Potency is the concentration of an active ingredient and is typically expressed as a percentage of a batch or as a multiple of the standard or usual potency.

Process manufacturers purchase products that have a certain active ingredient; for example, a drum of raw material whose potency is 75 percent means that 75 percent of the material in the container is active. The balance is filler or an inactive ingredient such as water or some other stabilizer that makes storage, use and transfer of the active ingredient safe and possible.

What manufacturers really care about is how active the ingredient is: its potency. Process manufacturers pay their raw materials vendors based on the concentration of what they receive. All production recipes are based on a specific nominal concentration of the material being used; inventory is valued based on concentration.

Fullscope’s Process Accelerators for chemical, food and beverage and life sciences industries extend ERP system Microsoft Dynamics AX by adding a number of fields around potency to improve its definition and automate its use in the manufacturing process. Key among these fields is “base attribute,” a generic term that refers to the key active characteristic of the product. Another is whether the attribute is fixed (i.e., can it or can it not be altered after the value of the base attribute is set?). A third is “adjustment principle,” which indicates which type of potency calculation or concentration adjustment (difference additive, compensating ingredient, or filler) has been used for the recipe. Finally, how the attribute value is to be recorded (e.g., inventory receipt or lab verification) is documented.

At the formula level, the Process Accelerators allows a target concentration to be set with the Dynamics AX ERP system. If what is available in inventory does not meet the established concentration of the recipe during batch production, the Process Accelerator will suggest adjustments accordingly based on the actual concentration of the selected active ingredient.

In the process industries, there are three types of concentration adjustments: one is called “difference additive,” simply consuming more or less of a material based on its concentration; a second is called “compensating ingredient,” where a quantity of a second ingredient is added according to whether the concentration of the active ingredient is over or under specification. (For example, water is added to compensate for the level of acidic acid in vinegar production.)  The third adjustment is simply adding “filler.”   Consider prescription medication. An ibuprofen capsule may need to be 300 mg, but the active ingredient (i.e., ibuprofen) is not 300 mg. Filler is added to the active medicinal ingredient to comprise the 300 mg capsule.

Fullscope Process Accelerators use this information to provide Batch Balancing to speed and improve production. In Dynamics AX ERP, a batch formula is defined interactively based on the concentration of a key ingredient or ingredients. The Process Accelerator picks inventory lots based on current potency, automatically calculates the required active ingredient, determines the quantity needed for the compensating ingredient or filler, and finally creates a material consumption transaction based on the adjusted formula.

This is a very common scenario in the food industry, where, for example, a manufacturer is producing a batch of yogurt. If the butterfat content of the milk is more or less than required, a quantity of water or skim milk needs to be added. For a host of reasons, companies don’t want the operator to have to do the math for that calculation. Therefore, the Process Accelerators automate the process and makes it simple for the operator to come up with a properly balanced set of ingredients. As each batch is launched, each Process Accelerator provides a screen for the operator that shows every ingredient and its actual concentration. It shows batch number, quantity, and attribute value. Depending on which inventory batch or lot is selected, when the operator hits a button to balance batch ingredients, the system automatically rescales the formula based on the lots selected. This procedure helps ensure quality, reduce costs, and eliminate waste.

Watch Next Month for:  Potency Pricing, Lot Genealogy and Traceability, and Product Sequencing

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Why deep industry functionality is important for chemical, food and beverage and pharmaceutical companies

While the process manufacturing market is typically categorized as large and mature, it remains one of the most competitive and dynamic segments of manufacturing. In today’s frenetic global markets, process manufacturers must evolve to meet the challenges of changing market demands, the increasing commoditization of products, and the volatility of pricing in energy and raw materials.

Industry analysts define process manufacturing as in the middle of a transformation in which established systems with deep functionality on older technology are being displaced by more sophisticated and agile systems. A modernization is clearly underway.

The stakes have never been higher for process manufacturers as they replace or upgrade their systems: they need to boost quality, efficiency, safety, and regulatory compliance for maximum productivity and process control. For the major process segments including chemicals, pharmaceuticals, food processing, pulp and paper, cosmetics and metals (industries whose business model is typically high volume, low margin), the ability to improve margins and to cost product and inventory based on the active ingredients central to their recipes are key to maintaining and improving competitive vitality.

Microsoft Dynamics AX is a leading ERP system for process manufacturers that offers broad and robust functionality, and it delivers low TCO through integration with other Microsoft products and technologies.

A new offering from Fullscope takes industry functionality to a deeper level. New Process Accelerators for Microsoft Dynamics AX provides powerful and detailed capabilities to help food and beverage, chemical and pharmaceutical manufacturers achieve the following:

  • Manage active ingredients throughout their operations by enabling them to buy raw materials and cost finished goods more precisely by potency.
  • Scale formulas up or down, automatically, by the identification of potent ingredients.
  • Track lot inheritance.
  • Define product sequencing, which is evaluated based on multiple characteristics, to reduce downtime and changeover costs in the production schedule.

Each Process Accelerator has been designed to address complex processes through an easy interface to automate activities as much as possible to reduce error.  Each one also provides flexibility for a manufacturer’s procurement, design, and regulatory compliance personnel so that they can easily value their inventory of materials for potency-dependent products, address factors that influence production, and trace with precision what was used in the production process. The idea is to automate processes for production and traceability as much as possible.

The Fullscope Process Accelerators for each industry integrate with the Process Industry layer of Microsoft Dynamics AX and provides new functionality concentrated in three basic areas:

  1. Potency, including automated batch balancing for raw materials and potency-based purchase pricing
  2. Lot genealogy
  3. Product sequencing

This article uses the word “potency,” but some process industries may use the terms assay, concentration, or even others. The underlying technology in the Process Accelerator supports these potency-like types of requirements found across the chemical, food and beverage and pharmaceutical industries.

Coming next month:  The Power of Potency