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Case study
Reading time 8 min
IMA Life
The growing market trend for pre-filled syringes and other Ready-To-Use components is strictly connected to the high prevalence of chronic diseases across the globe, the increase in the geriatric segment of the population, more sedentary lifestyles, the growing use of safety self-administration devices and the rising demand for vaccines.
On the other hand, the ongoing biopharmaceutical boom (biologic and biosimilar drugs) has also contributed to an increase in products targeted for parenteral delivery, which, in turn, has contributed to promoting the growth of the pre-filled syringe market, as pre-filled syringes are easy to use and ensure a high dosing accuracy while minimizing product loss. Companies targeting biologics face a new frontier in development and manufacturing as these drugs are targeted for smaller patient populations and are difficult to produce owing to the reactivity, viscosity and expense of the macromolecules.
Being patient safety and dosing accuracy the main issues for injectable administration, flexible and multi-product fill-finish operations are becoming more crucial as most of the new injectables require a delivery model that is patient-centric, safe and cost effective. Biologics and biosimilars are more process-intensive and the traditional aseptic process is not well suited to meet the need for medium-to small batch flexibility. Their complexity, as well as their advanced formulation (high-value drugs) change the way products are brought to the market and companies are now looking to reduce the total cost of production, which is higher in relation to pharma drugs.
Today’s challenge for manufacturing companies is to adopt new methods and technologies to process high-value drugs with high-mix batches into multiple formats or sizes (such as vials, cartridges and syringes for parenteral use) so as to ensure a flexible and repeatable process, in a controlled, safe environment. The process must be repeatable and minimize the risks, so as to reduce contamination potential and improve production quality and manufacturing efficiency in an aseptic and sterile fill-finish process. The growing use of a closed robotic filling system is in response to these changes and demands!
Meeting this growing demand for multi-product, fill-finish operations, IMA Life has designed and implemented a flexible and reliable “medium-to-low production batch” scalable solution for the filling and closing of a wide range of Ready-To-Use (RTU) disposable components:
Injecta, our ultimate, fully robotic fill-finish machine for RTU components pre-arranged in nest & tub or trays.
Injecta is our innovative approach to deliver a new aseptic filling machine concept for injectable pharmaceuticals. Its Quality By Design (QbD) development process has been outlined to meet the targeted product quality profile and operate in a faster, safer way, so as to proactively respond to the challenges posed by the increasing complexity of new drug substances (medium-to-small batch flexibility). To achieve the best possible improvement in terms of safety and productivity, INJECTA’s full fill-finish process is based entirely on robotics operating in a closed, “towards gloveless”, isolator environment.
In aseptic processing, operators are the primary source of contamination. INJECTA is designed to run with no mouse holes, conveyors, glass-to-glass contact or vibrating bowls which all create risks to the batch. Results: cost and time saving, major safety for operators and, thanks to the isolator environment, an increase in product quality and safety.
Whereas conventional attempts to use robots are typically confined to just one step of production, i.e. simply for moving vials from station to station or for removing the cover from a tub of nested containers, INJECTA uses the full potential of its robots.
Its specialised robots perform all handling activities with no glass-to-glass contact and without operator intervention. INJECTA is designed as a whole, exploiting all robotic capabilities in an integrated system. Kawasaki’s seven-axis robot arms are manufactured for the lowest degree of particle shedding.
They are resistant to positive/negative and high pressures and fully compatible for decontamination using H2O2 vapours. No human intervention is required: all activities/issues are solved through robot interactions.
INJECTA’s specialised robots not only provide precise, consistent handling activities, but also offer a high level of flexibility: they are completely digitally controlled with Industry 4.0 capability, thus allowing a better understanding of the manufacturing processes while meeting quality standards and increasing efficiency (integrated automation platform to drive knowledge/information and promote data-driven decision-making).
Flexibility:
Modularity:
Enhanced quality:
Business drivers:
Single rejection from the nest or with de-nesting: all processed RTU components are individually check-weighed (in case of de-nesting) or check-weighed all together while in nest, with single rejection of each individual non-conformity, safeguarding the nest.
Scalable design: unique production platform (from one up to ten filling pumps) performing the same identical product handling, filling and stoppering operations avoiding any additional production process re-qualification with consequent time-to-market reduction.
In conclusion, the intensive use of advanced robotically driven manipulations versus conventional handling systems saves process time and costs, thus improving product quality and manufacturing efficiency.
The result is “less time” spent validating aseptic conditions and superior agility for multi-product manufacturing: no size part changeover, rise of process capacity, minimization of product losses, reduced human intervention, smaller footprint. Pharmaceutical companies that move products to market faster will beat their competitors in an era that demands greater agility.
