Tag Archives: information

Multi-analyte Configuration for Cannabis Testing Services

Managing Cannabis Testing Lab Workflows using LIMS

By Dr. Susan Audino
No Comments
Multi-analyte Configuration for Cannabis Testing Services

With the state led legalization of both adult recreational and medical cannabis, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug potency. Cannabis-testing laboratories receive high volumes of test requests from cannabis cultivators for testing quantitative and qualitative aspects of the plant. The testing market is growing as more states bring in stricter enforcement policies on testing. As the number of testing labs grow, it is anticipated that the laboratories that are now servicing other markets, including high throughput contract labs, will cross into cannabis testing as regulations free up. As the volume of tests each lab performs increases, the need for laboratories to make effective use of time and resource management, such as ensuring accurate and quick results, reports, regulatory compliance, quality assurance and many other aspects of data management becomes vital in staying competitive.

Cannabis Testing Workflows

To be commercially competitive, testing labs offer a comprehensive range of testing services. These services are available for both the medical and recreational cannabis markets, including:

  • Detection and quantification of both acid and neutral forms of cannabinoids
  • Screening for pesticide levels
  • Monitoring water activity to indicate the possibility of microbiological contamination
  • Moisture content measurements
  • Terpene profiling
  • Residual solvents and heavy metal testing
  • Fungi, molds, mycotoxin testing and many more

Although the testing workflows differ for each test, here is a basic overview of the operations carried out in a cannabis-testing lab:

  1. Cannabis samples are received.
  2. The samples are processed using techniques such as grinding and homogenization. This may be followed by extraction, filtration and evaporation.
  3. A few samples will be isolated and concentrated by dissolving in solvents, while others may be derivatized using HPLC or GC reagents
  4. The processed samples are then subjected to chromatographic separation using techniques such as HPLC, UHPLC, GC and GC-MS.
  5. The separated components are then analyzed and identified for qualitative and quantitative analysis based on specialized standards and certified reference materials.
  6. The quantified analytical data will be exported from the instruments and compiled with the corresponding sample data.
  7. The test results are organized and reviewed by the lab personnel.
  8. The finalized test results are reported in a compliant format and released to the client.

In order to ensure that cannabis testing laboratories function reliably, they are obliged to follow and execute certain organizational and regulatory protocols throughout the testing process. These involve critical factors that determine the accuracy of testing services of a laboratory.

Factors Critical to a Cannabis Testing Laboratory 

  • Accreditations & Regulatory Compliance: Cannabis testing laboratories are subject to regulatory compliance requirements, accreditation standards, laboratory practices and policies at the state level. A standard that most cannabis testing labs comply to is ISO 17025, which sets the requirements of quality standards in testing laboratories. Accreditation to this standard represents the determination of competence by an independent third party referred to as the “Accreditation Body”. Accreditation ensures that laboratories are adhering to their methods. These testing facilities have mandatory participation in proficiency tests regularly in order to maintain accreditation.
  • Quality Assurance, Standards & Proficiency Testing: Quality assurance is in part achieved by implementing standard test methods that have been thoroughly validated. When standard methods are not available, the laboratory must validate their own methods. In addition to using valid and appropriate methods, accredited laboratories are also required to participate in appropriate and commercially available Proficiency Test Program or Inter-Laboratory Comparison Study. Both PT and ILC Programs provide laboratories with some measure of their analytic performance and compare that performance with other participating laboratories.

    Multi-analyte Configuration for Cannabis Testing Services
    CloudLIMS Cannabis Testing LIMS: Multi-analyte Configuration for Cannabis Testing Services
  • Real-time Collaboration: Testing facilities generate metadata such as data derived from cannabis samples and infused products. The testing status and test results are best served for compliance and accessibility when integrated and stored on a centralized platform. This helps in timely data sharing and facilitates informed decision making, effective cooperation and relationships between cannabis testing facilities and growers. This platform is imperative for laboratories that have grown to high volume throughput where opportunities for errors exist. By matching test results to samples, this platform ensures consistent sample tracking and traceability. Finally, the platform is designed to provide immediate, real-time reporting to individual state or other regulatory bodies.
  • Personnel Management: Skilled scientific staff in cannabis-testing laboratories are required to oversee testing activities. Staff should have experience in analytical chromatography instruments such as HPLC and GC-MS. Since samples are often used for multi-analytes such as terpenes, cannabinoids, pesticides etc., the process often involves transferring samples and tests from one person to another within the testing facility. A chain of custody (CoC) is required to ensure traceability and ‘ownership’ for each person involved in the workflow.

LIMS for Laboratory Automation

Gathering, organizing and controlling laboratory-testing data can be time-consuming, labor-intensive and challenging for cannabis testing laboratories. Using spreadsheets and paper methods for this purpose is error-prone, makes data retrieval difficult and does not allow laboratories to easily adhere to regulatory guidelines. Manual systems are cumbersome, costly and lack efficiency. One way to meet this challenge is to switch to automated solutions that eliminate many of the mundane tasks that utilize valuable human resources.. Laboratory automation transforms the data management processes and as a result, improves the quality of services and provides faster turnaround time with significant cost savings. Automating the data management protocol will improve the quality of accountability, improve technical efficiency, and improve fiscal resources.

cloudlims screenshot
Real Time Test Status in CloudLIMS

A Laboratory Information Management System (LIMS) is a software tool for testing labs that aids efficient data management. A LIMS organizes, manages and communicates all laboratory test data and related information, such as sample and associated metadata, tests, Standard Operating Procedures (SOPs), test reports, and invoices. It also enables fully automated data exchange between instruments such as HPLCs, GC-FIDs, etc. to one consolidated location, thereby reducing transcription errors.

How LIMS Helps Cannabis Testing Labs

LIMS are much more capable than spreadsheets and paper-based tools for streamlining the analytical and operational lab activities and enhances the productivity and quality by eliminating manual data entry. Cloud-enabled LIMS systems such as CloudLIMS are often low in the total cost of acquisition, do not require IT staff and are scalable to help meet the ever changing business and regulatory compliance needs. Some of the key benefits of LIMS for automating a cannabis-testing laboratory are illustrated below [Table 1]:

Key Functionality Benefit
Barcode label designing and printing Enables proper labelling of samples and inventory

Follows GLP guidelines

Instant data capture by scanning barcodes Facilitates quick client registration and sample access
3600 data traceability Saves time and resources for locating samples and other records
Inventory and order management Supports proactive planning/budgeting and real time accuracy
Custodian management Promotes overall laboratory organization by assigning custodians for samples and tests

Maintains the Chain-of-custody (CoC)

Test management Accommodates pre-loaded test protocols to quickly assign tests for incoming samples
Accounting for sample and inventory quantity Automatically deducts sample and inventory quantities when consumed in tests
Package & shipment management Manages incoming samples and samples that have been subcontracted to other laboratories
Electronic data import Electronically imports test results and metadata from integrated instruments

Eliminates manual typographical errors

Report management Generates accurate, customizable, meaningful and test reports for clients

Allows user to include signatures and additional sections for professional use

21 CFR Part 11 compliant Authenticates laboratory activities with electronic signatures
ISO 17025 accreditation Provides traceable documentary evidence required to achieve ISO 17025 accreditation
Audit trail capabilities Adheres to regulatory standards by recording comprehensive audit logs for laboratory activities along with the date and time stamp
Centralized data management Stores all the data in a single, secure database facilitating quick data retrieval
Workflow management Promotes better data management and resource allocation
High-configurability Enables modification of screens using graphical configuration tools to mirror testing workflows
State compliance systems Integrates with state-required compliance reporting systems and communicates using API
Adheres to regulatory compliance Creates Certificates of Analysis (CoA) to prove regulatory compliance for each batch as well as batch-by-batch variance analysis and other reports as needed.
Data security & confidentiality Masks sensitive data from unauthorized user access

 

Cloud-based LIMS encrypts data at rest and in-transit while transmission between the client and the server

Global accessibility Cloud-based LIMS provides real-time access to laboratory data from anytime anywhere
Real-time collaboration Cloud-based LIMS enhances real-time communication within a laboratory, between a laboratory and its clients, and across a global organization with multiple sites

Table 1. Key functionality and benefits of LIMS for cannabis testing laboratories

Upon mapping the present day challenges faced by cannabis testing laboratories, adopting laboratory automation solutions becomes imperative. Cloud-based LIMS becomes a valuable tool for laboratory data management in cannabis testing laboratories. In addition to reducing manual workloads, and efficient resource management, it helps labs focus on productive lab operations while achieving compliance and regulatory goals with ease.

For more information on this, check out a webinar here: Webinar: How to Meet Cannabis Testing Standards and Regulatory Requirements with LIMS by Stephen Goldman, laboratory director at the State of Colorado certified Cannabis testing facility, PhytaTech.

Integrating Your LIMS System With State Tracking Systems

By Cannabis Industry Journal Staff
No Comments

Cannabis Labs Virtual Conference: Part 3

Integrating Your LIMS System With State Tracking Systems
By Hannah O’Brien, Operations Manager, Confident Cannabis

Running a lab is hard. Running a cannabis lab is harder. Watch this webinar hosted by Confident Cannabis, the most popular and only free cannabis LIMS in the country, to learn how cannabis compliance and regulatory burdens impact analytical testing laboratories in any state, and how important purpose-built software solutions are to make their business run smoothly.

Consumer Education: Transparency is King

By Gabrielle Wesseldyk
2 Comments

Making Cannabis Transparent: The Future of the Industry is Information and Data

The last decade has been marked by great strides in the cannabis industry, as public awareness surrounding the health benefits of marijuana-infused products has spread and products have become increasingly well researched and scientifically advanced. Despite this significant progress, however, cannabis legislation and regulations continue to vary widely between states, ultimately contributing to a lack of clarity within the industry.

This issue was at the forefront of the DispensaryNext Conference and Expo agenda held in Denver a few weeks ago. During the expo’s Consumer Safety and Education discussion, a panel of industry leaders including Kevin Gallagher, director of compliance and government affairs at Craft Concentrates and executive director of the Cannabis Business Alliance (CBA); Eileen Konieczny, registered nurse and president of the American Cannabis Nurses Association; Kevin Staunton, director of business development at RM3 labs; and moderator David Kotler, a partner at Cohen Kotler P.A., highlighted a number of important issues for cannabis patients and adult-use consumers, as well as what’s next for physicians, testing labs and dispensaries across the industry. A number of common themes resonated in their discussion of opportunities and challenges, ultimately pointing to a need for increased research and data, and most notably, a growing demand for transparency industry-wide.

Medical practitioners and dispensary technicians need qualified and legitimate information.

Konieczny opened by stressing that the industry must stop calling dispensary sales associates “budtenders.” “I prefer the term ‘dispensary technician.’ These are knowledgeable people who are on the front lines, helping patients understand the products available to them. They deserve a title to reflect that our industry and their knowledge is much more than ‘bud,’” says Konieczny.

These are knowledgeable people who are on the front lines, helping patients understand the products available to them. The most prominent information gaps in the industry lie at the level of dispensary technicians and medical practitioners. The ideal scenario for patients who are looking to use cannabis as medicine is that their medical practitioner is educated about the endocannabinoid system and that the products are available locally so that a treatment plan can be developed based on their needs. But the reality is that many patients enter their local dispensary without much knowledge or support at all, relying on the professionalism of the dispensary staff to help them navigate the dizzying array of products.

Putting the patient’s safety and success first, it is imperative that everyone involved has the proper data and information to make the best choices. However, dispensary technicians should be extremely careful to avoid making health or benefit claims. As Gallagher noted, “It is not only illegal, but also unethical to make medical claims as a dispenser. There is a difference between a claim and a personal experience. A dispenser can tell their customer that a certain strain helped them personally, but they cannot tell the customer that the strain will cure their specific ailment.”

The industry needs transparency.

New cannabis consumers may have a certain degree of misunderstanding of the products they are consuming and unfortunately, manufacturers do not offer a high level of transparency in disclosing ingredients, thereby preventing these customers from becoming better informed.

While educating the public is essential, educating the industry is of equal importance.Furthermore, labels often contain small barely legible type, along with confusing and unnecessary content. According to Gallagher, the labels need to be simpler. “Products are overloaded with redundant, confusing language that most consumers don’t understand. This turns them off—especially if they’re inexperienced in this realm,” says Gallagher. When customers who are new to cannabis find products off-putting, it hurts not only the industry, but also their own health. Ill-informed consumers may have trouble understanding how cannabis can help them, and therefore they can miss the benefits it provides.

While these issues are prevalent, there are many ways they can be resolved—with transparency at the core.

Research is critical and paramount.

For cultivators or manufacturers, research and data hold the key to attracting new consumers. By providing details about what is in a product and implementing certifications to show the product is contaminant-free, manufacturers are able to provide transparency and offer differentiation.

During the panel, Konieczny pointed out another common mistake that many manufacturers make—not sharing test results. “Not many are posting their test results, and yet this is one of the leading avenues that can increase revenue,” says Konieczny. “Most people just want to feel well again, so providing test results adds a layer of legitimacy for patients who are wary to try a new product.”

With all of this in mind, it is perhaps most important to consider the way that this information is conveyed. Facts and research are useless if they are not accessible to consumers, who may not comprehend complex data. “We need to present information in plain language, keeping it clear and simple to understand,” expressed Konieczny. The simpler the delivery, the better it will be understood and knowledge is a very powerful tool for patients, consumers and the bottom line.

Educating the educators.

While educating the public is essential, educating the industry is of equal importance. For instance, thoroughly training dispensary technicians to ask the correct questions and identify first-time users will ensure consumer safety while avoiding improper use.

The industry as a whole depends on transparencyEducating professionals on better product labeling is another critical way that the industry is working to improve itself. There has recently been a push at the manufacturing level for standardization in product labeling, as establishing a clear standard can aid customers in successfully using cannabis. “In working groups with Colorado’s MED (Marijuana Enforcement Division), we aim to standardize specific product categories, remove irrelevant names, and harmonize medical and retail labeling regulations,” says Gallagher. “Ultimately, we want to consolidate language and make it more transparent in promoting public health and safety so that it can be easily read and understood.”

All panelists agreed transparency is paramount for the future of the cannabis industry and for growing a brand. Using lab data can provide value, setting a brand apart and building loyalty among consumers looking for someone they can trust.

“Transparency is king,” Gallagher urges. “The more we educate consumers and professionals, the more clarity we will see at all levels, ultimately minimizing risk and creating greater demand among those consumers. The industry as a whole depends on transparency.”