Monday, March 1, 2021

From Seed to Storage: Sources of Contamination in Cannabis

Unless cannabis is grown in a clean room with appropriate air filtration and other good laboratory practices, it is inevitable that contaminants will be found on cannabis flowers and products made with them. Many cultivators are discovering that contamination is a huge risk no matter how careful they are. The most common types of contamination are microbial but also include pesticides, heavy metals, and residual solvents. Contamination can happen during the cultivation, harvesting, drying and curing, or extraction processes. Cannabis plants and products can pick up molds or bacteria while growing (particularly if grown outdoors or in an unsanitary indoor environment) or during subsequent handling and processing. Cannabis is often exposed to contaminants when held in long-term storage. There are multiple ways cannabis can become contaminated from employees to supplies to environmental factors that are outside of your control. The best way to avoid an issue is by being aware of how cannabis can be contaminated in the first place.

  1. EMPLOYEES Handling cannabis improperly is one of the most common ways to contaminate it. Handwashing is the most basic and effective strategy to prevent cross contamination at your farm or facility. Employees should wear clean scrubs and face masks when handing the flower, especially during post-harvest processing. Gloves should also be worn and changed every time they come into contact with something other than the plant. Ensure your staff stays informed and follows best practices is ultimately the best line of defense.

  2. EQUIPMENT AND SUPPLIES There are a lot of tools that are used to grow and process cannabis, such as buckets, scales, and scissors. Make sure that there are supplies for each room and that these supplies aren’t being transferred from one area to another, which can increase the possibility of cross-contamination. Unsanitized equipment and supplies can easily cause contaminants in the form of mold, bacteria and even heavy metals from old equipment. If your machinery is contaminated with spores, you can easily cross contaminate your crop during any phase of the harvest process. This can either destroy your crop or become a major health threat if your final product is compromised. Establish equipment, surfaces and storage cleaning protocols using effective methods to eliminate pathogens.

  3. HARVEST AND POST-HARVEST A large percentage of mold begins after harvest as a result of poor air quality and high moisture levels. This situation becomes a prime time for the plant to become contaminated with mold. Mold can grow on almost any substance where moisture is present, and it reproduces by spores that can easily travel through the air with the right gust of wind and attach to your skin or plants. Extra care must be taken to ensure that–during drying and curing–temperature, humidity, and air circulation are being controlled. Later after the drying phase, you will also want to confirm that your final product is safe by testing for mold, mildew and other microbial pathogens.

  4. ENVIRONMENTAL A lot of cultivation facilities are in areas that do not have the best environments for growing cannabis. Between indoor and outdoor, each type of grow has its pros and cons. Indoor cannabis growers can potentially control the room's temperature, humidity, light intensity, and CO2 levels to achieve idyllic growth rates and conditions. The right combination of moisture, temperature, humidity, and light can help accelerate the growth of both cannabis and its pests. If contaminants or toxins enter one of your grow rooms, it may be difficult to detect and eliminate. Because fungal spores are extremely small, they can eventually get into a facility through the HVAC system. If growing indoors, you must completely sanitize your space to kill all microbes before you start. While this will prevent most issues, unfortunately traditional cleaning methods may not prevent all airborne spores that exist in small cracks, for example. You must also make sure there is always proper ventilation.

    Growing cannabis outdoors is the most natural and least expensive way. Plants grown outdoors with natural sunlight will grow to their full genetic potential and will have a full and natural terpene profile. Much less energy is required (no lights, no cooling/heating) and nutrients can be regenerated and recycled. However, plants grown outdoors are exposed to all of the elements, all the time. This includes the environment, weather, pests and animals, which can have a very big effect on the final product. For growing outdoors, it is common for cannabis producers to use pesticides and insecticides on their plants. Unfortunately, these pesticides can go on to create issues themselves if they are not thoroughly removed from the plant matter during processing as many fungicides and insecticides can be harmful to human health. Although pesticides are one way to control contamination, they’re not a perfect solution, and every state treats them differently.

As the legalization and medicinal utilization of cannabis increases around the world, so does the potential threat of contaminants making their way to consumers. Policing the quality and safety of cannabis products is far from straightforward. At the federal level in the United States, cannabis is still considered an illegal drug, so states have to determine on their own how to protect millions of cannabis users. The result is an uncertain and occasionally incoherent regulatory landscape with no consensus. Cannabis cultivators are familiar with the challenges faced as contaminants pose a potential threat to their consumers. By learning about the sources of contamination as well as prevention and remediation options, growers can more confidently face testing and consistently provide a safe product.

For further reading on this topic and references, read the Common Sources of Contamination in Cannabis Application Note. Visit the Cannabis Applications page to learn more about the benefits of utilizing chlorine dioxide gas and ultraviolet light for microbial decontamination and mold remediation.

Monday, February 22, 2021

FDA-Approved Contract Sterilization of Medical Devices

ClorDiSys Solutions, Inc is recently approved by the United States Food and Drug Administration (FDA) for contract sterilization of medical devices using our chlorine dioxide gas process (registration # 3013115071).  The ability for chlorine dioxide gas sterilization to be used in such a way is a tremendous advancement for the industry.  Ethylene oxide (EtO) has typically been the industry standard for medical device sterilization, especially in terms of contract sterilization.  However, for years, there has been a concern over EtO’s harmful environmental and health impact, as well as its overall volatility that prevents certain items like embedded batteries to be decontaminated.  In fact, in 2019, EtO contract sterilizer firms in Illinois were shut down over health concerns due to harmful emissions, an issue that rose in magnitude after five women claimed that working at the plant led to their cancer diagnosis.  Although these plants are dangerous, officials warned that shutting them down could lead to medical device shortages.  This dilemma stresses the need for alternative medical device sterilization options to become more prevalent in the industry.  Chlorine dioxide gas is a direct replacement for EtO, without the negative aspects that ethylene oxide is known to have.  Chlorine dioxide is a non-carcinogenic residue free gas that is a registered sterilant by the United States Environmental Protection Agency (EPA).  Its non-explosive behavior allows for items with sensitive components, such as embedded batteries, to be safely and effectively sterilized.  With no need for capital expense or additional in-house labor, contract sterilization services from ClorDiSys provide an affordable option for medical device manufacturers.  The devices can be initially sent to ClorDiSys so a cycle can be validated, and any necessary regulatory actions can be pursued.  Then, on an as needed or pre-scheduled basis, the device manufacturer can ship items for sterilization following their customized protocol.  Overall, contract sterilization provides a low-risk and low-cost option that ensures effective results with greater ease and peace of mind.

Learn more about ClorDiSys Contract Sterilization services here

Contact us for more information on any of the listed applications or to explore additional applications not listed. Specific testing with your device is always recommended.

Monday, February 15, 2021

What is Contract Sterilization?

ClorDiSys Solutions has decades of microbial remediation expertise and offers Contract Sterilization Services to a wide variety of industries. There are two basic types. One is where we sterilize FDA regulated 510K Medical Devices in our FDA registered facility. If you’re interested in learning more about that, please come back for next week’s blog where we discuss that topic. The other is when we decontaminate your devices, equipment, supplies, and products at our facility, then ship them back to you or onward to a third party like a customer. ClorDiSys utilizes chlorine dioxide gas for sterilization instead of other commonly used gamma irradiation, ethylene oxide gas, steam, or electron beam methods. Our chlorine dioxide gas is a US EPA registered sterilant capable of killing all viruses, bacteria, fungi, and spores. It is also effective against beta lactams such as Penicillins, Cephalosporins, and Carbapenums as well as amplicons and pinworm eggs. 

When outsourcing sterilization of components, supplies, medical devices, and equipment, consider your current needs as well as plans for future growth. The outsourcing of sterilization provides convenience, efficiency, and initial cost savings (dependent on size and frequency). ClorDiSys decontaminates a wide assortment of products within the multiple decontamination chambers at our New Jersey facility to fit whatever size items required. Customers can choose to single or double wrap items in Tyvek and may include biological indicators as well. Biological Indicators (BIs) are used to challenge the efficacy of a decontamination/sterilization cycle. Turnaround time is traditionally 24 hours, with items typically being shipped back the day after they arrive. In some cases, turnaround time can be hours, with the items arriving, being treated, and shipped on the same day. Upon completion, you will be issued a Contract Decontamination Certification Sheet describing the process and showing the sterilization cycle data.

Learn more about ClorDiSys Solutions’ Contract Sterilization Services here, and contact us for a free consultation.

Monday, January 25, 2021

How One Hospital Uses UV-C Light for Highly Effective Disinfection of Critical Areas

Hospital acquired infections (HAIs) and dangerous pathogenic contamination in the healthcare industry is a constant and prevalent problem. Now, add the ongoing COVID-19 pandemic to the mix of infection prevention and contamination control concerns, and hospitals have a lot to manage daily. Watch how New Jersey's leading academic health system is utilizing a variety of ultraviolet light products for the disinfection of their facilities' most critical areas and equipment.

Ultraviolet light products featured in the video (in order of appearance):

Flashbar Mounted UV-C Light Fixture

Torch+ UV-C Disinfection Tower

Torch UV-C Disinfection Tower

Lantern Portable UV-C Generator

Flashbox UV-C Disinfection Chamber

Thursday, January 14, 2021

Case Study: Decontamination prior to Renovation

In the pharmaceutical and medical device industry, contamination control and sterility are crucial components to maintaining the highest level of quality products expected of companies in these fields. ClorDiSys Solutions’ chlorine dioxide decontamination services have successfully treated many pharmaceutical facilities over the past 20 years, eliminating viruses, bacteria, molds, and beta lactams. New facilities, as well as buildings undergoing renovation, have been decontaminated to establish sterility prior to production starting up as well. One pharmaceutical company required our services to decontaminate five separate animal holding rooms and lab spaces (totaling approximately 25,000 cubic feet) prior to renovation. Our service technicians needed to gas each room individually, because we were unable to shut down the HVAC system. We used bubble tight dampers to isolate each room from the HVAC system. The decontamination took place with all process parameters being met to achieve the targeted 6-log sporicidal reduction in all rooms. The biological indicators were negative for growth after 36 hours of incubation, capping off a successful decontamination.

ClorDiSys Solutions offers many chlorine dioxide-based decontamination products and services to preserve pharmaceutical companies’ product integrity and trust. If you would like to learn more about how to establish the scope of a project or our decontamination services in general, please contact us at sales@clordisys.com or complete this form.