Supplement Manufacturing

Manufacturing standards vary greatly in the dietary supplement industry.

Manufacturing affects composition,
safety, and efficacy.

You can use "manufacturing standards" to more clearly identify excellent anti-aging supplements. Companies should offer up this info to you---unless they have something to hide.

We will cover 5 main areas: Contract Manufacturing, Manufacturing Equipment, Blending, Tests, and GMP Level.

NOTE: GMP means “Good Manufacturing Practices”---these are regulations that define the methods, equipment, facilities, and controls required for producing foods (including supplements) and drugs.

There are two levels---Food GMP and Pharmaceutical GMP.

The difference between levels is a key point when investigating dietary supplement manufacturing. We'll discuss this more later on.

Contract Manufacturing

Most supplement companies contract out their manufacturing. This can seriously degrade quality since companies give up direct control.

Who are contract manufacturers?

There are only a few respected contract manufacturers whose operations meet the highest quality standards. Then there’s everybody else. Some show a scary lack of professionalism, for example, allowing forklifts to drive next to blending areas.

What can you do about it?

Simple, look for a supplement company that self manufactures. It indicates a dedication to producing professional-grade products.

Blenders and Blending Procedures

Supplements contain many ingredients often in tiny amounts. Getting them into a tablet in their exact amounts takes quite a lot of sophistication. Normal blending gives an uneven mix with heavier ingredients settling at the bottom.

This is called stratification. It’s a concern for reputable manufacturers.

To avoid stratification, pharmaceutical blending methods and validation must be used. There should be multiple blends using the best equipment. Many contractors just dump all ingredients into a large batch blender.

Which blenders?

The standard in the supplement industry is a tumble blender. This one allows for random dispersion and reorientation of the ingredients. And accessories, like an internal agitator and intensifier bars, break up and extend low dose ingredients.

The huge companies in the pharmaceutical industry use state-of-the-art 3D blenders. However, they’re not widely used elsewhere because of cost. 3D blenders use three dimensional motion to ensure a homogenous mix without stratification.

Blending procedures?

Look for these four things:

• multiple blending protocols

• total blending time greater than 2 hours

• smaller batch sizes

• granulation

Check out this professional blending diagram from Xtend-Life Natural Products:

Tests Performed

High quality supplement manufacturing requires testing at various stages.

Quarantine Process (Pre-Manufacture)

• Full microbiological testing including total plate counts for bacteria, mould, yeast, coliforms, E-coli, and salmonella.

• Potency testing to confirm that the active ingredients are present in the amounts stated in manufacturer’s COA (Certificate of Analysis)

• Heavy metal testing for mercury, lead, arsenic, and cadmium.

Tableting Process

• Periodic tests every 30 minutes to ensure that thickness, weight, and hardness are within specifications.

Friability, Dissolution, and Disintegration

The tablets are tested for:

• Friability (resistance to crumbling/chipping/breaking)

• Dissolution (ability to dissolve)

• Disintegration (fragmentation and distribution of ingredients)

Microbiological Testing

• Further testing ensures that the tablets haven’t picked up contaminants during manufacturing. If this test is passed, a COA is issued for the batch and product is released for bottling and labeling.

GMP Levels

By law, dietary supplements must only comply with food GMP.

But food GMP does not mandate testing. It’s primarily concerned with safety---that ingredients used provide a "reasonable certainty of no harm". It doesn’t regulate dietary supplement quality.

Pharmaceutical GMP, however, has stringent standards for safety, efficacy, potency, and purity of both raw materials and finished products.

Only a few supplement manufacturers voluntarily meet the pharmaceutical level of GMP. Focus on these manufacturers; they're dedicated to quality.

Specific Questions To Ask

Remember, be clear which product you’re asking about.

1. Do you contract out your manufacturing? Answer: No.

   
   

2. If you contract out your manufacturing, did the manufacturer initially modify or upgrade its facility in order to meet detailed manufacturing process specifications you presented? Answer: Yes.

   
   

3. Do you regularly audit your contract manufacturer?
   Answer: Yes, at least yearly.

   
   

4. Do regulatory bodies audit your facility or your contract manufacturer’s facility? Who are they? Answer: Yes. Federal, state, or local.

   
   

5. What is the name of your contract manufacturer and what is their website address? Answer: Company-specific.

   
   

6. What type of blender is used for final mix blending of the following product …………….? Answer: Tumble or 3D blender.

   
   

7. Is the final blend mix put through a granulator before tableting? If yes how many hours pass between final blending and granulation?
   Answer: Yes, within 24 hours.

   
   

8. Please describe the blending procedures for (name of product). Are all the ingredients simply put together and fed into a blender?
   Answer: Look for multiple blending procedures.

   
   

9. How long does blending take? Answer: More than 2 hours.

   
   

10. What is the weight (in kg) of one mix batch?
    Answer: Smaller batch sizes are better.

    
    

11. Please list any tests performed during the manufacturing process.
    Answer: See list above as a guide.

    
    

12. Does your product meet USP or BP standards for disintegration?
    Answer: Yes.

    
    

13. Has your product been tested both in-house and independently to verify your disintegration rate claims? Answer: Yes.

    
    

14. Which GMP level do you meet for your manufacturing operations or those of your contract manufacturer? Answer: Pharmaceutical grade.

Manufacturing Wrap Up

Hope you got through all that manufacturing stuff okay. It’s important. Thousands of anti-aging supplements are poorly produced and sold every day. Reading this, while maybe a bit dry, put you ahead of just about every other consumer.