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Sean Riley, senior director, media and industry communications, PMMI, The Association for Packaging and Processing Technologies
Automated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.
The focus on specialized medicines and biologics has led to more small-batch production in aseptic manufacturing, which calls for flexible machinery and faster changeovers. Flexible and repeatable filling are more crucial as companies focus on targeted therapies for smaller populations. Nearly 50% of pharmaceutical and medical device companies have begun to replace legacy equipment with automated systems, according to PMMI’s 2017 report The Evolution of Automation (1).
The report also found that two out of five pharmaceutical and medical device manufacturers do not operate legacy equipment and can point to operating fully automated equipment in the future. Additionally, the majority (62%) of pharmaceutical and medical device companies predict spending more on capital equipment over the next two years, with smaller batch runs being a main driver. Expanding varieties of drug types and dosage forms, higher standards for quality and precision, and pressure to reduce development times are all factors fueling demand for greater speed in aseptic operations. Fully automated processes can go a long way to overcome these challenges.
In aseptic processing, people are the primary source of contamination because aseptic filling requires close coordination and involves complex interactions between the operator, sterilized products, the fill/ finish equipment system, and the cleanroom. Handling of sterile liquids in the pharmaceutical industry traditionally relies on consistent techniques that have not advanced much over the past 100 years. Innovation, such as near-zero particle generating designs and complete tolerance to biodecontamination cycles with gaseous hydrogen peroxide, are making automated lines easier to integrate.
The rise of costly biologics has pressured downstream fill/finish operations to ensure the highest levels of safety, quality, and cost efficiency. Automation at the fill/finish stage reduces the risk of contamination, and pharmaceutical processers are adopting systems that lead to as few human interactions as possible. By eliminating operator intervention, automated aseptic filling systems can reduce contamination potential and improve manufacturing efficiency. Traditional, one-axis automation works well for high-speed processes, but multi-axis robotic arms offer repeatability with the flexibility to easily change the process or the type of container being filled.
Operators can easily reprogram today’s robotic systems for changes after setup without the help of a programming specialist. Some platforms are recipe-driven, and an operator inputs the recipe information-such as the type of container and volume to be dispensed-through a touchscreen interface.
The use of nested components, such as vials, syringes, cartridges, stoppers, and caps, simplifies material flow within aseptic systems. The nested components configuration eliminates machinery and tooling used in traditional systems, cutting back on sources of particulates and contamination. Newly developed products, increasingly smaller batches, more highly potent products, and the need for flexible and efficient vial and syringe filling solutions are leading to constant demand to make the freeze-drying process fast, safer and more cost-effective, particularly regarding changeovers, driving demand for nested vials.
Robotics systems create streamlined decks for nested vials that are easier to clean than traditional automated systems. The use of pre-sterilized, disposable product contact path materials (e.g., bags, tubing, sterile connections) reduces material cross-contamination and speeds product changeovers by eliminating extensive system cleaning.
At PMMI’s Healthcare Packaging Expo (Sept. 23–25, 2019, Las Vegas), Groninger exhibited semi- and fully automated filling solutions for nested syringes, vials and cartridges that can process up to 400 objects per minute with 100% in-process control. The systems are flexible for multiple formats.
Another exhibitor, AWS Bio-Pharma Technologies, manufactures linear-style fillers that can process syringes, cartridges, and nested vials from one to 30 mm in diameter at speeds of up to 2000 units per minute. The RNFM series of filling systems are available in three models with various output options and production speeds to suit the needs of manufacturers of any size.
Another common use of robots in aseptic processing is to replace highly repeatable production processes. Robotic systems are agile and can switch quickly between vial, syringe, and cartridge formats, reducing the number of electro-mechanical components that complicate the machine’s interior. This also speeds up decontamination cycles.
With the use of cobots-collaborative robots that can work in proximity to humans with fewer concerns for injury due to their ability to sense obstacles-glove-boxes can be located next to the robot so that the operator can intervene in the isolator without stopping the production process. Robots also allow the design of gloveless isolators. A gloveless isolator is completely closed, removing batch contamination risks caused by mouse holes, conveyors, glass-to-glass contact, or sortation bowls and minimizing particle generation. Gloveless isolators make particle counts as low as ISO 2 levels possible, and their simple design allows for complete and consistent clean-in-place and vapor-phase hydrogen peroxide decontamination.
Vanrx Pharmasystems makes technologically advanced aseptic filling solutions that use robotics, machine vision, and gloveless isolator technologies to automate the packaging of injectable drugs into vials, syringes, and cartridges. The Vanrx gloveless isolator can run without need for human intervention. The workcell’s design eliminates sources of particle generation, such as aluminum crimp caps, and single-use consumables prevent cross-contamination. By eliminating glass-to-glass contact and reducing manufacturing complexity, the gloveless isolator reduces risk of product loss or recall.
Innovations in robotics can help manufacturers of aseptic drug products ensure that their products meet the long list of inspection criteria for pharmaceutical products and packaging. Aseptic products must be scanned for moving and deposited particles, fibers, and splinters. Packages must be inspected for defects including spots, cracks on the side walls or base, and defects in caps and seals.
Antares Vision, which exhibited at the Healthcare Expo, provides automated vision inspection machines for complete verification of pharmaceutical products in the production process. Antares Vision offers standalone or inline automatic machines for tablet and capsule inspection with accuracy up to 50 μm. The company’s Visual Rotating Inspectors can inspect a wide range of glass or plastic medical containers for liquids, powder, or lyophilized drugs.
Today’s robotic inspection systems can deliver small batches of reproducible inspection results without human intervention. Brevetti C.E.A. delivers automatic inspection systems for syringes, vials, ampoules, and cartridges. The company’s A1 Human-like Inspection Machine combines the advantages of motion and optics flexibility with the stability of inspection results.
1. PMMI, The Evolution of Automation (2017).