Over the past few years we have observed an exponential growth in the number of state-level, legal businesses (in the USA) who offer Cannabis Analysis (e.g. Potency Analysis or Profiles) and/or related businesses such as Hemp Oil Extraction. Most related products which incorporate Marijuana, CBD, THC, Cannabinoids, Terpenes and/or other related compounds require formal analytical laboratory testing which should follow good laboratory practices. This
article is targeted to help many of the people involved in this new analysis
business (or anyone using chromatography as the analytical technique of
choice for the same goals).
As a professional chromatography consultant, I have seen a large increase in the number of requests for my services to this new market. Most of these new businesses have questions about obtaining professional training, correct analysis procedures, improving reproducibility, documentation, optimizing method development, how to receive professional training in maintenance of the HPLC system(s) and need hands-on help to optimize the procedures used. Many users are not achieving acceptable results and need help finding out why. They want to know where they can take a class to learn HPLC method development and how to perform the required tests.
These new businesses would benefit greatly from professional guidance EARLY in their setup and establishment, to improve the internal methods and procedures of analysis used. Time spent on the "front-end" of any process is always time spent wisely (in this context, knowledge and practical experience = confidence). A chromatography professional can quickly identify areas which may need improvement and/or suggest changes that can directly improve your company's accuracy, reproducibility, increase efficiency and of course, impact your bottom-line too. Focus is placed on the exact areas that will benefit you (rather than wasting time with non-targeted approaches, sales biased classes and trial-and-error approaches).
- Please note that there are NO SCIENTIFICALLY LEGITIMATE ONE DAY, ONE WEEK or ONE MONTH LONG TRAINING CLASSES THAT CAN TEACH YOU HOW TO PERFORM HPLC METHOD DEVELOPMENT or ANALYSIS. NONE AT ALL. Most types of "Certification" offered are completely without scientific merit or value. The training needed takes many years of hands-on experience, in an industrial laboratory (not a school), to acquire just a basic level of proficiency (*Emphasis on 'Basic", not intermediate or expert). Be very cautious of anyone who claims to be able to provide you with all the training you need in a short time period.
It has been my professional experience that some of the most common training areas that client's would benefit from are: GLP (Good Laboratory Practices/Procedures and SOPs) and additional instrument operational training to demonstrate proficiency in analytical chromatography. Address these areas early on and continuously update them to reduce errors and improve results. Training should continue on a regular basis to gain experience.
While each confidential consultation visit I have with a client may show different key issues which need to be addressed, many labs can start to improve their analytical results by addressing and improving how they address:
- Documentation: Laboratory methods and sample analysis must be conducted using clearly written documentation. This should initially include having Standard Operating Procedures (SOPs) in place for all methods, procedures, qualification, verification and tests used. They should include SOPs, Document Control and Policy documents which also address: Training, Calibration, Maintenance, Frequency of the same, Mobile phase preparation, pH measurement, use of the balance and so on... I find that it is best to create an initial SOP Template to insure document uniformity (i.e. include such fields as: Business Name, SOP #, review/approval date(s)/names, Rev #, materials & tools needed, purpose, procedure steps, pass/fail definitions... plus any needed supporting documents).
- Sample Preparation Methods: Be sure to document, test, review / standardize specific sample preparation methods, for each sample type. Variations in: temperature, extraction solvent or the solution(s) dissolved in, homogenization or grinding methods, mixing, times used, glass or plastic containers used may result in significant variation of the final reported results.
- Correct Poor Reproducibility and/or Baseline Instability Issues: In chromatography analysis, if the method(s) used are not stable and reproducible, every time they are run, then little to no scientific value can be obtained from them. Methods used must follow basic good chromatography fundamentals and meet basic guidelines. Baseline noise or instability may directly impact integration results (which directly impacts reported results). Instrumentation must be operated in clean, climate controlled rooms. Failure to reproduce a result within acceptable limits (these will vary per method type) will invalidate the method used. Make sure that SOP's are followed, mobile phase solutions are made fresh each day (do not pre-mix solutions with acids and let them sit for several days before use; do not "top off" bottles), solutions should be degassed, HPLC columns are properly washed and re-equilibrated before each analysis, instruments are maintained (per a SOP) and serviced on a regular basis.
- Develop HPLC methods that follow good chromatography fundamentals: Retain, separate and resolve ALL peaks. Insure peak K primes are 2.0 or higher. If you have co-eluted peaks in your method, then method development is not finished. If you have ghost peaks or changing retention times, then you need to stop running samples and find out why. Be careful whose method(s) you use. A method that is "Validated" may not be scientifically valid method to use. Have the method checked by an experienced chromatographer.
- Continuous Training is Required to become Proficient: To be proficient, at a basic level in chromatography, takes most chromatographers several years working in an industrial environment to gain practical hands-on time. That assumes that they have had professional training outside of college, in an industrial lab, and can demonstrate an understanding of the fundamentals of good chromatography. Note, that method development skills require a much higher level of understanding and hands-on training to acquire the needed skill set. Make sure your scientists have the needed level of training to operate, run analysis methods and troubleshoot any issues that come up (and issues will come-up, even under ideal conditions). Please do not make the mistake of thinking they will "figure it out" on their own. Hire people who already have several years of industrial chromatography experience, then provide them with additional training opportunities to advance their skills in the application areas that your business needs. Get them help NOW, you will save money and time, plus get back on track moving forward with your project.
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