AKRON—Conformity in batch production in the custom mixing business is fundamental, and it is a holy grail of sorts for health care elastomers.
The implications of batch inconsistencies are acute, as they can cause major delays in the development of new materials.
A panel of experts at the Healthcare Elastomers Conference May 8 offered some advice for repeatability in the mixing process and current challenges posed by environmental regulations, including the measures potentially looking to ban PFAS chemicals.
"From a lab testing side, batch-to-batch variation can break down into two issues: is it a material issue or a manufacturing issue? We want to make sure the raw materials are consistent," said Kylie Knipp, senior technical account manager for Ravenna, Ohio-based Ace Laboratories, a rubber material testing firm. "If it is on the manufacturing or process side, then processability testing is needed.
"This is where we would start with inconsistencies."
Automation, artificial intelligence and data integrity are other remedies to avoiding batch variations, according to Khaled Boqaileh, CEO and co-founder of Kitchener, Ontario-based LabsCubed, which offers automated tensile testing equipment.
"We do not seek conformity in batch similarities, but certainly our customers do," Boqaileh said. "And this is where automation can come in to assist them ... in batch-to-batch uniformity."
Boqaileh said the complex nature of the testing processes and associated analytical data collection lend themselves well to simulation.
"Adding in a simulation piece and accelerating that piece, we know that will be the main thing," Boqaileh said. "And I would say the data integrity piece is the most important piece—not the AI piece."