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1. Introduction to manufacturing laboratories

According to McKinsey & Company, the U.S. manufacturing industry represents only 11 percent of U.S. gross domestic product (GDP) and eight percent of direct employment, yet it "makes a disproportionate economic contribution, including 20 percent of the nation’s capital investment, 35 percent of productivity growth, 60 percent of exports, and 70 percent of business R&D spending." These categories of economic contribution are important as many of them indirectly point to how the work of laboratories is interwoven within the manufacturing industry. As we'll discuss later in this chapter, manufacturing-based laboratories primarily serve three roles: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security (e.g., through exports and trade). We can be sure that if U.S. manufacturers' efforts represent huge chunks of total business R&D spending, trade, and capital expenditure (capex), a non-trivial amount of laboratory effort is associated with that spending. Why? Because R&D, trade, and manufacturing quality control (QC) activities rarely can occur without laboratories backing up their work.

Labs in the manufacturing sector provide vital services, including but not limited to quality assurance (QA), QC, production control, regulatory trade control (e.g., authenticity and adulteration), safety management, label claim testing, and packaging analysis. These activities occur in a wide array of manufacturing industries. Looking to the North American Industry Classification System (NAICS), employed by the U.S. Bureau of Labor Statistics (BLS), manufacturing industries and sub-industries include:

• apparel (e.g., knitted goods, cut-and-sew clothing, buttons and clasps)
• chemical (e.g., pesticides, fertilizers, paints, cleaning products, adhesives, electroplating solutions)
• electric power (e.g., light bulbs, household appliances, energy storage cells, transformers)
• electronics (e.g., sensors, semiconductors, electrodes, mobile phones, computers)
• food and beverage (e.g., baked goods, probiotics, preservatives, wine)
• furniture (e.g., mattresses, sofas, window blinds, light fixtures)
• leather (e.g., purses, saddles, footwear, bookbinding hides)
• machinery (e.g., mining augers, air conditioning units, turbines, lathes)
• materials (e.g., ceramics, cements, glass, nanomaterials)
• medical equipment and supplies (e.g., ventilators, implants, lab equipment, prosthetics, surgical equipment)
• metal forming and casting (e.g., steel beams, aluminum ingots, shipping containers, hand tools, wire)
• paper and printing (e.g., cardboard, sanitary items, stationery, books, bookbinding papers)
• petrochemical (e.g., solvents, fuel additives, biofuels, lubricants)
• pharmaceutical and medicine (e.g., antivenom, vaccines, lab-on-a-chip diagnostic tests, cannabis products, nutraceuticals)
• plastics and rubbers (e.g., dinnerware, tires, storage and shelving, outdoor furniture)
• textiles (e.g., carpeting, upholstery, bulk fabric, yarn)
• vehicular and aerospace (e.g., electric vehicles, reusable rocketry, railroad rolling stock, OEM auto parts)
• wood (e.g., plywood, flooring, lumber, handrails)

If you've ever used a sophisticated two-part epoxy adhesive to repair a pipe crack, used an indoor sun lamp, gotten a lot of mileage out of a pair of leather gloves, received a medical implant, taken a medication, eaten a Twinkie, or ridden on Amtrak, one or more laboratories were involved somewhere in the manufacturing process before using that item. From endless research and testing of prototypes to various phases of quality and safety testing, laboratory science was involved. The importance of the laboratory in manufacturing processes can't be understated.

But what of the history of the manufacturing-focused lab? What of the roles played and testing conducted in them? What do they owe to safety and quality? This chapter more closely examines these questions and more.

1.1 Manufacturing labs, then and now

In 1852, the Putnam's Home Cyclopedia: Hand-Book of the Useful Arts was published as a dictionary-like source of scientific terms. Its definition of a laboratory at that time in U.S. history is revealing (for more on the equipment typically described with a laboratory of that time period, see the full definition):

Laboratory. The workshop of a chemist. Some laboratories are intended for private research, and some for the manufacture of chemicals on the large scale. Hence it is almost impossible to give a description of the apparatus and disposition of a laboratory which would be generally true of all. A manufacturing laboratory necessarily occupies a large space, while that of the scientific man is necessarily limited to a peculiar line of research. Those who study in organic chemistry have different arrangements than that of the mineral analyst.

This definition highlights the state of laboratories at the time: typically you either had a small private laboratory for experiments in the name of research and development (R&D) and producing prototype solutions, or you had a slightly larger "manufacturing laboratory" that was responsible for the creation of chemicals, reagents, or other substances for a wider customer base. These laboratory types date back further than the mid-1800s, to be sure, though they also saw great change leading up to and after this time period.

A critical area to examine in relation to the evolution of manufacturing laboratories involves pharmaceuticals and the apothecary.

Of course, just because a small-scale experimental R&D process yielded a positive result didn't mean that process was scalable to large-scale manufacturing.

Sometimes a process was sufficiently simple that switching to more robust and appropriate apparatuses was all that was needed to scale up from experiment to full production. In other cases, a full-scale manufacturing laboratory process had yet to be developed, let alone the experiments conducted to develop a proof-of-concept solution in the experimental lab.

From small private manufacturing lab to larger-scale industrial manufacturing lab

In April 1917, Armour Fertilizer Company's president Charles McDowell presented his view of American research and manufacturing methods at the time, noting the following about the transition from research to manufacturing:

The definition of research is "diligent inquiry," and, if results are to be obtained, diligent inquiry is necessary; infinite patience is required. The reason for failures must be ascertained. One must learn to stand punishment; to wait; to act quickly; to differentiate between the unimportant and the worth while; and above all one must have good backing. Research chemists are often lacking in the ability to apply practically the results of their work, and a different type of man is often required for the second or small manufacturing stage. Frequently, things work well on a small scale and failure results when mass action comes into effect. Often the reverse is true. A third type of man frequently is required when the commercial manufacturing scale is to be carried out. All of this means team work. It means not only laboratory equipment but small manufacturing equipment. In our work, we maintain a manufacturing laboratory consisting of small manufacturing units where various processes can be carried out on a manufacturing scale. This equipment consists of mills, electrical and other furnaces, pressure tanks, vacuum pans, filter presses, dryers and other machinery used in standard work, so that a process developed in the laboratory can be tried out on a small commercial scale.

McDowell goes on to classify three types of research that leads up to the manufacturing process: pure scientific inquiry, industrial research, and factory research. He notes that of pure scientific inquiry, little thought is typically given to whether the research—often conducted by university professors—will have any real commercial value, though such value is able to emerge from this fundamental research. In regards to industrial research (discussed further in the next subsection), McDowell makes several observations that aptly describe the state of manufacturing research in the early 1900s. He notes that unlike pure scientific inquiry, industrial research has commercial practicality as a goal, often beginning with small-scale experiment and later seeking how to reproduce those theoretical results into large-scale manufacturing. He also reiterates his point about needing to "have good backing" financially. "The larger manufacturer maintains his own staff and equipment to carry out investigations along any line that may seem desirable," he says, "but the smaller industries are not able to support an establishment and must rely on either consulting engineers or turn their problems over to some equipped public or private laboratory to solve."

The rise of the industrial research lab

https://nap.nationalacademies.org/read/20233/chapter/4#34