Packaging Design for Cannabis Products: How to Build Trust and Gain Customers

To sell more cannabis products, you must build trust with your customers. Design Shack Magazine explains: “Trust is a key component of user loyalty, and a reason why people come to your company or brand.”

If you don’t get your package design right, people might simply ignore your cannabis products.But building trust is a big challenge for new medical cannabis businesses. That’s where good design can help:“While a lot of trust comes from past performance and a brand’s track-record, it also comes from the design. How a website, poster or package looks can impact how users feel about it and whether they take the leap from casual looker to brand loyalist.”

For a cannabis health supplement business, the product packaging design is one of the most important ways to reassure consumers and build trust.

When a prospective customer first sees your product, they see the packaging before they can touch or see the product. Good product packaging can raise concerns or instill comfort and confidence in a potential buyer.

If you don’t get your package design right, people might simply ignore your cannabis products.

So, let’s take a look at what your business can do to create great product packaging designs that will win over the skeptics and gain customers.

Include the Right Content On Product Packaging

Designing packaging that inspires trust starts with including the right content.

Start by telling people exactly what’s inside your packaging. For example, specify what your product is (CBD Extract Oil vs. Full-Spectrum Hemp Oil Caplets), how much of it there is, a production lot number and a potency level.

Include any qualifiers that may reassure your customers – such as “Organic,” “Non-GMO” or “CO2-Extracted.”

Image courtesy of Kannabia Seed Company

Communicate this information in clean, concise language that shows you have nothing to hide. And, speaking of not hiding – include contact information for your business. Many businesses bury their contact info on their websites and packaging. Don’t do that.

People trust businesses that are transparent and easy to reach. Customers want to know that if they have a question or something goes awry with an order that they can get help.

Including your web address, support email and phone number is a powerful way to reassure clients that your business is legitimate and trustworthy.

And, no packaging is complete without branding elements to help customers identify who your business is and what you’re about. This should include your company’s logo, identifying brand colors and any other small visual elements your brand may use.

Finally, make sure to follow the FDA guidelines for dietary supplement labels.

Your content checklist for product packaging

  • Include the essential details
    • What’s inside?
    • How much?
    • What’s the potency and dosage?
    • When does it expire?
    • What’s the lot number?
  • Include reassuring qualifiers that your audience will value
    • Organic, CO2-Extracted, Full Spectrum, Contains Less Than 0.3% THC, etc.
  • Include your company’s contact info
    • Web Address
    • Customer Support Email
    • Customer Support Phone number
  • Include your visual branding elements
    • Logo
    • Tagline
    • Brand Colors
    • Small branded graphic elements

Keep the Packaging Design Simple

Clean, simple design is reassuring and inspires trust.

Image courtesy of Receptra Naturals

That’s because simple design makes it easy for customers to find what they need or want to know.

It’s easy to miss information in a cluttered design – and people know this.

People naturally mistrust the dense chunks of text at the bottom of many advertisements and product packages. On the other hand, clean, easy-to-read fonts and plenty of white space ensure that your audience can read your product packaging and find the information they want quickly without too much trouble.

With fewer words and graphics competing for attention, the important stuff naturally stands out. And, a simple design also sends the message that there are no hidden loopholes or secrets that may work against your customers.

Keep the Design Of Your Product Packaging Professional

It doesn’t matter how great your product is if your business comes across as unprofessional. And, for medical cannabis businesses, the bar for establishing professionalism is even higher than for most companies.

Keep these tips in mind to communicate professionalism and reliability.

Image courtesy of Sagely Naturals

Make sure your packaging is error-free

Mistakes don’t look professional. How many times have you wondered how an error could have passed through so many hands unnoticed that it made it onto the final version?

Consumers notice errors in your packaging design. They see typos and often, discover incorrect or misleading information. Errors make customers think that your business is incompetent. Or worse – they might think that your business is deliberately misleading them. Make sure you proof-read everything before your packaging goes to production.

Showcase Your Cannabis Products Well Against Competitors

People buying your cannabis products will have other options. Don’t ignore your competition and be sure to understand how other dietary supplements and medicine is packaged.

Want to build trust by encouraging consumers to group your CBD products with other trusted medical brands? Follow these tips:

  • Provide a list of ingredients and instructions for safe dosing and usage. People expect this from reputable medicinal brands. Your product packaging should dothis too. And, remember to follow the FDA’s labeling requirements for dietary supplements.
  • Incorporate a safety seal into your packaging design. You’ll notice that most medicines, vitamins, and supplements have a safety seal to protect the contents. Whether you opt for a shrink-wrapped seal over the lid or a foil seal under the cap, adding a safety seal shows that your product has not been tampered with and implies that it’s safe to use.

Incorporating these elements will create a mental link between your product and other trusted medicinal products.

Be authentic to your cannabis brand

Last, but not least, your packaging design must align with your brand. When consumers sense a disconnect between the brand identity they’ve come to identify with your business and the packaging design for your products, it creates discomfort.

Image courtesy of Direct Cannabis Network

But packaging that is in line with (or expands upon) the brand identity consumers have come to know will create comfort and trust.

Kevin Keating at PKG Brand Design explains:

Your brand’s packaging design must reflect your company’s story, product, and values. If your packaging claims a “simple” snack product with dozens of ingredients, consumers are going to be left with a disingenuous feeling about your products and company. By ensuring that your messaging, design, and visual impact is in line with your company and your consumer’s preferences, you can build instant trust.

So, ensure that your packaging design is consistent with your existing visual identity. This includes the name of your business or cannabis product, your cannabis business logo, website, and marketing design.

A united and cohesive visual brand presence looks professional and helps to build familiarity – which is key to developing trust. Ultimately, many people judge products based solely on the product packaging. That’s why it’s essential to make sure your product packaging sends the right message.

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How to Vet Suppliers in Cannabis Product Manufacturing

The quality of your edible cannabis product can only be as reliable as the components that comprise it. The three types of components include active ingredients (such as CBD oil), packaging components  (such as the bottles that hold finished product) and inactive ingredients (such as coconut oil). When evaluating a potential supplier for these three areas, a risk-based method follows a vendor selection process that highlights critical ingredients and also adequately assesses excipients. With this approach, the vetting process for a supplier is based on the impact the potential ingredient or component will have on the quality and purity of the finished product.

Choose only those suppliers who can provide certification that the packaging components are food-grade or food-safeThere are three basic categories to guide vendor assessment. Is the supplier providing 1) a packaging component with product contact, 2) an excipient, or inactive ingredient, or 3) the active ingredient? Regardless of the category, due to the factious nature of cannabis, it is important to first verify with a vendor that it will sell its products to a company in the cannabis industry. Once that is determined, the evaluation process may begin.

Packaging Components

Sourcing validation is a critical initial step in the production process. (image credit: Lucy Beaugard)

Packaging components, such as bottles and caps, are considered primary packaging because they have direct contact with the finished product. Suppliers of the primary packaging must be able to provide assurance that their goods do not contain additives that are harmful to consumers. Therefore, choose only those suppliers who can provide certification that the packaging components are food-grade or food-safe. Reputable vendors will also be able to provide a certificate of compliance, also known as a certificate of conformance, which states that the component meets specifications required for that part. Many cannabis regulations require finished products to be sold in child-resistant packaging, so the supplier will need to provide child-resistant certification for the packaging components, if applicable.

Excipients

Excipients are ingredients that are added to a product for the purposes of streamlining the manufacturing process and enhancing physical characteristics such as taste and color. Some examples could include coconut oil, starch and alcohol. Though they do not have the same critical nature as active ingredients, their potential risk to a finished product is generally greater than that of a packaging component. As such, there are additional factors to consider for an excipient vendor. Verify with the supplier that it can provide the following documentation. While governing regulations may not require some information, the data included in these documents are important to ensure the quality of your finished product.

  • Certificate of Analysis (or, certificate of conformance), for each lot of material. The information on a certificate, including the tests performed, specifications and test results must be sufficient to determine if the material is acceptable for use in the product.
  • Allergen Statement. This statement is important to accurately include or disclaim allergens on the finished product label.
  • Residual Solvent Statement. Solvents are commonly used to bolster the manufacturing process for a material. In order to maintain acceptable levels of residual solvents in a final product, it is necessary to also consider the toxicity and level of each solvent in the raw material.
  • Heavy Metals Certification. Since metals pose a risk to consumer safety, it is important to know what amounts, if any, are being contributed to your product by raw materials.

Because changes in an excipient can impact your finished product, make every attempt to obtain a commitment from a supplier to notify you if changes are made to the excipient’s specifications.

Active Ingredients

Cannabis oil is the ingredient that, when the edible cannabis product is consumed, is biologically “active.” Thus, it is considered to be the active ingredient in cannabis products. Since cannabis oil has a direct impact on the quality of a product, it is critical that the oil supplier be appropriately evaluated. One of the main considerations for a cannabis oil supplier is whether the supplier is willing to host initial and periodic audits of its manufacturing facility. Such audits are crucial in assessing the capability of the vendor to comply with regulatory requirements and established procedures – can the supplier consistently provide quality material? The answer to this question is too important to risk for you and your customers.As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens.

Additionally, verify the oil supplier will provide key documentation, such as that listed above for excipients, to support the quality and purity of the oil. And last but not least, ensure the information reported by the supplier is adequate to meet the requirements of your finished product.

Evaluation guidelines and criteria such as these should be added to standard operating procedures to ensure consistency and quality across all products. As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens. The importance of consumer safety and bolstering industry integrity is paramount. Sourcing validation is a critical initial step in the production process that can directly impact a company’s success and longevity in the cannabis industry.

The post How to Vet Suppliers in Cannabis Product Manufacturing appeared first on Cannabis Industry Journal.

Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss

In a previous article I discussed the elephant in the room for clients of laboratory services- the possibility of errors, inaccurate testing and dishonesty.

Now, I will explain how the current “smoke and mirrors” of distillation claims are impacting the cannabis industry in the recreational and medical areas. We have all heard the saying, “ignorance is bliss.” But, the ignorance of how distillation really works is creating misinformation and misleading consumers.

That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.There have been reports of people claiming that “Distilled cannabis productsthat are Category 2 distillate are pesticide free and phosphate free, while Category 1 has pesticides and phosphates, but within acceptable limits”

The problem is that these claims of Category 1 and Category 2 cannot be proven just by saying they are distilled. Ignorance of the physical chemistry rules of distillation will lead to increased concentrations of pesticides and other organic contaminants in the supposedly purified cannabis distillate. That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.

So, let’s look at a basic physical chemistry explanation of the cannabis distillation process.

  • First off, you must have an extract to distill. This extract is produced by butane, carbon dioxide or ethanol extraction of cannabis botanical raw material. This extract is a tarry or waxy solid. It contains cannabinoids, terpenes and other botanical chemicals. It will also contain pesticides, organic chemicals and inorganic chemicals present in the raw material. The extraction process will concentrate all of these chemical compounds in the final extract.
  • Now you are ready to distill the extract. The extract is transferred to the vacuum distillation vessel. Vacuum distillation is typically used so as to prevent the decomposition of the cannabinoid products by thermal reactions or oxidation. Under a vacuum, the cannabinoids turn into a vapor at a lower temperature and oxygen is limited.
  • Part of the vacuum distillation apparatus is the distillation column. The dimensions of this column (length and width) along with the packing or design (theoretical plates) will determine the efficiency of distillation separation of each chemical compound. What this means is that the more theoretical plates in a column, the purer the chemical compound in the distillate. (e.g. Vigreux column = 2-5 theoretical plates, Oldershaw column = 10-15 plates, Sieve plate column = any number you can pay for).
  • The temperature and vacuum controls must be adjustable and accurate for all parts of the distillation apparatus. Failure to control the temperature and vacuum on any part to the apparatus will lead to:
    • Thermal destruction of the distillate
    • Oxidation of the distillate
    • Impure distillate

Now, you can see that a proper distillation apparatus is not something you throw together from a high school chemistry lab. But just having the proper equipment will not produce a pure cannabis product. The physical chemistry that takes place in any distillation is the percentage a chemical compound that occurs in the vapor phase compared to the percentage in liquid phase.So, how can you produce a cannabis distillate that is clean and pure?

For example, let’s look at whiskey distillation. In a simple pot still, alcohol is distilled over with some water to produce a mixture that is 25%-30% ethanol. Transferring this distillate to an additional series of pot stills concentrates this alcohol solution to a higher concentration of 85%-90% ethanol. So, each pot still is like a single theoretical plate in a distillation column.

But, if there are any chemical compounds that are soluble in the vapor produced, they will also be carried over with the vapor during distillation. This means that pesticides or other contaminants that are present in the cannabis extract can be carried over during distillation!

So, how can you produce a cannabis distillate that is clean and pure?

  • Produce a cannabis extract that has lower concentrations of bad chemicals. Since a lot of the cannabis extracts available for distillation are coming from grey-black market cannabis, the chances of contamination are high. So, the first thing to do is to set up an extraction cleanup procedure.
    • An example of this is to wash the raw extract to remove inorganic phosphates. Then recrystallize the washed extract to remove some of the pesticides.
  • Make sure that the distillation apparatus is set up to have proper temperature and vacuum controls. This will limit production of cannabis decomposition products in the final distillate.
  • Make sure your distillation apparatus has more than enough theoretical plates. This will make sure that your cannabis distillate has the purity needed.
  • Finally, make sure that the staff that operates the cannabis distillation processes are well trained and have the experience and knowledge to understand their work.

Inexperienced or under-trained individuals will produce inferior and contaminated product. Additional information of extract cleanup and effective vacuum distillation can be obtained by contacting the author.

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Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 5

Protection in the Court of Public Opinion

In the last four articles, I have outlined areas that impact your operations as they apply to laboratory quality programs. But this article will take a different path. It will focus on protecting your crop and brand along with any business that utilizes your crop, such as dispensaries or edible manufactures in the court of public opinion.

Now, the elephant in the room for cannabis companies is the difference between rules written by the state and their enforcement by the state. There are many anecdotal stories out there that can be used as case studies in identifying ways to protect your brand. Remember, consumers and the media caught them, not the regulators.

Cheating in the cannabis industry: growers, dispensaries, edibles manufactures, etc. This includes:

  1. Finding laboratories that will produce results that the client wants (higher potency numbers)
  2. Not testing for a particular contaminant that may be present in the cannabis product.
  3. Selling failed crops on the gray or black market.
  4. Claiming to regulators that the state rules are unclear and cannot be followed (e.g. So, give me another chance, officer)

So why should you be worried? Because, even if the state where you operate fails to enforce its own rules, the final end-user of your product will hold you accountable! If you produce any cannabis product and fail to consider these end-users, you will be found out in the court of public opinion by either the media or by the even more effective word of mouth (e.g. Social Media).

So, let’s take a look at some recent examples of these problems:

  1. “Fungus In Medical Marijuana Eyed As Possible Cause In California Man’s Death”
  2. “Pesticides and Pot: What’s California Smoking?”
  3. Buyers beware: California cannabis sold Jan. 1 could be tainted”

Each of these reports lists contamination by microbial stains or pesticides as being rampant within the California market whose products are used for medical or recreational use. Just imagine the monetary losses these cannabis businesses faced for their recalled cannabis product when they got caught. Remember, consumers and the media caught them, not the regulators.Institute a quality program in your business immediately.

How can you be caught? There are many different ways:

  1. Consumer complaints to the media
  2. Secret shopper campaigns (more to come on that in the next article)
  3. Media investigations
  4. Social media campaigns

What are the effects on your business? Product recalls such as these two to hit the California market recently.

So, what should you do to produce an acceptable product and provide reasonable protection to your cannabis business? Institute a quality program in your business immediately. This quality program will include areas of quality assurance and quality control for at least these areas.

  1. Growing
  2. Processing or formulating
  3. Shipping
  4. Dispensing
  5. Security
  6. Training of staff
  7. Laboratory services

Setting up and supporting these programs requires that your upper management impose both a rigorous training program and make employee compliance mandatory. Otherwise, your business will have an unreasonable risk of failure in the future.

Further information on preparing and instituting these types of quality assurance and quality control programs within your business can be found at the author’s website.

The post Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 5 appeared first on Cannabis Industry Journal.

Documentation: Are You Prepared?

Documents play a key role in the world of regulations and global standards. Documents tell a story on programs development, implementation and verification during an inspection or audit. Documents are used as evidence to determine conformance to the law or standard. However, do you know what kind of documents may be reviewed during a regulatory inspection or a food safety audit? Are you prepared to show that the implementation of regulatory requirements or a standard is done efficiently at your facility?

Inspectors and auditors will look for compliance either to regulations or to a standard criterion. Regulations and standards require that documentation is controlled, secured and stored in an area where they cannot deteriorate. Therefore, writing a Document Management Program (DMP) will help a business owner ensure consistency in meeting this and other requirements.Radojka Barycki will host a a plenary session titled, “Cannabis: A Compliance Revolution” at the 2018 Food Safety Consortium | Learn More

A well-developed and implemented DMP provides control over documents by providing a number sequence and revision status to the document. In addition, ownership for development, review and distribution of the documents are assigned to specific individuals within the company to ensure that there are no inconsistencies in the program. Documents must also have the name of the company in addition to a space to write the date when the record is generated. It is recommended to include the address if there are multiple operational sites within the same company.

There are different types of documents that serve as support to the operations:

  1. Program: A written document indicating how a business will execute its activities. When it comes to the food industry, this is a written document that indicates how quality, food safety and business activities are controlled.
  2. Procedures: General actions conducted in a certain order. Standard Operational Procedures (SOPs) allow the employee to know what to do in general. For example, a truck receiving procedure only tells the employee what the expected conditions are when receiving a truck (cleanliness, temperature, etc.) However, it doesn’t tell the employee how to look for the expected conditions at the time of the truck arrival.
  3. Work Instructions: Detailed actions conducted in a certain order. For example, truck inspection work instruction tells the employee what steps are to be followed to perform the inspection.
  4. Forms: Documents used to record activities being performed. 
  5. Work Aids: are documents that provide additional information that is important to perform the job and can be used as a quick reference when performing the required activities within the job. 
Are you prepared to face document requirements now and in the future?

The inspectors and auditors base their role on the following saying: “Say what you do. Do what you say. Prove it!” The programs say what the company do. The procedures, work instructions and work aids provide information on implementation (Do what you say) and the forms become records that are evidence (prove) that the company is following their own written processes.

Regulatory requirements for cannabis vary from state to state. In general, an inspector may ask a cannabis business to provide the following documentation during an inspection:

  1. Business License(s)
  2. Product Traceability Programs and Documents
  3. Product Testing (Certificate of Analysis – COAs)
  4. Certification Documents (applicable mainly to cannabis testing labs)
  5. Proof of Destruction (if product needs to be destroyed due to non-compliance)
  6. Training Documents (competency evidence)
  7. Security Programs

As different states legalize cannabis, new regulatory requirements are being developed and modeled after the pharma, agriculture and food industries. In addition, standards will be in place that will provide more consistency to industry practices at a global level. The pharma, agriculture and food industries base their operations and product safety in programs such as cGMPs, GAPs, HACCP-based Food Safety Management Systems and Quality Management Systems. Documents required during an inspection or audit are related to:

  1. Good Agricultural Practices (GAPs)
  2. Current Good Manufacturing Practices (cGMPs)
  3. Food Safety Plan Documents
  4. Ingredient and Processing Aids Receiving
  5. Ingredient and Processing Aids Storage
  6. Operational Programs (Product Processing)
  7. Final Product Storage
  8. Final Product Transportation
  9. Defense Program
  10. Traceability Program
  11. Training Program
  12. Document Management Program

In the always evolving cannabis industry, are you prepared to face document requirements now and in the future?

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Food Safety Consortium To Address Cannabis Safety, Edibles Manufacturing

The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis this year. As announced back in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.

The Food Safety Consortium itself is hosted by our sister publication, Food Safety Tech, but the Cannabis Quality series will be co-hosted by Cannabis Industry Journal as well. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers.

Ben Gelt, board chairman at the Cannabis Certification Council (CCC) will moderate a panel discussion where leaders in the edibles market will discuss supply chain, production and other difficulties in manufacturing infused products. That panel will include Nancy Whiteman, CEO of Wana Brands, Jacob Pasternack, CEO of Binske, Justin Singer, CEO of STI Brands, alongside other leaders in the infused products and edibles markets.

Radojka Barycki, CEO or Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.” Larry Mishkin, counsel to Hoban Law Group and partner at the law firm, Silver & Mishkin, which serves cannabis businesses in Illinois, will also be speaking earlier in the conference.

Cameron Prince, VP of Regulatory Affairs, The Acheson Group
Cameron Prince, VP of Regulatory Affairs, The Acheson Group

Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15th. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”

Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross-contamination can occur for edibles manufacturers as well. This year’s event will be held November 13-15 in Chicago, Illinois. To see the full list of speakers and register for the conference, go the Food Safety Consortium’s website.

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Safety & Efficacy: Ensuring Dosing Accuracy for Infused Products

Complications with dosing inaccuracies in the cannabis industry has always been a hot topic. In 2014, The Cannabist tested several Colorado infused products only to find that the results were different from what was indicated on the label. While the industry has come a long way at the state level since then, a study published in The Journal of the American Medical Association this past November found that 26 percent of CBD products sold online contained less CBD than the label. Similar to when you buy a bottle of wine or ibuprofen, people should be able to trust product labels.

Process validation in action at the Stratos facility
Process validation in action at the Stratos facility
(image credit: Lucy Beaugard)

There are processes that cannabis-infused product manufacturers can adopt to solve this issue. Incorporating process validation establishes reproducible customer experiences while in-process controls create product consistency and potency reliability. These operational and compliance techniques originated in the pharmaceutical industry and will undoubtedly become the future gold standard for best practices with cannabis manufacturers.

Product testing alone cannot assess quality for an entire lot or batch of product; therefore, each step of the manufacturing process must be controlled through Good Manufacturing Practices (GMP). Process validation is an aspect of GMPs used by the pharmaceutical industry to create consistency in a product’s quality, safety and efficacy. There are three main stages to process validation: process design, process qualification and continued process verification. Implementing these stages ensures that quality, including dosing accuracy, is maintained for each manufactured batch of product.

Validation: Step 1

Process design, the first phase of process validation, defines the manufacturing process based on previous product development and process research. The appropriate equipment, instruments and materials are selected as part of process design. Both standard operating procedures for equipment and operations as well as batch records for manufacturing steps are also finalized during this phase. The batch record must include critical process parameters (CPP), the parameters that must be maintained in order to produce product that consistently meets specified criteria. Mixing speed and time, temperature, pressure and flow rate are examples of common CPP. Training production personnel is also defined and performed as part of process design. Operators are trained on operating procedures and batch records in order to learn how to make the product successfully.

Process validation can help ensure accurate dosing.
Process validation can help ensure accurate dosing. (image credit: Lucy Beaugard)

Validation: Step 2

Process qualification, the next stage of process validation, is performed to evaluate the capability of a process for reproducible and robust manufacturing. Because reproducibility of a process cannot be fully assessed with a single batch, evaluation is typically performed on a minimum of three separate batches. For each batch included in the process qualification, the frequency and number of samples are increased over normal sampling to provide a more thorough assessment of each batch. The testing includes visual inspection for defects as well as quantitative tests such as weight or volume and potency. In addition to composite sampling, which is performed by combining samples from multiple time points throughout a batch (e.g. beginning, middle and end) to assess a batch as a whole, stratified sampling is performed. Stratified samples are taken from specified points throughout a batch, and rather than being combined, the samples are tested separately to indicate consistency throughout a given batch.

The Stratos product lineup- validation helped produce each of these consistently.

In addition to evaluating the reproducibility of a process, tests for robustness are performed during process qualification to demonstrate how changes in a process may impact the product. It is important to use different operators for performing manufacturing steps to ensure changes in personnel do not affect product quality. Switching out equipment and instruments will also reveal any sensitivities in a process. For example, when a different oven, mixer or tablet press is used, are the appearance, texture and potency impacted? If the product remains the same, that points toward the process being robust. Challenging the CPP will also provide important feedback regarding a process. If a step requires a temperature range of 50° – 70°C, it is recommended that the process be tested at the low end and high end of the range, to ensure the final product meets all required specifications. If the range assigned to a unit’s gross weight is 500 g ± 5%, then testing at 475 g and 525 g will offer more insight into how much variance the process truly can withstand.

Validation: Step 3

Once the process has been assessed for reproducibility and robustness, it transitions to continued process verification, which is the third and final stage of Process Validation. Performance of quality checks during each batch for the life of a product is part of this final stage. For infused products such as tablets, these checks include appearance – the tablets are the color and shape indicated by the batch record and they include the required imprint(s); weight – the tablets are within the specified weight range, which indicates correct tablet size and consistency of ingredients; hardness – tablets will dissolve/disintegrate for proper dosing; and friability – tablets will withstand stress of routine handling.

As your company grows in manufacturing volume, each of these three steps will become critical to safeguard against any inconsistencies. As we know in this industry, our most valuable asset is our license and success can be negatively impacted based on meeting compliance. Dedicating an internal role within quality and compliance will serve to future-proof your business against additional rules and regulations that are likely to come.

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Two Recalls Hit California Cannabis Market

Just weeks ago, the first voluntary cannabis product recall occurred under California’s new regulations. According to an article on MJBizDaily.com by John Schroyer, the recall for their vaporizer cartridges affects almost 100 dispensaries in California.

Bloom Brands, the company issuing the voluntary recall, mentioned in a press release that batches sold between July 1-19, 2018 were contaminated with the pesticide Myclobutanil and therefore does not meet the Bureau of Cannabis Control (BCC) standards. Below is an excerpt from the press release:

We are working closely with the BCC to remedy this issue and expect clean, compliant products to be back on shelves in three weeks…. At Bloom, we are continuing to work with the BCC and other partners to ensure that the space is properly regulated and safe for all customers. Transparency and safety remain our top concerns and we will provide updates as additional information becomes available. We apologize for any concern or inconvenience this serious misstep has caused. We thank you for your continued trust and confidence in our products.

Then, just days later, Lowell Herb Co. issued a voluntary recall on their pre-rolls. First reported by MJBizDaily.com, it appears the products initially passed multiple lab tests and was cleared for retail sales. Weeks after the batch passed tests, a laboratory reversed its decision, saying the products failed to pass the state’s testing standards. The contaminant in question was not mentioned.

The CCIA post calling out the BCC
The CCIA post calling out the BCC

Many seem to think these recalls are a product of the BCC’s unrealistic expectations in their lab testing rules. In a Facebook post days ago, the California Cannabis Industry Association called out the BCC for their unworkable rules. “The BCC has set testing standards that are nearly impossible to meet,” reads the post. “As a result recalls like this will be the norm and the industry will suffer a bottleneck in supply. Testing standards need to be realistic, not impossible.”

On July 13, California issued the first draft of their proposed permanent regulations, which would update and change the current emergency regulations. The proposed action levels for a batch to pass a pesticide test can be found on pages 105 and 106. The state’s regulatory bodies are holding public meetings on the proposed rules throughout August and stakeholders can also submit comments via email.

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Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 4

In the last three articles, I discussed the laboratory’s responses or defenses used to reply to your questions about laboratory results that place stress on the success of your business. The Quality Control (QC) results can cause this stress if they are not run correctly to answer the following questions:

  1. Are the laboratory results really true?
  2. Can the laboratory accurately analyze sample products like my sample?
  3. Can the laboratory reproduce the sample results for my type of sample?

Now let’s discuss the most important QC test that will protect your crop and business. That QC sample is the Matrix Sample. In the last article in this series, you were introduced to many QC samples. The Matrix Sample and Duplicate were some of them. Take a look back at Part 3 to familiarize yourself with the definitions.

The key factors of these QC sample types are:

  1. Your sample is used to determine if the analysis used by the laboratory can extract the analyte that is being reported back to you. This is performed by the following steps:
    1. Your sample is analyzed by the laboratory as received.
    2. Then a sub-sample of your sample is spiked with a known concentration of the analyte you are looking for (e.g. pesticides, bacteria, organic chemicals, etc.).
    3. The difference between the sample with and without a spike indicates whether the laboratory can even find the analyte of concern and whether the percent recovery is acceptable.
    4. Examples of failures are from my experiences:
      1. Laboratory 1 spiked a known amount of a pesticide into a wastewater matrix. (e.g. Silver into final treatment process water). The laboratory failed to recover any of the spiked silver. Therefore the laboratory results for these types of sample were not reporting any silver, but silver may be present. This is where laboratory results would be false negatives and the laboratory method may not work on the matrix (your sample) correctly. .
      2. Laboratory 2 ran an analysis for a toxic compound (e.g. Cyanide in final waste treatment discharge). A known amount of cyanide was spiked into a matrix sample and 4 times the actual concentration of that cyanide spike was recovered. This is where laboratory results would be called false positives and the laboratory method may not work on the matrix (your sample) correctly.
  2. Can the laboratory reproduce the results they reported to you?
    1. The laboratory needs to repeat the matrix spike analysis to provide duplicate results. Then a comparison of the results from the first matrix spike with its duplicate results will show if the laboratory can duplicate their test on your sample.
      1. If the original matrix spike result and the duplicate show good agreement (e.g. 20% relative percent difference or lower). Then you can be relatively sure that the result you obtained from the laboratory is true.
      2. But, if the original matrix spike result and the duplicate do not show good agreement (e.g. greater than 20% relative percent difference). Then you can be sure that the result you obtained from the laboratory is not true and you should question the laboratory’s competence.

Now, the question is why a laboratory would not perform these matrix spike and duplicate QC samples? Well, the following may apply:

  1. These matrix samples take too much time.
  2. These matrix samples add a cost that the laboratory cannot recover.
  3. These matrix samples are too difficult for the laboratory staff to perform.
  4. Most importantly: Matrix samples show the laboratory cannot perform the analyses correctly on the matrix.

So, what types of cannabis matrices are out there? Some examples include bud, leaf, oils, extracts and edibles. Those are some of the matrices and each one has their own testing requirements. So, what should you require from your laboratory?

  1. The laboratory must use your sample for both a matrix spike and a duplicate QC sample.
  2. The percent recovery of both the matrix spike and the duplicate will be between 80% and 120%. If either of the QC samples fail, then you should be notified immediately and the samples reanalyzed.
  3. If the relative percent difference between the matrix spike and the duplicate will be 20% or less. If the QC samples fail, then you should be notified immediately and the samples should be reanalyzed.

The impact of questionable laboratory results on your business with failing or absent matrix spike and the duplicate QC samples can be prevented. It is paramount that you hold the laboratory responsible to produce results that are representative of your sample matrix and that are true.

The next article will focus on how your business will develop a quality plan for your laboratory service provider with a specific focus on the California Code Of Regulations, Title 16, Division 42. Bureau Of Cannabis Control requirements.

The post Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 4 appeared first on Cannabis Industry Journal.

Orange Photonics Introduces Terpenes+ Module in Portable Analyzer

Last week at the National Cannabis Industry Association’s (NCIA) Cannabis Business Summit, Orange Photonics unveiled their newest product added to their suite of testing instruments for quality assurance in the field. The Terpenes+ Module for the LightLab Cannabis Analyzer, which semi-quantitatively measures terpenes, Cannabichromene (CBC) and degraded THC, adds three new chemical analyses to the six cannabinoids it already reports.

CBC, a cannabinoid typically seen in hemp and CBD-rich plants, has been linked to some potentially impactful medical applications, much like the findings regarding the benefits of CBD. The module that tests for it, along with terpenes and degraded THC, can be added to the LightLab without any changes to hardware or sample preparation.

Dylan Wilks, chief technology officer of Orange Photonics
Dylan Wilks, chief technology officer of Orange Photonics

According to Dylan Wilks, chief technology officer of Orange Photonics, this could be a particularly useful tool for distillate producers looking for extra quality controls. Cannabis distillates are some of the most prized cannabis products around, but the heat used to create them can also create undesirable compounds,” says Wilks. “Distillate producers can see potency drop more than 25% if their process isn’t optimized”. With this new Terpenes+ Module, a distillate producer could quantify degraded THC content and get an accurate reading for their QC/QA department.

We spoke with Stephanie McArdle, president of Orange Photonics, to learn more about their instruments designed for quality assurance for growers and extractors alike.

Stephanie McArdle, president of Orange Photonics
Stephanie McArdle, president of Orange Photonics

According to McArdle, this could help cultivators and processors understand and value their product when terpene-rich products are the end goal. “Rather than try to duplicate the laboratory analysis, which would require expensive equipment and difficult sample preparation, we took a different approach. We report all terpenes as a single total terpene number,” says McArdle. “The analyzer only looks for monoterpenes (some common monoterpenes are myrcene, limonene and alpha-pinene), and not sesquiterpenes (the other major group of cannabis terpenes, such as Beta- Caryophyllene and Humulene) so the analysis is semi-quantitative. What we do is measure the monoterpenes and make an assumption that the sesquiterpenes are similar to an average cannabis plant to calculate a total terpene content.” She says because roughly 80% of terpenes found in cannabis are monoterpenes, this should produce accurate results, though some exotic strains may not result in accurate terpene content using this method.

The LIghtLab analyzer on the workbench
The LIghtLab analyzer on the workbench

As growers look to make their product unique in a highly competitive market, many are looking at terpenes as a source of differentiation. There are a variety of areas where growers can target higher terpene production, McArdle says. “During production, a grower may want to select plants for growing based on terpene content, or adjust nutrient levels, lighting, etc. to maximize terpenes,” says McArdle. “During the curing process, adjusting the environmental conditions to maximize terpene content is highly desirable.” Terpenes are also beginning to get recognized for their potential medical and therapeutic values as well, notably as an essential piece in the Entourage Effect. “Ultimately, it comes down to economics – terpene rich products have a higher market value,” says McArdle. “If you’re the grower, you want to prove that your product is superior. If you’re the buyer, you want to ensure the product you buy is high quality before processing it into other products. In both cases, knowing the terpene content is critical to ensuring you’re maximizing profits.”

Orange Photonics’ LightLab operates very similarly to instruments you might find in a cannabis laboratory. Many cannabis testing labs use High Performance Liquid Chromatography (HPLC) to analyze hemp or cannabis samples. “The primary difference between LightLab and an HPLC is that we operate at lower pressures and rely on spectroscopy more heavily than a typical HPLC analysis does,” says McArdle. “Like an HPLC, LightLab pushes an extracted cannabis sample through a column. The column separates the cannabinoids in the sample by slowing down cannabinoids by different amounts based on their affinity to the column.” McArdle says this is what allows each cannabinoid to exit the column at a different time. “For example, CBD may exit the column first, then D9THC and so on,” says McArdle. “Once the column separates the cannabinoids, they are quantified using optical spectroscopy- basically we are using light to do the final quantification.”

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