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 an ISO-7 production and quarantine area and ISO-8 gowning room.
Picture of the entry area of the cleanroom.
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.
Management review meeting
Exterior building maintenance
Cleaning and sanitation of premises
Bulk Packaging & Storage
Inventory control and reconciliation
Maintenance and sanitation of equipment
Packaging materials destruction
Customer Complaints Handling
Handling of Returned Goods
Root cause analysis
Qualification of equipment and systems
Batch Record Template
We have a ISO certified cleanroom. Certification done by 3rd party certifying authority that uses NEBB Certified CPT techs. If your wondering what is an ISO rating is you can read our blog on it here.
ISO certification testing being done, filter testing, air particulate count
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.
Cleaning and Maintenance.
Regular cleaning intevals ensure any contamination is kept under control. Specialized cleaning agents and tools for a cleanroom are needed. Ceiling, walls and floors need to be wiped down and lint free wipers are used. Non shedding Mops are used. Deionized water is used with all cleaning agents. 70% isopropyl alcohol is used on all contact surfaces, walls, door handles, storage containers and equipment. 70% isopropyl alcohol is recommended over 99% isopropyl alcohol, the addition of more water in 70% allows the alcohol to penetrate the cells of bacteria. Water speeds up the denaturing process of proteins, causing membrane damage.
Alcohols act on bacteria by making the cell membranes permeable. Efficacy is increased with the presence of water which leads to cytoplasm leakage, denaturation of cell protein and eventual cell lysis. Higher concentrations of alcohol are in fact less effective at killing bacteria.
Full monthly clean being shown, everything is moved and a deep clean is being done.
Processing Kratom correctly requires the knowledge of the raw materials you are working with. Process controls for manufacturing are in place and documented for every step. All manufacturing equipment that comes in contact with our products must be cleaned according to mandated procedures between production runs and verified to ensure sanitation has been performed prior to use.
In our cleanroom we heat sterilize every gram of kratom we sell. As known as Pasteurization. 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 validated this process thru our written validation procedures.
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.
Batch reports being filled out to document every step of the process.
Lab testing Kratom is not only important but it is mandatory. Our specifications are the same as AHPA ( American Herbal Products Association). Each batch is tested for salmonella, ecoli, heavy metals, yeast and mold. We follow AHPA finished product standards. 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.
Product samples are also collected at various stages of production for chemical and microbiological analysis to ensure consistency and purity. Lot code confirmation, weight checks, label and material checks are performed according to exact written procedures.
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 don't have the systems in place and required by the FDA.
Ultimately it is up to the customer to make the choice about the safety of product they purchase. 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. Taking the proper steps to ensure a safe product is a very costly and time consuming process but everything we do is to provide our customers with the safest and best kratom products on the market today.