Quality control has always been a crucial aspect of any pharma production line. But it’s in the spotlight more than ever now that the pharma industry is moving towards simplified treatments for self-administration by patients.
The self-administration trend has seen syringes becoming a popular choice not only for vaccines but also for autoinjector devices. However, syringes present additional challenges – compared with vials – when it comes to quality control.
Syringes are arguably the most difficult containers to inspect, as they are delicate and require unique handling protocols. While other containers, such as vials and cartridges, largely 'stand still' and can therefore enter the inspection process independently, syringes typically have to be carried via a conveyor belt and then turned upside down. This is to ensure any particles hidden in the funnel sink into the liquid contents and can be detected.
Another complication is that, if the syringes are sterilized, the containers are typically in a nest-and-tub arrangement, which means they have to be de-nested by a robotic unit communicating with the inspection machine. This requires gentle handling to avoid glass-to-glass contact to mitigate the risk of cracks or breakages.
The small diameters of syringes also present an inspection challenge because of the limited space in which particles can move and therefore be detected. This requires high-speed spinning so that any unwanted particles move toward the outside of the containers – this is especially important for turbid drugs. High-speed spinning also helps with the detection of bubbles – as bubbles go up while impurities go down.
To address all these challenges, Stevanato Group has created the MAVIS automatic inspection platform for prefilled syringes, which can handle drugs ranging from water-like solutions and suspensions to viscous or lyophilized products. MAVIS can inspect up to 400 pieces per hour – and all in a compact footprint that includes up to 18 inspection stations, and de- and re-nesters.
At the heart of the machine are 60 independent motorized spindle rotation units that can be adjusted for different drug products and ensure precise rotation of the syringes during an inspection, with no glass-to-glass contact. The servo-driven clip-wheel and belt continuous motion operation provides a smooth and stable transport system, with grippers available for Luer-lock syringes. A combination of matrix and line-scan cameras gives unrivaled inspection capabilities.
MAVIS has been designed to be user-friendly, with two human-machine interfaces – and the de- and re-nesters at the same end of the machine so that it can be run by one operator if required. It is also easy to install and maintain, with 360° accessibility and the electrical cabinet incorporated into the machine.
The inspection control system has been designed to be easy to learn, without the need for a vision expert – the patent-pending visual interface requires no programming or scripting knowledge. Configurable outlets give maximum production flexibility and there is also an optional automatic recirculation feature.
Flexibility is another key trend in the pharma industry, as drug companies increasingly need to accommodate new drugs requiring small batches in different containers – along with their existing high-volume products. The latest generation of inspection machines needs to be flexible enough to adapt to these changing requirements.
In a bid to streamline operations and reduce costs for pharma companies, Stevanato Group plans to launch a new machine, as part of the MAVIS platform, in 2023 to inspect ampoules, vials and cartridges, as well as syringes. Instead of buying different units for different formats, pharma companies will be able to reduce costs by buying one single unit. And MAVIS is designed to keep format changes to a minimum – reducing production downtime.
The MAVIS platform also offers digital twin technology, a vision system emulator that enables the software configuration of the machine (the recipe) to be changed offline and validated during production – avoiding the typical two-week downtime involved in recipe optimization. Additionally, you can reprocess the images of an entire batch and if you need to amend the recipe parameters – such as the acceptance threshold or the set-up of an inspection station – you know immediately the impact this change could have, thus saving time and costs.
With the challenges of drug and container inspection more complex than ever before, it’s clear that automatic visual inspection has a vital role to play.