Weigh and Dispense

Precise ingredients are the backbone of safe and consistent recipe-based products, including combination Medical Devices. Weigh and Dispense supports manufacturers in complying with strict FDA, EU or other regulations to ensure the safety of products for good patient outcomes. The regulations require that manufacturers have complete traceability of both the discrete device and the corresponding batch components pertaining to the drug, coating, or active ingredients in a finished device.

The Weigh and Dispense module help manufacturers to accurately and safely control and track active ingredients with specific recipes and manufacturing procedures. The weigh and dispense process is the core of the electronic Batch Record (eBR).

Critical Manufacturing MES Weigh and Dispense module allows process/formulation engineers to set up processes. These then precisely guide the dispensing operators, using the correct recipe requirements for complete and strict adherence with safety regulations. The module tightly controls all weighing operations.

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Functionality provides:

Design and definition of the batch formulation, typically in terms of percentages, with tolerances for each product

Definition of product security handling requirements such as glasses, gloves, masks etc.

Defines product handling certification requirements for operators

Weigh and dispense dispatch list for each order

Integration with electronic scales

Automated label printing

Complete electronic Batch Record with electronic signatures in accordance with FDA requirements and Title 21 CFR Part 11

Comprehensive support for bar code scanning, mobile devices, electronic scales and integration with MES and ERP

Benefits of Weigh & Dispense

Fully integrated with Critical Manufacturing MES for full end-to-end process and history

Major efficiency gains by replacing all mechanical and manual methods and paper records to ensure accurate data collection

Complete traceability and regulatory compliance documentation in accordance with GxP/FDA

Expedites design-time and run-time for on-time delivery to manufacturing

Increases product quality and consistency to ensure patient safety