Pharmaceutical manufacturing: The process behind the pill
For most, taking a pill is easy. Behind that pill, however, is an intricate process, as pharmaceutical manufacturers know. As pills go through the tableting process, there are rigorous standards to ensure quality. Tablet press settings are particularly important. Manufacturers must carefully program tablet press settings to ensure the correct CQAs like content, hardness, weight, thickness and content uniformity to meet regulatory requirements.
Overcoming tableting challenges
IMA, a world leader in the design and manufacturing of automatic machinery used in processing and packaging, is no stranger to the significant set-up time required with any tablet press. Beyond the initial setup, the testing process is rather lengthy as well. Each medication has registration files that outline tablet type, dosage, and rules set forth by the FDA or presiding regulatory body.
During every production change, operators must reconfigure the tablet press according to stringent critical process parameters. Finished tablets are tested in a lab and then manufacturers adjust tablet press processes again as needed. Even the slightest change in weight, strength or dosage can completely compromise drug quality. This entire process relies heavily on operator insight and experience, which is difficult to standardize.
IMAGO and the PI System put optimal set points and short setup times within reach
IMA Active division recently developed its IMAGO application to use the PI System to analyze the relationships between process parameters on the tablet press to determine optimal settings based on current asset performance.
This data-centric application helps maximize production while also minimizing risk of human error. The software captures operator and pharmacist knowledge and uses it in conjunction with detailed data from the PI System and regulatory documentation. IMAGO then applies mathematical formulas to determine the correlation between variables as well as machine parameters that will influence the final product characteristics. By giving operators access to readily available set points for every recipe change, IMAGO enables process specialists to quickly adjust parameters throughout the tableting process.
“Before, tablet press machines relied on human experience for setup and adjustments,” said Marco Minardi, Automation Manager at IMA Active. “Now, with the PI System and IMAGO, technologists have rapid access to optimal set points, in an intuitive application, shortening the setup time while creating consistent, reliable medications.”
Petter Moree, industry principal for life sciences and pharmaceuticals, added that this application is “enabling plug & produce in the pharmaceutical industry by leveraging the industry standard infrastructure.” On the back end, “the embedded data collection and contextualization platform, the PI System, will drive value, data integrity, and scalability with additional equipment and systems to come”.
With access to real-time operations data, IMA Active will continue its quest to make complex machines easy to use and set new standards in pharmaceutical manufacturing.
The PI System enables 25 of the top 25 global pharmaceutical companies to help keep the world healthy and safe.