One thing all pharmaceuticals legally dispensed around the world have in common is packaging.
A final step in drug product finishing, pharmaceutical packaging at commercial scales requires a series of intricate product and packaging handling steps to prepare medicines for patients, dispensers and health care providers. Because of its complexity, packaging mass-produced drugs commercially can be extremely capital intensive.
Regardless of what is being packaged, the process is challenging operationally. Some processes can be completely automated, while others require sorting and kitting routines best left to human hands. Efficient drug packaging is technically and operationally demanding, which is why most of pharma’s IP owners outsource packaging to contract packaging organisations (CPOs).
Pharmaceutical demand spurs packaging services growth
Driven by worldwide economic growth, the global pharmaceutical industry is expanding exponentially. According to intelligence company IQVIA, the revenue of the global pharmaceutical market in 2020 stood at US$1.4 trillion and it is growing steadily.
Most of the pharma industry believes it is more profitable to outsource commercial and clinical packaging to CPOs and the contract packaging sector is expanding fast.with the market being valued at $12bn in 2020. According to Mordor Intelligence the CPO market is expected to reach $21bn by 2026, growing at a compound annual growth rate (CAGR) of 10.2% during the forecast period. Analysts note the pandemic created a significant spike in demand for vials, medicines, and other drugs.
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To accommodate this demand, pharma’s manufacturers marshalled their resources and in turn pushed their CPOs to increase capacity and throughput operationally to keep up. Further, if it wasn’t for drug packaging and the automation of the pharmaceutical packaging industry, the delivery of more than 11 billion doses of Covid vaccine to date would never have been accomplished.
How automation can aid the latest patient priorities
Relying on automated mechanised processes, digital controls and robotics, pharma’s contract packagers continue to leverage advanced technologies to execute pharma’s packaging processes and deliver these services cost-efficiently.
Patient priorities are driving pharma packaging in new and exciting directions, and many of today’s medical device combinations are adding yet another layer of complexity that automation can help to address.
To meet higher quality, cost and regulatory requirements in even larger volumes, contract packagers are expanding capacity, throughput as well as technical and operational capabilities. Many CPOs are now likely facing a series of key investment decisions about implementing automation, smarter technologies, and robotics to meet the growing demand.This trend is reflected by the tremendous growth in the market for pharmaceutical packaging equipment.
Business Research Company, which specialises in market research, said the market for primary, secondary packaging and labelling equipment in 2021 was $8.81bn and is expected to reach $13.23bn in 2025 at a CAGR of 10.7%.
Automation tactics and strategy
From the perspective of a CPO services provider, there are many factors driving automation decisions across packaging operations. These include gaps in the availability of skilled labour, the desire for throughput as well as worker environmental health and safety.
Even though complex packaging solutions can be automated with today’s advanced systems, automating them may not always be the best policy or solution. In terms of production speed, depending on the complexity of the packaging choreography, the value-add of automation (as it relates to quality and throughput) may not generate a big enough return on what can become an immense investment in time and resources.
Balancing flexibility, cost and efficiency with speed
Automating packaging processes successfully can challenge the most technically adept contract packagers. For many CPOs an effective strategy involves programming the whole production process, then walking operators through their involvement. Product changeovers are another aspect of automation strategy that must be factored holistically into the overall production and efficiency goals of the packaging process including recording output rates and material consumption. There are plenty of ins and outs, but the overall concept is to speed and de-risk the process while boosting efficiency, reliability and quality.
In spite of the pharma packaging industry’s need to automate, both the business case and the process case must be clearly defined before any capital investment is made. Each package presents unique requirements and because of that, many fully automated lines are dedicated to one product. If a particular package format has highly defined specifications and the CPO will be processing significantly large product volumes, a high-speed, high capacity and fully automated solution is likely to be highly cost-justifiable in that environment.
Whether it’s the product or the customer prompting a line change, product changeovers have a significant impact on operations and often dictate new process programming and operator training to accommodate new products. That can make a dedicated line expensive, and must be factored into automation strategy — the question is, will automating it add flexibility and aid more efficient product transitions?
Products prompt automation’s potential
The purpose of automation is to increase the packaging line throughput while reducing operator involvement. However, packaging complexity normally limits line parameters. When a drug product is comprised of several separate components the number of feeding stations required to accomplish assembly may inhibit the potential of the automation to accelerate the process or reduce error. On the other hand, if packaging a simple single vial in a box, automation can be leveraged to speed things up considerably, achieving gains in throughput capacity and reliability when fully configured with enabling automation and information technology solutions.
The variety of products and packages on the market, the business plans of the CPO, as well as the expanding needs of the industry’s clients will all factor into automation strategies and the where, when, and how to automate packaging processes. In any case, automating formerly manual operations can be challenging. With so many different dose sizes and shapes, as well as little standardisation, automating a multi-component feeding system can become complex and costly, and a “solution” for something that’s not broken to begin with.
Getting the best from people and processes
For many commercial operators in the region, including CPOs, it has become especially challenging to find workers with the necessary skills to staff operations adequately. To help fewer employees do more with less, machines are becoming ‘smarter’ and more able to support quality and efficiency goals.
Recently, there’s been an increasing focus on reimagining the human-machine interface (HMI) with wearable virtual information technologies and training tools that facilitate remote learning, machine maintenance, change-overs and quality assurance. Machine learning (ML) and artificial intelligence (AI) principles applied to robotics are quickly becoming more commonplace and these technologies are increasingly being applied by organisations across the CPO space.
In fact, orders for robots from the North American life sciences companies increased by 69% in 2020 compared to 2019, according to the Robotic Industries Association (RIA), a trade group focused on the robotics industry.
The positive impact of robots
Fast-developing robotics are finding a real place on the line. Industrial robots mechanically replicate repetitive physical operations like picking and placing and are found to be quite good at handling prefilled injector pen components or aggregating pallets. Bringing zero mental or physical fatigue robots can have a tremendous impact on both efficiency and the environmental health and safety of workers on the line.
One of the benefits of engaging a CPO is being able to defer all of packaging’s capital investment and operational complexity to an expert partner. Ultimately, the CPO industry’s primary mission is to help pharma bring products to market and patients more safely and efficiently. It’s also up to pharma’s contract packagers to strengthen this critical element of drug supply through the best means possible and automation provides that route. However, pharma is justifiably conservative and will always keep a careful watch on risk and costs. Fortunately for both pharma and its CPO partners, automation is more effective and affordable than ever and there is no doubt innovation will continue to develop to the point where most processes can be automated successfully.