Cannabis Needs Supplier Quality Agreements

Consumers often assume the product they are buying is, for all intents and purposes, what is labeled or described on the packaging. They make the purchase without second thought on what is being purchased. It is usually a fair assumption, and due to the innocuous nature of most products, the buyer is not out anything more than The time and frustration of sending the product back to the purchasing location. Consumer goods generally come with a guarantee to ensure that the consumer can will be satisfied with the product, or the manufacturer with replace or refund the product at their own expense. That is all well and good for the consumer, but what about business to business transaction where the buyer is another business?

In these cases the buyer would be out more than just time and frustration as the product purchased could cause a loss of income if the product is an ingredient for the buyer’s product line. For example, a nutrient supplier mixing up product lines and cannabis cultivator applying a feeding cycle of micro nutrients while assuming low concentration and subsequently burning up the entire crop. In this case there would be lost revenue due to loss of plants and lost time spent to this stage of growth, All of which must be restarted – both time and money lost.

In the worst case, a consumer of cannabis products like vape cartridges or tinctures is harmed from unsterilized containers due to poor handling practices or sterilization techniques. This would cause patients or consumers to shy away from the manufacturer all together. In these cases, the brand is harmed and those losses are hard to quantify. However, irreparable damage can be assured. So how do businesses protect themselves when buying from another manufacturer? How do these companies ensure that what they are buying is what they are getting? After all, the livelihood of their products and overall brand of their company is at stake.

Supplier Quality Agreements and vendor audits make these assurances so that business to business transaction are protected by more than just a replacement or refund. A supplier quality agreement is a contract between a supplier and a buyer for specific products that are being purchased. This contract details all aspects of the purchase, such as packaging quantities and labeling of the product and its contents, to the specifications that each shipment or lot of product must meet for the product to be accepted by the buyer. The agreement spells out the testing requirements and reporting of data that the buyer receives each time a purchase is made for a quantity of product. This ensures that each order must meet the specifications set by the buyer, and not the assumed quality of the manufacturer.

What sets these agreements apart from the normal consumer “guarantee” is the fact that these contracts can hold the manufacturer liable for defective product that is purchased and lost revenue due to the poor quality of the product. Supplier quality agreements protect the company’s best interests and transfer a part of the risk from the buyer to the supplier. It is worth noting that having a means of verifying the testing results is a best practice. This is a sure fire way to eliminate all doubts about the contents of the product.

At the end of the day, supplier quality agreements will allow the cannabis industry to concentrate on what they do best. The company is protected from losses in revenue and time spend while the consumer focus of health and safety is maintained. Let the trusted quality professionals at Orion help you navigate the complexities of supplier quality agreements so that you can spend less time worrying about your supplier and more time on your final products. Contact us today at Orion GMP Solutions or by email at info@oriongmp.com to get started on your supplier agreements.

Oregon Cannabis Quality Gets A Boost

Starting August 30, 2017, every batch of usable marijuana must be tested directly for pesticides according to the Oregon Health Authority’s testing rules in order to be compliant. This includes product that was sampled prior to August 30.

The state of Oregon is continuing to lead in terms of standardizing quality in the cannabis industry. As of August 30th, cannabis cultivators and producers test and qualify 100% of batches going to dispensaries from an ORELAP (Oregon Laboratory Accreditation Program) accredited testing laboratory. These labs undergo a biennial review from the state to ensure that the laboratory has procedures in place that adhere to internationally recognized standards.

Raw flower and concentrates including edibles must pass testing for pesticides, water activity and moisture content, potency of cannabinoid compounds, and microbiological contamination. Oregon Health Authority has created an overview of the testing and reporting requirements.

Before the mandate was in place, only 30% of batches required testing before approval to be sold in local dispensaries. In a bulletin published this week, cannabis organizations will be required to test all harvest and production batches of cannabis before going to market.

Initially, the reduced testing requirements were the consequence of a limited number of accredited testing laboratories. Currently, for a lab to be certified to test cannabis or its products it needed to be accredited by the ORELAB and licensed by the OLCC. The number of labs has increased from 5 to 10 since the initial requirements.

Since last year, there have been 3 instances of recalls in the state of Oregon. Two recalls were initiated by the Oregon Health Authority and 1 by the Oregon Liquor Control Commission. In our article, The Downfall of a Recall, we identified how all of these instances could be avoided with the proper quality systems in place.

The increase in inspections definitely has the patients and consumers best interests at heart but these inspections are simply filtering out the defective products. Quality can never be inspected into a product, rather it must be inherently incorporating into the production process. Oregon and the rest of the country must continue to push for standardization of the industry and regulation for the manufacture of cannabis and cannabis products.

To learn more about quality by design and creating processes that bring inherent quality to your products contact us at info@oriongmp.com or visit our website for more information.

Cannabis Testing Laboratory Guidelines

This might not sound savory to the manufacturing side, but often, there is high variation in the manufacturer’s product.

HempHacker and Orion GMP Solutions firmly believe that testing for product quality is useless when we are talking about GMP Cannabis. It must first be engineered into the product – Quality by Design, to be specific. Testing laboratories serve an important function in the industry. They have many different sample types, and their work must be both accurate and precise.

With multiple sample types (e.g edibles, raw flowers, solid and liquid extracts, and infused beverages), the analytical chemists of the cannabis industry have their work cut out for them. In GMP Cannabis Manufacturing, all the testing is done in-house. This is called in-process testing. In-process testings is an activity that measures your product’s quality attributes as it is being processed.

Several important points come up in these guidelines. When to test. What to test. How to test. These are the essential activities in a GMP Cannabis Testing Facility. In the Cannabis Industry 2.0 (i.e. GMP Cannabis), all laboratory testing will be done in-house, and it will not be hindered by restrictive legislation. Validated and repeatable test methods are mandatory for the analytical laboratory to provide consistent results. This is an important point, should be considered by every cannabis manufacturer.

This might not sound savory to the manufacturing side, but often, there is high variation in the manufacturer’s product. Think about it – how many different structures are there on the plant; how many different light angles are hitting those different structures, how many different samples were taken from the plant… There is a lot to think about, and those are only a few variables.

Take a look at this 36 page PDF developed for New Mexico Cannabis Testing Facilities. It describes everything you would ever want to know about a testing facility down to how they should document their work, to how they actually do their work.

While these guidelines do not explain all aspects of a GMP Cannabis In-Process Testing Laboratory, they do describe the activities well.

Validating SOPs for GMP Cannabis

The objective of validating a procedure is to demonstrate that the procedure is suitable for its intended purpose. This extends to all SOPs. They must be validated to prove that they accomplish their purpose. There are many different processes that can be validated in pharmaceutical operations. Some examples include, but are not limited to, process chemistry, analytical testing, lab facilities, cleaning, equipment, packaging, etc.

For the sake simplicity, this article will cover validation of analytical methods. Method development and validation are all about setting specifications and making sure that the method can reliably achieve those standards. The specifications are discovered during method development, where an analyst works by trial and error to find the right conditions, that are described by example below. It is a tedious process, but once the proper method for analysis is established (i.e. the right column, the right flow rates, the right wavelength, and right temperatures), you have data that should show a reproducible method. From there, it’s a matter of setting the amount of variance that is tolerable to still accomplish the method (i.e. validation parameters).

Analytical method development is the time when the robustness of a method is established. Robust in this sense, means that you can change parameters of the method without seeing variation in the results – that is, despite conditions being less than optimal, you still get good results. Validation checks the variation in methods – you must get the same results for a given method within a specified percentage or relative standard deviation. If a method has been proven to be robust, it has a much greater chance of passing validation (being within the specified variance).

There are three major types of analytical methods: identity tests, assays, and impurity tests. An identity test proves that a certain molecule is present in a sample. An assay shows how much of a molecule is present in a sample. An impurity test shows how much of the sample has degraded or the relative quantities of impurities present in a sample. There are 6 major parameters tested in the validation of analytical methods: accuracy, precision, specificity, detection limits, quantification limits, and range.

Validation parameters require qualified reference standards. Ideally they will be from a third party, manufactured in an ISO environment that ensures the purity. The qualified reference standards are how meaningful comparisons are made to assess each parameter.

accuracy – how close to the target value the method reliably achieves
precision – how close each measurement is to the other measurements in a series of measurements
specificity – identification of the exact molecule that’s being tested – i.e. the method can discriminate between molecules similar to the target molecule.
detection limit – the smallest quantity of a molecule that can be detected
quantification limit – the smallest quantity of a molecule that can be reliably quantified
range – the smallest and largest amount of a molecule that can be reliably quantified in an analytical test

Details of the method should be clearly listed and explained in the validation report. They are important because they clearly lay out the conditions to execute a given method. Here are a few examples of method conditions:

Description of the method – e.g. HPLC
Type of chromatography column – e.g. C18 Reverse Phase HPLC Column
Flow rate and method durations – e.g. 1mL/min – 20 min runtime
Detection Wavelength – e.g. 210nm
Column Temperature – e.g. 30C

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

Dehydrate your butane to improve Live Resin yields

Water kills butane hash oil yields

Butane picks up water during extractions and causes lower yields.

Butane picks up 3.25mL of water per liter and propane picks up 3.9mL of water per liter. To put it simply, water in butane and propane takes up space that prevents cannabinoids and terpenes from being fully extracted. That’s a problem.

How does water contaminate extractions?

Water contaminates extractions because of its effects on solubility – water in your butane and propane decreases the potential solubility of cannabinoids and terpenes, but it also picks up water soluble contaminants like plant chlorophyll, alkaloids, and flavonoids. If you’re looking for the simplest solution, just dehydrate your butane/propane. If you’re looking for perfection, purge your extractor with CO2.

Improve yields in 2 simple steps.

It’s all about the chemistry of inert conditions/reactions. There are two simple steps for high quality live resin extractions: 1. dehydrate your solvents; 2. purge your live plant materials and extractor with a dry gas like CO2. Putting together the steps of dehydrating your butane and purging your extractor will most certainly increase your yields, but it also functions to reduce contamination.

Dehydrating butane and propane is the most important step to improve yields in live resin and regular extractions.

Dehydrating your solvents is as easy as packing your extraction column with a substance such as 3A molecular sieves or activated alumina. Molecular sieves and activated alumina are used to dehydrate butane/propane in the gas phase – ie you do not pass liquid butane/propane through a column packed with these desiccants.

3A Molecular sieves are widely employed in the lab setting, where they’re used to dry solvents or keep solvents dried in the first place – they can hold up to 19-20% of their water weight. Molecular sieves are also FDA Approved for direct contact with consumable products. Activated alumina has a higher water capacity. It’s used in number of industrial drying applications for hydrocarbons, but there isn’t sufficient data proving its safety beyond “Satisfactory” compatibility with butane and propane.

Check out the post about recovery pump setup and see how to set up a system that will effectively dehydrate your butane and propane.

Desiccant math made easy.

You need to do little math to figure out how much space your molecular sieves will take up, and to figure out how many grams of molecular sieves you need. Molecular sieves cost approximately $100/500g, but they are nearly infinitely reusable. You can regenerate or dehydrate them by heating them up in a vacuum oven and pulling full vacuum. Here’s the math:

Most extraction artists use US pounds to measure their butane, so we have to do a few conversions. Let’s say you have 12 pounds of butane. You need to convert it to kilograms, so you can take into account the density of butane (assume 1bar/14.5psi and 20C/67F); you use the density to convert the mass (i.e. weight) of the butane into a volume (liters). Now you can multiply the number of liters by the water:butane conversion factor to determine the amount of water that the 12 pounds of butane can hold. Finally, multiply the amount of water in your butane by the water capacity of the molecular sieves. This shows you minimum number of milliliters or grams of molecular sieves you need to dehydrate your butane. That said, 675mL of molecular sieves weighs approximately 1000g. Buy two 500g containers and you’re home free.

Conclusion.

Dehydrating your butane is a step forward in improving your extractions. Not only does water in butane decrease extraction efficiency, but it also causes increases the extraction of plant contaminants like chlorophyll, alkaloids, and flavonoids. If you’re looking for perfection, you’re going to run your extractor like an organic chemist synthesizing a compound under inert conditions. You’re drying off all the water from the extractor walls with a hot air gun, then you’re pumping out the water trapped in the atmosphere by pulling a full vacuum. These steps make for a higher quality and more consistent product.

Resources:

Thermodynamic properties of butane and propane:

Activated alumina:

http://www.amazon.com/Activated-Alumina-Dessicant-Pellets-16in/dp/B009GA2EAO/ref=sr_1_5?ie=UTF8&qid=1441824106&sr=8-5&keywords=activated+alumina

Molecular sieves:

http://www.amazon.com/Millipore-MX1583D-1-Molecular-Sieve-Bottle/dp/B00ECL8B0Y/ref=sr_1_4?ie=UTF8&qid=1441825791&sr=8-4&keywords=3a+molecular+sieve

As always, if you have any questions please post them in the comments section. Your questions and time are valuable and we will make every attempt to help you through your process.