Tag Archives: A2LA

May 4, 2016

AOCS Highlights Cannabis Lab Standards, Extraction Technology

By Aaron G. Biros

The American Oil Chemists’ Society (AOCS) held its annual conference in Salt Lake City this week, with a track focused on cannabis testing and technology. Cynthia Ludwig, director of technical services at AOCS and member of the advisory panel to The Emerald Test, hosted the two-day event dedicated to all things extraction technology and analytical testing of cannabis.

Highlights in the discussion surrounding extraction technologies for the production of cannabis concentrates included the diversity of concentrate products, solvent selection for different extraction techniques and the need for cleaning validation in extraction equipment. Jerry King, Ph.D., research professor at the University of Arkansas, began the event with a brief history of cannabis processing, describing the physical morphologies in different types of extraction processes.

J. Michael McCutcheon presents a history of cannabis in medicine

Michael McCutcheon, research scientist at Eden Labs, laid out a broad comparison of different extraction techniques and solvents in use currently. “Butane is a great solvent; it’s extremely effective at extracting active compounds from cannabis, but it poses considerable health, safety and environmental concerns largely due to its flammability,” says McCutcheon. He noted it is also very difficult to get USP-grade butane solvents so the quality can be lacking. “As a solvent, supercritical carbon dioxide can be better because it is nontoxic, nonflammable, readily available, inexpensive and much safer.” The major benefit of using supercritical carbon dioxide, according to McCutcheon, is its ability for fine-tuning, allowing the extractor to be more selective and produce a wider range of product types. “By changing the temperature or pressure, we can change the density of the solvent and thus the solubility of the many different compounds in cannabis.” He also noted that, supercritical carbon dioxide exerts tremendous pressure, as compared to hydrocarbon solvents, so the extraction equipment needs to be rated to a higher working pressure and is generally more expensive.

John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right

John A. Mackay, Ph.D., senior director of strategic technologies at Waters Corporation, believes that cannabis processors using extraction equipment need to implement cleaning SOPs to prevent contamination. “There is currently nothing in the cannabis industry like the FDA CMC draft for the botanical industry,” says Mackay. “If you are giving a child a high-CBD extract and it was produced in equipment that was previously used for another strain that contains other compounds, such as CBG, CBD or even traces of THC extract, there is a high probability that it will still contain these compounds as well as possibly other contaminants unless it was properly cleaned.” Mackay’s discussion highlighted the importance of safety and health for workers throughout the workflow as well as the end consumer.

Jeffrey Raber, Ph.D., chief executive officer of The Werc Shop, examined different testing methodologies for different applications, including potency analyses with liquid chromatography. His presentation was markedly unique in proposing a solution to the currently inconsistent classification system for cannabis strains. “We really do not know what strains cause what physiological responses,” says Raber. “We need a better classification system based on chemical fingerprints, not on baseless names.” Raber suggests using a chemotaxonomic system to identify physiological responses in strains, noting that terpenes could be the key to these responses.

Cynthia Ludwig welcomes attendees to the event.

Dylan Wilks, chief scientific officer at Orange Photonics, discussed the various needs in sample preparation for a wide range of products. He focused on sample prep and variation for on-site potency analysis, which could give edibles manufacturers crucial quality assurance tools in process control. Susan Audino, Ph.D., chemist and A2LA assessor, echoed Wilks’ concerns over sample collection methods. “Sampling can be the most critical part of the analysis and the sample size needs to be representative of the batch, which is currently a major issue in the cannabis industry,” says Audino. “I believe that the consumer has a right to know that what they are ingesting is safe.” Many seemed to share her sentiment about the current state of the cannabis testing industry. “Inadequate testing is worse than no testing at all and we need to educate the legislators about the importance of consumer safety.”

46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program will be given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry. Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely.

The AOCS cannabis working groups and expert panels are collaborating with Emerald Scientific to provide data analytics reports compliant with ISO 13528. “In the absence of a federal program, we are trying to provide consistency in cannabis testing to protect consumer safety,” says Ludwig. At the AOCS annual meeting, many echoed those concerns of consumer safety, proposing solutions to the current inconsistencies in testing standards.

March 14, 2016

A2LA Accredits First Cannabis Laboratory to ISO/IEC 17025

By Aaron G. Biros

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Frederick, MD– The American Association for Laboratory Accreditation (A2LA) completed its first cannabis testing accreditation for Legend Technical Services, Inc., based in St. Paul, Minnesota. A2LA assessed the laboratory to ISO/IEC 17025 which include the general requirements for the competence of testing and calibration laboratories. The laboratory is now able to test medical cannabis in compliance with Minnesota’s Medical Cannabis Registry Program.

The American Assocation for Laboratory Accreditation (A2LA)

Their scope of accreditation (certificate 2950.01) will include testing for cannabinoid potency and profile, terpenes, pesticides, residual solvents, Mycotoxins, heavy metals and analyzing aerobic bacteria, yeast and mold, E. coli, Salmonella and gram-negative bacteria in medical cannabis products.

Roger Brauninger, biosafety program manager at A2LA

According to Roger Brauninger, biosafety program manager at A2LA, this bodes well for cannabis laboratory standards in the future. “We are pleased to provide accreditation to cannabis testing laboratories and recognize the potential international standards have to help ensure safety of all legal products entering the marketplace,” says Brauninger. “Legend Technical Services, Inc.’s accreditation with A2LA recognizes their commitment to providing the highest quality laboratory services and confidence in the safety of cannabis products that they test.”

A2LA’s cannabis accreditation program aims to establish a set of standards for quality in testing for cannabis edibles, concentrates and flower. Many states where cannabis is legal require ISO/IEC 17025 for cannabis laboratories as a baseline standard.

February 17, 2016

Amanda Rigdon to Offer Guidance on Method Validation at Cannabis Labs Conference

By Aaron G. Biros

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With multiple states now requiring third-party certification as part of licensing cannabis laboratories, there is a large role for laboratory accreditation in the cannabis industry. Using method validation can prove that your data is reproducible and that you have robust methods for sample preparation and calibration. All of these tools are instrumental in getting a laboratory accredited.

Amanda Rigdon, associate marketing manager for GC columns at Restek, Inc. — Amanda Rigdon, associate marketing manager for GC columns at Restek

Amanda Rigdon, associate marketing manager for gas chromatography columns at Restek, Inc., will deliver a presentation, Opportunities and Challenges for Method Validation in the Evolving Cannabis Industry, at the first annual Cannabis Labs Conference taking place this March 9^th in Atlanta, Georgia. The Cannabis Labs Conference will be co-located with the third annual Food Labs Conference and the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon) at the Georgia World Congress Center.

In her presentation, Rigdon will discuss established validation guidelines from a variety of regulatory bodies. “Method validation is absolutely critical to the cannabis industry,” she says. “Accurate test results not only help to protect consumers, but because of the high dollar value of cannabis products, accurate results can also protect producers from false positives, and laboratories in backing up their results.” She will also be sharing actual validation data from a number of cannabis analytical methods.

Scott Radcliffe, technical support scientist at Romer Labs, Inc., will share his validation methods of immunoassays for the detection of pathogens and mycotoxins in cannabis. He will include a discussion of specific rapid pathogen detection methods for Salmonella and E. coli O157 species. This will cover their small-scale validation studies with partner labs in Michigan and Washington for immunoassays.

stevegoldner — Stephen Goldner, Esq, founder of Pinnacle Laboratory and Regulatory Affairs Associates

Stephen Goldner, Esq, founder of Pinnacle Laboratories, will discuss how cannabis labs can apply FDA lab practices with recommendations for short and long term management implementation. Goldner’s presentation will include a discussion of preparation for FDA involvement in sate regulatory systems.

Beyond validation methods in laboratories, the Cannabis Labs Conference will feature several presentations on ISO/IEC 17025:2005 compliance, the need for standardization, seed-to-sale traceability, FDA best lab practices and cannabis quality. Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), will deliver the keynote presentation on the role of quality assurance in the cannabis industry.

November 4, 2015

The Role of 3rd Party Accreditation in Cannabis Safety

By Roger Brauninger

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Living in a world of ever-increasing interdependence and an era of limited state government, financial and human resources, it is imperative that those charged with protecting the health and safety of patients and users of medical and recreational cannabis products leverage what private sector institutions and existing frameworks already offer in setting up quality standards for laboratory testing operations. That this moment arrives now – at a point where state governments are being tasked with undertaking the most significant change in the regulation of this substance whilst the federal government appears unwilling to play a substantial role – makes this partnership both inevitable and absolutely necessary.

Accreditation is an internationally accepted conformity assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability test data. The accreditation infrastructure is well-established through accreditation bodies (ABs) and the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC), supported by regional cooperative arrangements, including those of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC). ILAC functions as a forum for harmonization of laboratory accreditation procedures and policies, thus reducing technical barriers to trade and promoting laboratory accreditation as a mechanism for establishing confidence in testing facilities. ILAC MRA signatory ABs are recognized, through a rigorous peer evaluation process, as competent to accredit testing organizations. All signatory ABs must meet the requirements of ISO/IEC 17011 and use ISO/IEC 17025 as the basis for accreditation of laboratories. In turn, under the ILAC MRA and the regional co-operations, competent laboratories are recognized globally, thus facilitating acceptance of the test results that accompany goods across international borders.

In other areas, such as the food supply and energy, both state and federal government have been an active participant in accreditation activities. According to The Administrative Conference of the United States in its Agency Use of Third-Party Programs to Assess Regulatory Compliance*, “…agencies in diverse areas of regulation have developed third-party programs to assess whether regulated entities are in compliance with regulatory standards and other requirements. Through these programs, third parties are charged with assessing the safety of imported food… Third parties also ensure that products labeled as organic and energy-efficient meet applicable federal standards. In these regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies. Regulatory agencies take on new roles in coordinating and overseeing these third-party actors.” While this reference largely deals with areas outside of cannabis regulation, it remains useful and relevant because of the manner in which cannabis products are used.

Traditionally, ABs have worked with regulators to establish specific technical requirements to supplement the ISO/IEC 17025 accreditation framework. In this partnership, the AB is responsible for executing the assessment and accreditation process but the regulator retains responsibility for the ultimate decisions on the acceptance of that organization’s accreditation. In the example of our food supply and its various sources, governmental recognition of accreditation bodies operating in accordance with international standards is much more practical than government agencies themselves accrediting the individual testing organizations or ABs. Thus the public/private partnership paradigm: To assess regulatory compliance a Regulatory Agency approves ABs that accredit organizations that assess whether Regulated Entities or Regulated Products are in conformity with a Regulatory Standard.*

In this example, all of the organizations are treated equally by the regulatory agency since they use the same recognition criteria for ABs and the same accreditation requirements in the assessment of conformity assessment bodies. This approach would also provide consistency at a point in time where many states are grappling with trying to find the best quality standard to use and which, to date, has resulted in many different standards being chosen or considered for implementation. This is especially true when one looks at the requirements put into place by the “early adopter” states. However, in those states that have entered this area more recently, it seems clear that the consensus is use of ISO/IEC 17025 as the most appropriate quality management standard for testing laboratories.