IMA and OSIsoft: setting the standard in table process data to accelerate production setup.

Introduction

Every day, millions of patients around the world take life-saving medications. Taking those pills is easy; the difficulty lies in the process of producing those tablets. Tablet press settings must be carefully programmed by operators to ensure correct dosage, hardness, and content uniformity to meet regulatory compliance and pill integrity. Capsules and tablets are then subjected to a lengthy, expensive testing process for Critical Quality Attributes, CQA. A world leader in the design and manufacture of automatic machines for processing and packaging, IMA, within its IMA Active division, developed its IMAGO application to use the PI System to analyze the relationships between parameters, or set points, on the tablet press and determine optimal settings based on current asset performance. IMA and OSIsoft partnered together to create an OEM solution that enables tablet press operators to quickly program machines so pharmaceutical companies can produce consistent products and shorten testing cycles.

Tight requirements equal long setup and testing timelines

Pharmaceutical companies often produce a number of drugs, many of which require drug substance to formulate into tablet drug product by compressing powder to form tablet. Registration files for each medication, dosage, and tablet type are established with the FDA or presiding regulatory body, creating tight requirements around the tablet press process. During every production change, operators must reconfigure the tablet press according to stringent critical process parameters. Finished tablets are then tested inside of a lab and, based on results, the tablet press is adjusted.
In a variable production context, where many different products have to be processed, operators’ and technologists’ experience is critical to setting machine parameters and making the appropriate adjustments, as even the slightest change—such as weight, strength or dosage—can compromise CQA. Even the most experienced technologist may invest a significant amount of time into setting up the production for a new product, and that setup is followed by a lengthy testing process. IMA, not wanting to rely solely on operator expertise, designed IMAGO to determine optimal set points using asset performance data to shorten the changeover time. 

Setting the standard for tablet press parameters

IMAGO is a data-centric application that helps to maximize production, minimize errors and deeply understand the tableting. The software captures operator and pharmacist knowledge and uses it in conjunction with detailed machine data from the PI System and regulatory documentation. IMAGO then applies mathematical formulas to determine correlations between variables, as well as which machine parameters can influence tablet characteristics. By giving operators access to readily available setpoints for every recipe change, IMAGO enables process specialists to quickly adjust parameters such as punch distance, speed, and more. Visualizing consistency and quality with the PI System The PI System is the operations data infrastructure underpinning the IMAGO software solution. An embedded PI System collects and contextualizes real-time tablet press data and sends that information to IMAGO. The PI System makes data acquisition and contextualization simple, enabling IMAGO to run its calculations and establish parameters using reliable and current tablet press performance data. IMA uses PI Vision to align with the company’s existing software and visualization tools, creating a seamless user experience.

IMA and OSIsoft: setting the standard in tablet press process data to accelerate production setup.

Thanks to the IMAGO application and the PI System, operators can easily make adjustments to tablet press settings. Together, IMAGO and the PI System help users to determine optimal set points based on current performance and make critical adjustments to achieve a consistent output for every product. By relying on specific algorithms rather than subjective operator skillsets or laboratory samples, IMAGO and the PI System significantly shorten tablet press setup and product testing time. This ultimately prevents product deviations, reduces spend and waste, and increases yield.
The IMAGO application is just a starting point for IMA Active and the PI System. With access to real-time operations data, IMA will continue its quest
to make complex machines easy to use and set new standards in the pharmaceutical industry.