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The Syndicate Blog

New Loyalty Discount for VIP Members

By TKS 2 months ago 80 Views No comments
We have increased the discount for VIP members to 5%. This discount is shown in checkout. You can always see your loyalty level in "My Account" and looking under loyalty program. We have also added a new level! The Godfather Level for those that have spent over $5000 lifetime sales and at least 20 orders.

We are a AKA GMP Qualified Vendor

By TKS 2 months ago 271 Views No comments

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.

3rd Party GMP Audit Completed

By TKS 2 months ago 169 Views No comments
We have just finished an extensive 3rd party GMP audit. All written procedures, policy's, product safety, personal, equipment, cleaning, receiving, packaging, manufacturing, shipping and our facility have been audited for GMP compliance. We are proud to have completed this and to prove to our customers the commitment to excellence we strive for. The audit was 20 pages long and covered every single aspect of 21 CFR 111.

Cleanroom ISO certification and new batch's on the way

By TKS 6 months ago 21632 Views 2 comments

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  

 

Kratom Consumer Protection Act being adopted

By Blogger W 6 months ago 429 Views No comments

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.