Integrated DNA Technologies (IDT) is a leader in life sciences manufacturing and developing products for the research and diagnostic market. It serves the areas of academic research, biotechnology, clinical diagnostics and pharmaceutical development. IDT synthesizes and ships an average of 36,000 custom products per day and serves more than 86,000 customers worldwide.

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With the challenges of double-digit growth; expanding into several new product markets and fulfilling FDA traceability requirements, IDT knew it needed a new business system.  Ultimately IDT selected Microsoft Dynamics AX ERP 2012 and implementation partner Edgewater Fullscope.

According to Aaron Warner, CIO, “From an integration perspective, IDT has easily combined Dynamics AX ERP with existing custom software used in our complex manufacturing environment. The consistency of interface design and familiarity of other Microsoft products greatly simplified the training requirements. Ultimately, we found the total cost of ownership to be lower than our projections.”

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Fullsope’s new series of Process Accelerators makes it easy for manufacturers to employ potency pricing procedures.

With potency pricing, a manufacturer sets purchase pricing and inventory value based on the received material’s active concentration (i.e., potency) or some other quality-controlled values (fat content, protein content, etc). This is a key requirement for process industries where low margins require costing and margin analysis at the lot level. It’s required in industries such as dairy and feed which measure and pay based on butterfat content or protein content, and is standard business practice for pricing precious metals. This is equally applicable to any process industries company that manufactures or distributes high valued, active ingredient based products.

Common enterprise resource planning (ERP) solutions price materials according to linear pricing schedules, but in process industries, multiple factors come into play in determining compensation for a supplier. The Fullscope Process Accelerators:

  • Provide a flexible formula that allows companies to pay suppliers based on actual quality results for potency.
  • Assign actual inventory value for each inventory lot that is potency-controlled.
  • Help record more accurate margins based on the actual potent value of materials sold or consumed.

Using milk again as an example, a typical dairy producer will send a tanker with paperwork specifying that this tanker of milk has a certain stated butterfat and protein content. But the manufacturer, the buyer of the milk, wants to run their own tests because the agreement is that payment will be made based on the manufacturer’s quality analysis result. Or, payment could be based on the average of the milk vendor’s value and the manufacturer’s value: the buyer and supplier can meet halfway.

A typical ERP solution pricing scheme won’t address that scenario.

Fullscope Process Accelerators use an advanced pricing formula that gives the manufacturer the ability to define which characteristics are going to drive the price. It can be the concentration alone or multiple characteristics of an incoming shipment. The formula applies equally well to chemicals, food, or metals. The system will calculate a price and hence the inventory value based on those user‑defined characteristics.

A large part of our Process Accelerators’ elegance and utility comes from flexibility: even though the metals industry will use a different formula than those used by the dairy or chemical industries, each can build their own formulas easily.

Lot Genealogy and Traceability

Lot genealogy is the ability to automatically transfer properties of a raw material lot to a manufactured item’s lot. An effective lot genealogy system must transfer key lot characteristics. For example, a manufacturer may use a metal coil that has a certain alloy content and mechanical strength. If this coil is cut into a smaller one, those properties need to follow the smaller coil as well. Sometimes this is referred to as parent-child inheritance. A manufacturer wants the characteristics from the original coil to carry over into the product that ultimately contains the small coil. They also want to be able to transfer shelf life information. There are rules about combining materials with different shelf lives into one package. One should take the earliest individual material shelf life and make that the expiration date for the overall product.

Genealogy applies to two things: first, the attributes or characteristics, and second, the shelf life. Both need to be carried over. In a formula where the raw material defines the shelf life or the characteristics, the finished good, which will consume the raw materials, needs to inherit the properties of its raw materials.

Here’s a bit of terminology: an end item is a typical formula where something is consumed and made into a finished good. A co‑product occurs when an end item is produced, but there is also a co‑product that can be used for some other purpose—either to resell or to use in another production process. Take, for example, a jumbo roll of paper 60 inches wide. A manufacturer may cut five 11-inch rolls out of it, leaving 5 inches of trim. That trim is a co-product. It’s still good and can be reused or re-blended to make more paper.

Fullscope Process Accelerators set lot genealogy at the formula level and allows inheritance for both end items and co-products.

Product Sequencing

The Process Accelerators also add key capabilities to Dynamics AX in this arena. It adds functionality that considers demand for a product having a certain characteristic such as color, flavor, or package size that can prove problematic if produced out of sequence; or, conversely, it may prove more cost effective if sequenced properly.

Consider paint production. Sequencing from light to dark (white-yellow-green-blue-red-black) can minimize cleanup and setup during changeover. The Fullscope Process Accelerators allow manufacturers to define an optimum sequence based on prioritization of simple or complex characteristics of the product.

So What’s the Takeaway?

Process manufacturers focus their business activities around the development, manufacturing, assembling, and selling of products and the delivery of related services. The defining characteristic of process manufacturing—namely, that once a process manufacturer produces a product, that product cannot be reduced back to its constituent parts—makes control of the manufacturing process critical and risk-intense.

By providing more powerful functionality to Microsoft Dynamics AX ERP, Fullscope Process Accelerators help strengthen the already strong position of Dynamics AX among mid- to large-sized process manufacturers in the chemical, pharmaceutical, food processing, pulp and paper, metals, and cosmetics/health and beauty segments. It does so by leveraging three key areas—potency, lot genealogy, and product sequencing—to mitigate risk, provide more efficient and effective control of the manufacturing process, and improve both asset valuation and margins to better compete in a demanding global marketplace.

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

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

Companies in pharmaceutical and life sciences manufacturing share a technology requirement for a strong enterprise resource planning (ERP) system to enforce the common principles of validation projects. The goal of these validation projects is to demonstrate consistent, secure and traceable transactions for any product throughout all stages of its lifecycle. By examining three key pillars of applications validation, the importance of the underlying ERP system becomes evident.

Consistent Processes: Life sciences and pharmaceutical companies depend on ERP systems to help maintain consistent and repeatable quality. First and foremost, the recipes (the formula or bill or material [BOMs] and the routings) must be approved and locked into place so that when production is launched, only the authorized recipe is issued. These recipes are tied to specific documents called “operations procedures” which outline the specific materials, quantities and processes necessary to make a consistent quality product. The recipes require valid quality control testing with operational tie-ins to ensure an intermediate meets the specifications before it moves to the next operation. Any raw material, intermediate or finished product that is tested and falls outside of the pre-defined specification must immediately generate a non-conformance alert that is sent to internal stakeholders. An authorized formula, tied to its approved operations document, tied to an internal quality management application, is the first step to maintaining consistent processes.

Secure Processes: The CFR Part 11 compliance code addresses security.  ERP applications help support security requirements by applying electronic signatures to insure authorization for certain business process steps. For example, many life sciences companies lock down their formulas or BOMs in order to comply; and in most cases, authorized individuals can look and review formulas, but not change them. Electronic signatures can add another level of password requirement, so if someone tries to change or update a formula, a pop-up window requests an additional password. Electronic signatures frequently are used with formulas, BOMs, routings, quality specifications, and operations procedure documents.

Traceability:  The final pillar of control is the ability to track all components of the product from its raw material purchase through work in process to the final customer ship-to location. Many pharmaceutical manufacturers have co- and by-product issues, and some split and merge lots during the production process. It is essential for an ERP application in companies with highly regulated environments to manage both discrete (medical device manufacturing), as well as process (pharmaceutical and life sciences manufacturing) production requirements.