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Tablets & Capsules March 2019 15 have these capabilities and may even have dedicated analytical testing departments. "Many pharmaceutical companies, particularly those in the small to mid-size range, do not have the expertise or laboratory capabilities in-house to perform all the neces- sary analytical tests," said Richard Sidwell, vice president and chief scientific officer at Recro Gainesville, a Georgia-based CDMO. "This is especially true for new development projects, which often stretch their organiza- tions into new technologies or analytical areas." Even larger manufacturers with in-house testing capa- bilities may still choose to have a contractor perform these services. The Grand View Research market report states, "Not all companies have an infrastructure that is compatible for all types of analytical testing. Hence, out- sourcing these operations is the most suitable option, which also helps save time and cost," [2]. "For solid dosage formulations, having the right equip- ment is essential to properly test materials and solve for- mulation and manufacturing problems," said Robert Sedlock, director of technical training at Natoli Scientific, Telford, PA. "A solid dosage lab like ours has all the equipment necessary to characterize materials, run compaction simulations, and alter the formulation if needed." Should a manufacturer decide to invest in test- ing equipment, they will have to account for the time it takes to buy, install, and validate the units. This can slow a product's entry into the market. According to Kerry Johanson, chief operating officer at Material Flow Solutions, Gainesville, FL, even if you have analytical testing equipment, your employees may not have the expertise to apply the results to real-life situ- ations inside a plant. "It's important to understand the materials of a formulation before you can solve a formula- tion problem or optimize a manufacturing process. Analytical testing can also ensure that instruments and equipment you purchase for a project will work with the particular material you're manufacturing." Another issue is space. Consulting firms and contract organizations have dedicated labs and facilities to per- form analytical testing and troubleshooting, which can be difficult and risky for pharmaceutical manufacturers to achieve. "Adding permanent capacity to accommo- date new development projects can be quite expensive and time-consuming," said Sidwell. "W hen the uncer- tainty of project success is still high, it is often more pru- dent to leverage someone else's capacity. If the project is unsuccessful, clients can simply end their contract, instead of having to repurpose or unwind added capacity of their own." Sidwell also points out that manufacturers who are already outsourcing other aspects of product develop- ment may find it more convenient to outsource analyti- cal testing to the same organization. "Conducting ana- lytical testing and other services at separate locations opens the door to a range of risks, logistical problems, and delays, such as shipping, communication, and con- tract and vendor management." © 2019 Donaldson Company, Inc. Donaldson.com 800.365.1331 © 2019 Donaldson Company, Inc. Donaldson.com 800.365.1331 Make Donaldson your first call for replacement filters and parts—no matter the collector. We stock over 90,000 filters and replacement parts including: Live, expert service specialists can help you determine the size and style you need within minutes. Plus, our Ready 2 Ship program means your order is out the door within 24 hours. Call now to order your replacement filters and parts. n Cartridge filters n Bag filters n Pleated bag filters n PowerCore ® filter packs n Panel filters n Parts (hardware, motors, cages, rotary valves, ductwork, controls, fans, and more) FINDING THE RIGHT REPLACEMENT FILTER IS A PIECE OF CAKE