Difference between revisions of "User:Shawndouglas/sandbox/sublevel9"

From LIMSWiki
Jump to navigationJump to search
(40 intermediate revisions by the same user not shown)
Line 1: Line 1:
We continue to look at 20 broad industry categories and the laboratories associated with them. For each you'll find a brief description with common services and how the lab type affects the average person. As discussed previously, using our client type + function model we dig into examples found in the private, government, and academic sectors and then outline function through activities, sciences, test types, equipment, and unique attributes.
<div class="nonumtoc">__TOC__</div>
{{ombox
| type      = notice
| style    = width: 960px;
| text      = This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
}}


<div align="center">-----Return to [[User:Shawndouglas/sandbox/sublevel4|the beginning]] of this guide-----</div>
==Sandbox begins below==
__TOC__


==Labs by industry: Part 2==
==2. Sample Management==
===Clinical and academic research===
{|
[[File:Methoxamine in it's current manufactured form in a solution in both a syringe and vial..jpg|left|400px]]
| STYLE="vertical-align:top;"|
{{clear}}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-7]
  | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
  | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-9]
  | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status.
|-
  | style="padding:5px; width:500px;" |[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-10]
  | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
  | style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
|-
|}
|}


Clinical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the Food and Drug Administration, unlike the previously mentioned clinical and public health laboratories. Clinical research labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)<ref name="FCRDefinition">{{cite web |url=https://firstclinical.com/fda-gcp/?show=2004/Definition+of+Central+Laboratory |title=Definition of Central Laboratory |work=First Clinical Research |publisher=First Clinical Research, LLC |date=19 April 2004 |accessdate=01 June 2017}}</ref><ref name="MinorHandbook06">{{cite web |url=https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover |title=Handbook of Assay Development in Drug Discovery |editor=Minor, L.K. |publisher=CRC Press |year=2006 |pages=488 |isbn=9781420015706}}</ref>:  
==3. Core Laboratory Testing and Experiments==
 
{|
* clinical studies
| STYLE="vertical-align:top;"|
* bioequivalence studies
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
* study design and management
|-
* high-volume specimen testing
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
* custom assay development
|-
* test kit development and supply
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
Clinical studies and trials aside, other types of research may require laboratory services as well. (For the purposes of this guide, we refer to it as "academic research," a broad catch-all category for other research involving laboratories that doesn't readily fit into other industry categories.) Take for example the archeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.<ref name="AugustanaArchLab">{{cite web |url=http://www.augie.edu/archeology-laboratory |title=Archeology Laboratory |publisher=Augustana University |accessdate=01 June 2017}}</ref><ref name="SLUArchLab">{{cite web |url=http://www.slu.edu/department-of-sociology-and-anthropology/research-labs-and-facilities/archaeology-laboratory |title=Archeology Laboratory |publisher=Saint Louis University |accessdate=01 June 2017}}</ref> Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory<ref name="NokiaHistoryBell">{{cite web |url=https://www.bell-labs.com/explore/history-bell-labs/ |title=History - Bell Labs |publisher=Nokia Group |accessdate=01 June 2017}}</ref> and the university-affiliated University of New Hampshire InterOperability Laboratory.<ref name="UNH-IOL_FAQ">{{cite web |url=https://www.iol.unh.edu/about/faq |title=UNH-IOL FAQ |publisher=University of New Hampshire InterOperability Laboratory |accessdate=01 June 2017}}</ref>
|-
 
  | style="padding:5px; width:500px;" |
''How do clinical and academic research laboratories intersect the average person's life on a daily basis?'' If you've had a medical device implanted, taken a prescription medication, visited an archeological exhibit in a museum, or experienced improvements in how you communicate with others, then you've been touched by a clinical or academic research laboratory. Without these facilities we'd have fewer medications and assistive devices, and by extension shorter life spans. We'd know less about humanity's past growth and development, and we'd lack the technology to rapidly disseminate those findings around the globe.  
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<br />[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-1]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7]
 
  | style="background-color:white;" |'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
====Client types====
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)]<br />[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-2]
'''Private''' - Private clinical research labs are most often "central laboratories" (see the end of this section for more on this term) that are contracted by pharmaceutical companies and medical device manufacturers.
  | style="background-color:white;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
 
|-
Examples include:
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-3]
 
  | style="background-color:white;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
* [http://www.acmgloballab.com/Central-Laboratory-Services/Clinical-Trials-Research-Central-Lab-Services-Clinical-Research-Laboratory.aspx ACM Global Central Laboratory]
|-
* [http://www.covance.com/services/clinical-testing/central-laboratory-services.html Covance Central Labs]
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-4]
* [https://www.jmilabs.com/clinical-trial-support/ JMI Laboratories]
  | style="background-color:white;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.
 
|-  
'''Government''' - These labs are typically set up by a government agency to perform specific research into medical conditions such as cancer, depression, or HIV infection.
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-6]
 
  | style="background-color:white;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
Examples include:
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-7]
* [https://frederick.cancer.gov/ Frederick National Laboratory for Cancer Research]
  | style="background-color:white;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
* [https://clinicalcenter.nih.gov/ccc/crc/ NIH Clinical Trial Center]
|-
* [https://www.fda.gov/ScienceResearch/FieldScience/ Office of Regulatory Affairs' Field Laboratories]
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-8]
 
  | style="background-color:white;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
'''Academic''' - Many academic institutions set up their own clinical research activities, often within an affiliated medical center. These research efforts often serve as training grounds for students to learn more about clinical research and its administration.
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-9]
Examples include:
  | style="background-color:white;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
 
|-
* [http://ictr.johnshopkins.edu/clinical/clinical-resources/human-subjects-research-core/ictr-clinical-research-units-crus/services/clinical-research-unit-core-lab/ Johns Hopkins Clinical Research Unit Core Laboratory]
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-10]
* [https://careers.insidehighered.com/job/1326323/clinical-research-laboratory-assistant/ University of Colorado Denver Anschutz Medical Campus]
  | style="background-color:white;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
* [https://www.mir.wustl.edu/research/research-support-facilities/clinical-research-lab-crl Washington University Clinical Research Laboratory]
|-
 
  | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]
====Functions====
  | style="background-color:white;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
 
|-  
''What are the most common functions?'' research/design, clinical studies, contract lab work
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-12]
 
  | style="background-color:white;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
''What materials, technologies, and/or aspects are being analyzed and researched?'' artifacts, biological specimens, communication networks, medical devices, etc. (depending on academic discipline practiced in the lab)
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-13]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]
''What sciences are being applied in these labs?'' archeology, clinical research, information theory, etc. (depending on academic discipline practiced in the lab)
  | style="background-color:white;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.
 
|-
''What are some examples of test types and equipment?''
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
'''Common test types include''':
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br />
Absorption, Acoustic startle, Acute contact, Acute oral, Acute toxicity, Adhesion, Age determination, Amino acid analysis, Angle of repose, Antimicrobial, Antigen, Behavioral, Blood culture, Blood gases, Bioavailability, Bioburden, Biocompatibility, Bioequivalence, Biomechanical, Biomolecular, Biosafety, Calorimetry, Carcinogenicity, Clinical diagnostic, Colorimetric, Compaction, Compendial, Complete blood count, Cytology, Cytopathology, Cytotoxicity, Detection, Developmental and reproductive toxicology, Dietary exposure, Ecotoxicology, Efficacy, Electrolyte and mineral panel, Electromagnetic compatibility, Electromagnetic interference, Electrophoresis, Endocrine disruptor screening program, Endotoxin, Environmental fate, Environmental metabolism, Extractables and leachables, Feasibility, Fluid dynamics, Functional observational battery, Genetic, Genotoxicity, Hematocrit, Hemoglobin, Hematotoxicity, Human factors, Immunohistochemistry, Impact, Impurity, Inhalation, Irritation, Kidney function, Learning and memory, Lipid profile, Liver function, Locomotor activity, Metabolic, Microfluidics, Minimum bactericidal concentration, Minimum inhibitory concentration, Nanoparticulate, Neurotoxicity, Nutritional, Osmolality, Osmolarity, Oxidation reduction potential, Oxidation stability, Parasitic, Pathogen, Pathogenicity, pH, Pharmacokinetic, Phototoxicity, Protein analysis, Protein characterization, Red blood cell count, Refractive index, Sensitization, Solubility, Specific gravity, Thyroid function, Toxicokinetic, Urine culture, Validation, Verification, Virucidal efficacy, Wildlife toxicology
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-14]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4]<br />
'''Industry-related lab equipment may include''':
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4]<br />
autoclave, balance, biohazard container, biosafety cabinet, centrifuge, chromatographic, clinical chemistry analyzer, colorimeter, desiccator, dissolved oxygen meter, dry bath, electrophoresis system, ELISA plate reader, fluorometer, freezers, fume hood, genetic analyzer and sequencer, homogenizer, hotplate, incubator, magnetic stirrer, mass spectrometry equipment, microcentrifuge tube, microplate reader, microscope, multi-well plate, orbital shaker, PCR machine, personal protective equipment, pH meter, Petri dish, pipettor, powered air purifying respirators, refractometer, spectrophotometer, syringes, test tube and rack, thermal cycler, thermometer, urinalysis device, water bath
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br />
''What else, if anything, is unique about the labs in the clinical and academic research fields?'' It's important to note that some clinical research laboratories may be referred to as "central laboratories." Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term. However, it seems to be used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.<ref name="FCRDefinition" /><ref name="KarelinSelecting13">{{cite web |url=http://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/ |title=Selecting a Central Laboratory |author=Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. |work=Contract Pharma |publisher=Rodman Media, Inc |date=06 May 2013 |accessdate=01 June 2017}}</ref>
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />
====LIMSwiki resources====
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8]
 
  | style="background-color:white;" |'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
* [[Translational research]]
|-  
* [[Translational research informatics]]
|}
 
|}
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=Eu62G5a8oEAC&printsec=frontcover |title=Principles and Practice of Clinical Research |editor=Gallin, J.I.; Ognibene, F.P. |publisher=Academic Press |year=2012 |pages=796 |isbn=9780123821683}}
 
 
<div align="center"><hr width="50%"></div>
 
===Cosmetic===
[[File:Cosmetics-1078712 1280.jpg|left|400px]]
{{clear}}
Cosmetic labs provide research and development as well as quality control functions to the world of cosmetics. From makeups and moisturizers to hair dyes and lipsticks, the cosmetic laboratory is responsible for making safe and effective products of many types. Cosmetic chemists tend to mostly work in private laboratories or as part of a private-public research partnership, though some work in academic labs.<ref name="BrowneTheJob">{{cite web |url=http://work.chron.com/job-description-cosmetic-chemist-17987.html |title=The Job Description of a Cosmetic Chemist |author=Browne, C. |work=Chron |publisher=Hearst Newspapers, LLC |accessdate=01 June 2017}}</ref> Cosmetic labs are found largely in the private sector, though they exist in the government and academic sectors and provide many different services, including (but not limited to):
 
* formulation and development of products<ref name="BrowneTheJob" />
* safety testing of products<ref name="BrowneTheJob" />
* process engineering improvement<ref name="BrowneTheJob" />
* chemical and material research<ref name="BrowneTheJob" />
* substantiation of compatibility and efficacy claims<ref name="NWUCEL">{{cite web |url=http://health-sciences.nwu.ac.za/pharmaceutical-and-biomedical-services/cel |title=CEL |publisher=North-West University |accessdate=01 June 2017}}</ref>
* allergy testing
* contaminate testing
 
''How do cosmetic laboratories intersect the average person's life on a daily basis?'' In private industry, cosmetic scientists are tasked with creating a safe product free from contaminates and allergens that may negatively affect a user. At the higher government level, some labs are responsible for substantiating manufacturer claims, testing cosmetics, and even manufacturing cosmetic components<ref name="NWUCEL" />; the U.S. Food and Drug Administration (FDA), for example, certifies some color additives as safe for consumers in its own lab.<ref name="FDASmallBus16">{{cite web |url=https://www.fda.gov/cosmetics/resourcesforyou/industry/ucm388736.htm |title=Small Businesses & Homemade Cosmetics: Fact Sheet |publisher=Food and Drug Administration |date=05 October 2016 |accessdate=01 June 2017}}</ref> Without these labs, the soaps, shampoos, moisturizers, and makeup on the market wouldn't likely exist, or if they did, they would be of unknown quality, posing a threat to human health. When we use such a product, we are reminded that a laboratory was at some point involved in its creation.
 
====Client types====
 
'''Private''' - Private cosmetic labs are either found as part of a major company initiative (think L’Oréal Group and its laboratories<ref name="LOrealUSAResearch">{{cite web |url=http://www.lorealusa.com/group/discover-l%27or%C3%A9al-usa/l%E2%80%99or%C3%A9al-usa-research-and-innovation |title=L’Oréal USA Research And Innovation |publisher=L’Oréal Group |accessdate=01 June 2017}}</ref>) or as a third-party contract lab that provides development, manufacturing, and consulting services to clients.
 
Examples include:
 
* [http://ariellabs.com/ Ariel Laboratories]
* [http://cosmeticlaboratories.com/ Cosmetic Laboratories]
* [http://cla-cosmeticlabs.com/services/ Cosmetic Laboratories of America]
 
'''Government''' - Governments around the world differ in how they regulate and test cosmetics. Though not common, some governments will dedicate space for laboratory testing, certification of constituents, and testing of efficacy and compatibility claims.<ref name="NWUCEL" /><ref name="FDASmallBus16" />
 
Examples include:
 
* [http://www.fdaghana.gov.gh/index.php?option=com_content&view=article&id=25&Itemid=3 Ghana Food and Drugs Authority, Cosmetic Laboratory]
* [http://www.thehindu.com/news/national/other-states/odisha-government-identifies-land-for-cosmetic-testing-lab/article8514721.ece Government of Odisha's Central Cosmetic Testing Laboratory]
* [http://www.hsa.gov.sg/content/hsa/en/Applied_Sciences/Pharmaceuticals_Cosmetics_Tobacco/Overview/Cosmetics.html Singapore Health Sciences Authority's Cosmetics Laboratory]
 
'''Academic''' - Academic programs in cosmetic science aren't abundant, but they can be found. (The Society of Cosmetic Chemists lists a few U.S.-based programs [http://www.scconline.org/resources/ here].) The laboratories associated with this course of study are presumably similar in makeup to a chemistry teaching laboratory in a typical university, with a few additions, including research facilities.
 
Examples include:
 
* [http://view2.fdu.edu/academics/university-college/school-of-natural-sciences/academic-programs/ms-in-cosmetic-science/ Farleigh Dickinson University Cosmetic Science Programs]
* [http://pharmacy.uc.edu/program-information/graduate/cosmetic/overview University of Cincinnati Cosmetic Science Programs]
* [http://health-sciences.nwu.ac.za/pharmaceutical-and-biomedical-services/cel North-West University Cosmetics Efficacy Laboratory]
 
====Functions====
 
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
 
''What materials, technologies, and/or aspects are being calibrated, researched, and quality controlled?'' colorants, dyes, emulsions, lacquers, polymers, silicones, surfactants
 
''What sciences are being applied in these labs?'' biochemistry, biology, chemical engineering, chemistry, cosmetic science, macromolecular science, pharmaceutical science, process engineering
 
''What are some examples of test types and equipment?''
 
'''Common test types include''':
 
Absorption, Allergy, Antimicrobial, Bioburden, Biocompatibility, Comparison, Compliance/Conformance, Composition, Contamination, Detection, Efficacy, Expiration dating, Flammability, Fluorescence, Formulation, Fragrance, Impurity, Ingredient, Irritation, Labeling, Oxidation reduction potential, Oxidation stability, Pathogen, Performance, pH, Photostability, Preservative challenge, Proficiency, Purity, Pyrogenicity, Quality control, Safety, Sensitization, Stability, Water activity
 
'''Industry-related lab equipment may include''':
 
autoclave, balance, chromatographic, digital imaging devices, ESR spectroscopy equipment, fluorescent laser scan microscope, Fourier transform infrared spectroscopy equipment, microscope, multiphotone tomography equipment, pH meter, Raman spectroscopy equipment, test tube and rack, thermometer, transepidermal water loss (TEWL) instrumentation
 
''What else, if anything, is unique about the labs in the cosmetic industry?'' In the U.S., whereas the Centers for Medicare & Medicaid Services (CMS) regulates clinical laboratory testing<ref name="CMSCLIA">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html |title=Clinical Laboratory Improvement Amendments (CLIA) |publisher=Centers for Medicare & Medicaid Services |date=05 April 2017 |accessdate=01 June 2017}}</ref>, the FDA regulates cosmetic laboratories.<ref name="FDAAuthority">{{cite web |url=https://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074162.htm |title=FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated |publisher=Food and Drug Administration |date=15 November 2016 |accessdate=01 June 2017}}</ref> Regulation of cosmetic laboratories in other countries varies; in Singapore, for example, the Health Sciences Authority helps enforce cosmetic testing of its Health Products Act.<ref name="HSACosmetics">{{cite web |url=http://www.hsa.gov.sg/content/hsa/en/Applied_Sciences/Pharmaceuticals_Cosmetics_Tobacco/Overview/Cosmetics.html |title=Cosmetics |publisher=Health Sciences Authority |date=17 July 2014 |accessdate=01 June 2017}}</ref>
 
====LIMSwiki resources====
 
* None
 
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=HGp_CwAAQBAJ&printsec=frontcover |title=Cosmetic Science and Technology: Theoretical Principles and Applications |author=Sakamoto, K.; Lochhead, R.; Maibach, H.; Yamashita, Y. |publisher=Elsevier |year=2017 |pages=854 |isbn=9780128020548}}
 
 
<div align="center"><hr width="50%"></div>
 
===Energy===
[[File:Pomiary rezystancji uzwojenia transformatora z rdzeniem amorficznym miernikiem Sonel MMR-6000.jpg|left|400px]]
{{clear}}
The energy laboratory is largely a place for the research and development of energy sources and devices, though it also is a place for researchers to focus on improving energy efficiency in current fuels, systems, and structures. These labs are found in the government and academic sectors, and occasionally in the private sector, providing many different services, including (but not limited to)<ref name="NRELResearch">{{cite web |url=https://www.nrel.gov/research/ |title=Research |work=National Renewable Energy Laboratory |publisher=Alliance for Sustainable Energy, LLC |accessdate=02 June 2017}}</ref>:
 
* chemical and biomolecular engineering
* applied research and development
* analysis and improvement of energy efficiency
* analysis and improvement of transportation systems
* development of energy systems
* discovery and development of materials
* integration of energy systems
 
''How do energy laboratories intersect the average person's life on a daily basis?'' "I want my phone's battery to last longer!" you shout, as you put it on the charger for the second time in a day. The truth is your device probably has a better battery life than the generation before it, and the generation before it, etc., but you're at the same time making it do more demanding tasks than it used to at the same time. Yet advances continue to be made in energy storage.<ref name="ArgonneResearchers16">{{cite web |url=https://phys.org/news/2016-03-pave-battery.html |title=Researchers continue to pave way for improved battery performance testing |author=Argonne National Laboratory |work=Phys.org |publisher=Science X |date=31 March 2016 |accessdate=02 June 2017}}</ref> You can thank an energy laboratory and its scientists for that and similar advances that affect you on a daily basis.
 
====Client types====
 
'''Private''' - Private laboratories tend to focus on a company's R&D or provide third-party analysis of materials used as fuel sources.
 
Examples include:
 
* [http://www.biomassenergylab.com/index.htm Biomass Energy Lab]
* [https://www.energylab.com/ Energy Laboratories]
 
'''Government''' - Along with academic labs, government labs (public and public-private) make up the majority of energy laboratories and typically provide much of the funding for energy research, at least in the United States.<ref name="KotokFinancing06">{{cite web |url=http://www.sciencemag.org/careers/2006/07/financing-your-research-alternative-energy |title=Financing Your Research in Alternative Energy |work=Science |author=Kotok, A. |publisher=American Association for the Advancement of Science |date=14 July 2006 |accessdate=02 June 2017}}</ref>
 
Examples include:
 
* [https://www.netl.doe.gov/ National Energy Technology Laboratory]
* [http://www.nrel.gov/ National Renewable Energy Laboratory]
* [https://energy.usgs.gov/GeochemistryGeophysics/GeochemistryLaboratories.aspx#3898249-overview U.S. Geological Survey's Geochemistry Laboratory]
 
'''Academic''' - Higher education continues to be a major source for the study, research, and application of energy sources and equipment. From the optimization of commercial and industrial buildings to alternative fuels and clean energy systems, the academic-affiliated energy lab is pushing energy science forward at a significant pace.
 
Examples include:
 
* [http://esl.tamu.edu/ Texas A&M's Energy Systems Laboratory]
* [https://rael.berkeley.edu/ University of California - Berkeley's Renewable & Appropriate Energy Laboratory]
* [http://www.hnei.hawaii.edu/ University of Hawaii at Manoa's Hawaii Natural Energy Institute]
 
====Functions====
 
''What are the most common functions?'' analytical, research/design, and QA/QC, and teaching
 
''What materials, technologies, and/or aspects are being calibrated, researched, and quality controlled?'' biomass, emissions, energy efficiency, energy storage and retrieval, hydropower, petrochemicals, solar energy, thermal energy, thin films, wind power
 
''What sciences are being applied in these labs?'' chemical engineering, chemistry, engineering, environmental science, material science, mechanical design, microbiology, thermodynamics
 
''What are some examples of test types and equipment?''
 
'''Common test types include''':
 
Accelerated stress testing, Aging, Calorimetry, Characterization, Climatics, Combustion, Contact mechanics, Contamination, Degredation, Design verification testing, Dielectric withstand, Durability, Efficiency, Electromagnetic compatibility, Electromagnetic interference, Electrostatic discharge, Emissions, Endurance, Flash point, Fluid dynamics, Friction, Geothermal, Hydraulic, Lightning, Mechanical, Mechanical durability, Power quality, Proficiency, Resistance - capacitance - inductance, Solar, Temperature, Thermal, Torque, Validation, Velocity and flow, Voltage
 
'''Industry-related lab equipment may include''':
 
calorimeter, climate test chamber, gas turbine, geothermal energy absorber, hydrogen fuel cell, impulse turbine, light sensor, photovoltaic trainer/system, plasma light system, porosimeter,  reaction turbine, solar thermal system, temperature sensor, viscometer, wind turbine
 
''What else, if anything, is unique about the labs in the energy industry?'' By and far, energy laboratories seem to have the most prominent footprint in the government and academic sectors. Privately run energy laboratories exist but appear to be the minority, appearing as either R&D labs inside a larger manufacturing company or as niche third-party testing facilities for biomass and/or petrochemicals. As an aside, since agriculture and forest biomass<ref name="FSForestBiorefine">{{cite web |url=https://www.fpl.fs.fed.us/research/research_emphasis_areas/introduction.php?rea_id=3 |title=Forest Biorefinery - Introduction |work=Forest Products Laboratory |publisher=U.S. Forest Service |accessdate=02 June 2017}}</ref> as well as petrochemicals can be used as fuel sources, the energy industry has ties to the agriculture, forestry, and petrochemical industries. Of course, the power and utility industry — which focuses on large-scale energy solutions for communities — is closely linked as well.
 
====LIMSwiki resources====
 
* None
 
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=SFvOBQAAQBAJ&printsec=frontcover |title=Principles of Sustainable Energy Systems |editor=Kreith, F., Krumdieck, S. |edition=2nd |publisher=CRC Press |year=2013 |pages=790 |isbn=9781466556973}}</ref>
 
 
<div align="center"><hr width="50%"></div>
 
===Environmental===
[[File:K4641-1rootscientists.jpg|left|300px]]
{{clear}}
Environmental laboratories are responsible for the analysis and research of a wide variety of materials and environments with the purpose of promoting human, animal, and ecosystem health. These labs also act as compliance enforcement entities for regulators. These labs provide services to energy and utility companies, engineering firms, pharmaceutical companies, governments, and other industry forces. These labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to):
 
* exposure testing<ref name="BangertEnviro96">{{cite web |url=https://www.nap.edu/read/9191/chapter/6 |chapter=Chapter 5: Environmental Testing Laboratories and Instruments |title=Risk & Innovation: Small Companies in Six Industries: Background Papers Prepared for the NAE Risk and Innovation Study |author=Bangert, C.E.; Lynch, R.A. |publisher=National Academies Press |date=1996 |pages=83–108 |doi=10.17226/9191}}</ref>
* field testing<ref name="BangertEnviro96" />
* radiological testing<ref name="MNDoHEnviro">{{cite web |url=http://www.health.state.mn.us/divs/phl/environmental/ |title=Environmental Laboratory |publisher=Minnesota Department of Health |accessdate=03 June 2017}}</ref><ref name="STLCoEnviro">{{cite web |url=http://www.stlouisco.com/HealthandWellness/EnvironmentalServices/EnvironmentalLaboratories |title=Environmental Laboratories |publisher=Saint Louis County |accessdate=03 June 2017}}</ref>
* heavy metals testing<ref name="BangertEnviro96" />
* air quality monitoring<ref name="BangertEnviro96" />
* environmental assessments<ref name="BangertEnviro96" />
* environmental engineering<ref name="SarigiannisWelcoming">{{cite web |url=http://www.enve-lab.eu/index.php/about/welcoming-letter/ |title=Welcoming Letter: Message from the director Prof. Dimosthenis A. Sarigiannis |work=EnvE-Lab |publisher=Aristotle University of Thessaloniki |accessdate=03 June 2017}}</ref>
 
''How do environmental laboratories intersect the average person's life on a daily basis?'' The easiest way environmental labs tie into the average person's life is through the potable water supply. Without these labs, more people would become ill or even die due to improperly or non-treated drinking water supplies. We need not look further than the Flint, Michigan water crisis, where improper funding for testing and treatment of contaminated water led to the metal lead leaching into the drinking water.<ref name="CNNFlint17">{{cite web |url=http://www.cnn.com/2016/03/04/us/flint-water-crisis-fast-facts/ |title=Flint Water Crisis Fast Facts |work=CNN |publisher=Turner Broadcasting System, Inc |date=10 April 2017 |accessdate=03 June 2017}}</ref> It may be easy to take clean drinking water for granted, but remember that a lab is most likely in place to ensure it's clean in the first place.
 
====Client types====
 
'''Private''' - Private environmental labs cater to industry and the government, providing third-party testing services, often under contract.
 
Examples include:
 
* [http://aellabs.com/ American Environmental Laboratories]
* [http://www.caduceonlabs.com/ Caduceon Environmental Laboratories]
* [https://www.pacelabs.com/ Pace Analytical Services]
 
'''Government''' - Government-affiliated labs not only provide analytical services for states and municipalities; they also may conduct academic and field research to better guide local, state, and federal environmental policy.
 
Examples include:
 
* [http://www.health.state.mn.us/divs/phl/environmental/ Minnesota Department of Health's Environmental Laboratory]
* [http://www.stlouisco.com/HealthandWellness/EnvironmentalServices/EnvironmentalLaboratories Saint Louis County Environmental Health Laboratories]
* [https://www.epa.gov/aboutepa/about-national-health-and-environmental-effects-research-laboratory-nheerl U.S. Environmental Protection Agency's National Health and Environmental Effects Research Laboratory]
 
'''Academic''' - The environmental labs affiliated with higher education are usually researched-based, though they may occasionally provide third-party analyses. These labs are often directly affiliated with a local or even international watershed or ecosystem, providing valuable field training to students while monitoring changes to the location over time and issuing public reports.
 
Examples include:
 
* [http://www.enve-lab.eu/ Aristotle University of Thessaloniki's Environmental Engineering Laboratory]
* [http://web.plattsburgh.edu/academics/envsci/chemlab.php SUNY Plattsburgh's Lake Champlain Research Institute]
* [http://www.wm.edu/as/kecklab/ William & Mary's Keck Environmental Field Laboratory]
 
====Functions====
 
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
 
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' acoustics, air quality, allergens, biological specimens, contaminates, finished products, hazardous waste, pesticides, raw materials, sediment, soil, solid waste, water quality
 
''What sciences are being applied in these labs?'' chemistry, chemical engineering, environmental engineering, environmental science, microbiology, organic and inorganic chemistry, radiation chemistry
 
''What are some examples of test types and equipment?''
 
'''Common test types include''':
 
Absorption, Acute contact, Acute oral, Acute toxicity, Allergy, Anion, Antimicrobial, Atterberg limits, Bioaccumulation, Bioavailability, Bioburden, Biodegradation, Chemical and biochemical oxygen demand, Colorimetric, Conductivity, Consolidation, Contamination, Decomposition, Degradation, Density, Ecotoxicology, Emissions, Environmental fate, Environmental metabolism, Environmental monitoring, Geochemistry, Geophysics, Humidity, Hydraulic conductivity, Isotope analysis, Leak, Metallurgical analysis, Minimum bactericidal concentration, Minimum inhibitory concentration, Mobility, Organic carbon, Oxidation reduction potential, Permeability, pH, Photostability, Plant metabolism, Pressure, Proficiency, Radioactivity, Radiochemical, Refractive index, Seismic, Sensory, Soil microflora, Specific gravity, Temperature, Terrestrial toxicology, Turbidity, Wildlife toxicology
 
'''Industry-related lab equipment may include''':
 
balance, Bunsen burner, burette, colorimeter, centrifuge, chromatographic, crucible, desiccator, dropper, enzyme immunoassay, Erlenmeyer flask, extractor, Florence flask, flow meter, fume hood, funnel, graduated cylinder, hot plate, moisture analyzer, mortar and pestle, multi-well plate, organic carbon analyzer, oven, particle counter, pH meter, pipestem triangle, reagent dispenser, remote sensors, ring stand, rotary evaporator, sediment analyzer, spectrometer, spectrophotometer, stirring rod, thermometer, viscometer
 
''What else, if anything, is unique about the labs in the environmental industry?'' "The environmental laboratory industry will be undergoing continuous radical change in coming years as environmental markets continue to evolve," stated Bangert and Lynch in a 1996 study for the National Research Council. "The model laboratory of the future, therefore, is likely to be far different from that of today," they added.<ref name="BangertEnviro96" /> Fast forward 20 years, and we see their then vision for the future of environmental testing labs came to fruition: today's environmental testing lab uses a [[laboratory information management system]] (LIMS) to manage data in an automated, innovative lab that provides analytical services as well as research.<ref name="BangertEnviro96" /><ref name="DePalmaInsights13">{{cite web |url=http://www.labmanager.com/insights/2013/09/insights-on-starting-and-running-an-environmental-lab |title=Insights on Starting and Running an Environmental Lab |author=DePalma, A. |work=Lab Manager |publisher=LabX Media Group |date=10 September 2013 |accessdate=03 June 2017}}</ref> And they need to be agile as the concepts of "climate change," "biodiversity," and "sustainable ecosystems" continue to weave their way into the focus of environmental laboratories.<ref name="SimmondsTheImport09">{{cite web |url=http://your.kingcounty.gov/dnrp/library/water-and-land/science/newsletter/2009/june/0906-3-monitoring-import.pdf |title=The Importance of Environmental Monitoring and Analysis |work=King County's SciFYI |author=Simmonds, J. |publisher=King County |date=June 2009 |accessdate=03 June 2017}}</ref><ref name="ERDCEnvironmental">{{cite web |url=http://www.erdc.usace.army.mil/Media/Fact-Sheets/Fact-Sheet-Article-View/Article/476745/environmental-laboratory/ |title=Environmental Laboratory |publisher=U.S. Army Corps of Engineers - Engineer Research & Development Center |accessdate=03 June 2017}}</ref> As such, these labs will play an ever-increasing role in helping scientists better understand how we are impacting our environment.
 
====LIMSwiki resources====
 
* [[Environmental informatics]]
* [[Hydroinformatics]]
 
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=VUCcAQAAQBAJ&printsec=frontcover |title=Environmental Chemistry: A Global Perspective |author=vanLoon, G.W.; Duffy, S.J. |publisher=Oxford University Press |year=2011 |pages=545 |isbn=9780199228867}}
 
 
<div align="center"><hr width="50%"></div>
 
===Food and beverage===
[[File:Laboratório de Tecnologia de Alimentos.jpg|left|400px]]
{{clear}}
Food and beverage laboratories are responsible for developing, protecting, and supporting the food, beverages, and nutritional supplements humans and animals consume. From creating new flavor enhancers for food to ensuring the quality and safe consumption of a wine, these labs play a vital role in most parts of the world where processed food and agricultural products are produced. These labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)<ref name="NielsenFood15">{{cite book |title=Food Analysis Laboratory Manual |author=Nielsen, S. |publisher=Springer |pages=177 |edition=2nd |year=2015 |isbn=9781441914620}}</ref>:
 
* reverse engineering
* claims testing
* contaminate testing
* batch variation testing
* extractable and leachable testing
* allergen testing
* shelf life testing
* non-routine quality testing
* packaging testing
 
''How do food and beverage laboratories intersect the average person's life on a daily basis?'' Have you ever enjoyed a candy bar, soda, or snack cake? A laboratory and food scientists were behind its production. Don't care much for processed foods? A laboratory is still involved in the quality and safety testing of raw fruits and vegetables, milk, and nuts. And when food supplies become contaminated, government testing labs are often in the thick of determining the source of the contamination as quickly as possible before more people become ill. Whether it's the unique flavor profile of a potato chip you love or the fact you can reliably acquire safe foods, remember that a laboratory is often behind it.
 
====Client types====
 
'''Private''' - Whether manufacturers seek help with a formulation problem or a government subcontracting contamination analysis, private food and beverage labs are there. These labs may appear within a major food corporation or act as third-party contact labs for work as needed.
 
Examples include:
 
* [https://www.avomeen.com/services/food-and-beverage-testing/ Avomeen Analytical Services]
* [http://www.dtsfoodassurance.com.au/ DTS Food Assurance]
* [http://www.eag.com/food/ EAG Laboratories]
 
'''Government''' - The government-affiliated labs of the food and beverage industry typically act as protectors of the local, regional, or national food supply. Some may be responsible for developing and enforcing regulations as well.
 
Examples include:
 
* [http://www.ava.gov.sg/explore-by-sections/food/laboratory-services/food-testing Agi-Food & Veterinary Authority of Singapore's Food and Food Product Laboratory]
* [http://health.mo.gov/lab/foodbeverageanalysis.php Missouri State Public Health Laboratory, Chemistry Unit]
* [http://www.agriculture.pa.gov/Protect/FoodSafety/Laboratory/Pages/default.aspx Pennsylvania Department of Agriculture Food Safety Laboratory Division]
 
'''Academic''' - Academic food and beverage labs are usually teaching labs, often associated with a university's agriculture department.
 
Examples include:
 
* [http://www.fshn.chhs.colostate.edu/research/BSL/index.aspx Colorado State University Brewing Science and Food Microbiology Laboratory]
* [http://ifstl.jifsan.umd.edu/about/ University of Maryland, Joint Institute for Food Safety and Applied Nutrition's International Food Safety Training Lab]
* [http://www.fst.vt.edu/aboutus/facilities.html VirginiaTech's Food Analysis, Meat Chemistry, and Enology Laboratories]
 
====Functions====
 
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
 
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' candy, dairy, fruits, grains, meats, nuts, oils, proteins, soft drinks, starches, sugars, vegetables, vitamins
 
''What sciences are being applied in these labs?'' biochemistry, chemical engineering, chemistry, fermentation science, microbiology, molecular gastronomy, nutrition and food science
 
''What are some examples of test types, terminology, and equipment?''
 
'''Common test types include''':
 
Absorption, Active ingredient, Alcohol level, Allergy, Altitude, Amino acid analysis, Ash, Bioavailability, Bioburden, Biodegradation, Biomolecular, Boiling - freezing - melting point, Comparison, Compliance/Conformance, Contamination, Density, Detection, Efficacy, Expiration dating, Extractables and leachables, Flavor, Fluid dynamics, Fluorescence, Fragrance, Genotoxicity, GMO detection, HACCP, Hazard analysis, Identification, Ingredient, Iodine value, Isotope analysis, Labeling, Moisture, Mold - fungal - mycotoxin, Mutagenicity, Nutritional, Oxidation reduction potential, Oxidation stability, Pathogen, PDCAAS, Permeability, Peroxide value, pH, Plant metabolism, Polarimetry, Preservative challenge, Proficiency, Purity, Quality control, Radioactivity, Radiochemical, Refractive index, Safety, Sanitation, Saponification value, Sensory, Shelf life, Smoke point, Sulfide, Thermal, Total viable count, Turbidity, Viscosity, Water activity
 
'''Industry-related lab equipment may include''':
 
alcohol analyzer, balance, biosafety cabinet, centrifuge, chiller, chromatographic, colorimeter, ELISA equipment, evaporator, fat analyzer, freezer, fume hood, gravimetric diluter, hot/forced air oven, incubator, Kjeldahl digestion apparatus, laminar airflow workstation, media sterilizer, microscope, moisture analyzer, muffle furnace, Petri dish, photometric analyzer, protein analyzer, refractometer, spectrometer, titrator
 
''What else, if anything, is unique about the labs in the food and beverage industry?'' As previously mentioned in the agriculture section, the food and beverage industry has strong ties to the agriculture industry, though broadly speaking the food and beverage industry is typically dealing with the end products of agriculture.
 
While most industries see global standards coalesce around their industry, this holds especially true for food and beverage laboratories. Given the vital nature of a clean and safe food supply, regulation and global standardization remains a strong goal for the industry.<ref name="NitaGlobal17">{{cite web |url=http://www.foodsafetymagazine.com/signature-series/global-standards-impacting-food-and-beverage-processors/ |title=Global Standards Impacting Food and Beverage Processors |author=Nita, I. |work=Food Safety Magazine |date=18 January 2017 |accessdate=03 June 2017}}</ref>
 
====LIMSwiki resources====
 
* None
 
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=14VPAwAAQBAJ&printsec=frontcover |title=Practical Food Safety: Contemporary Issues and Future Directions |editor=Bhat, R.; Gomez-Lopez, V.M. |publisher=John Wiley & Sons |year=2014 |pages=632 |isbn=9781118474594}}
 
* {{cite book |url=https://books.google.com/books?id=duFMBgAAQBAJ&printsec=frontcover |title=Microbiological Examination Methods of Food and Water: A Laboratory Manual |author=da Silva, N.; Taniwaki, M.H.; Junqueria, V.C. et al. |publisher=CRC Press |year=2012 |pages=484 |isbn=9780203168394}}
 
 
<div align="center"><hr width="50%"></div>
 
==References==
{{Reflist|colwidth=30em}}
 
<!--Place all category tags here-->

Revision as of 21:23, 19 September 2019

This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

2. Sample Management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-2-1
EPA ERLN Laboratory Requirements 4.11.14 		2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
ASTM E1578-18 C-2-2
EPA ERLN Laboratory Requirements 4.11.14 		2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
ASTM E1578-18 C-2-3
EPA ERLN Laboratory Requirements 4.11.14 		2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
ASTM E1578-18 C-2-4
EPA ERLN Laboratory Requirements 4.11.14 		2.4 The system shall require the recording of a standard and reagent's first opening date.
ASTM E1578-18 C-2-5
EPA ERLN Laboratory Requirements 4.11.14 		2.5 The system shall allow only active standards and reagents to be shown as available for use.
ASTM E1578-18 C-2-6
EPA ERLN Laboratory Requirements 4.11.14 		2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
ASTM E1578-18 C-2-8
EPA ERLN Laboratory Requirements 3.2
ISO/IEC 17025:2017 7.4.2 		2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 211.84
42 CFR Part 73.17
ASTM E1492-11 4.2.1
ASTM E1578-18 C-2-9

2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1
ASTM E1578-18 C-2-10 		2.10 The system shall be able to link test methods and specifications to standards and reagents.

21 CFR Part 211.84
21 CFR Part 211.166–7
21 CFR Part 211.194 (e)
21 CFR Part 212.40 (c)
21 CFR Part 212.61
21 CFR Part 212.70 (e)
21 CFR Part 225.58
21 CFR Part 226.58
21 CFR Part 606.65 (c)
21 CFR Part 606.151
ASTM E1578-18 C-2-11
EPA ERLN Laboratory Requirements 3.1.2.1
EPA ERLN Laboratory Requirements 4.3.2
EPA ERLN Laboratory Requirements 4.11.3.2
EPA QA/G-5 2.2.5
USDA Administrative Procedures for the PDP 8.5
WHO Technical Report Series, #986, Annex 2, 17.7
WHO Technical Report Series, #986, Annex 2, 17.22–25

2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.

3. Core Laboratory Testing and Experiments

Regulation, Specification, or Guidance Requirement

21 CFR Part 211.84 (d)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1
ASTM E1578-18 C-3-1
ISO 15189:2012 5.3.2.7

3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
21 CFR Part 211.84 (e)
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-2 		3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-3 		3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
ASTM E1578-18 C-3-4 3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.
ASTM E1578-18 C-3-6 3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
ASTM E1578-18 C-3-7 3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
ASTM E1578-18 C-3-8 3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
ASTM E1578-18 C-3-9 3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
ASTM E1578-18 C-3-10 3.9 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
AIHA-LAP Policies 2018 2A.7.8.2
ASTM E1578-18 C-3-11 		3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
ASTM E1578-18 C-3-12 3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
42 CFR Part 493.1241
ASTM E1578-18 C-3-13
EPA ERLN Laboratory Requirements 4.9.11 		3.12 The system should effectively alert users upon entry of out-of-specification test results.

21 CFR Part 211.194
21 CFR Part 212.60 (g)
21 CFR Part 606.160
ASTM E1578-18 C-3-14
EPA ERLN Laboratory Requirements 3.1.2.3–4
EPA ERLN Laboratory Requirements 3.2
EPA ERLN Laboratory Requirements 4.3.4
EPA ERLN Laboratory Requirements 4.8.1–4
EPA ERLN Laboratory Requirements 4.11.16
USDA Data and Instrumentation for PDP 5.4.2
USDA Data and Instrumentation for PDP 8.1.3
WHO Technical Report Series, #986, Annex 2, 15.8

3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
Retrieved from "https://www.limswiki.org/index.php?title=User:Shawndouglas/sandbox/sublevel9&oldid=36304"