Process development of non-ionising, microbial remediation for medicinal cannabis flower

Abstract

The compact morphology and dense flower structure, makes cannabis flower more susceptible to higher microbial levels. This adds a layer of complexity in the control of biological burden during cultivation and production. Microbial contamination can result in product losses and pose significant health risks to patients, particularly to immunocompromised individuals. The study aims to evaluate if a non-ionizing microbial remediation solution for medicinal cannabis flower, can be designed based on current and potential microbial remediation technologies. A product plan for a non-ionising microbial remediation process was defined using quality function deployment. A house of quality matrix study using competitor analysis, regulatory requirements and desired characteristics, resulted in a set of weighted functional requirements. A closed-system setup with cold plasma ozone generation was selected for further planning and design. A second house of quality matrix was used to convert the identified technical and quality requirements into suitable engineering characteristics. The identified critical process parts were classified according to their criticality using failure mode effects analysis and a specification for the critical process parts was proposed. Using quality by design, critical quality attributes were defined. Through a risk assessment, the relationship between these attributes and process parameters was evaluated, establishing a control strategy for process development and validation. Ozone concentration and cycle time can have a direct effect on the microbial remediation performance. Low ozone concentration and short cycles can reduce microbial remediation efficacy, while the opposite can increase oxidation byproducts and alter the product’s phytochemical composition and physical properties. A suitable process development method and general process validation protocol were proposed. However, practical and validation data are needed to define an optimal process development and validation approach. The proposed strategy and design parameters aim to remediate microbial content to a more acceptable level rather than achieve full decontamination and must not be used to mask poor handling practices. The system provides an additional microbial remediation and control strategy to lower bioburden and enhance patient safety without significantly altering product quality.