Comment · Fri, October 22, 2021 · ND Owner
Reddit AMA | In-House Lab Edition
Original post in this thread
NootropicsDepotGuru · 77 points
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We are very excited to announce that Nootropics Depot will be conducting its first-ever Reddit AMA (Ask Me Anything), which is a semi-live Q&A session, about our In-House Analytical Laboratory and we would love for you to join us! See below for full details and get your question(s) ready. We hope to see you there!
WHEN
STARTS: October 20th | 9am AZ MST
ENDS: October 22nd | 9am AZ M…
What they were answering
Dear-Mission-8143 · 1 points
Thank you for all of the info! What is the sampling rate for your incoming lots? What are lot sizes, batch quantities, etc?
u/MisterYouAreSoDumb · ND Owner
My pleasure! What do you mean by sampling rates? Do you mean how often do we test batches? We test every single batch that enters our facility. We think skip-lot testing is ridiculous. If you don't get data on every single batch, how can you put your name behind the results? Moreover, we test the finished goods before approving them, and we also test in-process during manufacturing. So let's say we are making L-theanine capsules. The raw material batch enters our facility and goes into quarantine. Samples are taken from the batch based on our sampling SOPs. We use sampling probes and take samples from the top, middle, and bottom of the barrels, then make a composite sample to test. That way we get a representative sample of the entire batch, not just one part of one barrel. We have built these SOPs over the years based off data we have acquired from thousands of samples. You will get suppliers that try to sneak in bad barrels into a larger batch, or who don't properly mix the batch inside each barrel. Your sampling techniques are crucial in ensuring that your results are representative of the entire batch, not just a part of the batch.
Once we approve a batch, it is taken from quarantine and moved into bulk powder storage and put into our MRP software. Retained samples of the raw material batch are also taken and stored in our lab. Once it is put into production and sent to our encapsulation team, they formulate the mixture and run a test run of capsules. Those capsules are then sent to our lab and assayed to ensure the formulation was done properly. That way we know there is exactly as much L-theanine in each capsule as should be. Then once the capsule batch is done, the batch as a whole is QC tested. We take samples of capsules and ensure they meet our specs for total weight, filled weight, and variability capsule-to-capsule. A representative sample of capsules is once again taken and assayed to ensure everything is in spec. Once it is passed, the capsule batch is put into bulk capsule storage and entered into our MRP software for use in packaging into bottles later.
Once a production run of capsule bottles is made, we take retained samples of sealed finished bottles from that run. Those retained samples are stored in a specific section of the warehouse in case we need to show them to the FDA during an audit or run testing later. As these lots get closer to their expiration date, we pull the retains and assay them for stability testing. This allows us to build a dataset to see how stable things are over longer periods.
As for lot sizes and batch quantities, that depends on the product. Some products are slow sellers, so we do smaller runs of raw material and finished goods lots. Other products are insanely fast selling, and we go through thousands of kilos a month and millions of capsules a month. It's easier to amortize the costs over larger batches, but sometimes the volume is just not there. However, we use the same level of rigor on every batch, whether it is small or big.