Our 400 s/f Cleanroom is comprised of a gowning area, quarantine and a main product production area. Our facility is FDA registered as a Dry Food Manufacturer / Processor and Packer / Re-packer for - Dietary Supplements, Vitamins and Minerals, Herbals and Botanicals.
We are current wih local state and federal regulations. The cleanroom itself is certified ISO-7 production area and ISO-8 gowning, quarantine area. Certification done by 3rd party ISO accredited certifying authority. If your wondering what is an ISO rating is you can read our blog on it here.
ISO certification is not necessary for supplements however we believe in going above and beyond to prove and show safety protocols are in place for our customers and not only do we say they are in place we prove it.
Picture of the entry area of the cleanroom as well as some warehouse area.
Inside the main production area
When working in a cGMP ( current good manufacturing practices) environment for supplements certain requirements must be done. This is outlined by the FDA in 21 CFR 111.
Some of those you can see but most are done behind the scenes in the form of ( SOP's) Standard Operating Procedures. Everything has a SOP. There is even an SOP on SOP's.
Being able to document and explain in simple terms your process from start to finish - what, when, how, were and why. Here are a few SOP's.
Handling of Kratom requires proper cleanroom dress. Making sure all hair is covered a face mask and gloves are worn. Cleanroom coverall's or appropriate covering, shoe covers, ect. The biggest cause for contamination in a cleanroom is people. Wearing the correct clothing is necessary to ensure no contamination will happen with the products you are working with.
In our cleanroom we heat sterilize evey gram of kratom we sell. This not only eliminates any potential for salmonella but also drastically lowers yeast, mold, ecoli and enterobacteriaceae sometimes to levels undetectable on lab reports.
We have dialed in this process thru testing many different samples with various degrees and times and have been able to process kratom that is safe and still keeps its color and smell and it's strong alkaloid profile. In some lab tests we have been able to increase the mitragynine levels from heat over base line samples.
Powder filling machine shown filling a 16oz bag.
Lab testing Kratom is not only important but it is mandatory. Our standards are the same as AHPA ( American Herbal Products Association). If a sample exceeds the thresh hold then that Lot is not used. All lab reports are available on request and held encase of FDA audit. We keep retention samples of all batches for 3 years as required by the FDA.
One of the biggest concerns right now in the Kratom Industry and with the AKA (American Kratom Association) is that the majority of products being sold are Not Tested and processed in a cGMP facility. Unfortunately alot of products are being sold from homes and garages or even a business location that doesn't have the systems in place and required by the FDA.
Ultimately it is up to the customer to make the choice about their health and safety. If a kratom vendor can not show their cleanroom and lab reports at a minimum then I would be cautious about the safety of the products being offered. There has been to many salmonella out breaks regarding kratom and high lead scares to take any chances.