Methyl-Life Manufacturing Process
Methyl-Life® Manufacturing Process
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Here at Methyl-Life, we are proud of the superior quality of our ingredients and our process. After all, we were born from the desire of our founder, Jamie Horn, to make products that she would want to take herself as part of her own MTHFR treatment plan!
Our products are pure. That means no junk, no fillers. Never.
So we have a rigorous manufacturing process to ensure that each supplement we produce is a product that meets our standards.
A Methyl-Life® product’s life journey begins here.
1. Ingredient Research
Methyl-Life looks to find the best active ingredients available in the world.
2. Ingredient Purchase
Methyl-Life only buys top ingredients from cGMP-compliant ingredient manufacturers.
- cGMP stands for “current Good Manufacturing Practices,” as determined in a set of standardized guidelines for process and procedure. These are handed down from the FDA in pamphlet form. The manufacturing guidelines indicate that manufacturing facilities need to have Standard Operating Procedures (SOPs) in place to ensure the facilities are in compliance with the FDA standards for “Good Manufacturing Practices.”
3. Ingredient Shipment
After purchase, the active ingredients go directly to cGMP-certified contract manufacturing facilities in the USA. These are where Methyl-Life products are developed and created!
4. Ingredient Acceptance
The cGMP-contract, product-manufacturing facilities in the USA only accept the ingredients after using a testing lab to verify all of the below:
- Identity– to ensure it’s the material that was purchased and 100% matches its specification sheet or Certificate of Analysis (CofA)
- Purity– to ensure the ingredient actually matches the stated purity ratios indicated on the specifications sheet (CofA)
- Potency– to ensure the material matches the stated potency ratios listed on the CofA
- Microbes– to ensure the ingredient has not been contaminated by bacteria, mold, or other pathogens (i.e., e Coli, Salmonella, etc.)
- Metals– to ensure the material does not have any heavy metal content above the FDA limits
If any ingredient fails this verification process, it is rejected and not used. It gets sent back to its original manufacturer.
5. Product Formulation
The cGMP-contract, product-manufacturing facilities in the USA work closely with Methyl-Life to ensure the formula that customers need is correctly calculated, measured, blended, tableted/capsuled, weighed, tested, sealed, and has successfully passed all quality-control requirements with flying colors.
Methyl-Life then takes an extra measure of care to ensure that our formulas are created with a 10-20% active ingredient overage. This is so the products will survive a 2-year shelf life and still be able to easily pass a potency test proving it meets its label claims. The FDA only requires a 5% overage.
A little-known fact for comparison: many companies are using generic methylfolate ingredients that are amorphous salt-based (even some patented ingredients are amorphous salt-based). These amorphous, salt-based ingredients can lose up to 16% potency per year because they are less stable. And, if these companies don’t formulate with a very large amount of the overage in the formula, the product will not be as potent as the claim on the label says it is. By contrast, Methyl-Life uses an internationally patented crystalline salt-based methylfolate, which should not lose more than 2% potency per year due to its superior stability.
Another little-known fact is that 3rd-party lab testing on finished products is not required by the FDA or the cGMP process. However, at Methyl-Life, we feel this is extremely important, as it allows us to validate the work of our contract manufacturers. It’s just another check we can do to ensure our products are made to the standard we require for our customers. Methyl-Life pays to have these additional tests done on each production batch that gets run. The products are sent away to a specialized lab that can measure the exact potencies in the product and further verify our products meet—and often exceed—their label claim.
6. Finished Product Shipment
Once the cGMP-contract, product-manufacturing facilities in the USA finalize the Methyl-Life products, the products get shipped in their fully sealed and final packaging to the Methyl-Life Fulfillment Center.
From our Fulfillment Center, the products get shipped to you with our full confidence that every product you get will be of the highest quality!
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