The legalization of cannabis in Canada nearly four years ago has led to continued growth throughout the value chain. A report released just this past summer titled Cannabis in North America: Ease of Access and Format Diversity Drive Adult Use predicts value sales are expected to grow by 19% by year’s end and even double by 2025.
In turn,
Health Canada is continuing to focus on enforcing regulations that maintain both the quality and safety of the many recreational and medicinal products being made available to the public.
This is placing added pressure on manufacturers, growers, and producers of everything from dried cannabis flowers, extracts, and concentrates to vape oils, edibles, topicals and more. It’s also where guidelines such as those detailed by Health Canada and the International Council for Harmonisation (ICH) are becoming more standard in this industry.
Prior to the storage and distribution of cannabis products, analytical lab facilities need to perform several highly regulated tests to measure the potency of THC and CBD content, including microbial testing for yeast and mold and stability testing to guidelines set by the ICH. Alpha Controls & Instrumentation offers a comprehensive range of instruments from industry-leading brands such as
Kaye Instruments,
Fluke,
Rotronic,
Michell Instruments,
Burns Engineering and
Setra Systems that assist producers with these tests, including:
• Validators for calibration and mapping
• Water activity systems for moisture content
• Dry wells and oil baths for temperature verification
• Temperature and humidity sensors for HVAC Control
• Pressure monitoring for autoclaves and clean rooms
Alpha Controls also offers a suite of
validation and ISO/IEC 17025-accredited
calibration services. For example, Alpha Controls assists customers with controlling and logging of critical parameters such as temperature, humidity, moisture and light – all of which can have significant impacts on the shelf life and integrity of the finished product.
This is important as
GPP protocols set out by Health Canada dictate cannabis, and anything that will be used as an ingredient, must be stored under conditions that maintain its quality. These protocols note that cannabis and anything that will be used as an ingredient that requires refrigeration are stored at 4°C or less. Cannabis or ingredients that require freezing must be stored at -18°C or less.
Health Canada further notes that controls for temperature, humidity and light are in place and monitored using calibrated monitoring devices – including devices that activates and de-activates the system to maintain the temperature and humidity at pre-determined levels.
Alpha Controls also provides professional mapping protocols and execution of the mapping to meet customers’ GPP/GMP requirements and ICH guidelines for storage in warehouses, walk-in chambers and stability chambers, etc.
This, too, is important given that manufacturers are expected to follow certain controls and testing when storing cannabis products for any period of time – whether short- or long-term – to ensure that the quality and stability of the final product is maintained. That can range from ensuring the capacity and design of the system is adequate for the conditions of the building to installing recording devices in refrigerated and freezer storage areas that can monitor, record and control the temperature.
As background, GPP requirements in Canada dictate cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with standard operating procedures (SOPs). The SOPs need to include all steps necessary to be in compliance with GPP with a view to avoiding adverse impacts on the quality of the cannabis such as contamination.
It also includes producers needing to demonstrate compliance by providing records, for temperature and humidity generated from production, packaging, labelling, storage or testing; for temperature and humidity deviations, and to demonstrate adequate cleaning, maintenance and calibration, if applicable, for the temperature and humidity monitoring devices.
For more information,
contact us to learn how Alpha Controls & Instrumentation can assist in meeting your cannabis regulatory requirements.
