Our 400 s/f GMP kratom 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 for Dietary Supplements, Vitamins and Minerals, Herbs and Botanicals. We are current with local state and city regulations. Registered with the Oregon Dept. of Agriculture and have been inspected by ODA. We have been 3rd party audited for cGMP's by an independent company. 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.
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. Manufacturing and processing standards
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 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.
Safely 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 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.
Being able to document, explain and validate your process shows you have control.
Lab testing Kratom is not only important but it is mandatory. We do internal macroscopic and organoleptic analysis of all our herbs. Our specifications are the same as AHPA ( American Herbal Products Association). Each batch is tested for salmonella, ecoli, heavy metals, yeast, mold and total coliforms. Providing safe kratom finished products.
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.
All our kratom powders are pasteurized and sifted!
On the left large STEMS that are discharged, anything over 50 mesh in size. On the right is an ultra fine pure kratom LEAF powder.
The larger stem and veins are sifted again in a large sift were rare earth magnets are used and bright light for additional screening.
You can see how small 50 mesh really is above
Why The Kratom Syndicate?
You can rest assured everything we process is done with extreme care and knowledge of the industry. Most kratom vendors don't process kratom in a Good Manufacturing Practice Environment.
Some Vendors that do GMP use 3rd party contract manufacturers because of how involved the GMP process is. Out of their hands and out of sight. We specialize in kratom. The only product that comes across our equipment is kratom. No cross contamination or fears of allergens.
Every batch of kratom is third-party tested by an accredited laboratory according to cGMP guidelines and our written specifications. Quality, Purity and Strength are verified before the release of each batch.
To ensure a safe product all batches are tested for heavy metals, ecoli, salmonella, total coliforms, entrobacteria, yeast and mold. We provide an additional step and pasteurize every gram of powder. This is a very time consuming and very effective process. We have cleaning and process validation plans in place. We have on site analytical testing for equipment and contact surfaces. This testing provides microbial contamination levels and validates equipment and surfaces that they are then clean to use.
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 a lot 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. Buying safe kratom should be at the top of every customers list.
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 doses of lead to take any chances.
Taking the proper steps to ensure a safe product is a very costly and time consuming process for business owners but everything we do is to provide our customers with the safest and best kratom products on the market today. We are proud to be your GMP Kratom Vendor.
If you ever have any questions please reach out to our customer service and we would be happy to talk to you.