Microbial Impurity Testing
The same conditions that are ideal for the cultivation of cannabis can also be ideal for the proliferation of microorganisms such as bacteria, fungi, and yeast. If cannabis and cannabis products are not properly screened, they can be contaminated with a variety of harmful pathogens and for many patients. Ingesting contaminated cannabis or cannabis products can lead to serious illness, health complications or accelerated degradation of the material. To address this issue, SC Labs offers reliable microbial testing with Real-Time Polymerase Chain-Reaction (qPCR) technology and 3M Petrifilm.
Real-Time Polymerase Chain-Reaction (qPCR)
qPCR utilizes the natural mechanisms of genetic amplification and engineered fluorescent probes to detect and identify specific species. The combination of excellent sensitivity and precise specificity enables qPCR technology to be the future of DNA-based testing methods and screening for microbial impurities. DNA probes are designed to bind to the 16s RNA region which is unique to particular species. When this binding occurs, a fluorescent molecule is cleaved from the probe, and the fluorescence is detected with calibrated instrumentation. The intensity of fluorescence, measured in refractory units (RFU), is captured by the instrumentation and displayed on an x,y graph.
SC Labs’ qPCR assay has been successfully validated against performance requirements set forth by the Bureau of Cannabis Control, Title 16 California Code of Regulations, § 5713 Validation of Test Methods for microbial analysis of samples and the US Food and Drug Administration Guidelines for the Validation of Analytical Methods for the Detection of Microbial Pathogens in Foods and Feeds, 2nd Edition, April 2015, Single Laboratory Validation for a Qualitative Detection Emergency Use method guidelines for the detection of Shiga-toxin producing E. coli (STEC), Salmonella species, Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger and Aspergillus terreus.
3M Petriﬁlm plates are ISO 9002 certiﬁed for design and manufacturing, and they are included in the official methods of analysis of AOAC International1. They are also recognized in the United States by the American Public Health Association; the USDA Agricultural Marketing, Food Safety and Inspection Service; and the US Food and Drug Administration.
Petrifilms have a ready-made culture medium that contains a cold-water-soluble gelling agent, nutrients, indicator dye, and a built-in grid to provide contrast and help facilitate counting colony forming units (CFU) per gram of sample. Plating is a quality indicator and cannot always discern harmful pathogens from beneficial or benign organisms. Certain colonies can be isolated and identified using qPCR.
SC Labs readily offers plating services with the following 3M Petrifilm products: Rapid Yeast and Mold Count Plates, E. coli/Coliform Count Plates, and Aerobic Count Plate. Additionally, we can provide plating services with other 3M Petrifilm products, such as Enterobacteriaceae and Environmental Listeria, among others.
Environmental swabs are a tool to screen facilities and identify sources of contamination. A variety of different surfaces can be swabbed—table tops, vents and ventilation systems, fans, manufacturing equipment, etc. Each individual swab is in a self-contained tube that can be reliably resealed. The swabs are pre-moistened with a neutralizing buffer to ensure microbial organisms maintain viability during transport.
SC Labs can provide assistance with instructions on how to map, track, and swab facilities. Swabbing not only provides peace of mind before investing production resources, it pinpoints high-risk areas and sources of contamination.