What’s the key to ensuring sterility when packaging prefilled syringes?
The prefilled pharmaceutical packaging sector has grown in leaps and bounds in recent years, driven by the rise of parenteral drug delivery and the introduction of new ways for patients to self-administer injectable formulations safely.
This growth in the use of injectable drug delivery, such as prefilled syringes, brings challenges for pharmaceutical companies, particularly when it comes to maintaining a sterile environment when packaging the products.
In this article, Boy Tjoa, Director of Operations at Tjoapack, explores the challenges of maintaining sterility when packaging prefilled syringes and discusses how to tackle the complex requirements associated with parenteral products.
The injectable drug delivery market has been growing steadily in recent years. Its robust growth during the last half-decade shows no sign of slowing any time soon.
In fact, according to market analysts, the value of the sector globally is expected to increase from $362.4 billion in 2016 to $624.5 billion by 2020 at a compound annual growth rate (CAGR) of 11.5%.1
The growth in this delivery method has primarily been driven by the administration of biologics to treat diseases such as cancers, autoimmune disorders and other rare and chronic conditions.
Worldwide growth in diagnoses of these diseases have boosted demand for monoclonal antibodies and, in turn, biologics.
Boy Tjoa, Director of Operations, Tjoapack
To help patients access these parenteral drugs, developers have been busy introducing new technologies to allow self-administration in the home or other non-clinical settings, something that has markedly increased during the current global pandemic.
Ease of use for patients is an ever-present conundrum for drug developers, particularly when it comes to parenteral drugs; patients need to be able to administer the drugs themselves, freeing up clinicians’ time and resources.
In the case of biologics and injectable drug delivery, the answer, increasingly, is prefilled syringes. Already charged with the drug product, they are easy for patients to use themselves in their daily lives, limiting mess and waste, and ensuring that the correct dose is administered.
However, the growth in the popularity of prefilled syringes poses challenges for pharmaceutical companies, particularly when it comes to maintaining a clean, sterile environment while packaging them.
Failure to achieve this goal can have significant negative ramifications for the patients using the drug, making it vital that companies implement solutions that maintain the high hygiene and sanitary standards required in pharmaceutical manufacturing.
There are also additional complexities added by the variation in components and the unique storage requirements associated with these products, such as cold chain.
The secondary packaging for prefilled syringes differs considerably from that of other dosage media. The variability of packaging design for the dosage form means that the process can be far more complex than other formats.
The plunger rod and label are the only components that are always present, regardless of the syringe. Added to these, there may be either a staked or loose needle, a safety device and, sometimes, an additional finger flange on the safety device — or just a backstop depending on the needs of the drug or the patients using it.
In addition, it’s not uncommon to find additional inserts, such as alcohol pads or multiple leaflets/booklets that all add complexity to the packaging process.
All of these elements need to be carefully considered and companies must have the required flexibility to make one or more additions or to remove elements altogether.
This means that there are multiple points in the process that must be managed and monitored to maintain product safety and sterility, minimise the risk of contamination, ensure that all the necessary components are included and that the drug product is stored in the correct conditions.
Failure to take these factors into account could lead to unsafe batches being released that are unfit for patient use.
So, what should pharmaceutical packagers consider to ensure a clean environment to package prefilled syringes? Flexibility is key!
It is imperative that they carefully design their production line and process to ensure that it’s capable of handling many different syringe packaging designs and, more crucially, to maintain optimum hygiene regardless of the product being packaged.
When talking about secondary packaging for prefilled syringes and sterility, it’s necessary to take the same precautions that you would when maintaining a clean environment for the secondary packaging of other dosage forms.
However, additional safety procedures must be observed when it comes to handling; the products involved are often more toxic than those in other dosage media.
As such, it is vital that there are good spill responses in place in the event of a breakage to protect line operatives and minimise the impact of the spillage on the surrounding products on the line.
Following packaging, it is crucial that companies have the equipment and protocols in place to ensure and maintain cold-chain storage and transportation of the filled syringes to ensure their longevity as they are shipped to patients.
Again, storage and transit conditions must be able to safeguard the syringes from breakage to minimise the risk of exposure to the workers handling the products.
The challenge of maintaining a sterile, hygienic environment and managing the complex packaging needs of prefilled syringes doesn’t need to be tackled by pharmaceutical companies on their own.
They can seek help from packaging experts, in the form of contract packaging organisations (CPOs). For a long time, the secondary packaging stage has been viewed simply as an integral part of the broader drug manufacturing operation.
However, the complexities of packaging specialist dosage forms, such as prefilled syringes, mean that expert support and capacity are often required, which some companies may not have in-house.
To address this gap, CPOs are playing a more prominent role in delivering prefilled syringe packaging services; the global sector is forecast to grow to $188.79 billion during the next 7 years.2
CPOs offer a number of key advantages to projects when it comes to delivering efficient packaging services for new dosage forms such as prefilled syringes.
Possessing in-depth knowledge of the market and regulations, CPOs can provide tailored solutions to meet customer-specific needs.
By working with CPOs, the developers of prefilled syringe drugs can benefit from their experience and expertise, taking the heavy lifting out of maintaining a sterile packaging line that complies with stringent global and local safety legislation. Ultimately, it can add significant value to their business.
In short, the future looks bright for the prevalence of prefilled syringes as a drug dosage form. Given their ease of use by patients in a variety of settings, they offer incredible potential for drug companies looking to maximise growth in the coming years.
With this in mind, it’s even more important that manufacturers take steps to optimise safe handling of these products on their lines to ensure compliance with legislation and maintain the highest quality standards.
By partnering with CPOs as strategic outsourcing partners for their prefilled syringe secondary packaging, companies can achieve this goal by benefiting from years of specialist expertise in packaging for these challenging formats.
Access to this support will help pharmaceutical companies to navigate this complex landscape as efficiently as possible, ensuring they are taking advantage of the growth opportunities while continuing to meet the stringent regulations across the global pharmaceutical market.