The Syndicate Blog
We are now a Qualified Kratom Vendor on the AKA's website. You can see it here https://www.americankratom.org/abou-aka/gmp-participants.html
Part of being in the AKA's GMP Qualified Vendor Program means you have done a 3rd party audit of your GMP facility for compliance. As of this writing there are only 11 businesses that have completed this and have signed up.
The AKA GMP Standards Program was created to establish a higher level of manufacturing processes for Kratom Vendors. AKA GMP participants have committed to implementing and following the manufacturing and processing standards.
We are working hard to get caught up and new batch's are in progress. The team has worked 8 weeks straight 7 days a week to keep up with orders and finish the cleanroom move. We have applied to be a AKA approved vendor and it is in progress. We have an ISO classification testing scheduled which our production and isolation room will be an ISO 7 and gowning ISO 8.
Manufacturing supplements does not require a certified ISO rating just a "cleanroom" with industry standards. We wanted to take it a step further and built ours to be able to show and document to our customers it has been inspected and certified by a 3rd party. Customer safety and our transparency to show our customers we are truly serious about being a leading vendor in this industry.
ISO Classifications are 1-8. They are a critical factor in cleanroom design.
An important design feature is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that filtered outside air replaces the existing volume in a building or chamber. In a normal home, an air-conditioner changes room air 0.5 to 2 times per hour. In a cleanroom, depending on classification and usage, air change occurs anywhere from 10 to more than 600 times an hour.
Achieving the optimal air change rate requires proper ceiling
fan coverage. The cleanest modular cleanroom
incorporates filter/fan units (FFUs) in every 2’ x 4’ (610 mm x 1219 mm) ceiling bay. This near-100% coverage provides a laminar flow of filtered air to quickly remove contaminants from the room, thus meeting FS209E standards for Class 10 and ISO Class 1 standards.
Our cleanroom is positive pressure.
What is positive pressure?
Positive Pressure Cleanrooms are designed to maintain positive pressure, preventing "unclean" (contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces. So inside the cleanroom air flow is restricted to just a few small vents. Only purified air is introduced from special Hepa filters that are 99.9999% rated.
An ISO 7, 15-25% of the ceiling is filter units.
Contact surfaces and equipment are all stainless steel making them easy to clean and they won't support bacteria growth. We also do random microbial testing on contact surfaces on site. Keep an eye on our blog for more updates and info
Georgia just passed there own version.
Sponsored by Representatives Hill, Caldwell, Jones, Mathiak, and Newton, the Georgia version of the Kratom Consumer Protection Act does the following:
- Restricts kratom sales to kids under the age of 18
- Requires clear labeling of kratom products labels that shows:
- The amount of mitragynine and 7-hydroxymitragynine in the product
- A list of each ingredient listed in order of predominance
- Clear directions for use
- Precautionary statements on the safety and effectiveness of the product
- The name and address of the manufacturer
It's great to see progress being made to clear out the bad actors and protect comsumers. Hopefully more states will follow and the FDA will look at the science and the vendors in the industry will rapidly adopt cGMP standards.