Cake and the MedTech Industry
July 22, 2019
To bake a good cake, you must get the processes right. These include mixing to the right consistency and baking at the correct temperature for the appropriate length of time – but fundamental to your success is the recipe. To create your masterpiece, you must add the right ingredients in the proper quantities. The same is true for the MedTech manufacturers producing combination medical devices.
Of course, the criticality of precision in the MedTech industry is much more important than baking a cake. The addition of ingredients for recipe-based products must be accurate and consistent to ensure product safety and good patient outcomes. Furthermore, strict regulations require complete traceability of the drug, coating or active ingredients included within a discrete device.
A helping hand
To support the MedTech industry, Critical Manufacturing has introduced a new ‘Weigh & Dispense’ module. Integrated within its future-ready Manufacturing Execution System (MES), it provides a safe and convenient way to control and track recipes, with complete records of active ingredients and full recipes incorporated within the comprehensive electronic batch record (eBR). All weighing operations are precisely controlled and monitored to ensure the highest product quality and safety.
The new module allows process/formulation engineers to set up processes which precisely guide dispensing operators to ensure all requirements of the recipe are met. Batch formulations are designed and defined with tolerances set for each product. The module covers all aspects of weighing and dispensing operations with operators informed about the need to wear glasses, gloves, masks, etc. to safely handle the ingredients, along with any handling certification requirements. All information is stored in the eBR which incorporates electronic signatures in accordance with FDA Title 21 CFR Part 11.
Weighing the benefits
As part of the MES, the fully integrated Weight & Dispense module ensures full end-to-end traceability and control of recipes. It integrates with electronic scales and incorporates automated label printing for safe and efficient operations. Mechanical processes, manual operations and paper records can all be replaced to ensure accurate data collection and increased production efficiency. Fully compliant with GxP/FDA regulations, the Weigh & Dispense module has been specifically designed to help manufacturers increase product quality and consistency, which, in turn, helps ensure product safety and good patient outcomes.
Ultimately, the accurate, consistent and traceable addition of active ingredients to medical devices is much more critical than baking a cake, the results have to be perfect, safe and reliable, every time! Critical’s Weigh & Dispense module removes human error which can cause costly mistakes, device con-compliance or the ultimate risk to patient safety.
The Weigh & Dispense module is just one capability of the Critical Manufacturing MES – a modern platform designed for Industry 4.0. Incorporating features specific to the best practices of the MedTech industry, this MES offers a pathway to embrace the huge increases in efficiency, productivity, reliability and quality to be gained from a smart shop floor. Completely modular, the MES enables integration of smart and legacy systems to provide a practical and economical route to embrace digital transformation at a rate that suits individual business needs.
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by Julie Fraser, Iyno Advisors