Comply with strict FDA and EU regulations to ensure the safety of products for good patient outcomes.
Watch WebinarComply with strict FDA and EU regulations to ensure the safety of products for good patient outcomes.
Watch WebinarPrecise ingredients are the backbone of safe and consistent recipe-based products to ensure good patient outcomes. Manufacturers in formulation industries must ensure that the correct ingredients are dispensed in the right quantities and meet the specified formula tolerances.
Weigh and Dispense ensures that manufacturing processes for batches and entire lots meet with strict compliance requirements for FDA, EU or other international regulations, which require complete traceability of the batch components pertaining to the drug, coating, or active ingredients in a finished product.
The Critical Manufacturing MES Weigh and Dispense module allows process/formulation engineers to define the formulas for different products and provides a visual step-by-step wizard that guides the operator through the Weigh & Dispense process, using integrated electronic scales.
The system validates that the operator is trained and certified, verifies the shelf life and expiration date of ingredients and the calibration status of the scales. When dangerous substances are used in a formulation, the operator is informed of the hazards and safety equipment required to complete a process.
Weigh and Dispense unit is the heart of any operation, as even a milligram can make a huge difference.
Definition of the batch formulation, with tolerances for each product.
Definition of product hazards and safety handling requirements such as the usage of glasses, gloves, respirators, etc.
Definition of product handling certification requirements for operators.
Visual Weigh and Dispense guided process with integrated electronic scales.
Automated label printing for each dispensed material.
Complete electronic Batch Record (eBR) with electronic signatures in accordance with FDA requirements and Title 21 CFR Part 11.
Weigh & Dispense module is designed to help manufacturers increase product quality and consistency, ensuring product safety and good patient outcomes.
Fully integrated with Critical Manufacturing MES for a complete end-to-end process and history.
Reduces errors by replacing all manual calculation methods and verifications.
Provides complete traceability and regulatory compliance documentation in accordance with GxP/FDA.
Accelerates process for designing and using new and updated formulas.
Increases product quality and consistency by ensuring that products meet the required specifications.
