A well-designed, reliable raw material storage and conveyance environment can make or break a pharmaceutical manufacturing environment. Raw material storage and conveyance is fundamental to quality assurance and profitability. Increasingly, this environment also has become integral to the rigorous regulatory requirements for tracking and tracing products throughout the supply chain. To meet quality and standardization objectives, a design solution must be based on an overview of the entire process from delivery of raw materials to the manufacturing site to delivery of product ingredients to the manufacturing line. The correct design basis is predicated, particularly, on an understanding of raw material characteristics and facility conditions.
DUE DILIGENCE: STARTING A DIALOGUE
The correct design approach is practicing due diligence. Owners and their internal process engineers contribute to a solid basis of design with information about their overall objectives, constraints and future potential changes, as well as knowledge of specific issues associated with raw materials and the facility itself.
Manufacturers and vendors often have detailed information about the properties of the raw materials they supply in material safety data sheets. However, when in doubt about the properties of a raw material, the prudent engineering team always sends out samples for independent testing and verification.
Operations, quality assurance, maintenance and procurement personnel often have valuable insights about their issues, challenges and past experience with raw materials storage and conveyance systems. Experienced engineering teams communicate with them when developing and reviewing the basis of design. In fact, when an engineering team initiates dialogue with all stakeholders, they often gain unique and valuable insights that cannot be obtained in any other way.
For example, talking with operations and maintenance personnel often yields information about subtle operational parameters that can positively influence design, such as how the product is used, handling methods or storage times in intermediate bins or conveyors. There may be variations in environmental conditions that affect the material, or there can be material properties that affect handling, which may not be included with the supplier’s information.
Pragmatic engineering teams ask questions that reveal issues that might not be readily apparent, even to a design engineer. For example, O&M personnel might have noticed bridging or plugging problems that have created unanticipated maintenance or cleaning issues. As a result of this insight, the engineering team would select equipment and design the system to mitigate these issues.
They might have noticed that seals or bearings on rotary airlocks wear out because of the physical environment, causing leakage. As a result of this insight, the engineering team might include an air purge or airlocks in the bearing housing. Or they might report product clogging of the conveying line due to heat build-up in the material storage and conveyance process. In this situation, the engineering team employs air cooling in the conveyance system.
GET TO THE HEART
To get to the heart of these issues, it is essential to uncover memories about issues from months or years in the past. To facilitate the concentration required for this, engineers should interview operations personnel away from their day-to-day activities in a place without distractions, such as a conference room, for an hour or two at a time.
Recounting various design scenarios, the team starts by asking questions about the fundamentals: Quantities of raw material used today, future projections, current supply sources, current conveyance rates and their adequacy, problems in receiving materials, and so forth. Once personnel have answered these fundamental types of questions, the engineering team can go into some of the more obscure issues and problems.
Often, the engineering team can draw out the most valuable insights by asking the conceptual question, “What would you change about this system to make it better?” This question gets at some of the operational problems that are the result of overlooking a key parameter in the original design.
The dialogue should not end with the initial interview process. The engineering team provides and reviews a description of operations so that stakeholders understand how the system is going to work when it is installed and have an opportunity to offer feedback. Their feedback, especially about specific points in the operator-system interface, contributes to refinements in the final design.
This communication process is a wise investment that ultimately saves the owner time, effort and expense because it enables the engineering team to design a system that meets functional objectives with minimal operational and maintenance downtime.
STORAGE: GOOD DESIGN IS IN THE DETAILS
Understanding raw material characteristics is fundamental to good design in every component of the environment, yet even some experts fail to consider important details. Storage is a crucial aspect of the design.