Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"

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[[File:LC MS pic.jpg|right|400px]]'''Pesticides''': Gas and liquid chromatography methods are by and large the staple of testing methods for pesticides, which remain "the hardest analyses that are going to be done in the cannabis industry."<ref name="CassidayTheHighs16">{{cite web |url=https://www.aocs.org/stay-informed/inform-magazine/featured-articles/the-highs-and-lows-of-cannabis-testing-october-2016 |title=The Highs and Lows of Cannabis Testing |author=Cassiday, L. |work=INFORM |publisher=American Oil Chemists' Society |date=October 2016 |accessdate=07 July 2021}}</ref> Notably, high-performance liquid chromatography–tandem-mass spectrometry (HPLC-MS/MS) tends to be one of the most thorough methods says Emerald Scientific's CTO Amanda Rigdon. "Ninety-five percent of the pesticides out there can be analyzed by HPLC-MS/MS, although there are some that you would need a GC-MS/MS for," she says.<ref name="CassidayTheHighs16" /> A popular sample extraction method for detecting multiple pesticide residues in cannabis is the QuEChERS (quick, easy, cheap, effective, rugged, and safe) method, which shows "acceptable recoveries and relative standard deviations" for almost all known pesticides<ref name="DePalmaChallenges18">{{cite web |url=https://www.labmanager.com/insights/challenges-of-cannabis-contaminant-testing-1928 |title=Challenges of Cannabis Contaminant Testing |author=DePalma, A. |work=Lab Manager |publisher=LabX Media Group |date=10 September 2018 |accessdate=07 July 2021}}</ref><ref name="LCGCTrends16">{{cite web |url=http://images2.advanstar.com/PixelMags/lcgc-na/pdf/2016-08-bg.pdf |format=PDF |title=Real-World Chromatography Applications: Current Trends in Cannabis, Environmental, Food, Pharmaceutical, and Biopharmaceutical Analysis |work=LCGC North America 2016-2017 Annual Industry Trends and Directory Issue |author=LCGC |publisher=UBM |pages=584–7 |date=August 2016 |accessdate=07 July 2021}}</ref><ref name="KowalskiEval17">{{cite journal |title=Evaluation of Modified QuEChERS for Pesticide Analysis in Cannabis |journal=LC GC |author=Kowalski, J.; Dahi, J.H.; Rigdon, A. et al. |volume=35 |issue=5 |pages=8–22 |year=2017 |url=https://www.chromatographyonline.com/view/evaluation-modified-quechers-pesticide-analysis-cannabis}}</ref><ref name="WinklerPesticide18">{{cite web |url=https://www.labcompare.com/10-Featured-Articles/338461-Pesticide-Testing-for-the-Cannabis-Industry-The-Importance-of-LC-MS-MS-for-Obtaining-Accurate-Results-in-a-Complex-Matrix/ |title=Pesticide Testing for the Cannabis Industry: The Importance of LC-MS/MS for Obtaining Accurate Results in a Complex Matrix |author=Winkler, P.C.; Egerton, D.; Butt, C. et al. |work=Labcompare Featured Articles |publisher=CompareNetworks, Inc |date=06 June 2018 |accessdate=07 July 2021}}</ref>, though the release of heat and increase in pH of QuECHERS may degrade particularly sensitive pesticides in the sample.<ref name="JordanAComp18">{{cite journal |title=A Comprehensive Approach to Pesticide Residue Analysis in Cannabis |Journal=Cannabis Science and Technology  |author=Jordan, R.; Asanuma, L.; Miller, D.; Macherone, A. |publisher=UBM |volume=1 |issue=2 |date=19 June 2018 |url=https://www.cannabissciencetech.com/view/comprehensive-approach-pesticide-residue-analysis-cannabis}}</ref> However, other methods such as solvent extraction (such as with acetonitrile) with dispersive solid-phase extraction (dSPE) cleanup<ref name="LCGCTrends16" /><ref name="WinklerPesticide18" /><ref name="JordanAComp18" /> and energized dispersive guided extraction (EDGE) may also been used.<ref name="CEMAnal18">{{cite web |url=https://www.azom.com/article.aspx?ArticleID=16383 |title=Analyzing Pesticide Residue of Cannabis |author=CEM Corporation |work=AZO Materials |publisher=AZoNetwork |date=25 July 2018 |accessdate=07 July 2021}}</ref> Common testing methods that have been used, after sample preparation, include<ref name="APHLGuide16">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/EH-Guide-State-Med-Cannabis-052016.pdf |format=PDF |title=Guidance for State Medical Cannabis Testing Programs |author=Association of Public Health Laboratories |pages=35 |date=May 2016 |accessdate=07 July 2021}}</ref><ref name="ShimadzuCLTS">{{cite web |url=https://www.ssi.shimadzu.com/products/literature/life_science/shimadzu_cannabis_brochure.pdf |archiveurl=https://web.archive.org/web/20160327180816/https://www.ssi.shimadzu.com/products/literature/life_science/shimadzu_cannabis_brochure.pdf |format=PDF |title=Cannabis Testing Laboratory Solutions |publisher=Shimadzu Corporation |archivedate=27 March 2016 |accessdate=07 July 2021}}</ref><ref name="CEMAnal18" /><ref name="KowalskiEval17" /><ref name="WinklerPesticide18" /><ref name="JordanAComp18" />:
The analytical methods of testing cannabis constituents and contaminants, as well as their associated workflows, depend on the type of laboratory conducting testing. For example, an extraction-specific lab's workflow will look a bit different from the workflow of a commercial production lab or a state-mandated, independent quality testing lab. And medical cannabis testing labs may ignore terpenes entirely, for instance.<ref name="KirkhamTesting15">{{cite web |url=https://lift.co/magazine/testing-for-terpenes-in-cannabis |title=Testing for Terpenes in Cannabis |author=Kirham, E. |work=Lift & Co. |date=01 April 2015 |accessdate=07 July 2021}}</ref> Broadly speaking, however, non-extraction cannabis testing lab workflows will have some aspects in common. Those workflow similarities, from beginning to end, include<ref name="AudinoManag18">{{cite web |url=https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/ |title=Managing Cannabis Testing Lab Workflows Using LIMS |author=Audino, S. |work=Cannabis Industry Journal |date=07 February 2018 |accessdate=07 July 2021}}</ref><ref name="AgilentEstab20">{{cite web |url=https://www.agilent.com/cs/library/brochures/compendium-cannabis emethods-5994-2242EN-agilent.pdf |title=Establish Your Cannabis Lab Fast |publisher=Agilent Technologies, Inc |date=17 July 2020 |accessdate=07 July 2021}}</ref><ref name="MSWorkflows21">{{cite web |url=https://www.sigmaaldrich.com/technical-documents/articles/analytical/test-procedures-for-cannabis-testing-and-analysis.html |title=Workflows and Procedures for Cannabis Testing and Analysis |publisher=Millipore Sigma |date=2021 |accessdate=13 January 2021}}</ref>:


* Gas chromatography–electron capture detection (GC-ECD)
# reception of test orders—often through a secure web portal—and samples, as well as the start of sample tracking with RFID and barcodes for chain-of-custody purposes;
* Gas chromatography–mass spectrometry (GC-MS)
# assignment of tests to analysts and instruments;
* Gas chromatography–tandem-mass spectrometry (GC-MS/MS)
# processing of samples—including any required quality control (QC) samples—as well as any necessary grinding, homogenization, extraction, filtration, and evaporation processes;
* Liquid chromatography–mass spectrometry (LC-MS; also high-performance or HPLC-MS)
# chromatographic separation, or any other non-chromatographic preparative methods, for samples, based upon the target constituent or contaminant;
* Liquid chromatography–tandem-mass spectrometry (LC-MS/MS; also high-performance or HPLC-MS/MS)
# actual qualitative and/or quantitative analysis, based on standards and reference materials, with appropriate notification of out-of-range or -specification results;
# exporting of instrument data, preferably to an information management system like a LIMS, where the data are processed and recorded with the associated existing sample data;
# organization and review of results by designated laboratory personnel, with results either getting approved or not approved; and
# reporting of approved results in a compliant format, e.g., a certificate of analysis (COA), and distributed to appropriate stakeholders (often through a secure web portal).


For quantification of pesticides in cannabis, the AOAC's SMPR 2018.011, EPA's Residue Analytical Methods (RAM), and FDA's Pesticide Analytical Manual (PAM) provide guidance to labs.<ref name="APHLGuide16" /><ref name="SMPR2018.011">{{cite web |url=https://www.aoac.org/wp-content/uploads/2020/01/SMPR2018_011.pdf |format=PDF |title=AOAC SMPR 2018.011 - Standard Method Performance Requirements (SMPRs) for Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials |author=Association of Official Agricultural Chemists |date=26 August 2018 |accessdate=07 July 2021}}</ref><ref name="EPAResidue17">{{cite web |url=https://archive.epa.gov/pesticides/methods/rammethods/web/html/ram12b.html |title=Residue Analytical Methods (RAM) |publisher=United States Environmental Protection Agency |date=20 February 2016 |accessdate=07 July 2021}}</ref><ref name="FDA_PAM">{{cite web |url=https://www.fda.gov/food/laboratory-methods-food/pesticide-analytical-manual-pam |title=Pesticide Analytical Manual (PAM) |publisher=United States Food and Drug Administration |date=19 September 2018 |accessdate=07 July 2021}}</ref>
Of course, the specific details of the methods you choose to employ will slightly modify your workflows, as will your lab's own process and procedure (P&P) documentation. For example, your workflow for testing heavy metals may differ slightly from the U.S. FDA's ICP-MS methodology. Ultimately, your workflow will be based upon many factors, including the analyses you decided to perform, methods you choose, the equipment you use, the way your lab is laid out, the P&P you follow, and the data management systems and automation you choose. Some components of your workflow will remain the same, however, regardless of the mentioned factors. Sample tracking and accurate weight reconciliation, while maintaining complete chain-of-custody, remain vital throughout the entire process, from test ordering to after the results are reported. Additionally, any calculations performed must be steadfastly accurate for every type of workflow, at every step. These aspects are practically non-negotiable given the regulatory requirements for cannabis track-and-trace mechanisms (see the next section on reporting and certification for more).


 
That said, workflows can usually be optimized in any laboratory, saving time and money while increasing productivity.<ref name="GrimmReeng09">{{cite journal |title=Reengineered Workflow in the Anatomic Pathology Laboratory: Costs and Benefits |journal=Archives of Pathology & Laboratory Medicine |author=Grimm, E.; Schmidt, R.A. |volume=133 |issue=4 |pages=601–4 |year=2009 |doi=10.1043/1543-2165-133.4.601 |pmid=19391659}}</ref><ref name="HawkerNonanal17">{{cite journal |title=Nonanalytic Laboratory Automation: A Quarter Century of Progress |journal=Clinical Chemistry |author=Hawker, C.D. |volume=63 |issue=6 |pages=1074–82 |year=2017 |doi=10.1373/clinchem.2017.272047 |pmid=28396562}}</ref> Keeping P&P documents, methods, and training documentation aligned with a rapidly changing industry like cannabis testing is vital to ensuring smooth workflows. Other minor considerations for smoothing out workflow problems in the cannabis testing laboratory include adding additional automation elements<ref name="AudinoManag18" /><ref name="LTImport19">{{cite web |url=https://www.labtechsupplyco.com/important-advice-in-designing-your-cannabis-lab/ |title=New Publication in the Journal of Forensic Science on Fast Discrimination of Marijuana |publisher=DPX Technologies |date=28 September 2020 |accessdate=07 July 2020}}</ref><ref name="CannalysisLab20">{{cite web |url=https://www.analyticalcannabis.com/articles/cannalysis-lab-decreases-processing-time-by-94-with-lab-automation-software-312343 |title=Cannalysis Lab Decreases Processing Time by 94% with Lab Automation Software |author=Cannalysis |work=Analytical Cannabis |date=08 April 2020 |accessdate=07 July 2021}}</ref>, optimizing workspaces (e.g., well-spaced lab tables, sufficient cabinets and storage)<ref name="DPXNewPub20">{{cite web |url=https://dpxtechnologies.com/new-publication-in-the-journal-of-forensic-science-on-fast-discrimination-of-marijuana/ |title=Important Advice in Designing Your Cannabis Lab |publisher=LabTech Supply Co |date=20 September 2019 |accessdate=07 July 2021}}</ref>, and staggering shifts (e.g., for improving social distancing success during a pandemic).<ref name="SchanemanCanna20">{{cite web |url=https://mjbizdaily.com/cannabis-labs-watchful-of-supply-disruptions-during-coronavirus-crisis-as-testing-demand-remains-strong/ |title=Cannabis labs watchful of supply disruptions during coronavirus crisis as testing demand remains strong |author=Schaneman, B. |work=Marijuana Business Daily |date=26 March 2020 |accessdate=07 July 2021}}</ref> It's best to address these and other such issues early on to ensure the best outcomes from your workflows.
'''Solvents''': Testing for solvents is largely standardized into a few options, which have parallels to existing pharmaceutical testing standards outlined in Chapter 467 of ''United States Pharmacopeia and The National Formulary'' (USP <467>)<ref name="USPNF467">{{cite web |url=https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/generalChapter467Current.pdf |archiveurl=https://web.archive.org/web/20160804174451/https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/generalChapter467Current.pdf |format=PDF |title=<467> Residual Solvents |work=United States Pharmacopeia and The National Formulary |publisher=United States Pharmacopeial Convention |date=01 July 2007 |archivedate=04 August 2016 |accessdate=07 July 2021}}</ref><ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="ShimadzuCLTS" /><ref name="PocevaOpti16">{{cite journal |title=Optimization of HS-GC-FID-MS Method for Residual Solvent Profiling in Active Pharmaceutical Ingredients Using DoE |journal=Journal of Chromatographic Science |author=Poceva Panovska, A.; Acevska, J.; Stefkov, G. et al. |volume=54 |issue=2 |pages=103–11 |year=2016 |doi=10.1093/chromsci/bmv123 |pmid=26290585}}</ref><ref name="L'HeureuxAdvancing18">{{cite web |url=https://www.cannabissciencetech.com/view/advancing-chromatography-methods-cannabis-analysis |title=Advancing Chromatography Methods for Cannabis Analysis |work=Cannabis Science and Technology |author=L'Heureux, M.L. |publisher=UBM |date=20 April 2018 |accessdate=07 July 2021}}</ref>:
 
* Headspace–gas chromatography/mass spectrometry (HS-GC/MS)
* Headspace–gas chromatography–flame ionization detection–mass spectrometry (HS-GC-FID-MS)
* Full evaporation technique–headspace–gas chromatography–flame ionization detection (FET-HS-GC-FID)
 
Massachusetts and Oregon—and likely other states—have used a variety of guidance documents such as USP <467>, reports from the Commission of the European Communities' Scientific Committee on Food (now the European Food Safety Authority), and the International Conference on Harmonization's (ICH) Q3C(R5)<ref name="APHLGuide16" /><ref name="MDPHResponse">{{cite web |url=http://www.mass.gov/eohhs/docs/dph/quality/medical-marijuana/lab-protocols/external-comment-response-020416-final.pdf |archiveurl=https://web.archive.org/web/20171013214634/https://www.mass.gov/eohhs/docs/dph/quality/medical-marijuana/lab-protocols/external-comment-response-020416-final.pdf |format=PDF |title=Response to Public Comments |author=Bureau of Healthcare Safety and Quality |publisher=Massachusetts Department of Public Health |date=12 February 2016 |archivedate=13 October 2017 |accessdate=07 July 2021}}</ref><ref name="FarrerTech15">{{cite web |url=https://www.oregon.gov/oha/ph/PreventionWellness/marijuana/Documents/oha-8964-technical-report-marijuana-contaminant-testing.pdf |format=PDF |title=Technical Report: Oregon Health Authority’s Process to Determine Which Types of Contaminants to Test for in Cannabis Products, and Levels for Action |author=Farrer, D.G. |publisher=Oregon Health Authority |date=December 2015 |accessdate=07 July 2021}}</ref><ref name="USPNF467">{{cite web |url=https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/generalChapter467Current.pdf |archiveurl=https://web.archive.org/web/20160804174451/https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/generalChapter467Current.pdf |format=PDF |title=<467> Residual Solvents |work=United States Pharmacopeia and The National Formulary |publisher=United States Pharmacopeial Convention |date=01 July 2007 |archivedate=04 August 2016 |accessdate=07 July 2021}}</ref> to set their action level testing values for particular solvents. The AOAC provides another standardized option in the form of their SMPR 2019.002.<ref name="SMPR2019.002">{{cite web |url=https://www.aoac.org/wp-content/uploads/2019/10/SMPR-2019_002.pdf |format=PDF |title=AOAC SMPR 2019.002 - Standard Method Performance Requirements (SMPRs) for Identification and Quantitation of Selected Residual Solvents in Cannabis-Derived Materials |author=Association of Official Agricultural Chemists |date=09 October 2019 |accessdate=07 July 2021}}</ref>
 
 
'''Heavy metals''': The methods used for quantifying levels of highly toxic metals in plants depend on ease-of-use, level of accuracy, and overall cost. Sample preparation typically includes the use of closed-vessel [[microwave digestion]] to get the sample into solution for analysis.<ref name="CEMAnal18" /><ref name="BoyleSelecting18">{{cite journal |title=Selecting Microwave Digestion Technology for Measuring Heavy Metals in Cannabis Products |journal=Cannabis Science and Technology |author=Boyle, R.; Ferrell, E. |volume=1 |issue=3 |date=21 September 2018 |url=https://www.cannabissciencetech.com/view/selecting-microwave-digestion-technology-measuring-heavy-metals-cannabis-products}}</ref> Once prepared, the following methods are most common for testing cannabis and other plants for heavy metals<ref name="KuzdzalACloser16">{{cite web |url=https://www.ssi.shimadzu.com/sites/ssi.shimadzu.com/files/Industry/Literature/Shimadzu_Whitepaper_Emerging_Cannabis_Industry.pdf |format=PDF |title=A Closer Look at Cannabis Testing |author=Kuzdzal, S.; Clifford, R.; Winkler, P.; Bankert, W. |publisher=Shimadzu Corporation |date=December 2017 |accessdate=07 July 2021}}</ref><ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="DavisAnalysis15">{{cite web |url=http://www.ssi.shimadzu.com/products/literature/aas/ssi-icp-002.pdf |archiveurl=https://web.archive.org/web/20170214222831/http://www.ssi.shimadzu.com/products/literature/aas/ssi-icp-002.pdf |format=PDF |title=Analysis of "The Big Four" Heavy Metals in Cannabis by USN-ICP-OES |author=Davis, D.; Long, K.; Masone, J.; Firmin, P. |publisher=Shimadzu Corporation |date=August 2015 |archivedate=14 February 2017 |accessdate=07 July 2021}}</ref><ref name="ShimadzuCLTS" />:
 
* [[Inductively coupled plasma atomic emission spectroscopy|Inductively coupled plasma–atomic emission spectroscopy]] (ICP-AES), sometimes called inductively coupled plasma optical emission spectrometry (ICP-OES) (at times coupled with an ultrasonic nebulizer)
* [[Inductively coupled plasma mass spectrometry|Inductively coupled plasma–mass spectrometry]] (ICP-MS)
* Inductively coupled plasma–tandem-mass spectroscopy (ICP-MS/MS)
 
For quantification of metals in cannabis, the U.S. FDA's ICP-MS methodology document is often used.<ref name="APHLGuide16" /><ref name="FDAAnalysisofFoods11">{{cite web |url=http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/Metals/UCM272693.pdf |archiveurl=https://web.archive.org/web/20170218071933/http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/Metals/UCM272693.pdf |format=PDF |title=Analysis of Foods for As, Cd, Cr, Hg and Pb by Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) |publisher=United States Food and Drug Administration, Center for Food Safety and Applied Nutrition |date=25 April 2011 |archivedate=18 February 2017 |accessdate=07 July 2021}}</ref>
 
 
'''Mycotoxins and microorganisms''': A standard method of testing for the existence of microorganisms is through the process of culturing a sample in a Petri dish, a common diagnostic method in microbiology. [[ELISA|Enzyme-linked immunosorbent assay]] (ELISA) is also used, particularly to identify mycotoxins. However, Petri culture analysis isn't rigorous, and ELISA can be time consuming, as it's limited to one mycotoxin per test.<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="KennardYouAre16">{{cite web |url=https://populace.tantaluslabs.com/you-are-probably-smoking-mouldy-weed-why-does-quality-assurance-matter/ |title=You are Probably Smoking Mouldy Weed - Why Does Quality Assurance Matter? |work=Populace |author=Kennard, M. |publisher=Tantalus Labs |date=02 June 2014 |accessdate=07 July 2021}}</ref> The following are other, more precise techniques that are improving laboratorians' analyses, particularly using DNA snippets of microbiological contaminants<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="KennardYouAre16" /><ref name="ThompsonAMicro16">{{cite journal |title=A microbiome assessment of medical marijuana |journal=Clinical Microbiology and Infection |author=Thompson III, G.R.; Tuscano, J.M.; Dennis, M. et al. |pages=S1198-743X(16)30605-X |year=2017 |doi=10.1016/j.cmi.2016.12.001 |pmid=27956269}}</ref><ref name="L'HeureuxTesting18">{{cite web |url=https://www.cannabissciencetech.com/view/testing-pesticides-and-mycotoxins-cannabis-how-meet-regulatory-requirements |title=Testing for Pesticides and Mycotoxins in Cannabis: How to Meet Regulatory Requirements |work=Cannabis Science and Technology |author=L'Heureux, M.L. |publisher=UBM |date=06 August 2018 |accessdate=07 July 2021}}</ref>:
 
* [[Real-time polymerase chain reaction|Quantitative polymerase chain reaction]] (qPCR)
* [[Shotgun sequencing#Metagenomic shotgun sequencing|Whole metagenome shotgun (WMGS) sequencing]]
* [[Matrix-assisted laser desorption/ionization]] (MALDI)
* High-performance liquid chromatography (HPLC)
* Liquid chromatography–tandem-mass spectrometry (LC-MS/MS)
* Liquid chromatography–electrospray ionization–tandem-mass spectrometry (LC-ESI-MS/MS)
* Liquid chromatography–atmospheric pressure chemical ionization–tandem-mass spectrometry (LC-APCI-MS/MS)
 
The extent of mycotoxin testing required remains in question by several entities. The APHL claims "[t]here is no readily available evidence to support the contention that cannabis harbors significant levels of mycotoxins."<ref name="APHLGuide16" /> The Oregon Health Authority takes a more middle-ground approach, noting that testing for ''E. coli'' and ''Salmonella'' will "protect public health," though ''Aspergillus'' only deserves a warning for people with suppressed immune systems due to its prevalence in the environment.<ref name="FarrerTech15" /> USP <561> recommendations largely limit mycotoxin testing of botanical products to those borne from root or [[rhizome]] material<ref name="USPNF561">{{cite web |url=https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c561.pdf |archiveurl=https://web.archive.org/web/20171202221121/https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c561.pdf |format=PDF |title=<561> Articles of Botanical Origin |work=United States Pharmacopeia and The National Formulary |publisher=United States Pharmacopeial Convention |date=01 July 2007 |archivedate=02 December 2017 |accessdate=07 July 2021}}</ref>, "which THC-containing cannabis products presumably do not possess," emphasizes the APHL.<ref name="APHLGuide16" /> Regardless, U.S. Pharmacopeia's Chapter 561 remains a useful document for testing guidelines and limits regarding microbials<ref name="USPNF561" /><ref name="APHLGuide16" />, as does the AOAC's SMPR 2019.001 for the detection of ''Aspergillus''.<ref name="SMPR2019.001">{{cite web |url=https://www.aoac.org/wp-content/uploads/2019/10/SMPR-2019_001.pdf |format=PDF |title=AOAC SMPR 2019.001 - Standard Method Performance Requirements (SMPRs) for Detection of ''Aspergillus'' in Cannabis and Cannabis Products |author=Association of Official Agricultural Chemists |date=09 October 2019 |accessdate=07 July 2021}}</ref> In the less common case of dealing with powdered cannabis—a relatively new THC extract form—Chapter 2023 provides at least some testing parallels, though Dr. Tony Cundell, a microbiologist consulting for the pharmaceutical industry, suggests USP <2023> doesn't go far enough for immunocompromised patients.<ref name="CundellMicro15">{{cite web |url=https://www.americanpharmaceuticalreview.com/Featured-Articles/177487-Microbiological-Attributes-of-Powdered-Cannabis/ |title=Microbiological attributes of powdered cannabis |work=American Pharmaceutical Review |author=Cundell, T. |publisher=CompareNetworks, Inc |date=31 July 2015 |accessdate=07 July 2021}}</ref>
 
Somewhat related and worth mentioning is moisture content testing. As previously mentioned, warm, moist environments are conducive to microorganism growth, and regularly measuring water activity is useful for the prevention of microbial growth.<ref name="FarrerTech15" /> The APHL references specifications from the Dutch Office of Medical Cannabis that recommend water content be between five to ten percent in cannabis.<ref name="APHLGuide16" />


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}

Revision as of 20:45, 4 February 2022

The analytical methods of testing cannabis constituents and contaminants, as well as their associated workflows, depend on the type of laboratory conducting testing. For example, an extraction-specific lab's workflow will look a bit different from the workflow of a commercial production lab or a state-mandated, independent quality testing lab. And medical cannabis testing labs may ignore terpenes entirely, for instance.[1] Broadly speaking, however, non-extraction cannabis testing lab workflows will have some aspects in common. Those workflow similarities, from beginning to end, include[2][3][4]:

  1. reception of test orders—often through a secure web portal—and samples, as well as the start of sample tracking with RFID and barcodes for chain-of-custody purposes;
  2. assignment of tests to analysts and instruments;
  3. processing of samples—including any required quality control (QC) samples—as well as any necessary grinding, homogenization, extraction, filtration, and evaporation processes;
  4. chromatographic separation, or any other non-chromatographic preparative methods, for samples, based upon the target constituent or contaminant;
  5. actual qualitative and/or quantitative analysis, based on standards and reference materials, with appropriate notification of out-of-range or -specification results;
  6. exporting of instrument data, preferably to an information management system like a LIMS, where the data are processed and recorded with the associated existing sample data;
  7. organization and review of results by designated laboratory personnel, with results either getting approved or not approved; and
  8. reporting of approved results in a compliant format, e.g., a certificate of analysis (COA), and distributed to appropriate stakeholders (often through a secure web portal).

Of course, the specific details of the methods you choose to employ will slightly modify your workflows, as will your lab's own process and procedure (P&P) documentation. For example, your workflow for testing heavy metals may differ slightly from the U.S. FDA's ICP-MS methodology. Ultimately, your workflow will be based upon many factors, including the analyses you decided to perform, methods you choose, the equipment you use, the way your lab is laid out, the P&P you follow, and the data management systems and automation you choose. Some components of your workflow will remain the same, however, regardless of the mentioned factors. Sample tracking and accurate weight reconciliation, while maintaining complete chain-of-custody, remain vital throughout the entire process, from test ordering to after the results are reported. Additionally, any calculations performed must be steadfastly accurate for every type of workflow, at every step. These aspects are practically non-negotiable given the regulatory requirements for cannabis track-and-trace mechanisms (see the next section on reporting and certification for more).

That said, workflows can usually be optimized in any laboratory, saving time and money while increasing productivity.[5][6] Keeping P&P documents, methods, and training documentation aligned with a rapidly changing industry like cannabis testing is vital to ensuring smooth workflows. Other minor considerations for smoothing out workflow problems in the cannabis testing laboratory include adding additional automation elements[2][7][8], optimizing workspaces (e.g., well-spaced lab tables, sufficient cabinets and storage)[9], and staggering shifts (e.g., for improving social distancing success during a pandemic).[10] It's best to address these and other such issues early on to ensure the best outcomes from your workflows.

References

  1. Kirham, E. (1 April 2015). "Testing for Terpenes in Cannabis". Lift & Co.. https://lift.co/magazine/testing-for-terpenes-in-cannabis. Retrieved 07 July 2021. 
  2. 2.0 2.1 Audino, S. (7 February 2018). "Managing Cannabis Testing Lab Workflows Using LIMS". Cannabis Industry Journal. https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/. Retrieved 07 July 2021. 
  3. emethods-5994-2242EN-agilent.pdf "Establish Your Cannabis Lab Fast". Agilent Technologies, Inc. 17 July 2020. https://www.agilent.com/cs/library/brochures/compendium-cannabis emethods-5994-2242EN-agilent.pdf. Retrieved 07 July 2021. 
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