Tag Archives: physical;

Steven Burton

Standardization: A Guide Through the Minefield

By Steven Burton
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Steven Burton

Now that cannabis edibles have been legalized nationally in Canada, many existing and aspiring license holders have been surprised to discover that they must comply with food safety regulations. This became crystal clear when Health Canada published their Good Production Practices Guide For Cannabis in August 2019.

With this development, it should be obvious to everyone that Good Manufacturing Practices (GMP) certifications are simply not enough.

Hazard Analysis and Critical Control Point (HACCP) based preventative control programs are now the absolute minimum and higher levels of certification (GFSI) should be on everyone’s wish list.

HACCP is a methodology that is all about identifying biological, chemical and physical hazards and determining how they will be controlled to mitigate the risk of injury to humans. Recently, bio-terrorism and food fraud hazards have been added to the list and it is a good idea to address quality hazards as well.

The process of developing a HACCP program involves identifying these hazards with respect to ingredients, materials, packaging, processes and cross-contamination points (explicitly required in Canada only). However, it is a specific ingredient hazard that I’d like to talk about here.

HACCPAs this market has emerged, I’ve met with many cannabis companies as the onerous levels of knowledge and effort required to build and maintain an effective HACCP program manually has dawned upon the industry. Many are looking for technological solutions to quickly solve this problem. During these discussions, a curious fact has emerged that set off the food safety alarm klaxons around here.

Most people alive today are too young to remember this but, with few exceptions, the standardization of ingredients is a relatively modern phenomenon. It used to be that the fat content of your milk varied from season to season and cow to cow. Over time, the food industry standardized so that, amazingly, you can now choose between milks with either 1% or 2% fat, a level of precision that would border on miraculous to someone born in the early 20th century.

The standardization of ingredients is important in terms of both quality and safety. Take alcohol for example. We know that a shot of spirits generally contains 40% alcohol. Different products may vary from this standard but, if I pour a shot of my favourite Bowmore No.1 single malt in Canada or Tasmania, this year or 10 years from now, I can expect a consistent effect from the 40% alcohol content of the quantity I’ve imbibed.

Imagine a world in which this was not the case, where one shot would be 40% but the next might be 80%. Things could get out of control quite easily at the 80% level so, to avoid this, distillers monitor and blend their product to ensure they achieve the 40% target, which is called the “standardization marker”.

With respect to cannabis, the obvious standardization marker is THC. During the manufacturing process, edibles manufacturers do not normally add cannabis flower directly into their products but instead add a THC concentrate produced during previous production steps. However, we’ve found that the wisdom of standardizing these concentrates has not yet dawned upon many in the industry, which is alarming at best and dangerous at worst.

The reason for this is that, since cannabis is inherently a heterogeneous plant, one cannot precisely achieve a particular marker value so the outcome of the concentration process is variable. The food industry long ago overcame this problem by blending or diluting to achieve a consistent marker concentration, but the cannabis industry has not yet adopted this advance.

The cannabis edibles industry is still immature and it will take time to bring all the necessary risk mitigation processes into place but one excellent place to start is to seriously consider standardizing concentrates to a THC marker.Instead, manufacturers simply keep track of the strength of each batch of concentrate and then adjust the quantity added to their recipes to achieve the desired THC content. This seems logical on the surface but presents a serious risk from the HACCP perspective, namely a chemical hazard, “Excessive psychoactive compound concentrations due to human error at levels that may be injurious to human health”.

The reality is that workers make mistakes, which is why it is imperative to mitigate the risk of human error insomuch as possible. One of the best ways to do this is to standardize to avoid the scenario where a worker, faced with a row of identical containers that are differentiated only by a tiny bit of text, accidentally grabs the wrong bottle. The error isn’t caught until the product has been shipped, consumed, and reports of hospital visits start coming in after the authorities trace the problem back to you. You must bear the costs of the recall, your reputation has been decimated and your company is floundering on the financial rocks.

US-based Drip More, LP recently found this out the hard way after consumers complained that their product tasted bad, bitter and/or harsh. An investigation determined that excessive nicotine content was the source of the problem and a voluntary recall was initiated. Affected product that had already been sold in 26 states. The costs of this recall have not been tallied but they will be staggering.

The cannabis edibles industry is still immature and it will take time to bring all the necessary risk mitigation processes into place but one excellent place to start is to seriously consider standardizing concentrates to a THC marker. This strategy is cheap, easy and you’ll never be sorry.

Soapbox

3 Food Safety Precautions for Edibles

By Cindy Rice
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You’ve survived seasons of cannabis cultivations, bringing in quality plants in spite of mold, mites, drought and other challenges that had to be conquered. Extraction methods are sometimes challenging, but you are proud to have a cannabinoid extract that can be added into your own products for sale. Edibles are just waiting to be infused with the cannabinoids, for consumers demanding brownies, gummies, tinctures and almost any food and beverage imaginable. You’ve been through the fire, and now the rest is easy peasy, right?

Food processing and sanitation
Avoiding cross contamination should be a priority for edibles manufacturing

Actually, producing edibles may not be so seamless as you think. Just as in the rest of the food industry, food safety practices have to be considered when you’re producing edibles for public consumption, regardless of the THC, CBD, terpene or cannabinoid profile. Once you’ve acquired the extract (a “food grade ingredient”) containing the active compounds, there are three types of hazards that could still contribute to foodborne illness from your final product if you’re not careful- Biological, Chemical and Physical.

Biological hazards include pathogenic bacteria, viruses, mold, mildew (and the toxins that they can produce) that can come in ingredients naturally or contaminate foods from an outside source. Chemical hazards are often present in the kitchen environment, including detergents, floor cleaners, disinfectants and caustic chemicals, which can be harmful if ingested- they are not destroyed through cooking. Physical objects abound in food production facilities, including plastic bits, metal fragments from equipment, staples or twist ties from ingredient packages, and personal objects (e.g., buttons, jewelry, hair, nails.)

There are three main safety precautions that can help control these hazards during all the stages of food production, from receiving ingredients to packaging your final products:

1. Avoid Cross Contamination

  • Prevent biological, chemical or physical hazards from coming into contact with foods
  • Keep equipment, utensils and work surfaces clean and sanitized.
  • Prevent raw foods (as they usually carry bacteria) from coming into contact with “Ready-to-eat” foods (foods that will not be cooked further before consuming).
  • Keep chemicals away from food areas.

2. Personal Hygiene

  • Don’t work around foods if you’re sick with fever, vomiting or diarrhea. These could be signs of contagious illness and can contaminate foods or other staff, and contribute to an outbreak.
  • Do not handle ready-to-eat foods with bare hands, but use a barrier such as utensils, tissues or gloves when handling final products such as pastries or candies.
  • Wash hands and change gloves when soiled or contaminated.
  • Wear hair restraints and clean uniforms, and remove jewelry from hands and arms.

3. Time & Temperature control

  • Prevent bacterial growth in perishable foods such as eggs, dairy, meats, chicken (TCS “Time and Temperature Control for Safety” foods according to the FDA Model Food Code) by keeping cold foods cold and hot foods hot.
  • Refrigerate TCS foods at 41˚ F or below, and cook TCS foods to proper internal temperatures to kill bacteria to safe levels, per state regulations for retail food establishments.
  • If TCS foods have been exposed to room temperature for longer than four hours (Temperature Danger Zone 41˚ F – 135˚ F,) these foods should be discarded, as bacteria could have grown to dangerous levels during this time.

As cannabis companies strive for acceptance and legalization on a federal level, adopting these food safety practices and staff training is a major step in the right direction, on par with standards maintained by the rest of the retail food industry. The only difference is your one specially extracted cannabinoid ingredient that separates you from the rest of the crowd… with safe and healthy edibles for all.

Disposable Gloves: The Unregulated Cannabis Threat

By Lynda Ronaldson
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Today in the states where medical and recreational cannabis is legal, cannabis products purchased from licensed facilities are required to have undergone testing by accredited labs. The compliance testing verifies advertised potency levels and checks for microbial contamination, herbicides, pesticides, fungicides and the presence of mold and mildew, among other potential contaminants.

Until recently, little attention has been given to disposable gloves and their possible involvement in the contamination of the products they handle.  What factors should you consider when purchasing gloves?

Disposable Gloves Facts

Disposable gloves, like cannabis products, are not made of equal quality. There are several different types of disposable gloves on the market, and huge variations in glove quality and chemical compositions exist between and within each glove type.

Recent scientific studies have revealed how gloves produced in factories with poor manufacturing standards and raw material ingredients can contaminate the products they handle. High-level toxins in disposable gloves were found to affect lab results, toxins in gloves contaminated the food they touched, and pathogen contamination of unused disposable gloves has been proven. Should the cannabis industry take more interest in the disposable gloves they are using? With so much at stake if compliance test results are compromised, we think so!

Glove Procurement: Factors to Consider

What factors should you consider when purchasing gloves?

  1. Industrial grade gloves- There is no such thing as an industrial grade glove certification, although it does give an incorrect impression that gloves are strong and resilient. Industrial grade means they have not been subjected to inspection nor have passed any specific testing requirements.
  2. Food contact gloves are certified under FDA Title 21 CFR Part 177, which states the components of the glove comply with the FDA regulations and the gloves consist of “substances generally recognized as safe for use in food or food packaging.” Few controls exist for glove manufacturing relating to the reliability of raw materials and manufacturing processes, and costs can be reduced with the use of cheap, toxic materials.
  3. Medical grade gloves have to pass a series of technical tests in order to meet the safety requirements specified by the FDA. Gloves are tested for puncture and abrasion resistance, must meet tension and elongation tests and are also tested for chemical substance resistance. Manufacturers of these gloves must receive 510k certification. As this study shows, even medical gloves can contain high levels of toxic ingredients, affecting laboratory test results.
  4. The Acceptable Quality Level (AQL) refers to a quality standard for measuring pinhole defects- the lower the AQL, the less defects the gloves have. There are no AQL requirements for food grade or industrial grade gloves, meaning there are no guidelines for the number of failures per box. Medical grade gloves must have an AQL of 2.5 or less, meaning 2.5 failed gloves per 100 gloves is an acceptable level.
  5. For Californian cannabis companies, are your disposable gloves Prop. 65 compliant? Accelerator chemicals, such as 2-Mercaptobenzothiazole (MBT) found in some nitrile gloves, have recently been added to the Prop. 65 chemicals known to cause cancer.

How Gloves Can Contaminate Products

Physical, chemical and microbiological hazards have been identified in disposable glove supply chains. Gloves of any grade are not tested for cleanliness (microbial and bioburden levels), raw material toxicity and chemical composition, or pathogen contamination.

100% of glove factories supplying the United States are based in Southeast Asia. These factories are generally self­-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance or conditions. A clear opportunity exists for accidental or intentional contamination within the glove-making process, especially to reduce costs.

In order to safeguard their customers from product contamination, a selection of tests and certifications, some of which are unique within the glove industry, are being implemented by glove supplier Eagle Protect. These tests make sure Eagle’s gloves coming into the United States are made in clean, well run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove Fingerprint testing program, consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS); surface free energy determination; in vitro cytotoxicity analysis; and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, we believe these tests are essential to further reduce risks or pathogen contamination associated with them, keeping your cannabis products safe.

Deibel Cannabis Laboratories Launches Cannabis-Specific HACCP Program

By Dr. Laurie Post
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Manufacturers of cannabis products need a program tailored to the cannabis industry that helps assure the safety of cannabis products with respect to known hazards such as pesticides, residual solvents, microbial impurities, heavy metals and mycotoxins. Deibel Cannabis Laboratories has developed a course that that will teach those manufacturing cannabis products how to manage known product safety hazards using a Hazard Analysis and Critical Control Point (HACCP) system.

HACCP has a long history of use in the food industry based on preventing potential hazards from occurring rather than reacting to issues when they arise. This program was started in the US but is globally recognized, used by food companies around the world to help produce safe products for consumers. Deibel Cannabis Laboratories applies the same prevention based system of HACCP to the creation of safe and wholesome cannabis goods whether they be edible, medicinal or topical. They also explore ways cultivators can use HACCP principles in their operation.12

Deibel Labs was founded by Dr. Robert Deibel in the 1970’s. Dr. Deibel is one of the original pioneers of HACCP, expanding the program from its original three HACCP principles to the seven principles we recognize today. Dr. Deibel developed the first “HACCP Short Course,” teaching this prevention-based program to food industry leaders in the 1970s.

According to Charles Deibel, president of Deibel Labs, this is an important step for the cannabis space. “Deibel Labs is proud to continue in our historic role as leaders in HACCP training by providing the cannabis industry with a training course developed by Deibel Labs associates who are International HACCP Alliance accredited lead instructors with years of experience in crafting and implementing HACCP plans for the food industry.”

They are launching a pilot two-day Cannabis HACCP Class to select clients at the end of January in Santa Cruz, CA. The full Cannabis HACCP course schedule for 2019 is currently in development. Accreditation by the HACCP Alliance is expected by early January, assuring that a standardized and internationally recognized training curriculum is provided by accredited instructors.

The course is forward-thinking, anticipating that sometime in the near future cannabis manufacturers will be required to control and document the safe production, handling and preparation of products according to state or even federal regulatory standards. Participants will be able to develop their own model HACCP program in an interactive group learning environment.

Attendees will:

  • Understand how Prerequisite Programs provide the foundation on which HACCP programs are built including GMPs, Sanitation and Pest Control Programs
  • Be able to identify where and how product safety problems can occur using a Hazard Analysis that considers Biological, Chemical and Physical Hazards
  • Gain the skills, knowledge, and tools necessary to develop effective Critical Controls, formulate corrective actions, conduct program verification and validation activities
  • Learn how to document activities and maintain records

Stay tuned for more information on when the 2019 course schedule is announced and how to register.

HACCP

Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 3

By Kathy Knutson, Ph.D.
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HACCP

Parts One and Two in this series have defined Good Manufacturing Practices, introduced Hazard Analysis and Critical Control Points (HACCP) and explained the first HACCP step of hazard analysis. A food safety team will typically work from a flow diagram to identify biological, chemical or physical hazards at each step of processing and packaging. Once the hazard is identified, the severity and probability are debated. Hazards with severe consequences or high probability are carried through the HACCP plan as Critical Control Points (CCPs).

Critical Control Points definedHACCP is a do-it-yourself project.

Where exactly will the hazard be controlled? CCPs are embedded within certain steps in processing and packaging where the parameters, like temperature, must be met to ensure food safety. Failure at a CCP is called a deviation from the HACCP plan. The food safety team identifies where manufacturing problems could occur that would result in a product that could cause illness or injury. Not every step is a CCP! For example, I worked with a client that had several locations for filters of a liquid stream. The filters removed food particles, suspended particulates and potentially metal. We went through a virtual exercise of removing each filter one-by-one and talking through the result on controlling the potential hazard of metal. We agreed that failure of the final filter was the CCP for catching metal, but not the other filters. It was not necessary to label each filter as a CCP, because every CCP requires monitoring and verification.

Identification of a CCP starts more documentation, documentation, documentation.

Do you wish you had more reports to write, more forms to fill out, more data to review? No. Nobody wants more work. When a CCP is identified, there is more work to do. This just makes sense. If a CCP is controlling a hazard, you want to know that the control is working. Before I launch into monitoring, I digress to validation.

CCP validationThis is where someone says, “We have always done it this way, and we have never had a problem.”

You want to know if a critical step will actually control a hazard. Will the mesh of a filter trap metal? Will the baking temperature kill pathogens? Will the level of acid stop the growth of pathogens? The US had a major peanut butter recall by Peanut Corporation of America. There were 714 Salmonella cases (individuals) across 46 states from consumption of the contaminated peanut butter. Imagine raw peanuts going into a roaster, coming out as roasted peanuts and being ground into butter. Despite the quality parameters of the peanut butter being acceptable for color and flavor, the roasting process was not validated, and Salmonella survived. Baking of pies, pasteurization of juice and canning all rely on validated cook processes for time and temperature. Validation is the scientific, technical information proving the CCP will control the hazard. Without validation, your final product may be hazardous, just like the peanut butter. This is where someone says, “We have always done it this way, and we have never had a problem.” Maybe, but you still must prove safety with validation.

The hazard analysis drives your decisions.

Starting with the identification of a hazard that requires a CCP, a company will focus on the control of the hazard. A CCP may have one or more than one parameter for control. Parameters include time, temperature, belt speed, air flow, bed depth, product flow, concentration and pH. That was not an exhaustive list, and your company may have other critical parameters. HACCP is a do-it-yourself project. Every facility is unique to its employees, equipment, ingredients and final product. The food safety team must digest all the variables related to food safety and write a HACCP plan that will control all the hazards and make a safe product.

Meeting critical limits at CCPs ensures food safety

The HACCP plan details the parameters and values required for food safety at each CCP.The HACCP plan identifies the minimum or maximum value for each parameter required for food safety. A value is just a number. Imagine a dreadful day; there are problems in production. Maybe equipment stalls and product sits. Maybe the electricity flickers and oven temperature drops. Maybe a culture in fermentation isn’t active. Poop happens. What are the values that are absolutely required for the product to be safe? They are often called critical limits. This is the difference between destroying product and selling product. The HACCP plan details the parameters and values required for food safety at each CCP. In production, the operating limits may be different based on quality characteristics or equipment performance, but the product will be safe when critical limits are met. How do you know critical limits are met?

CCPs must be monitored

Every CCP is monitored. Common tools for monitoring are thermometers, timers, flow rate meters, pH probes, and measuring of concentration. Most quality managers want production line monitoring to be automated and continuous. If samples are taken and measured at some frequency, technicians must be trained on the sampling technique, frequency, procedure for measurement and recording of data. The values from monitoring will be compared to critical limits. If the value does not reach the critical limit, the process is out of control and food safety may be compromised. The line operator or technician should be trained to know if the line can be stopped and how to segregate product under question. Depending on the hazard, the product will be evaluated for safety, rerun, released or disposed. When the process is out of control, it is called a deviation from the HACCP plan.

A deviation initiates corrective action and documentation associated with the deviation. You can google examples of corrective action forms; there is no one form required. Basically, the line operator, technician or supervisor starts the paperwork by recording everything about the deviation, evaluation of the product, fate of the product, root cause investigation, and what was done to ensure the problem will not happen again. A supervisor or manager reviews and signs off on the corrective action. The corrective action form and associated documentation should be signed off before the product is released. Sign off is an example of verification. Verification will be discussed in more detail in a future article.

My thoughts on GMPs and HACCP were shared in a webinar on May 2nd hosted by CIJ and NEHA. Please comment on this blog post below. I love feedback!