Pre-Weigh Station Renovation

McClure Engineering recently completed the design work for a small batch pre-weigh facility on behalf of a confidential pharmaceutical client based in St. Louis, Missouri. This specialized facility is responsible for accurately measuring and weighing small quantities of materials or products, specifically small powders that will later be mixed with large batch ingredients and used in tablet production. Given the critical role of small batch weighing facilities in maintaining product quality, this facility is regulated by the Food and Drug Administration (FDA), European Medicines Agency (EMEA), and World Health Organization (WHO). McClure Engineering, leveraging its extensive experience in designing spaces for pharmaceutical and food and beverage manufacturers, successfully developed a material transfer station suite for the small batch weigh-up system used in the production of non-sterile solid dosage medication. The suite incorporated various requirements, including temperature, humidity, and pressure cascade specifications, as well as an Airlock and a Material Storage Room.

The primary objective was to ensure a seamless process while minimizing the impact of particles on operators and complying with current Good Manufacturing Practice (cGMP) requirements. To achieve this, the material transfer station was designed to facilitate the efficient transfer of small batch raw materials from drums to the weigh-up area, effectively capturing any airborne particles and reducing potential health risks for operators. Strict adherence to industry standards was maintained throughout the design process of the suite, with a particular focus on product containment. The suite was meticulously designed to meet cGMP requirements, employing specific space pressure cascades to ensure containment of potential contaminants and prevent their spread throughout the facility.

The main challenge of this project involved weighing small batch powders without exposing operators to the powder. The design aimed to reduce air particle counts to a level a lower level for the operators. This was achieved by constructing a new cGMP Weigh Up Suite, incorporating new material transfer stations that enable product transfer and weighing batches with minimal exposure.

The HVAC system played a crucial role in maintaining a clean and controlled environment. It was designed to provide air purification through HEPA filtration, effectively removing unwanted particles or impurities from the air. This ensured that the space remained clean and conducive to the production of high-quality medications.

Furthermore, the comprehensive design included the incorporation of a collector tailored specifically to the material transfer station. This advanced system provided precise control over particle counts, further enhancing the overall quality and safety of the production process.

The project also encompassed an electrical design component, ensuring seamless communication and functionality between the various systems involved in the material transfer process, particularly the weigh-up unit.

Through meticulous attention to detail in terms of process flow, containment measures, air quality control, and electrical integration, the material transfer station for the small batch weigh-up system was successfully implemented. It provided a safe, efficient, and compliant environment for the production of non-sterile solid dosage medication, safeguarding the well-being of both operators and end-users.

Process Engineering for the Material Transfer Station

At McClure Engineering, we provide comprehensive Process Engineering services to our pharmaceutical clients, offering expertise in optimizing production processes for maximum efficiency, enhanced product quality, increased throughput, and cost reduction. Our primary focus is to ensure a safe and sustainable operating environment throughout the entire lifecycle of the process, from initial conceptualization and design to implementation, operation, and continuous improvement.

For this project, our Process Engineering expertise extended to the Material Transfer Station, where we undertake various critical tasks. Firstly, we meticulously analyzed and optimized the material handling and process flow, ensuring seamless movement of materials within the system. Secondly, we designed a robust process system that facilitates the transfer and weighing of products for batch processes, prioritizing operator safety and protection. Additionally, we addressed process exhaust requirements, including the implementation of effective dust collection mechanisms to maintain a clean and hazard-free environment. Lastly, we supported equipment validation procedures to ensure compliance and reliability.

By leveraging our Process Engineering capabilities, McClure Engineering delivers integrated solutions that enhance productivity, minimize costs, and uphold the highest standards of quality and safety within pharmaceutical manufacturing operations.