Responding to customer demands for robotic applications for primary packaging of cell and gene therapies, Steriline introduced its new robotic nest filling machine at Interphex 2023.
 
The robotic systems are designed to provide a high level of safety and flexibility for the production of toxic and non-toxic drugs.
 
Steriline has been supplying many small batch, highly flexible systems for oncology products and small batch CDMOs.
 
James Rorke, vice president North American operations Steriline, told Contract Pharma that in the past customers would often need to scale up from their development department.  “A customer can have internal R&D that they are doing very manual processes to create very small batches – and often they will perform smaller batches on a higher throughput machine. In doing so, there can be considerable losses as these higher throughput machines often require a minimum volume of containers and closures – say 2000-3000 vials that are often lost.”
 
Rorke said that feedback from customers regarding robotic systems has been positive and that the new technology is ideal for customers needing to quickly change over their product from one batch format to a different batch.
 
“Traditionally it has taken a very long time to do that,” said Rorke. “A couple of hours, a couple of days. Sometimes, a week before they can turn the line over to be ready for a different product or a different format size. With our robotic systems we are able to bring that down to within hours.
 
In addition, Rorke said that the robotic technology is extremely cost effective from an uptime point of view and the number of batches through a machine per year is much higher.
 
“And when you’ve got small batch, high value product, you are able to bring more batches through in a month, in a year and in a quarter. And with that very high valuable product and being able to capture the yield being as high as we can get good product into good vials, the ROI on that is very fast.”
 
Rorke pointed out that the introduction of isolator technology in the past 10 to 15 years, has really brought the operator away from the process. “That has been the biggest step forward in aseptic processing has been in isolator technology. As that advances we are doing less and less aseptic interventions in a batch process.”
 
Steriline’s systems are also designed to reduce the risk of human error and improve overall quality. 
 
According to Rorke, the operator is the number one source of contamination in an aseptic process. “When we can remove the operator from aseptic interventions our sterility assurance rises, if we are able to remove the operators from even being in contact with the process as we do in isolators, that increases sterility assurance considerably.”
 
Rorke said that the company is launching several different products at Interpack next month including a robotic 3D control and picking solution, a new servo platform filling machine, and a robotic assembly system for volumetric pumps.