The life sciences manufacturing sector has played an unparalleled role in the COVID-19 global health crisis. The spotlight quickly turned to pharmaceutical manufacturing when it became clear that the most efficient way through the pandemic would likely depend on first developing an effective vaccine and then being able to manufacture and distribute it in rapid, high volumes. The life sciences industry has always been at the forefront of manufacturing technology adoption; new therapies and medications are constantly being developed. This constant innovation creates unique challenges and opportunities.
Automating Production of the Most Anticipated Vaccine in History
When the US Government launched Operation Warp Speed to fast-track the development and distribution of a coronavirus vaccine, the industry responded. One of our customers began building manufacturing infrastructure in anticipation of an approved vaccine so they would be ready to start production immediately upon approval. Flexware provided systems integration and automation engineering remote and field support to get manufacturing operations up and running, including data collection systems and batch reporting. Our experience with automation, coupled with our background working with some of the leading life science companies, means we can support customers at all levels of the manufacturing process. From formulation, batch mixing, and filling, to testing, packaging, and labeling, we have built a long list of competencies in the life science space that includes MES, tracking and traceability, compliance and data integrity, digital transformation, and IIoT applications. Understanding the compliance processes and regulatory nature of the pharmaceutical industry is something that’s difficult to navigate, and our experience has provided us with the vocabulary and knowledge to speak to these unique challenges and educate customers on what is possible.
Managing Lifecycle Upgrades
Being able to operate a manufacturing line for as long as possible with as little interference as possible is beneficial due to the understandably extensive regulations. Once a process is validated, any change – even a simple software update – must be submitted to a review board for approval. Once approved, that change has to be implemented outside of the manufacturing environment, tested, and validated before it can be integrated. The time and costs required to do this add up fast, so manufacturing systems need to be ultra-reliable and operate for years between lifecycle upgrades.
Life Sciences Quality Control with Electronic Records and Signatures
One of our global pharmaceutical clients found itself facing a challenge that threatened the integrity of its product, so in coordination with our customer, we developed and implemented a solution that provides insight and parameters around who was interacting with the equipment. This customer required a flexible system that would make it easy for operators to make adjustments when needed but also needed restrictions in place on certain actions to prevent anything from being changed that would put the product at risk. Safeguards around a variety of key process parameters are important when dealing with therapeutics, and even a small error could taint millions of doses of potentially life-saving medicines.
The customer specifically wanted an HMI that would log who was operating the machinery and determine what functions that particular operator could perform. Depending on the level of training they have or their job functions, the operators would have different levels of clearance and, if necessary, not be permitted to perform certain functions. Flexware’s solution utilized RFID tags carried by the operators and RFID readers on the HMI displays. The system recognizes who is using the HMI and can authenticate their authority to operate the equipment based on the training they’ve received or some other predetermined requirement.
Flexware Brings Life Sciences Expertise to Every Stage of Manufacturing
If you are in need of a technology integrator with a mastery of the manufacturing floor that can bring insight to the enterprise and business operations who also has the expertise to integrate the equipment and help you turn plant-floor data into actionable intelligence, Flexware is your partner. With our added ability to write custom software applications that connect your laboratory to manufacturing and manufacturing to your warehouse, we feel that Flexware is uniquely positioned to improve your overall plant operations.
Flexware has been working with high-profile life science companies for 25 years, and during that time, we have established a track record of helping customers overcome complex productivity and performance challenges. One of the benefits that come with experience is our ability to leverage our background working in highly regulated industries and applying it in other areas where control, traceability, and compliance are critically important. Whether you’re solving a life sciences problem or working in another heavily regulated industry, we would love to hear about your challenges and explore solutions.
We’d love to hear what’s next for you.
VP of Strategic Initiatives
Husband, father to four crazy boys, and a new grandpa. Music and baseball junkie. During the weekends, you’ll find me building and fixing things. I love the country.