Once the facility validation requirements have been met, processes within the facility can be validated. Process Validation is the next step in generating accurate laboratory data. Below are a handful of processes that have been validated in Botanacor’s laboratory.
Once hemp products enter the laboratory, they’re exposed to different instruments, utensils, and glassware throughout the testing. Residue from samples can remain within the glassware and carry over into the next sample that comes in contact with the glassware if not cleaned properly, thereby influencing the results. To resolve this potential issue, each executed glassware washer cycle and load pattern is validated. Only the validated cycles using validated load patterns are used.
Our proprietary database used to process samples and calculate results has been validated to ensure accuracy. Every data input, every calculation, every reported result, every transaction from input of the sample and customer information to the reported result is challenged through a rigorous validation to ensure the integrity of the data from start to finish.
Did the product get from Point A to Point B safely, securely, and without compromising the integrity of the product? Transportation of hemp products using validated procedures ensures the product isn’t negatively impacted and preserves the efficacy of the products. Our transportation sample containers are autoclaved (using validated sterilization cycles with a validated autoclave) prior to transportation to ensure sterility.
Samples are transported using a proprietary transportation system capable of holding temperatures below 8°C for the period from the time it leaves the customer site to the time it arrives at Botanacor’s site in a secure container. Once at our facility, samples are processed into our validated database and placed into our validated refrigerators for storage until testing is executed.