The final internship of my program (HRB 790) involved working with the Quality Control Manager to conduct microbial testing of MUIH manufactured botanicals. The purpose of this internship was to create a repeatable and cost-effective method for aseptic botanical testing outside of a formal laboratory. This method would provide a low-cost testing option that would allow small scale herbal businesses and manufacturers to meet part of the requirements for Good Manufacturing Processes (GMP) compliance without significant financial hardship.
The internship work involved several different components. First, was reviewing and updating the documentation from previous internships to ensure completeness and applicability. This process began at home where I modified the material to make it relevant to the tinctures being tested. During the time at the Dispensary doing the actual testing, the SOPs and documents had to be examined and re-examined, with feedback and lessons learned incorporated into the final product.
The next component of the internship was the specimen inoculation in the MUIH Dispensary. The inoculation required following the steps outlined in the revised SOP with careful attention to detail to ensure an aseptic environment. Carrying out the botanical testing according to the procedures required a degree of skill, training, and competency that I was able to leverage from previous trimesters’ work in botanical testing. I found myself prepared for the procedures involved, particularly with the measuring of ingredients and using the pipettes according to aseptic techniques.
The inoculation itself required measuring out exact dilutions of the tinctures, keeping all the materials well organized, and ensuring exact and accurate application of the inoculation solution. The materials were then taken home and observed over several days before they were analyzed for microbial growth.
The results of the testing were part of the research poster presented at the 2019 MUIH Research Symposium. See below.
The final part of the internship involved creating Certificates of Analysis (CoA) for the botanical extracts that were tested. These CoAs are an important step towards GMP Compliance, which is legally required in many states and at the federal level, depending on the product and institution. GMPs are often cost prohibitive for small businesses and manufacturers. This experience taught me the procedural and administrative steps necessary for testing documentation. Below is an example of one of the CoAs I completed.