Uncompromising Quality
Unlike most other supplement companies, we control the manufacturing of all the products we develop through our fully-owned company, Natural Products (NZ) Ltd., which is a member of the XtendLife group (refer to Company Ownership).
Natural Products (NZ) Ltd. operates from a purpose-built facility in Christchurch, New Zealand. Both the facility and processes are registered and audited by the local council authority Environmental Health Licensing unit, directly responsible to the New Zealand Ministry of Health. The Company has implemented hazard analysis critical control point programs (HACCP) and good manufacturing practices, and is currently going through the ISO22000:2005 registration process, which is a new ISO standard which specifically covers the manufacture of supplements.
The equipment used is all state-of-the-art and includes some equipment rarely seen in either supplement or pharmaceutical manufacturing companies, such as a special 3D Blender.
This Blender ensures a much better homogeneous mix that is simply not possible with normal blenders. Through its unique action, it is possible to avoid stratification (division) of ingredients in multi complex formulations. There is more to making a good dietary supplement than just ensuring a consistent blend, however. Granulation of the mixed powders is also an important step that is missed out in many manufacturing facilities. We use technically advanced granulators through which the blended powders are passed prior to tableting.
It is easy to talk about quality, but few manufacturers actually achieve it! This statement is borne out by the significant number of supplements in the world market today that are either not true to the ingredient label, or have contaminants present. The reasons for this are manifold. It can be due to:
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Dishonest management
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Pressure from shareholders to cut corners and improve profitability
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Poor manufacturing processes
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Substandard raw ingredients Quality can ONLY be achieved if the correct steps are taken and there are no short cuts.
To better understand these correct steps, you may wish to view one of our typical production flow charts.
The Production and Testing Process
The following is a simple explanation of the steps and processes we take with tablets to ensure that the quality of the products we produce are unsurpassed by any other manufacturer in the world. Similar processes are taken with our Liquid Soft Gels and Capsules.
| Step 1: | Raw Ingredients |
| Step 2: | The Quarantine Process |
| Step 3: | The Weighing Process |
| Step 4: | The Blending/Mixing Process |
| Step 5: | The Granulation Process |
| Step 6: | The Tableting Process |
| Step 7: | Friability and Disintegration Testing |
| Step 8: | Enteric Coating Process |
| Step 9: | More Disintegration Testing |
| Step 10: | Microbiological Testing |
For each raw ingredient, there are a multitude of manufacturing suppliers scattered around the world. To most people, there would seem to be no difference between the same ingredient supplied by any one of these different manufacturers. But, in reality, there can be an enormous difference in efficacy and potency, just as there can be an enormous difference in price.
When we source our raw ingredients, price is given a very low priority. Our highest priority is QUALITY – which means EFFICACY and PURITY. This is crucial as the finished product can only be as good as the raw ingredients used.
When choosing a supplier, we do not just rely on Certificates of Analysis when making a decision. We do a series of crosschecks before purchasing. With most ingredients, there is a wide range of potencies available, particularly for herbal extracts which can have anything from 5% to 90% of the active ingredient present.
We have specific requirements and zero flexibility when selecting our raw ingredients. If they do not conform to the specifications we need for a particular formula, we will not use them.
Step 2: The Quarantine Process
This process begins when the raw ingredients arrive in our facility. At that point, a sample is taken of the product and the ingredient is placed into a quarantine area until an analysis is completed on the sample. This is what we do to the sample:
-Full Microbiological Testing – this includes total plate counts for bacteria, mould and yeast, coliforms, E-coli and Salmonella.
-Potency Testing – to confirm that the active ingredients are present in the amounts stated in the manufacturers COA (Certificate of Analysis).
-Heavy Metal Testing – we check that there is no contamination with Mercury, Lead, Arsenic or Cadmium. Providing the sample passes ALL tests, it is then released for use in the manufacturing process. All materials that are sensitive to room temperature (such as enzymes) are stored at all times in chillers.
This is the start of the manufacturing process for each product. Two technicians carry out this process with one cross-checking the other and maintaining a record of each ingredient. The ingredients for each batch are then grouped, ready to be used in the blending/mixing process.
Step 4: The Blending/Mixing Process
This is one of the most crucial stages. We use a variety of pharmaceutical mixers in the various blending stages and finish with our special 3D Blender. Unlike most other manufacturers, who use a ribbon type blender and mix for around 20 minutes. Our blending process goes through five stages and takes five hours for each batch.
This is critical in order to ensure there is no stratification of ingredients and to ensure that low dose ingredients are properly and evenly dispersed throughout the mix.
Step 5: The Granulation Process
Within a couple of hours of completing the blending process, the powder is passed through the granulation machine. The reason for the short time frame between blending and granulation is to ensure there is no “settling” of the blended powders with different specific gravities.
The granulation process ensures that the integrity of the blend remains intact during the rest of the manufacturing process.
The granulated powder is fed into an Automatic Tableter. Periodic checks are made to ensure that the hardness is within specifications.
Step 7: Friability and Disintegration Testing
After the tableting process is complete, the tablets are tested for Friability (not to be confused with cooking, but to the tablet’s resistance to breakage) and Disintegration (the fragmentation and distribution of ingredients).
Our standards exceed those set out by the US and British Pharmacopoeia. Providing the tablets pass this testing, they then move to Step 8.
Step 8: Enteric Coating Process
This is another sophisticated process, rarely used in the supplement industry primarily because of the high cost. At XtendLife, however, we consider the need for this process too important to overlook.
Most of the tablets we manufacture, therefore, utilize this indispensable delivery system. Enteric Coating enables the tablets to pass through the stomach without the ingredients being damaged by stomach acids. This can increase the potency of some ingredients many fold. It also ensures sensitive (and very expensive) ingredients such as SAMe retain their integrity.
The process requires the application of a special polymer film to the tablet, which protects the tablet during its passage through the stomach. When it reaches the upper intestine, which has a different pH, the film disintegrates and passes harmlessly out of the body whilst the active ingredients are absorbed through the intestinal wall. For more info on this system, please click here.
Step 9: More Disintegration Testing
Samples of the tablets are now taken and tested for disintegration by simulating the pH levels of both the stomach and the upper intestine. Providing they pass, the tablets move on to Step 10.
Step 10: Microbiological Testing
A further set of tests are now carried out to ensure that the tablets have not picked up any contaminants during the manufacturing process. If this test is passed, a Certificate of Analysis is prepared for that batch and the product is released for bottling and labeling.
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