Book:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories/Laboratory roles and activities in the industry

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1.2 Laboratory roles and activities in the industry

Today, the "manufacturing laboratory" is a complex entity that goes beyond the general idea of a lab making or researching things. Many of the historical aspects discussed prior still hold today, but other aspects have changed. As indicated in the introduction, the world of manufacturing encompasses a wide swath of industries and sub-industries, each with their own nuances. Given the nuances of pharmaceutical manufacturing, food and beverage development, petrochemical extraction and use, and other industries, it's difficult to make broad statements about manufacturing laboratories in general. However, the rest of this guide will attempt to do just that, while at times pointing out a few of those nuances found in specific industries.

The biggest area of commonality is found, unsurprisingly, in the roles manufacturing-based labs play today, as well as the types of lab activities they're conducting within those roles. These roles prove to be important in the greater scheme of industry activities, in turn providing a number of benefits to society. As gleaned from prior discussion, as well as other sources, these laboratory roles can be broadly broken into three categories: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security. Additionally, each of these categories has its own types of laboratory activities.

The scientific disciplines that go into these laboratory roles and activities is as diverse as the manufacturing industries and sub-industries that make up the manufacturing world. For example, the food and beverage laboratory taps into disciplines such as biochemistry, biotechnology, chemical engineering, chemistry, fermentation science, materials science, microbiology, molecular gastronomy, and nutrition.[1][2][3][4] However, the paper and printing industry taps into disciplines such as biochemistry, biology, chemistry, environmental science, engineering, forestry, and physics.[5][6] By extension, the reader can imagine that these and other industries also have a wide variety of laboratory techniques associated with their R&D, manufacturing, and post-production activities.

The following subsections more closely examine the three roles manufacturing-based labs can play, as well as a few examples of lab-related activities found within those roles.

1.2.1 R&D roles and activities

Food Safety Lab (Gibson - 52032197020.jpg

The National Institute of Standards and Technology (NIST) and its Technology Partnerships Office offer a detailed definition of manufacturing-related R&D as an activity "aimed at increasing the competitive capability of manufacturing concerns," and that "encompasses improvements in existing methods or processes, or wholly new processes, machines or system."[7] They break this down into four different technology levels[7]:

  • Unit process-level technologies that create or improve manufacturing processes,
  • Machine-level technologies that create or improve manufacturing equipment,
  • Systems-level technologies for innovation in the manufacturing enterprise, and
  • Environment- or societal-level technologies that improve workforce abilities and manufacturing competitiveness.

Obviously, this definition applies to actual development of and innovation towards methods of improving and streamlining manufacturing processes. However, this same concept can, in part, can be applied to the actual products made in a manufacturing plant. Not only does product-based R&D focus on improving "existing methods and processes," but it also focuses on "manufacturing competitiveness" by developing new and innovating existing products that meet end users' needs. Manufacturing-based R&D laboratories play an important role in this regard.

The laboratory participating in this role is performing one or more tasks that relate to the development or improvement of a manufactured good. This often leads to a commercial formulation, process, or promising insight into a product. The R&D lab may appear outside the manufacturing facility proper, but not necessarily always. Some manufacturing companies may have an entire research complex dedicated to creating and improving some aspect of their products.[8] Other companies may take their R&D to a third-party consulting lab dedicated to conducting development and formulation activities for manufacturers.[9][10] Industrial research activities aren't confined to manufacturers, however. Some higher education institutions provide laboratory-based research and development opportunities to students engaging in work-study programs, often in partnership with some other commercial enterprise.[11]

The following types of lab-related activities may be associated with the R&D role:

Overall product development and innovation: Jain et al. note in their book on managing R&D activities that in 2010, 60 percent of U.S. R&D was focused on product development, while 22 percent focused on applied research and 18 percent on basic research. However, they also argue that any R&D lab worth its weight should have a mix of these activities, while also including customer participation in the needs assessment and innovation activities that take place in product development and other research activities. Jain et al. define a manufacturer's innovation activities as "combining understanding and invention in the form of socially useful and affordable products and processes."[12] As the definition denotes, newly developed products ("offerings") and processes (usually which improve some level of efficiency and effectiveness) come out of innovation activities. Additionally, platforms that turn existing components or building blocks into a new derivative offering (e.g., a new model or "generation" of product), as well as "solutions that solve end-to-end customer problems," can be derived from innovation. Those activities can focus on more risky radical innovation to a new product or take a more cautious incremental approach to improvements on existing products.[13]

Reformulation: Reformulation involves the material substitution of one or more raw materials used in the production of a product to accomplish some stated goal. That goal may be anything from reducing the toxicity or volume of wastes generated[14][15][16] and improving the overall healthiness of the product[17][18], to transitioning from traditional holistic medicine approaches to more modern biomedical approaches.[19] Examples of products that have seen reformulation by manufacturers include:

  • Paints and other coatings[14],
  • Fuels such as gasoline[16],
  • Foods and beverages[17][18], and
  • Pharmaceuticals and cosmetics.[15][19]

In the end, reformulation is a means for improving impacts on the end user, the environment, or even the long-term budget of the manufacturer. The type of lab activities associated with reformulation largely varies by product; the laboratory methods used to reformulate gasoline may be quite different from those in a food and beverage lab. Reformulation can also be a complicated process, as found with pharmaceutical products. The reformulated product "must have the same therapeutic effect, stability, and purity profile" as the original, while maintaining pleasing aesthetic qualities to the end user. Adding to the problem is regulatory approval times of such pharmaceutical reformulations.[15]

Nondestructive testing and materials characterization: Raj et al. describe nondestructive testing (NDT) as "techniques that are based on the application of physical principles employed for the purpose of determining the characteristics of materials or components or systems and for detecting and assessing the inhomogeneities and harmful defects without impairing the usefulness of such materials or components or systems."[20] NDT has many applications, including with food, steel, petroleum, medical devices, transportation, and utilities manufacturing, as well as electronics manufacturing.[21][22][23] It also plays an important role in materials testing and characterization.[24] NDT and materials testing is often used as a quality control mechanism during manufacturing (see the next subsection), but it can also be used during the initial R&D process to determine if a prototype is functioning as intended or a material is satisfactory for a given application.[20]

Stability, cycle, and challenge testing: Multiple deteriorative catalysts can influence the shelf life of a manufactured product, from microbiological contaminants and chemical deterioration to storage conditions and the packaging itself. As such, there are multiple approaches to taming the effects of those catalysts, from introducing additives to improving the packaging.[25] However, stability, cycle, and challenge testing must be conducted on many products to determine what deleterious factors are in play. The analytical techniques applied in stability, cycle, and challenge testing will vary based on, to a large degree, the product matrix and its chemical composition.[25] Microbiological testing is sure to be involved, particularly in challenge testing, which simulates what could happen to a product if contaminated by a microorganism and placed in a representative storage condition.[26][27] Calorimetry, spectrophotometry, spectroscopy, and hyperspectral imaging may be used to properly assess color, particularly when gauging food quality.[25] Other test types that may be used include water content, texture, viscosity, dispersibility, glass transition, and gas chromatography.[25] In the end, the substrate being examined will be a major determiner of what kind of lab methods are used. The lab method chosen for stability, cycle, and challenge testing should optimally be one that errs on the side of caution and is appropriate to the test, even if it takes longer. As Chen notes: "A longer test cycle is less a concern for stability protocol as the study typically has a limited number of samples. Applying a less reliable method to the limited number of samples in a stability study can be problematic."[27]

Packaging analysis and extractable and leachable testing: Materials that contact pharmaceuticals, foods and beverages, cosmetics, and more receive special regulatory consideration in various parts of the world. This includes alloys, bioplastics, can coatings, glass, metals, regenerated cellulose materials, paper, paperboard, plastics, printing inks, rubber, textiles, waxes, and woods.[28] As such, meeting regulatory requirements and making inroads with packaging development can be a complicated process. Concerns of chemicals and elements that can be extracted or leach into sensitive products add another layer of complexity to developing and choosing packaging materials for many manufactured goods. This requires extractable and leachable testing at various phases of product development to ensure the packaging selected during formulation is safe and effective.[27][29] Extractable and leachable testing for packaging could involve a number of techniques ranging from gas and liquid chromatography to ion chromatography and inductively coupled plasma mass spectrometry.[30]

1.2.2 Pre-manufacturing and manufacturing roles and activities

The laboratory participating in these roles is performing one or more tasks that relate to the preparative (i.e., pre-manufacturing) or quality control (QC; i.e., manufacturing) activities of production. An example of preparative work is conducting allergen, calorie, and nutrition testing for a formulated food and beverage product. Calorie and nutrition testing—conducted in part as a means of meeting regulation-driven labeling requirements—lands firmly in the role of pre-manufacturing activity, most certainly after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.[31] Allergen testing works in a similar fashion, though the manufacturer ideally uses a full set of best practices for food allergen management and testing, from confirming allergens (and correct labeling) from ingredients ordered to performing final production line cleanup (e.g., when a new allergen-free commercial formulation is being made or an unintended contamination has occurred).[32] These types of pre-production analyses aren't uncommon to other types of manufacturing, discussed below.

As for in-process manufacturing QC, some QC and quality assurance (QA) methods may already be built into the manufacturing process in-line, not requiring a lab. For example, poka-yoke mechanisms that inhibit, correct, or highlight errors as they occur, as close to the source as possible—may be built in-line to a manufacturing process to prevent a process from continuing should a detectable error occur, or until a certain condition has been reached.[33][34] However, despite the value of inline QC/QA, these activities also happen beyond the production line, in the laboratory (discussed further, below).

The following types of lab-related activities may be associated with the pre-manufacturing and manufacturing role:

Various pre-manufacturing analyses: Also known as pre-production, some level of laboratory activity takes place here. Like the previously mentioned food and beverage industry, the garment manufacturing industry, for example, will have its own laboratory-based pre-production activities, including testing various raw material samples for potential use and quality testing pre-production samples before deciding to go into full production.[35] In another example, a manufacturer intending to produce "a new chemical substance for a non-exempt commercial purpose" in the U.S. must submit a pre-manufacture notice to the Environmental Protection Agency (EPA), which must include "test data on the effect to human health or the environment."[36] Given this regulatory requirement, some final pre-approval testing much occur to ensure the chemical meets regulatory requirements before full manufacturing processes begin.

Quality control testing: While QC testing can appear in multiple manufacturing laboratory roles, it's most noticeable in the pre-manufacturing and manufacturing role. Manufacturers in many industries have set up formal testing laboratories to better ensure that their products conform to a determined set of accepted standards, whether those standards come from a standards-setting organization or are internally derived. QC testing is a multi-pronged approach that includes both non-laboratory and laboratory analyses, whether it is in real-time or periodically during manufacturing activities. The previously mentioned inline poka-yoke mechanisms provide an example of non-laboratory QC activities. However, when rigorous mechanical, chemical, or some other form of testing of a manufactured product is required at different stages of production, a laboratory will be involved. This type of in-process inspection occurs after roughly 10 to 30 percent of products are completed.[37] Manufacturers can take multiple approaches to QC testing, depending on the circumstances of manufacturing. This includes 100 percent inspection methods, Six Sigma approaches, X-bar charting, total quality management, statistical quality control, Taguchi approaches, and more.[38]

The actual types of analyses going on during QC will entirely depend on the material being tested, the functionality of the item, and the intended goal of testing. For example, polymerase chain reaction (PCR) testing of infant formula for the pathogenic bacterium Cronobacter sakazakii[39] during production runs is entirely different from periodic Rockwell, Brinell, or Vickers hardness testing of aerospace fasteners.[40] NDT and materials testing, discussed in the prior subsection about R&D, can also occur during the various phases of manufacturing, as part of an overall quality control effort.[20]

1.2.3 Post-production regulation and security roles and activities

Infrared spectrometer for screening for food adulteration, in CAFIA laboratory, Czech Republic.png

The laboratory participating in these roles is performing one or more tasks that relate to the post-production examination of products for regulatory, security, or accreditation purposes. Labs are often third parties accrediting a producer to a set of standards, ensuring regulatory compliance, conducting authenticity and adulteration testing, conducting security checks at borders, and applying contamination testing as part of an overall effort to track down contamination sources. In addition to ensuring a safer product, society also benefits from these and similar labs by better holding producers legally accountable for their production methods and obligations.

The following types of lab-related activities may be associated with the post-production regulation and security role:

Authenticity and adulteration testing: This type of testing is largely conducted to ensure products ingested, injected, inserted, and/or handled by humans and animals are safe to use and authentic to consumer expectations. Anything from food and pharmaceuticals to children's toys and fishing sinkers may be tested to ensure they contain what the manufacturer claims is contained in them. Foods and beverages, for example, are subject to a variety of food supply chain laws and regulations across national and international borders. As such, scientists have developed a number of analytical techniques "to identify foods or food ingredients that are in breach of labeling requirement and may consequently be adulterated." Among these techniques are DNA fingerprinting; visible, ultraviolet, infrared, fluorescence emission, and nuclear magnetic resonance spectroscopy; mass spectrometry; isotopic analysis; chromatography; polymerase chain reaction; differential scanning calorimetry; chemometric; and "electric nose and tongue" techniques.[41][42] In the United States, certain toys are subject to being tested and certified to the ASTM F963-17 standard by the U.S. Consumer Product Safety Commission (CPSC), with some toys being tested for heavy metals in surface coatings, nitrosamines in rubber, and contaminates in pastes, putties, and gels.[43] Authenticity and adulteration testing may occur during post-production as part of meeting a manufacturer's regulatory requirements, or it may be conducted at a state or national border as part of a set of international trade rules. In most cases, the testing will be done by a third party laboratory or a regulatory body.

Accreditation-led testing: In some cases, governments and other regulatory bodies provide a higher standard for a manufacturing-related laboratory process, which requires accreditation to that standard. For example, labs optionally accredited to Laboratory Accreditation for Analyses of Foods (LAAF) rules are recognized by the FDA as meeting the process requirements of the LAAF program for testing of specific sprouts, eggs, water, and certain foods being considered for import into the country.[44] LAAF represents one of several legal and regulatory forces driving accreditation of manufacturing-related laboratories to a higher standard. It also means greater potential for more testing opportunities for the third-party lab wishing to expand into enforcement and security roles. Similarly, the previously mentioned CPSC accredits labs to perform the specific testing required by children's product safety rules.[45] Again, as with authenticity and adulteration testing, accreditation-led testing is typically conducted by third-party labs separate from the manufacturer; however, this type of testing is a step above non-accredited labs and their methods, which may be required by certain manufacturers.

1.2.4 Tangential laboratory work

The following tangential laboratory roles aren't necessarily found directly in the manufacturing center. However, some level of laboratory work is required in these roles, which intersect with the manufacturing industry in some capacity.

Processing equipment design, monitoring, and sanitation: "Sanitation provides the hygienic conditions required to produce safe food," say Ho and Sandoval in chapter seven of Food Safety Engineering.[46] "Improper sanitation of equipment can potentially introduce hazardous contamination to food and enhance pathogen harborage in the food-processing environment."[46] They note the value of sanitation standard operating procedures (SSOPs) to the production facility, which dictate sanitation methods and frequencies, monitoring methods, and record keeping methods.[46] These SSOPs are not only driven by good manufacturing practice (GMP) but also appropriate and effective laboratory testing.

While Ho and Sandoval focus on food and beverage production, the proper design, monitoring and sanitation of manufacturing equipment extends beyond that industry, into areas such as pharmaceutical production and medical device manufacturing. That foundation of laboratory testing has occurred historically with the both the experience of regulated manufacturers and those scientists engineering and standardizing hygienic solutions for manufacturing industries. Combined, these industry and laboratory experiences have driven regulations and standards on hygienic design throughout the world. Broadly speaking, this has culminated in a set of manufacturing requirements, addressing physical and chemical properties such as being nontoxic, corrosion-resistant, and non-absorbent, to mechanical properties such as being durable and smooth, and operational properties such as being cleanable and low-maintenance.[47][48] In turn, these properties require laboratory and engineering knowledge about metals, alloys, plastics, and many other materials.[48] Here we find multi-disciplinary knowledge in materials science, microbiology, chemistry, physics, and more, implying a corresponding necessity for knowledge on a wide variety of testing methods.

Calibration: Just as laboratories require their precision equipment be regularly calibrated to specific tolerances, manufacturers too require their equipment to be calibrated. Multiple types of equipment along the production line require the utmost in accuracy and consistency in order to create a finished product that is safe and fully functional. Manufacturers who fall behind on their calibration obligations are more prone to higher rates of rejected components and products, more cost overruns, more missed deadlines, and greater reputation damage.[49] As such, manufacturers increasingly depend on industrial maintenance providers, OEM providers, and laboratories to ensure their instruments and equipment meet operational tolerances.


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