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Weigh and dispense procedures are a critical step in the pharmaceutical manufacturing process to ensure product quality and demonstrate regulatory compliance. Manufacturers use these procedures to ensure correct amounts of raw materials are used in the production of drugs and medicines in accordance with the master batch record.
While important, a weigh and dispense prodcedure is generally a manual, time-consuming process that can be prone to human error. Investing in digital solutions provides a number of key benefits, making pharmaceutical manufacturing more efficient and accurate in an industry where there is no margin for error.
In this post, we’ll review what a digital weigh and dispense procedure can look like for your operations, as well as the benefits that come with digitizing this critical step of the pharmaceutical production process.
What is weigh and dispense and why is it important?
Weigh and dispense involves obtaining a specific amount of raw material from its source container and transferring it to other designated containers. These material aliquots are the starting point for production in a plant or even recipe and formulation research in the laboratory.
Manufacturers in formulation spaces must ensure that the precise amount of the correct ingredient is added to the product formulation. Even slight deviations in the formula can lead to variations and potentially hazardous products.
This is even more critical in the pharmaceutical industry because a single product can have various parts, each requiring different formulations. For instance, there’s a recipe for the active ingredient in a drug. However, the drug might require a preservative or coating, which also has a complex formula. Weighing and dispensing the precise aliquots ensures product integrity and quality.
Besides meeting in-house quality thresholds, weigh and dispense procedures are important for ensuring manufacturers are compliant with regulatory bodies like the U.S. Food and Drug Administration (FDA). Whenever a pharmaceutical product is being created and the various ingredients are measured out, a record must be made to reflect that the material quantity aligns with the approved formulation and is reflected in the batch record for that production run.
Additionally, the conditions under which the materials are measured or weighed must also be considered as reflected in the FDA’s guidance for Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Automate data collection and streamline compliance activities
Guid operators through weigh and dispense procedures and integrate with ERP systems and IIoT to automate your procedures.
Weigh and dispense in practice
Typical pharma manufacturing operations consist of condensed production runs featuring numerous changeovers because of the different products being created. As such, weigh and dispense can be quite complex because each product batch requires precise measurements before the respective run.
Compounding the situation is the fact that pharmaceutical product recipes contain various kinds of raw materials. They can be solid pellets, powders, or liquids with different viscosities. These materials also require various safe handling techniques to eliminate hazards and cross-contamination.
Furthermore, employees must know how to operate diverse measurement equipment and handle different personal protective equipment. As such, weigh and dispense procedures require considerable technical skill and effort.
Manufacturers with traditional production techniques rely on manual and mechanical weigh and dispense procedures. This results in a lot of manual, paper-based record-keeping, making the process more challenging.
Benefits of digital weigh and dispense procedures
More and more pharmaceutical manufacturers are embracing technology across various stages of their production processes. Pharma 4.0 has ushered in robust digital solutions to manage manufacturing processes. Weigh and dispense procedures are yet another area where pharmaceutical manufacturers could benefit from digitization. Some of the key benefits of digitizing weigh and dispense include:
Comprehensive material verification and control: Digital weigh and dispense tools can integrate easily into systems of record, enabling proper material verification and management.
For instance, the software allows operators to follow the Bill of Materials (BOM) more accurately. In addition, these tools possess verification capabilities like code scanning and automatic label generation and printing, ensuring that the operator works with the correct materials.
Additionally, integration with the BOM ensures that the correct amounts are weighed and dispensed through automated scale control and IoT integrations.
Reduction in errors: Digital tools negate the need for physical, paper-based record-keeping to document material weights and processes. This eliminates one of the biggest potential sources of error in the production process and ensures the data is available for review by internal quality teams or regulators as needed.
Additionally, digital weigh and dispense tools facilitate accurate and seamless inventory reconciliation, eliminating mistakes that could seep into other facets of the operation.
Streamlined production processes: Integrating weigh and dispense procedures with digital work instruction tools helps simplify the pharma production process in various ways. For instance, these tools are capable of defining batch formulas and tolerance for each product.
Additionally, the integrated solutions list and define the appropriate safety gear and procedures required during the weighing and dispensing process. Furthermore, user-friendly digital work instructions help to guide operators using proper, approved techniques.
More manageable regulatory compliance: Digital weigh and dispense systems enable manufacturers to adhere to the rules and regulations set by governing bodies. By using a digital system to conduct weigh and dispense processes, manufacturers are able to easily document these steps of the production process and ensure the final product is aligned with the master batch record.
Additionally, digital tools feature remote authorized and centralized access, allowing manufacturers to easily provide compliance auditors with relevant documentation as necessary.
How Tulip can help improve weigh and dispense
Using Tulip, manufacturers are able to quickly and easily build apps that help guide operators through their weigh and dispense procedures.
Using a digital interface, operators are able to engage with digital work instructions to ensure scales and measuring devices are correctly calibrated and no steps in the process are missed.
Additionally, Tulip can integrate with existing systems to keep track of material quantities and inventory in real-time. Having a seamless, integrated system of apps provides businesses with end-to-end process visibility and a digital audit trail of every ingredient and step that went into producing the final product.
If you’re interested in learning how Tulip can help improve your weigh and dispense procedures, reach out to a member of our team today!
Improve quality and streamline compliance with Tulip
See how Tulip can help digitize your master batch records to streamline compliance and increase productivity.