Our Science Team completed an extensive manufacturer’s validation, demonstrating our method for purifying DNA and detecting microbial contamination on cannabis flower, concentrates, and infused products meets the validation pillars of accuracy, precision, specificity, linearity and limit of detection.
Essentially the document proves:
- The SenSATIVAx® Plant/Microbial DNA Purification Kit can accurately and consistently purify plant and microbial DNA present on cannabis flower samples.
- The SenSATIVAx® Marijuana Infused Product (MIP)/Extract DNA Purification Kit can accurately and consistently purify microbial DNA present on cannabis-infused products and cannabis extracts.
- The PathoSEEK® Microbial Safety Testing Solution can precisely detect and quantify the DNA of specific microbial targets present in samples purified with the SenSATIVAx kits.
All the experiments described in the 50+ page document were conducted in the Medicinal Genomics (MGC) laboratory, as well as several Independent Cannabis Testing Labs in Massachusetts. Several experiments used live pathogenic microbes and were conducted in Medicinal Genomics’ BioSafety Level 2 Laboratory.
The Only Document of its Kind
The SenSATIVAx® and PathoSEEK® Manufacturer Validation Document sets Medicinal Genomics products apart from all other DNA purification and microbial detection methods in the cannabis testing market. No other microbial detection platform manufacturer has completed such a comprehensive and robust validation of the following cannabis matrices:
- Cannabis-infused gummy
- Cannabis-infused chocolate
- Cannabis-infused candy
- Cannabis-infused oil
- Cannabis tincture
- Cannabis wax
- Cannabis shatter
This document is another example of MGC applying world-class operations and continuous process improvement to deliver premier customer service. MGC’s quality system, which governs our business operations, is intended to meet the requirements set forth directly in ISO9001 and ISO13485 standards. It is a requirement of the system that all employees adhere to the spirit and intent of the quality policy.
A Template for Cannabis Testing Labs
The experiments in the SenSATIVAx® and PathoSEEK® Manufacturer Validation Document were designed to satisfy the validation requirements cannabis testing laboratories must meet. Cannabis testing labs can use the SenSATIVAx® and PathoSEEK® Manufacturer Validation Document to design their own validation experiments and verify their results.