but also the possibility to influence the new products of Becton Dickinson - syringe, nest and tub - as well as the process flow. Thus, the question which machine components or stations of the processing line had to be matched or redesigned in order to be able to process syringe, nest and tub was the main concern in the development process. It was only after conclusion of the engineering phase that the bid was accepted; and inova beat the competition.
There were clear requirements: The new syringe filling line should be able to process the products in the high-performance range, it should go extremely easy on the product and at the same time the economic efficiency and safety should be increased through automation of operations that had previously been executed manually. Furthermore, inova achieved an unrivalled degree of flexibility in the processing of nested syringes for Solvay Pharmaceuticals, who produce own products and also work as contract filler for other pharmaceutical companies.
For the new top-quality product of Becton Dickinson and the new line design inova has
- for the first time employed robotics for the processing of tubs and nests,
- for the first time implemented robotics in combination with isolator technology,
- redesigned or enhanced various processing units for sorting, feeding, filling and closing as well as line components and work stations.
Smooth transitions
Six work stations have been brought 'in line”; starting with the inova tub transport system, type TTS, with integrated tub unloading station: The tubs, filled with a nest with a defined number of syringes, are transferred to the TTS 1. The inova TTS 2 serves at the same time as accumulation space, at the outfeed of which the individual tubs are fed via alternating gate and roller conveyor to the inova robot SHR 120. The tubs are stopped even before they reach the work station, so that the robot can pull them into work position one by one. Here the tub is centered. The robot pulls off the Tyvek paper, the protective and intermediate film, of the tub and places it in a paper tray. Then the open tub is transferred to the inova TTS 3 and further on the inova filling and closing machine R3-10-I.
Various formats of nested syringes are filled and closed on the inova line: For the intermittent processing at the downstream stations of the line, the nests filled with syringes are taken out of the tubs and inserted into a special centering device. Here the syringes are processed nest line after nest line: during the insertion of the front stopper into the syringes, at the filling station and during the insertion of the plunger stopper. In their nest the filled and closed syringes are then returned to the tub and transferred to the inova TTS 4. The tub transport system TTS 4 is equipped with stop and push-out stations, with outfeed slides for good products, rejects and checking purposes.
Comprehensive isolator application
The entire inova line is equipped with isolator technology - with is another unique feature. The isolator does not only cover the filling and closing machine but also the entire linked machine system including the robot. The basic advantage of the isolator technology is the possibility to ensure sterile conditions on a much smaller and, most of all, precisely defined area compared to conventional clean rooms. The machine design as closed system requires considerably less investments than commensurate building services engineering.
The performance is convincing too, with an output of 18,000 syringes/h. At the same time inova managed to clearly improve the dosing accuracy requested in the customer's specifications and the quotation, with a redesign of the filling module that works without fine adjustment. But precision is also necessary at the stopper insertion station: The stopper positioning precision achieved by inova is by far exceeding the requirements.
For business assessments it is not only the high output that counts, but also the fact that the complete line can be operated by two operators. The automation of the processing also adds to the safety aspect. Automatic procedures are reproducible, whereas there is always a much higher error risk inherent in human action. This can be further minimized through the use of robotics.
When designing the complete line, inova attached great importance to the possibility of handling a wide range of different formats of syringes. The line, which is developed in compliance with GMP regulations, is especially prepared for future formats that are suitable for high-performance processing with isolator technology. Already the inova line masters two completely different syringe products that differ not only in the syringes themselves, but also in the execution of nests and tubs.
The order consists of two identical filling and closing lines. The first line is already installed at the customer's and is currently being validated.