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| ==1. Introduction to manufacturing laboratories==
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| 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."<ref name="CarrDeliver22">{{cite web |url=https://www.mckinsey.com/capabilities/operations/our-insights/delivering-the-us-manufacturing-renaissance |title=Delivering the US manufacturing renaissance |author=Carr, T.; Chewning, E.; Doheny, M. et al. |work=McKinsey & Company |date=29 August 2022 |accessdate=24 March 2023}}</ref> These categories of economic contribution are important as many of them indirectly point to how the work of [[Laboratory|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.<ref>{{Cite journal |last=Ischi |first=H. P. |last2=Radvila |first2=P. R. |date=1997-01-17 |title=Accreditation and quality assurance in Swiss chemical laboratories |url=http://link.springer.com/10.1007/s007690050092 |journal=Accreditation and Quality Assurance |volume=2 |issue=1 |pages=36–39 |doi=10.1007/s007690050092 |issn=0949-1775}}</ref><ref>{{Cite book |last=Crow |first=Michael M. |last2=Bozeman |first2=Barry |date=1998 |title=Limited by design: R&D laboratories in the U.S. national innovation system |url=https://books.google.com/books?hl=en&lr=&id=OVPZvqz2e6UC |chapter=Chapter 1: The Sixteen Thousand: Policy Analysis, R&D Laboratories, and the National Innovation System |publisher=Columbia University Press |place=New York |pages=1–40 |isbn=978-0-585-04137-7}}</ref><ref>{{Cite journal |last=Grochau |first=Inês Hexsel |last2=ten Caten |first2=Carla Schwengber |date=2012-10 |title=A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories |url=http://link.springer.com/10.1007/s00769-012-0905-3 |journal=Accreditation and Quality Assurance |language=en |volume=17 |issue=5 |pages=519–527 |doi=10.1007/s00769-012-0905-3 |issn=0949-1775}}</ref><ref>{{Cite journal |last=Ribeiro, À.S.; Gust, J.; Vilhena, A. et al. |year=2019 |title=The role of laboratories in the international development of accreditation |url=https://www.imeko.info/index.php/proceedings/7687-the-role-of-laboratories-in-the-international-development-of-accreditation |journal=Proceedings of the 16th IMEKO TC10 Conference "Testing, Diagnostics & Inspection as a comprehensive value chain for Quality & Safety" |pages=56–9}}</ref>
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| 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<ref name="BLSManufact23">{{cite web |url=https://www.bls.gov/iag/tgs/iag31-33.htm |title=Manufacturing: NAICS 31-33 |work=Industries at a Glance |publisher=U.S. Bureau of Labor Statistics |date=24 March 2023 |accessdate=24 March 2023}}</ref>:
| | '''Title''': ''LIMS Selection Guide for Materials Testing Laboratories'' |
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| * apparel (e.g., knitted goods, cut-and-sew clothing, buttons and clasps)
| | '''Edition''': First Edition |
| * chemical (e.g., pesticides, fertilizers, paints, cleaning products, adhesives, electroplating solutions)
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| * electric power (e.g., light bulbs, household appliances, energy storage cells, transformers)
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| * electronics (e.g., sensors, semiconductors, electrodes, mobile phones, computers)
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| * food and beverage (e.g., baked goods, probiotics, preservatives, wine)
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| * furniture (e.g., mattresses, sofas, window blinds, light fixtures)
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| * leather (e.g., purses, saddles, footwear, bookbinding hides)
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| * machinery (e.g., mining augers, air conditioning units, turbines, lathes)
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| * materials (e.g., ceramics, cements, glass, nanomaterials)
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| * medical equipment and supplies (e.g., ventilators, implants, lab equipment, prosthetics, surgical equipment)
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| * metal forming and casting (e.g., steel beams, aluminum ingots, shipping containers, hand tools, wire)
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| * paper and printing (e.g., cardboard, sanitary items, stationery, books, bookbinding papers)
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| * petrochemical (e.g., solvents, fuel additives, biofuels, lubricants)
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| * pharmaceutical and medicine (e.g., antivenom, vaccines, lab-on-a-chip diagnostic tests, cannabis products, nutraceuticals)
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| * plastics and rubbers (e.g., dinnerware, tires, storage and shelving, outdoor furniture)
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| * textiles (e.g., carpeting, upholstery, bulk fabric, yarn)
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| * vehicular and aerospace (e.g., electric vehicles, reusable rocketry, railroad rolling stock, OEM auto parts)
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| * wood (e.g., plywood, flooring, lumber, handrails)
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| 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.
| | '''Author for citation''': Shawn E. Douglas |
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| 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.
| | '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] |
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| ===1.1 Manufacturing labs, then and now===
| | '''Publication date''': ??? 2023 |
| 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)<ref name="AntisellPutnamArts52">{{cite book |url=https://books.google.com/books?id=vsI0AAAAMAAJ&pg=PA284 |title=Putnam's Home Cyclopedia: Hand-Book of the Useful Arts |author=Antisell, T. |publisher=George P. Putnam |volume=3 |pages=284-5 |year=1852 |accessdate=31 March 2023}}</ref>:
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| <blockquote>'''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.</blockquote>
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| 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.<ref name="AntisellPutnamArts52" /><ref name="PorterTheChem30">{{cite book |url=https://books.google.com/books?id=zy8aAAAAYAAJ&pg=PA17&dq=manufacturing+laboratory |title=The Chemistry of the Arts; being a Practical Display of the Arts and Manufactures which Depend on Chemical Principles |chapter=Chemistry Applied to the Arts |author=Porter, A.L. |publisher=Carey & Lea |year=1830 |pages=17–18 |accessdate=06 April 2023 |quote=The larger laboratories, or workshops, which are used only in particular branches of business, and the necessary apparatus attached to them, will be considered under the several substances which are prepared in them. Besides the workshop, every operative chemist ought to devote some part of his premises as a small general elaboratory, fitted up with some furnaces and other apparatus as may enable him to make any experiment seemingly applicable to the improvement of his manufacturing process without loss of time, and immediately upon its inception.}}</ref><ref name="MarshSpeech46">{{cite book |url=https://books.google.com/books?id=ptg-AAAAYAAJ&pg=PA11&dq=manufacturing+laboratory |title=Speech of Mr. Marsh, of Vermont, on the Hill for Establishing the Smithsonian Institution, Delivered in The House of Representatives of the U. States, April 22, 1846 |author=Marsh, G. P. |publisher=J. & G.S. Gideon |year=1846 |page=11 |accessdate=06 April 2023 |quote=How are new substances formed, or the stock of a given substance increased, by the chemistry of nature or of art? By new combinations or decompositions of known and pre-existing elements. The products of the experimental or manufacturing laboratory are no new creations; but their elements are first extracted by the decomposition of old components, and then recombined in new forms.}}</ref> 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. This is best characterized by the transition from the humble apothecary lab to the small-scale manufacturing laboratory before the mid-1800s, to the full-scale pharmaceutical manufacturing lab and facility well beyond the mid-1800s.
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| ====1.1.1 From apothecary to small-scale manufacturing laboratory====
| | The table of contents for ''LIMS Selection Guide for Materials Testing Laboratories'' is as follows: |
| A critical area to examine in relation to the evolution of manufacturing laboratories involves pharmaceuticals and the apothecary, which is steeped in the tradition of making pharmaceutical preparations, as well as prescribing and dispensing them to customers. The idea of an individual who attempted to make medical treatments dates back to at least to 2000 BC, from which Sumerian documents reveal compounding formulas for various medicinal dosage types.<ref name="AllenAHist11">{{cite journal |url=https://www.perrigo.com/business/pdfs/Sec%20Artem%2011.3.pdf |archiveurl=https://web.archive.org/web/20130128014521/https://www.perrigo.com/business/pdfs/Sec%20Artem%2011.3.pdf |format=PDF |title=A History of Pharmaceutical Compounding |journal=Secundum Artem |author=Allen Jr., L.V. |volume=11 |issue=3 |year=2011 |archivedate=28 January 2013 |accessdate=06 April 2023}}</ref> By 1540, Swiss physician and chemist Paracelsus made a significant contribution to the early apothecary, influencing "the transformation of pharmacy from a profession based primarily on botanic science to one based on chemical science."<ref name="AllenAHist11" /> Thanks to Paracelsus and other sixteenth century practitioners, the concept of the apothecary became more formalized and chemistry-based in the early seventeenth century. With this formalization came the need for the regulation of apothecaries to better ensure the integrity of the profession. For example, the Master, Wardens and Society of the Art and Mystery of Pharmacopolites of the City of London was founded in 1617 through the Royal Charter of James the First, requiring an aspiring apothecary to conduct an apprenticeship or pay a fee, followed by taking an examination proving the individual's knowledge, skill, and science in the art.<ref name="AllenAHist11" /><ref name="Plough97">{{cite journal |url=https://www.google.com/books/edition/Pharmaceutical_Journal/ScDyXwC8McwC?hl=en&gbpv=1&dq=manufacturing+laboratory&pg=PA164&printsec=frontcover |title=The Plough Court Pharmacy |journal=The Pharmaceutical Journal |publisher=Pharmaceutical Society of Great Britain |volume=LVIII |pages=164–7, 247–51 |date=January to June 1897 |accessdate=06 April 2023}}</ref>
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| However, despite this sort of early regulation, medical practitioners took exception to apothecaries encroaching upon the medical practitioners' own services, and apothecaries took exception to the untrained and uncertified druggists who were still performing the work of pharmacists. (As it turns out, these sorts of recriminations would continue on in some form or another into the beginning of the twenty-first century, discussed later.) But as an 1897 article from ''The Pharmaceutical Journal'' portrayed, the apothecaries likely wanted to have their cake and eat it too. "[W]hile the apothecaries urged, in the interest of the public, the desirability of a guarantee for the the competences of every person authorised to practise pharmacy," the journal noted, "they also sought, in their own interest, to extend the scope of their medical practice."<ref name="Plough97" /> This led to further debate and changes over time, including British Parliament declaring medicinal preparations as "very proper objects for taxation" in 1783, while at the same time requiring non-apprenticed apothecaries to apply annually for a license. By this time, most apprenticed apothecaries ceased being perceived as mere pharmacists and more as medical practitioners, though the Society's power of conferring medical qualifications, given to them in 1617, were by this point largely lost.<ref name="Plough97" />
| | :[[User:Shawndouglas/sandbox/sublevel10|1. Introduction to materials and materials testing laboratories]] |
| | ::1.1 Materials testing labs, then and now |
| | :::1.1.1 Materials testing 2.0 |
| | ::1.2 Industries, products, and raw materials |
| | ::1.3 Laboratory roles and activities in the industry |
| | :::1.3.1 R&D roles and activities |
| | :::1.3.2 Pre-manufacturing and manufacturing roles and activities |
| | :::1.3.3 Post-production quality control and regulatory roles and activities |
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| By the end of the eighteenth century, apothecaries and druggists were setting up their own manufacturing laboratories to make chemical and pharmaceutical products. However, these labs were likely still limited in scope. In 1897, ''The Pharmaceutical Journal'' portrayed manufacturing labs as such, in the scope of the growing Plough Court Pharmacy run by William Allen and Luke Howard<ref name="Plough97" />:
| | :[[User:Shawndouglas/sandbox/sublevel11|2. Standards, regulations, and test methods affecting materials testing labs]] |
| | ::2.1 Globally recognized materials manufacturing standards |
| | :::2.1.1 American Society of Civil Engineers (ASCE) materials standards |
| | :::2.1.2 ASTM International Volume 15.04 |
| | :::2.1.3 Canadian Standards Association (CSA) A3000 series |
| | :::2.1.4 International Organization for Standardization (ISO) 10993 |
| | :::2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family |
| | ::2.2 Regulations and laws around the world |
| | :::2.2.1 21 CFR Part 175 and 176 - United States |
| | :::2.2.2 Building Standard Law - Japan |
| | :::2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom |
| | :::2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia |
| | :::2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada |
| | ::2.3 Standardized test methods for materials |
| | ::2.4 Materials laboratory accreditation |
| | :::2.4.1 A note about engineering and construction materials testing |
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| <blockquote>It is, however, difficult to at the present time to realise what must have been the position of a manufacturing chemist in 1797, or to comprehend, without some reflection, how limited was the range of his operations and how much his work was beset with difficulties which are now scarecely conceivable. At that time chemical industry was confined to the production of soap, the mineral acids, and some saline compounds then used in medicine. Among the latter, mercurial preperations held an important place, and some of these appear to have first received attention by the firm of Allen and Howard. The early laboratory account books of the firm mention ammoniacals, caustic potash, borax, argentic nitrate, and cream of tartar, as well as ether, benzoic acid, and refine camphor, which were then articles of the materia medics, citric, tartatic and oxalic acids, etc.</blockquote>
| | :[[User:Shawndouglas/sandbox/sublevel12|3. Choosing laboratory informatics software for your materials testing lab]] |
| | ::3.1 Evaluation and selection |
| | :::3.1.1 Technology considerations |
| | ::::3.1.1.1 Laboratory informatics options |
| | :::3.1.2 Features and functions |
| | ::::3.1.2.1 Base features |
| | ::::3.1.2.2 Specialty features |
| | :::3.1.3 Cybersecurity considerations |
| | :::3.1.4 Regulatory compliance considerations |
| | :::3.1.5 System flexibility |
| | :::3.1.6 Cost considerations |
| | ::3.2 Implementation |
| | :::3.2.1 Internal and external integrations |
| | ::3.3 MSW, updates, and other contracted services |
| | ::3.4 How a user requirements specification fits into the entire process (LIMSpec) |
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| To be sure, other types of manufacturing were occurring during the rise and dominance of the apothecary, not just pharmaceutical manufacture. But, retrospectively, the pharmaceutical manufacturing lab in general was likely not in the best of shape as the nineteenth century approached. With several changes in Europe and United States in the early 1800s, the apothecary's manufacturing lab arguably saw more formalized and regulated activity, through various releases of pharmacopoeias<ref name="AllenAHist11" /><ref name="AndersonPharm13">{{cite web |url=http://www.histpharm.org/ISHPWG%20UK.pdf |format=PDF |title=Pharmacopoeias of Great Britain |work=A History of the Pharmacopoeias of the World |author=Anderson, S.C. |publisher=International Society for the History of Pharmacy |pages=1–8 |year=2013 |accessdate=06 April 2023}}</ref>, openings of new pharmacy schools (though still limited in scope)<ref name="DCTheEarly18">{{cite journal |url=https://books.google.com/books?id=P3kgAQAAMAAJ&pg=RA2-PA243-IA1&dq=manufacturing+laboratory |title=The Early Days of Pharmaceutical |journal=The Druggists Circular |volume=LXII |issue=6 |pages=244–5 |date=June 1918 |accessdate=06 April 2023}}</ref>, publishing of books<ref name="DCTheEarly18" />, and additional formalization of regulating legislation (such as Britain's Apothecaries Act of 1815).<ref name="Plough97" /> By the time the ''United States Pharmacopeia'' came upon the scene in 1820, the apothecary was viewed as "competent at collecting and identifying botanic drugs and preparing from them the mixtures and preparations required by the physician."<ref name="AllenAHist11" /> Pharmaceutical historian Loyd Allen, Jr. refers to this time period as "a time that would never be seen again," a sort of Golden Age of the apothecary, given the increasingly rapid rate that scientific and technological discoveries were being made soon after, particularly in synthetic organic chemistry.<ref name="AllenAHist11" />
| | :[[User:Shawndouglas/sandbox/sublevel13|4. Resources for selecting and implementing informatics solutions]] |
| | ::4.1 LIMS vendors |
| | ::4.2 Consultants |
| | ::4.3 Professional |
| | :::4.3.1 Trade organizations |
| | :::4.3.2 Conferences and trade shows |
| | ::4.4 LIMSpec |
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| Of course, the manufacturing lab—pharmaceutical and otherwise—had other issues as well. For example, just because a small-scale experimental R&D process yielded a positive result didn't mean that process was scalable to large-scale manufacturing. "Frequently, things work well on a small scale, and failure results when mass action comes into effect," noted Armour Fertilizer Company's president Charles McDowell in April 1917, while discussing American research methods.<ref name="McDowellAmerican17">{{cite journal |url=https://books.google.com/books?id=8pMPAQAAIAAJ&pg=PA546&dq=manufacturing+laboratory |title=American Research Methods |journal=Journal of the Western Society of Engineers |author=McDowell, C.A. |volume=XXII |issue=8 |year=1917 |pages=546–65 |accessdate=06 April 2023}}</ref> 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.<ref name="RobertsonDesulph43">{{cite journal |url=https://books.google.com/books?id=3u01AQAAMAAJ&pg=RA1-PA444&dq=manufacturing+laboratory |title=Desulphuration of Metals |journal=Mechanics' Magazine, Museum, Register, Journal, and Gazette |editor=Robertson, J.C. |volume=38 |date=01 July 1843 |page=444 |accessdate=06 April 2023}}</ref> 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.<ref name="JacksonChemical43">{{cite journal |url=https://books.google.com/books?id=hrYxAQAAMAAJ&pg=PA379&dq=manufacturing+laboratory |title=Chemical Salts as Fertilizers |journal=New England Farmer, and Horticultural Register |author=Jackson, C.T. |publisher=Joseph Breck & Co |volume=XXL |issue=48 |page=379 |date=31 May 1843 |accessdate=06 April 2023}}</ref>
| | :[[User:Shawndouglas/sandbox/sublevel14|5. Taking the next step]] |
| | ::5.1 Conduct initial research into a specification document tailored to your lab's needs |
| | ::5.2 Issue some of the specification as part of a request for information (RFI) |
| | ::5.3 Respond to or open dialogue with vendors |
| | :::5.3.1 The value of demonstrations |
| | ::5.4 Finalize the requirements specification and choose a vendor |
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| Another challenge the manufacturing lab had was in ensuring the stability of any laboratory manufactured solution. Discussing the British Pharmacopoeia-introduced substance of sulphurous acid for afflictions of the throat, Fellow of the Chemical Society Charles Umney noted the stability considerations of the substance when made in the manufacturing laboratory<ref name="UmneySulphurous69">{{cite journal |url=https://books.google.com/books?id=POkKAAAAYAAJ&pg=PA516&dq=manufacturing+laboratory |title=Sulphurous Acid |journal=Pharmaceutical Journal and Transactions |author=Umney, C. |publisher=John Churchill and Sons |volume=X |issue=IX |pages=516–20 |year=1869 |accessdate=06 April 2023}}</ref>:
| | :[[User:Shawndouglas/sandbox/sublevel15|6. Closing remarks]] |
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| <blockquote>Now the Pharmacopoeia solution (which is about 37 volumes) was designedly made nearly one of saturation at the average summer temperature of this country, and, if one may be excused for making a guess, we described from calculations made from the above data of Bunsen's, and not practically worked out to see whether such a solution could be ordinarily obtained in the manufacturing laboratory without chance of failure, and, when made, be kept without great alteration in the various stages it would have to pass through, even if only from the manufacturer to the wholesale druggist, then to the pharmacists, in whose store it might retain for a year or more, being perhaps placed in a temperature many degrees above the point at which it was saturated, thereby causing expansion, liberation of gas, and inconvenience.</blockquote>
| | :[[User:Shawndouglas/sandbox/sublevel16|Appendix 1. Blank LIMSpec template for manufacturing labs]] |
| | | ::A1. Introduction and methodology |
| Difficulties aside, as the 1800s progressed, the resources of a collaboratory manufacturing laboratory were often greater than those of the individual private laboratory, with enterprising businesses increasingly turning to larger labs for greater and more high-quality quantities of materials. For example, in a letter from the Royal Institution of Great Britain, editor William Crookes discussed the discovery of thallium, noting that the manufacturing lab of noted manufacturing chemists Hopkin and Williams were able to prepare chloride of thallium for him from two hundredweight (cwt) in less time than it took Crookes to make 10 pounds of sulfur in his private laboratory.<ref name="CrookesOnThe63">{{cite journal |url=https://books.google.com/books?id=0JHOIc5pHYwC&pg=PA172&dq=manufacturing+laboratory |title=On the Discovery of the Metal Thallium |journal=The Chemical News and Journal of Physical Chemistry |author=Crookes, W. |volume=VII |issue=175 |pages=172–6 |date=April 1863 |accessdate=06 April 2023}}</ref> This trend would continue into the late 1800s, for pharmaceutical and other manufactured goods.
| | ::A2. Primary laboratory workflow |
| | | ::A3. Maintaining laboratory workflow and operations |
| ====1.1.2 From small-scale private manufacturing lab to larger-scale industrial manufacturing lab====
| | ::A4. Specialty laboratory functions |
| By the 1860s, numerous changes to the paradigm of the manufacturing lab were beginning to take shape, with noticeable momentum away from the small-scale private manufacturing labs to those larger in scope and output, putting competitive pressures on the smaller manufacturing labs.<ref name="PearsonThePrep11">{{cite journal |url=https://books.google.com/books?id=GyFFAQAAMAAJ&pg=PA415&dq=manufacturing+laboratory |title=The Preparation and Testing of Drugs |journal=The Journal of the Franklin Institute of the State of Pennsylvania |author=Pearson, W.A. |volume=CLXXI |issue=4 |pages=415–21 |date=April 1911 |accessdate=12 April 2023 |quote=All the large drug laboratories have been developed since 1860 ... The increase in number of manufacturing laboratories and the consequent increase in competition exerted an influence on the wholesale druggist.}}</ref> Take, for example, one of the largest U.S.-based enameled brick factories for its time, in 1896, which "[i]n addition to their manufacturing laboratory for slips, enamels and glazes, they maintain an analytical chemical laboratory, and have two chemists in their employ."<ref name="LockingtonEnamled96">{{cite journal |url=https://books.google.com/books?id=lj9PAQAAIAAJ&pg=RA1-PA350&dq=manufacturing+laboratory |title=Enamled Brick at Oaks, PA |journal=The Clay-Worker |author=Lockington, W.P. |volume=XXV |issue=4 |pages=350–51 |date=April 1896 |accessdate=07 April 2023}}</ref> Ten years prior, a report on the visit to the experimental and manufacturing laboratories of Louis Pasteur highlights the need for a more sizeable facility for meeting demand for the anthrax vaccine<ref name="RobertsonReport86">{{cite journal |url=https://books.google.com/books?id=a-AfAQAAIAAJ&pg=PA223&dq=manufacturing+laboratory |title=Report of Visit to the Laboratories of M. Pasteur at Paris |journal=The Veterinary Journal and Annals of Comparative Pathology |author=Robertson, W. |volume=XXIII |pages=223–7 |year=1886 |accessdate=07 April 2023}}</ref>:
| | ::A5. Technology and performance improvements |
| | | ::A6. Security and integrity of systems and operations |
| <blockquote>To meet the demands upon the laboratory work for the supply of anthrax vaccine, the preparation of this is now carried out in an establishment apart from the experimental laboratory in connection with the Ecole Normale, where it was originally started. In the Rue Vaquelin, under the charge of educated assistants, M. Chamberland carries out the preparation on a large scale—the necessity for this being apparent when regard is had to the statement of the quantity demanded for France and other countries.</blockquote>
| | ::A7. Putting those requirements to practical use and caveats |
| | | ::A8. LIMSpec in Microsoft Word format |
| The author, William Robertson, then goes into greater detail of the many rooms and floors of the building housing the manufacturing laboratory and its apparatuses, highlighting the grandness of the lab's efforts.
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| The change from small-scale private to larger-scale industrial manufacturing labs—in turn seemingly being supplanted by analytical laboratories<ref name="TWDDrugClerks02">{{cite journal |url=https://books.google.com/books?id=qG8gAQAAMAAJ&pg=PA405&dq=manufacturing+laboratory |title=Drug Clerks and Labor Unions |journal=The Western Druggist |author=The Western Druggist |volume=XXIV |issue=7 |page=405 |date=July 1902 |accessdate=12 April 2023}}</ref>—is arguably best seen in the transition from the apothecary and pharmacist to the large-scale pharmaceutical manufacturer. During this time of change in the late 1800s, laws dictating higher manufacturing quality, educational requirements, and restrictions on who can sell medicines were derided, debated, or cheered, depending on who was involved.<ref name="LillyTheRel83">{{cite journal |url=https://books.google.com/books?id=VlyFy6zJQpUC&pg=RA2-PA258&dq=manufacturing+laboratory |title=The Relation of Manufacturing Pharmacists to Pharmacy Laws |journal=The Pharmacist and Chemist |author=Lilly, J.K. |volume=XVI |issue=1 |pages=258–9 |date=January 1883 |accessdate=06 April 2023}}</ref><ref name="ParkerSomeAsp96">{{cite journal |url=https://books.google.com/books?id=bSnnAAAAMAAJ&pg=PA183&dq=manufacturing+laboratory |title=Some Aspects of Technical Pharmacy |journal=American Druggist and Pharmaceutical Record |author=Parker, C.E. |volume=XXVIII |issue=6 |pages=183–4 |date=25 March 1896 |accessdate=12 April 2023}}</ref>
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| Reading for a meeting at the Kings County Pharmaceutical Society of Ohio, Charles E. Parker had the following to say about the state of the apothecary-turned-pharmacist in 1896, which fully highlights the transition from small-scale private to larger-scale industrial manufacturing of pharmaceuticals<ref name="ParkerSomeAsp96" />:
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| <blockquote>The modern pharmacist succeeds to all the responsibilities and obligations of the ancient apothecary without opposition, but his utmost efforts have not preserved to him his inheritance of former privileges and emoluments ... Technical skill is of no use to the professional side of pharmacy unless it is used, and used for the public welfare as well as that of its possessor. The dispenser is the ''typical'' pharmacist. But where in former years his sphere included many activities and much manipulative expertness in the preparation of drugs, and even the production of many of them, the midern tendancy is for him to become a mere compounder and dispenser. Of course he is expected to know how, but actually is seldom required to perform the operations once a matter of constant routine. Step by step the productive processes of his little laboratory have been transferred to the works of large manufacturers. Year by year the pharmaceutical improvements and useful inventions which would once have conferred reputation and profit upon the dispensing pharmacies where they originated, have found a better market through these same manufacturers ... In addition, it is to be considered that some of the requisites of modern pharmacy are of a nature involving the use of expensive machinery and large plant, which places their production quite beyond the reach of the pharmacy.</blockquote>
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| Writing for the ''Pharmaceutical Review'' in 1897, editor Dr. Edward Kremers penned an editorial on the role of the manufacturing laboratory in the growing pharmaceutical industry, noting that "[d]uring the past hundred years a most remarkable industrial revolution has taken place," and that pharmacy was also victim to that, lamenting that the apothecaries of the beginning of the century—along with the druggists of 1897—had largely become "relics of the past."<ref name="KremersTheManu97">{{cite journal |url=https://books.google.com/books?id=4BU4AQAAMAAJ&pg=PA61&dq=manufacturing+laboratory |title=The Manufacturing Laboratory in the Household of Pharmacy |journal=Pharmaceutical Review |author=Kremers, E. |volume=15 |issue=4 |pages=61–7 |date=April 1897 |accessdate=12 April 2023}}</ref> Kremers also touched upon another complaint popular at the time: that of pharmacy as a money-making venture.<ref name="TWDDrugClerks02" /><ref name="KremersTheManu97" /> In his editorial, Kremers says:
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| <blockquote>It is a hope cherished by some that higher education will revolutionize pharmacy of today and lift her out of her present unenviable situation. The manufacturing industries, however, have revolutionized pharmacy of fifty years ago and are to no small extent coresponsible for the present state of affairs. The pharmaceutical profession as a whole is justified in asking what a particular branch is doing for the general good. Is the pharmaceutical manufacturer in the erection of his buildings, in the equipment of his laboratories and in the selection of his working force simply bent upon making so many thousands of dollars a paying investment, viewed from a merely commercial standpoint, or are his doings influenced to some extent to at least by higher than purely necessary motives.</blockquote>
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| By the early years of 1900, recognition of the sea-level change to the apothecary, pharmacist, and manufacturing laboratory had arguably gained traction, and by 1920 it was largely accepted<ref name="BealAward19">{{cite journal |url=https://books.google.com/books?id=GQlOAAAAMAAJ&pg=PA475&dq=manufacturing+laboratory |title=Award of the Joseph B. Remington Honor Medal |journal=The Midland Druggist and Pharmaceutical Review |author=Diner, J.; Beal, J.H. |volume=LIII |issue=12 |pages=475–9 |date=December 1919 |accessdate=12 April 2023}}</ref>. Writing for ''The Rocky Mountain Druggist'' in 1908, pharmaceutical doctor Geo H. Meeker laid it out in no uncertain terms:
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| <blockquote>Large manufacturing establishments can, for the most part, furnish the druggist at lower prices, with better authentic goods than he himself could produce, assay and guarantee. The inevitable result is that the druggist of today purchases finished products rather than raw materials as did the apothecary of yesterday. It is obvious that a large manufacturing establishment, conducted on ethical lines, employing a complete corps of specialists, buying raw materials to the best advantage and by assay only, making preparations on a large and intelligent technical scale and testing and assying the finished products, does a work that is too immense in its scope for the individual apothecary ... Our present remnant of the drug store laboratory is, as in the past, essentially a manufacturing laboratory. It is of limited and rapidly vanishing scope because the small local laboratory man cannot successfully compete with his rivals, the great and highly-organized factories.</blockquote>
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| Similar comments were being made by Pearson in 1911<ref name="PearsonThePrep11" />, Thiesing in 1915<ref name="Thiesing15">{{cite journal |url=https://books.google.com/books?id=b_5EAQAAMAAJ&pg=PA1203&dq=manufacturing+laboratory |title=Proceedings of the Joint Session of the Commercial Section and Section on Education and Legislation - Chairman Thiesing's Address |journal=The Journal of the Americam Pharmaceutical Association |author=Thiesing, E.H. |volume=IV |issue=10 |pages= |date=October 1915 |accessdate=12 April 2023}}</ref>, and Beal in 1919.<ref name="BealAward19" /> Beal in particular spoke solemnly of the transition, largely complete by the time of his acceptance of the Joseph P. Remington Honor Medal in 1919. Speaking of Remington and his experiences in pharmacy, until his death in 1918, Beal said<ref name="BealAward19" />:
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| <blockquote>Professor Remington's professional experience bridged the space between two distinct periods of pharmaceutical development. When he began his apprenticeship the apothecary, as he was then commonly called, was the principal manufacturer as well as the purveyor of medical supplies ... He lived to see the period when the apothecary ceased to be the principal producer of medicinal compounds and became mainly the purveyor of preparations manufactured by others, and when the medicinal agents in most common use assumed a character that required for the successful production the resources of establishments maintained by large aggregations of capital and employing large numbers of specially trained workers.
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| To those who knew him intimately it was evident that although Professor Remington did not welcome the passing of the manufacturing functions of the apothecary to the large laboratory, he at length came to realize that such a change was inevitable, that it was but a natural step in the process of social evolution, and that the logical action of the apothecary was not to resist that which he could neither prevent nor change, but to readjust himself to the new conditions.</blockquote>
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| Of course, by then, the rise of the industrial research lab within large-scale manufacturing enterprises was in full swing.
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| ====1.1.3 The rise of the industrial research lab within large-scale manufacturing====
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| Like the small, privately owned manufacturing labs evolving to large-scale company-run manufacturing labs, so did the research processes of prior days. The individual tinkering with research in their private laboratory and making small batches of product gave way to a collective of individuals with more specialized talents cooperatively working in a large industrial manufacturing center towards a common, often complex research goal, i.e., within the industrial research laboratory.<ref name="MeesTheOrg20">{{cite book |url=https://books.google.com/books?id=rDIuAAAAYAAJ&printsec=frontcover&dq=industrial+research+laboratories |title=The Organization of Industrial Scientific Research |chapter=Chapter 1: Introduction |author=Mees, C.E.K. |publisher=McGraw-Hill Book Company, Inc |pages=4–10 |year=1920 |accessdate=12 April 2023}}</ref><ref name="BoydPutting24">{{cite journal |url=https://books.google.com/books?id=lYkiAQAAMAAJ&pg=RA23-PA22&dq=industrial+research+laboratories |title=Putting Research to Work |journal=A.E.C. Bulletin - Invention and The Engineer's Relation to It |author=Boyd, T.A. |publisher=American Engineering Council |pages=22–9 |date=May 1938 |accessdate=12 April 2023}}</ref> Those larger manufacturing entities that didn't have an industrial research lab were beginning to assess the value of adding one, while smaller enterprises that didn't have the resources to support an extensive collection of manufacturing and research labs were increasingly joining forces "to maintain laboratories doing work for the whole industry."<ref name="MeesTheOrg20" />
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| In 1917, the previously mentioned Charles McDowell presented his view of American research and manufacturing methods of the early 1900s, referring to research as "diligent inquiry."<ref name="McDowellAmerican17" /> In his work, McDowell stated three types of research that leads up to the manufacturing process: pure scientific inquiry, industrial research, and factory research. He noted 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. As for factory research, McDowell characterized it as full-scale factory-level operations that range from haphazard approaches to well-calculated contingency planning, all of which could make or break the manufacturing business.
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| In regards to the middle category of industrial research, McDowell made several observations that aptly described the state of manufacturing research in the early 1900s. He noted 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 reiterated 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 said, "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."<ref name="McDowellAmerican17" />
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| In his 1920 book ''The Organization of Industrial Scientific Research'', Mees presented these three types of research somewhat similarly, though in the context of the industrial laboratory and its operations. Mees argued that industrial laboratories could be classified into three divisions<ref name="MeesTheOrg20" />:
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| * Laboratories "working on pure theory and the fundamental sciences associated with the industry," aligning in part with McDowell's "pure scientific inquiry";
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| * Work laboratories "exerting analytical control over materials, processes and product," aligning slightly with McDowell's "factory research" but more akin to the modern quality control lab; and
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| * Industrial laboratories "working on improvements in product and in processes," aligning with McDowell's "industrial research."
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| Mees argued in particular that those industrial research laboratories that simply improve products and processes were not doing enough; they should, necessarily, also direct their primary goals towards more fully understanding the fundamental and underlying theory of the topic of research.<ref name="MeesTheOrg20" /> In other words, Mees suggested that those labs simply working on theoretical and fundamental science research, as well as those labs conducting industrial research to improve products and processes, shouldn't necessarily function in separate vacuums. "Research work of this fundamental kind involves a laboratory very different from the usual works laboratory and also investigators of a different type from those employed in a purely industrial laboratory," he noted. Of course, this hybrid approach to fundamental and industrial research was largely reserved for the largest of manufacturers, and solutions were needed for smaller manufacturing endeavors. Here Mees argued for the adoption of both cooperative laboratories and consulting laboratories.
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| * https://nap.nationalacademies.org/read/20233/chapter/4#34
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| ==References==
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| {{Reflist|colwidth=30em}}
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