In a world that increasingly favors streamlined, uniform manufacturing practices, the production team at Diazyme Laboratories lives a decidedly not-so-uniform existence. But also, such is life in the ultra-customized medical test reagent game.
 
To explain: California-based Diazyme relies upon its enzyme and antibody technologies to develop diagnostic reagents, which are then used on a wide variety of automated chemistry analyzers. Its customers are among the leading diagnostics machinery suppliers in the world – companies that, in turn, provide equipment tasked with reading medical tests for a far-ranging roster of ailments.
 
Diazyme's reagent products, are then used for diagnosing such disparate health conditions as cardiovascular disease, liver issues, various cancers, renal disease and diabetes. Diazyme also makes serology test kits for infectious disease – including COVID-19. The diagnostic tests for these wide-ranging list of maladies transpire on an equally wide range of testing equipment – and therein lies the production problem.
 
“We’re about the furthest thing from a ‘one size fits all’ operation,” said Dr. Abhijit Datta, Diazyme’s VP of Operations. “On any given day, we might need to fill reagent solutions for five or six uniquely shaped and sized containers. So we are always looking for a compromise between speed and customization.” The issue, of course, becomes finding equipment that can handle such a wide range of containers efficiently without sacrificing quality.”
 
With an international portfolio of high-profile customers whose equipment uses differing, often proprietary reagent containers and cartridges, the question for Diazyme Laboratories became “how much automation is possible?” Knowing full well that any steps toward automation would require a highly tailored custom job, Datta and his team turned to TurboFil Packaging Machines of Mount Vernon, NY to help determine the answer. 
 
TurboFil is an equipment specialist dedicated to the design and development of liquid filling and assembly machines for the pharmaceutical, medical device, health & beauty and chemical industries, addressing some of the industry's most challenging applications.
 
TurboFil frequently collaborates with customers to develop, design and construct customized, built-to-spec machines.
 
The teams at Diazyme and TurboFil knew they had their work cut out for them, and the first machine was a sizable step in the right direction. The unit comprised a conveyor belt container transport system coupled with a Unipuck mechanism – an adjustable fixture that allowed for the handling of a wide variety of containers. The design was devised from one TurboFil employs to meet the needs of contract packagers, who are accustomed to switching frequently between container types.
 
The machine also featured a servo-driven capping system, which offered the flexibility of electronically changing the capping torque and speed. For ease of changeover, the unit also utilized tools and guiderails consistent across all container types.
 
Once the TurboFil filler/capper was up and running, the Diazyme team realized they needed something extra: specifically, a compact workstation capable of handling ultra-small containers. Building upon the successes on the initial design, the TurboFil team constructed a floorspace-friendly, semi-manual unit with a star wheel indexer. Complete with automatic cap torqueing, the machine was a significant step up from traditional benchtop units; with only two operators (a bottle and cap placer, respectively), the module achieved speeds up to 30 containers per minutes – markedly faster than conventional benchtop models.
 
Third Time’s a Charm
It was the third iteration that truly hit the mark. Building upon the progress they’d made, TurboFil’s engineering team upped the automatic ante by combining the best attributes of its predecessors, then adding additional capabilities for unprecedented robustness.
 
The monoblock design shifted manual bottle placement onto a magazine, allowing an operator to load several containers simultaneously. It kept the star wheel design for premium container handling versatility and, for exacting quality control, incorporated precision electro-magnetic force restoration (EMFR) checkweighing cells both pre- and post-fill. The servo-driven capper that had proven highly valuable remained, and a wraparound labeling station was added – one capable of applying labels to containers of different shapes, including round, triangular and even trapezoidal.
 
The solution’s key facet is speed of interchangeability: the star wheels are quick and easy to replace, and an HMI interface stores and alternates between containers and recipes intuitively and expediently. Where necessary, the system also entails unique change parts for varying bottles – but the idea was to keep these to a minimum.
 
With this solution in place, Diazyme now prepares reagent containers for up to 10,000 kits daily, despite the need to handle as many as 10 different container configurations to meet that mark.
 
And they’re not done.
 
To meet Diazyme’s growing customer demand, TurboFil is currently putting the finishing touches on another monoblock unit. It’s essentially the same as the third unit, minus the labeler – and plus one cost-saving catch.
 
“Due to evolving needs, the first machine we supplied was decommissioned,” said Deborah Smook for TurboFil. “So what we’re doing is reusing certain components from that machine to construct the latest one – including the cap feeder.” The recycled reagent machine is scheduled to be operational later this year.