Advanced aseptic blow-fill-seal (BFS) technology has been a popular solution for sterile packaging in the respiratory and ophthalmic markets for years. With the COVID pandemic, Woodstock Sterile Solutions has demonstrated that the sterile manufacturing and packaging provided with BFS can also benefit the diagnostic market.
Diagnostic tests have long been performed outside the doctor’s office, with pregnancy tests and blood glucose monitoring kits, but the pandemic increased the need for home diagnostic kits that tested for the COVID virus. Moving testing out of a controlled environment is a challenge, and companies that develop these test kits need to provide packaging to ensure the tests provide accurate results for consumers. Woodstock had not worked in the diagnostic market in the past, but we saw that our BFS packaging could offer a viable solution for healthcare companies. BFS helps to minimize the risk of human contamination, allows for precise filling, and can be easily customized to meet specific needs for the diagnostic market.
Woodstock has developed expertise in the manufacturing of ampules and vials using BFS technology over the years. Our fill-finish capabilities are in line with the requirements of the diagnostic market, and thanks to our manufacturing flexibility, we can modify our capabilities downstream to provide finishing solutions, such as in cards or singles.
Not all diagnostics interact with humans, and they don’t require the same level of quality control that our BFS solutions do for the respiratory and ophthalmic markets. This means that our systems can easily meet the quality requirements for the diagnostics market.
In addition to providing quality, another important consideration for customers in the diagnostic market is controlling the fill volume. Healthcare providers have specific requirements for the amount of solution that should be included in each vial in order to give consumers the correct dose. Manufacturers who invest in state-of-the-art equipment and modern production processes, like Woodstock Sterile Solutions, can optimize the filling of BFS vials, ensuring that patients receive precise doses without any waste. This approach not only maximizes the quality and effectiveness of treatments, but also increases cost-effectiveness and profitability for the manufacturer. At Woodstock Sterile Solutions, we can fill each container precisely, meaning that we can produce more vials with the same amount of solution.
We recently completed our first project for a customer in the diagnostics market, using our BFS packaging to hermetically seal at-home COVID tests, and there were some challenges we learned from along the way.
First, our client was eager to move quickly, which isn’t the typical process in the respiratory and ophthalmic market. We also found that their testing requirements were different, as they had requirements focused on different quality attributes for the container than those that are typical of other markets. Lastly, there were different procedures that needed to be followed and different paperwork that needed to be developed. We worked hard with our team to align our process with the needs of the client, and to deliver the finished product on their timetable.
The result: From the time we signed the contract until we released the first batch of diagnostic tests it took a total of five months. For the respiratory and ophthalmic markets, the process typically takes nine to 12 months, due to more rigorous requirements. Our team was able to quickly adapt our manufacturing process, maintaining our high standards within our existing quality systems while adjusting within the boundaries of the diagnostics market to meet the needs of our customer.
This project reinforced the importance of collaboration with the customer, understanding their requirements and being transparent about our capabilities. We were able to build a strong foundation within the diagnostics market and established a strong relationship with a key partner in the industry. We are now well positioned to expand in the diagnostics market and are determining next steps in modifying our manufacturing facility to accommodate the increased demand.
