Technical Reference
Glossary
Technical terminology for cannabis sterilization, process control, and regulatory compliance.
21 CFR Part 58
The U.S. FDA regulation governing Good Laboratory Practice (GLP) for nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.
Aspergillus
A genus of filamentous fungi commonly found in soil, decaying vegetation, and organic matter. Several Aspergillus species are regulated contaminants in cannabis testing, as they can produce mycotoxins and cause aspergillosis in immunocompromised individuals.
BBI / Biological Indicator
A standardized preparation of bacterial spores used to verify the lethality of a sterilization process. Biological indicators provide direct evidence of microbial kill by demonstrating that organisms with known resistance to the sterilization method have been inactivated.
Biomass sterilization
The process of eliminating viable microorganisms from bulk plant material, including cannabis flower, trim, and other botanical matter. Distinguished from surface decontamination by its penetrative action throughout the material matrix.
CFU/g (Colony-Forming Units per gram)
A quantitative measure of viable microbial contamination expressed as the number of colony-forming units per gram of sample material. CFU/g is the standard unit for reporting microbial load in cannabis testing and regulatory compliance.
Colony-forming unit
A unit of measurement representing a single viable microorganism or cluster of microorganisms capable of producing a visible colony when cultured on appropriate growth media under defined conditions.
Disposition (product loss event)
In cannabis quality control, the regulatory outcome determination for a product lot that fails microbial or other compliance testing. Disposition may result in remediation, reclassification, or destruction depending on jurisdiction and contamination type.
GLP (Good Laboratory Practice)
A quality system of management controls and documentation requirements for non-clinical laboratory studies intended to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of test data. Defined in the U.S. by 21 CFR Part 58.
GMP (Good Manufacturing Practice)
A system of regulations, codes, and guidelines for the manufacture of drugs, medical devices, and certain foods that ensures products are consistently produced and controlled according to quality standards. GMP compliance is increasingly required for cannabis operations targeting pharmaceutical pathways.
H₂O₂ decomposition
The chemical breakdown of hydrogen peroxide (H₂O₂) into water (H₂O) and oxygen (O₂). This decomposition is complete and irreversible, leaving no chemical residuals—the fundamental reason VHP sterilization produces zero residue on processed materials.
In-process control
Checks and measurements performed during manufacturing or processing operations to monitor and, if necessary, adjust the process to ensure the product conforms to specifications. In VHP sterilization, in-process controls include temperature, pressure, concentration, and exposure time monitoring.
IQ/OQ validation
The combined Installation Qualification and Operational Qualification process that documents a system is correctly installed, configured to specification, and operates consistently within defined parameters before being placed into production use.
IQ/OQ/PQ (Installation/Operational/Performance Qualification)
A three-stage validation framework used in pharmaceutical and regulated manufacturing. Installation Qualification (IQ) verifies equipment is installed correctly; Operational Qualification (OQ) confirms it operates within specified parameters; Performance Qualification (PQ) demonstrates consistent performance under actual production conditions.
ISO 10993-11
An international standard specifying test methods for evaluating systemic toxicity of medical devices and their constituent materials. Part of the ISO 10993 series on biological evaluation of medical devices, this standard addresses tests for systemic toxicological effects.
ISO 22441
The international standard (ISO 22441:2022) governing low-temperature vaporized hydrogen peroxide sterilization of medical devices. In January 2024, the FDA designated ISO 22441 as the recognized consensus standard for VHP sterilization, establishing it as an Established Category A method.
Kill-step
A validated processing step designed to eliminate or reduce microbial populations to acceptable levels. In cannabis processing, the kill-step is the critical control point where microbial remediation occurs, requiring documented parameters and verification.
Log reduction
A mathematical expression of microbial population reduction where each log represents a 90% decrease. A 1-log reduction equals 90% kill; 3-log equals 99.9% kill; 6-log equals 99.9999% kill. Log reduction provides a standardized method for comparing sterilization efficacy across different methods and conditions.
Microbial remediation
The process of reducing microbial contamination in cannabis or other materials to levels that meet regulatory compliance thresholds. Remediation differs from sterilization in that it targets specific reduction levels rather than complete elimination of all viable organisms.
MSO (Multi-State Operator)
A cannabis company that holds licenses and operates in multiple U.S. states. MSOs face unique compliance challenges as they must navigate varying state regulations while maintaining consistent quality and safety standards across jurisdictions.
Non-ionizing sterilization
Sterilization methods that achieve microbial inactivation without using ionizing radiation (gamma rays, X-rays, or electron beams). VHP sterilization is a non-ionizing method that preserves material chemistry by avoiding the molecular bond disruption associated with ionizing energy.
Post-harvest purification
Processing steps applied to cannabis after harvest to reduce microbial load and ensure compliance with regulatory standards. Post-harvest purification addresses contamination that occurs during cultivation, drying, curing, or handling.
Reactive Oxygen (rO)
The trademarked designation for BoxPurify's proprietary VHP-based sterilization chemistry. Reactive Oxygen® refers to the controlled, system-mediated oxidative activity within TheBOX® chamber—not uncontrolled reactive oxygen species or free-radical chemistry.
Reactive Oxygen®
BoxPurify's registered trademark for the proprietary reagent and process framework integrated within TheBOX® sterilization system. Reactive Oxygen® describes controlled vapor-phase hydrogen peroxide delivery under extreme vacuum conditions, achieving microbial elimination while preserving material integrity.
rO indicator strip
A chemical indicator used within TheBOX® system to provide visual confirmation that Reactive Oxygen® vapor has reached all areas of the sterilization chamber during a processing cycle. Indicator strips support process verification alongside biological indicators.
Schedule III cannabis
The proposed U.S. Drug Enforcement Administration reclassification of cannabis from Schedule I to Schedule III under the Controlled Substances Act. Schedule III classification would acknowledge accepted medical use and enable cannabis products to enter FDA-regulated pharmaceutical pathways.
SGS Galson
An ISO/IEC 17025 accredited laboratory providing industrial hygiene and environmental monitoring services. SGS Galson has conducted independent third-party environmental safety validation studies for TheBOX® system operations.
TheBOX®
BoxPurify's registered trademark for its VHP-based cannabis sterilization system. TheBOX® delivers Reactive Oxygen® under extreme vacuum conditions, achieving documented microbial reduction while preserving terpene, cannabinoid, and moisture profiles in processed material.
Vapor-phase oxidant
A gaseous or vaporized chemical agent that achieves antimicrobial action through oxidation. In VHP sterilization, hydrogen peroxide vapor acts as the vapor-phase oxidant, diffusing throughout the material matrix under vacuum conditions to contact and inactivate microorganisms.
VHP (Vaporized Hydrogen Peroxide)
A low-temperature sterilization method in which hydrogen peroxide is converted to vapor and delivered under controlled conditions to achieve microbial inactivation. VHP is an FDA-designated Established Category A sterilization method with ISO 22441:2022 as its recognized consensus standard.
WuXi AppTec
A global pharmaceutical and medical device open-access capability and technology platform company providing research, development, and manufacturing services. WuXi AppTec laboratories have conducted biocompatibility and safety testing relevant to VHP sterilization applications.
Process Control for Regulated Cannabis Operations