Chewing food is one thing. Converting it into usable energy inside your cells is something else entirely. It requires the presence of hundreds of millions of chemical "teeth" in the form of vitamins and minerals, also known as micronutrients. Without them, the flow of energy in the body and the building of its tissues stop. When we prepare our meals directly from nature, they come with an abundance of micronutrients built-in. Unfortunately, the foods we typically choose to put in our mouths each day aren’t nearly as well equipped.
Consumers usually don’t get excited about micronutrient supplements. Perhaps this is because they aren’t marketed with the same verve reserved for products purported to shave off abdominal fat or increase the size of your biceps, for instance. That’s not to say they can’t help you accomplish such feats. Quite the contrary, biochemically speaking, a micronutrient supplement may be far more likely to help you build your body than many other types of dietary supplements. One of the reasons for this is that these other products contain ingredients (including synthetic chemicals) that your body doesn’t have a physiological requirement for. Thus, they lack the power and versatility of micronutrients. Worse still, their use may be associated with undesirable side effects, some as yet uncharacterized.
Your body needs the micronutrients found in Super Pak, in contrast. During any given second of the day, a single cell might carry out in excess of 10 million chemical reactions requiring an equally impressive number of vitamin and mineral molecules. These reactions help make energy available and otherwise contribute to the building of your cells and tissues, abs and biceps included. Viewed from this perspective, a micronutrient supplement like Super Pak deserves some serious verve indeed.
Super Pak becomes especially exciting when you take an in-depth and behind–the-scenes look at how it is manufactured. This isn’t something that is normally done for a dietary supplement of any kind. Then again, Super Pak isn’t exactly normal, as we shall see. For instance, the lab that manufactures its cluster of tablets doesn’t make the formula for any other company; it is a completely custom and exclusive formulation. Because of the lab’s small size and high level of technical expertise, it is able to make Super Pak precisely according to BI’s specifications and nutritional philosophy. That philosophy may be summarized in a single sentence: You can’t eat perfectly all of the time.
Particularly as we get older, sub-optimal micronutrient intake becomes more prevalent. At any age, however, it is easy to choose the Big Mac over the broiled fish, the cupcake and coffee over the oatmeal and OJ, the white rice over the brown, and so on. So how do you fill the resultant micronutrient gaps? This is the job of BI’s Super Pak, designed to supply your body with super-dietary quantities of vitamins, minerals and other micronutrients –quantities that would be impossible to obtain from a single day’s eating, practically speaking. Importantly, almost all of Super Pak’s ingredients are delivered in compressed tablets that have been engineered to disintegrate inside your digestive tract in a sustained fashion, for up to 6 hours. This allows you to absorb and utilize a higher percentage of each micronutrient, ideally 100%. Soft gelatin capsules (softgels) are used for only 3 of Super Pak’s ingredients for reasons related to their oil-solubility. This paper will therefore focus largely on the manufacturing of its tablets.
Each Super Pak consumer box contains 30 sealed packets and is intended to be used on a 30-day cycle. Each packet contains::
› 1 large, oval, yellow-orange, sustained-release tablet supplying B vitamins (up to 10,000% of DV)
› 1 large, oval, beige, sustained-release tablet supplying 1000 mg vitamin C (1670% of DV) from ascorbic acid and rose hips
› 1 large, oval, brown, sustained-release tablet supplying 1000 mg vitamin C (1670% of DV) from ascorbic acid and rose hips plus 725 mg bioflavonoids
› 1 small, round, white tablet supplying selenium (114% of DV)
› 2 large, oval, gray tablets supplying minerals (up to 500% of DV) plus vitamin D (200% of DV)
› 1 small, round, speckled tablet supplying 5 digestive enzymes plus betaine (a methyl donor and osmolyte)
› 1 small softgel capsule supplying vitamins A & D (200% of the Daily Value of each)
› 1 large softgel capsule supplying vitamin E (α, β, γ, and δ tocopherols)(3333% of DV)
For a complete list of ingredients, refer to the Super Pak
product label at the following PDF:
*The white tablet supplies 70 mcg of selenium. Another 10 mcg occurs in the mineral tablets. The total is 80 mcg, representing 114% of DV.
Part 1: Tablet Manufacturing
The Super Pak Tablet Manufacturing Lab
Located in California and occupying roughly 30,000 square feet, the Super Pak manufacturing lab has been in operation since 1977. It began making Super Pak’s mineral tablets in the 1980s when BI sold them individually. It has been making the complete cluster of tablets since 2000.
The lab is run by a father and son team with well over half a century of experience between themselves. The father, who founded the company, is a pharmacist with licenses in 5 states. He is also trained in chemistry and food science and has been manufacturing tablets for the dietary supplement industry since the early 1950s. The son has been working with the lab since 1979.
The California Food & Drug Branch -essentially, the California arm of the FDA- has given the Super Pak manufacturing lab a Processed Food Registration (PFR). As the California Department of Public Health explains on its Web site*, the PFR functions as a health permit for the lab. Anyone who manufactures processed food products (including dietary supplements) in the state must register and pay for a PFR.
On June 25, 2007, the FDA published 21 CFR Part 111 in the Federal Register**. This document lays out the minimum requirements, known as Good Manufacturing Practices (GMP), for anyone engaged in the business of manufacturing, packaging, labeling, or warehousing dietary supplements. Sometimes referred to conversationally as the "new GMPs", they are thought to be even more stringent in some regards than those set forth for the pharmaceutical industry.
The California Food & Drug Branch inspects the Super Pak manufacturing lab annually. Before the new GMPs were published, states like California that had a Food & Drug Branch established their own regulations and carried out their own inspections. States lacking a Food & Drug Branch enjoyed more freedom, by comparison. One such state, Utah, has been a popular place for dietary supplement manufacturers to set up shop in recent years.
Dietary supplement manufacturers are required to become compliant with the new GMPs according to a 3-year plan as follows:
- Companies with 500 or more employees: compliance required by June 25, 2008.
- Companies with 20-499 employees: compliance required by June 25, 2009.
- Companies with fewer than 20 employees: compliance required by June 25, 2010
- The FDA designed this tiered structure with the hope that it would reduce the disruption for small businesses. With only 15 employees, the Super Pak manufacturing lab is considered to be "in compliance" because of its small size and the fact that it has always met if not exceeded the manufacturing requirements that were in place before 21 CFR Part 111 and that continue to be enforced by the California Food & Drug Branch.
Athletes and non-athletes alike will be happy to learn that the Super Pak manufacturing lab does not produce any drugs, over-the-counter or otherwise. It is strictly a manufacturer of dietary supplements. Thus, there are no banned substances on the premises.
Developing the Formula
Any great meal begins with a great recipe, or formula. The Super Pak
formula was initially created by the research and development team at BI
headquarters in Cold Spring, KY. It was then given to the tablet manufacturing
lab, whose job it was to bring it to life. Note that this isn’t always the case.
Supplement companies may instead hire a contract manufacturer or another
outside party to create a product formula, offering them only a few rough
guidelines to get them started (e.g.
Keep the cost under $X per unit). In
contrast, BI develops every formula in-house and then selects the most suitable
manufacturer(s) to turn it into a tangible reality. With its small size and
highly experienced product development team, the Super Pak manufacturing lab is
able to make this elaborate micronutrient formula precisely according to BI’s specifications.
Sourcing the Ingredients
Super Pak contains a long list of ingredients, more than 40 in all. Sourcing them can be a daunting task. Besides Super Pak’s actives –micronutrients, enzymes and other compounds that are intended to provide nutritional benefits- there are inactives -lubricants and binders, for example- that address manufacturing-related challenges. Different suppliers charge different prices for ingredients of each kind and they can vary considerably with market conditions. The manufacturing lab therefore relies on multiple suppliers, sometimes even for a single ingredient. This allows BI to reduce its costs and pass along the savings to consumers. But how does it control for ingredient quality?
Each supplier is required to provide the manufacturing lab with a Certificate of Analysis (COA) for its ingredients. This is a good start, but it isn’t a sure-fire guarantee of quality in and of itself. Arguably even more important than the COAs are the lab’s longstanding supplier relationships, some of which date back to the production of its first tablet in the 1970s. The lab director relates:
"We only deal with people who are reputable. We’ve been in business since 1977 so we know who we are dealing with. You need to be wary. If you receive an email from a new supplier listing prices that sound too good to be true, then you must proceed with caution. The suppliers who provide Super Pak’s ingredients are people we’ve been dealing with for years. We have confidence in them. When our products are assayed, no problems are found. As a small family-owned business, we can’t afford to manufacture poor-quality products. If we have to take a batch back, that’s money out of our pockets. For this reason alone we are extremely motivated to get things right the first time."
COAs, longstanding supplier relationships –both of these things help ensure that the quality of Super Pak’s ingredients is high from one order to the next. The manufacturing lab goes a step further by insisting on purchasing each ingredient individually before blending them with the others. For instance, the lab could purchase a pre-blended B vitamin mix from a supplier and incorporate it into a tablet. This would offer some advantages, such as reducing the cost of granulation (discussed below). However, it would also mean giving up control over things like dose that affect the quality of the finished product.
BI wants to make sure that you get 100% of what is stated on the Super Pak label. This may require adding a bit extra of certain ingredients, termed overage, the actual amount depending on the nature of the ingredient and whether or not it can be obtained in pure form. A highly reactive vitamin may require a larger overage to be added before blending in order to compensate for any loss of potency that occurs. Pyridoxine (vitamin B6), which cannot be obtained in the pure form, also requires an overage.
The quality of Super Pak’s ingredients is also maintained through physical inspection. When the ingredients arrive at the lab they are quarantined in a fenced-off section of the warehouse. Here they are carefully examined by a supervisor who has been working at the lab since 1982 and an ingredients weigher who has been there for a decade. (In order to be compliant with 21 CFR Part 111 by June 2010, the lab will also be required to perform chemical analyses on each ingredient that goes into Super Pak.)
With so many years of industry experience, the Super Pak manufacturing lab knows how micronutrients are supposed to look. The lab director explains:
"You can have 10 white powders laid out on a table in front of you and if you are experienced enough, you will be able to see the differences between them and pick out even the slightest discrepancies. Let’s say we open up a container of a particular vitamin and see specks on the powder. In this case we will get on the phone with the supplier, tell them that this is unacceptable and reject the shipment."
Every ingredient the lab receives is given its own discrete lot number, not just for that particular ingredient, but that particular batch. Thus, the vitamin C that was purchased last month for Super Pak has a different lot number than the vitamin C that was purchased this month, even if everything else about it is the same. Who was the supplier? The manufacturer? The shipper? Did it come via UPS or Yellow Freight? These and other things are documented. The lab has records going back to the 1970s.
Making the Tablets
Once the ingredients have been double- and triple-checked, it is time to begin blending them together and forming tablets. This is where we encounter one of the biggest manufacturing challenges: Vitamins, and particularly minerals, don’t like being compressed into tablets. To overcome this, the lab carries out granulation. Granulation involves mixing small particles (fine powders) with ingredients termed binders (e.g. starch, cellulose) so that they can stick together to form larger particles known as granules. The granules are then dried, lubricated (e.g. as with magnesium stearate) and mixed with any necessary diluents, disintegrating agents, or ingredients that you don’t want to granulate.
Besides making compression easier, granulation helps protect the potency of the micronutrients found in Super Pak’s tablets by providing a degree of internal coating. Lab technicians are careful to granulate together only those ingredients that are "compatible", or less likely to react with one another.
With granulation complete we are ready to move the mixture over to the tablet presses for compression. The Super Pak manufacturing lab has rotary presses of multiple sizes: Smaller, faster machines for smaller tablets and bigger, slower machines for bigger tablets. The presses are very strong, applying 5-6 tons or more of pressure to make a single Super Pak tablet. Throughout the compression process the tablets are weighed. "Weighing is probably the most critical thing," explains the lab director. He continues:
"It ensures that the average weight of the tablets is correct. It can’t be more than a fraction of a percentage point off target. You are also checking the thickness and hardness of the tablets. These also must be consistent. For example, if you run a batch of tablets and they are found to be on average 0.25 inches thick, and then you run another batch and the average thickness is 0.275 inches, then they may not fit inside the packet. Hardness is important because if a tablet is too soft it may break into pieces. Make the tablet too hard, on the other hand, and the consumer may not be able to digest it properly; bioavailability will be impaired. We make certain that each batch of Super Pak tablets is right on target for optimal bioavailability and consumer satisfaction."
- Once formed, the tablets proceed to the coating stage. Coating provides the Super Pak consumer with a number of benefits:
- 1.Because each tablet contains a large number of ingredients, there is a greater risk of them interacting when sealed inside the packet. Coating the outside of the tablets helps minimize this risk.
- 2.Coating protects the micronutrients from moisture, heat and light, which are their 3 greatest enemies.
- 3.Coating hides unpleasant tastes and odors.
- 4.Coating makes Super Pak’s tablets easier to swallow.
- After coating, the weights of the tablets are verified again in preparation for shipping them to the packager.
- The lab makes tablets for Super Pak 4 times a year. Each production run yields enough tablets to supply the needs of approximately 200,000 packets. Of all the tablet manufacturing steps, compression takes by far the longest. Several days may be required to produce a batch of Super Pak tablets on the presses, whereas it may only take a few hours with the blenders to mix the individual ingredients together. Minerals are particularly hard to compress. They also inflict more wear and tear on the tableting machinery than do vitamins. Thus, they require special care.
- Super Pak’s tablets are manufactured in such a way as to provide a
number of important benefits. The first of these concerns disintegration.
- Once a tablet is swallowed it needs to fall apart, or disintegrate.
If this doesn’t happen, its micronutrient cargo cannot be absorbed. Sometimes
it is desirable that ingredients be absorbed quickly. In this case you may want
to go with a chewable tablet, since the act of chewing breaks the tablet into
smaller particles whose ingredients are that much more ready to be absorbed. Chewable
tablets do have their disadvantages, mind you. They require more in the way of
fillers, for instance. Keeping the size of the tablet constant, this reduces
their nutrient density. Some fillers are needed to hide the bad taste of
vitamins and minerals. Sugars and other sweetening agents may also be necessary,
which of course adds calories.
- The rapid disintegration of chewable tablets can also be a weakness. In
the case of water-soluble vitamins, faster absorption may simply result in a
higher percentage of the absorbed dose being excreted in the urine. In order to
give consumers super-dietary quantities of micronutrients while minimizing waste,
BI knew that it would have to sustain their absorption over time. This required
making non-chewable compressed tablets and using techniques like granulation to
slow down their disintegration. Rather than breaking down in, say, 30 minutes,
the tablets can release their micronutrient cargoes over a period of up to 6
hours. This theoretically allows your cells to utilize a higher percentage of
the absorbed dose.
- Super Pak’s tablets are manufactured in such a way as to provide a number of important benefits. The first of these concerns disintegration.
- Once a tablet is swallowed it needs to fall apart, or disintegrate. If this doesn’t happen, its micronutrient cargo cannot be absorbed. Sometimes it is desirable that ingredients be absorbed quickly. In this case you may want to go with a chewable tablet, since the act of chewing breaks the tablet into smaller particles whose ingredients are that much more ready to be absorbed. Chewable tablets do have their disadvantages, mind you. They require more in the way of fillers, for instance. Keeping the size of the tablet constant, this reduces their nutrient density. Some fillers are needed to hide the bad taste of vitamins and minerals. Sugars and other sweetening agents may also be necessary, which of course adds calories.
- The rapid disintegration of chewable tablets can also be a weakness. In the case of water-soluble vitamins, faster absorption may simply result in a higher percentage of the absorbed dose being excreted in the urine. In order to give consumers super-dietary quantities of micronutrients while minimizing waste, BI knew that it would have to sustain their absorption over time. This required making non-chewable compressed tablets and using techniques like granulation to slow down their disintegration. Rather than breaking down in, say, 30 minutes, the tablets can release their micronutrient cargoes over a period of up to 6 hours. This theoretically allows your cells to utilize a higher percentage of the absorbed dose.
Granulation and coating help protect the potency of Super Pak’s long list of ingredients. If the packets are kept in a cool, dry place away from light, they can maintain their shelf life quite well. The lab does everything it can to make sure that Super Pak tablets maintain their potency for at least 2 years. The results of assays and other feedback indicate that they have been successful. Besides granulation and coating, the use of overages (described above) also helps ensure that the product is as powerful as BI’s discerning consumers expect.
Figure 1. Outline of the Super Pak manufacturing process. Finished softgels (soft gelatin capsules) are combined with tablets at the packaging step.
Part 2: Packaging
Super Pak’s tablets and softgels are typically shipped directly from their respective manufacturers to the packaging lab where they are sealed inside packets and placed into the consumer box.
Located about 120 miles northwest of the tablet manufacturing lab is the Super Pak packaging lab. In business since 1954, it, too, is family-owned. Though the lab has maintained a license to manufacture pharmaceuticals in the state of California, it does not package any. Thus, there are no banned substances on the premises. The lab is laid out so as to give each piece of equipment used in the packaging of Super Pak its own segregated room. Among other things, this helps prevent cross-contamination between products that are being run.
Packaging begins with an order. BI will issue a purchase order for, say, 5,000-10,000 units of Super Pak, the exact number depending on need but usually falling within this range. Once the lab receives a purchase order, it makes sure that adequate inventories of necessary materials are on hand –tablets, softgels, consumer boxes (provided by BI), packet film, master shippers, bubble wrap and so on.
Once Super Pak’s various components are received, the lab confirms that they are what they are supposed to be –that lot numbers and counts match, there are no damaged products, etc.- essentially, that everything about the product agrees with how it is described in the accompanying paperwork. If everything matches, then it is released into inventory. At this point packaging set-up begins in accordance with the Super Pak master manufacturing record. This is a written document that outlines how the various components are assembled to produce the finished good ready for consumers.
Though Super Pak’s tablets and softgels are complete upon arriving at the packaging lab, quality control is far from over. Inside the lab’s quality assurance office, for instance, retention samples of the finished product and its various components are kept. The lab director provides an example of how they are used:
"When we receive Super Pak’s vitamin C tablets from the manufacturer, we do the counts [count the number of tablets to make sure the proper number of them was received] and compare them with the vitamin C retention samples. We make sure that the product is the proper size, shape, color and so forth by comparing them with the samples. This is done with every Super Pak component in order to make sure that the quality is consistent from batch to batch."
Manufacturers will also provide the packaging lab with COAs. For instance, if BI ordered 100,000 vitamin C tablets for Super Pak, then they might receive a COA from the manufacturer essentially stating "Here are the tests we performed to confirm that there are 100,000 tablets in this batch, each containing 1000 mg of vitamin C." At the end of a production run the packaging lab will provide a Certificate of Compliance (COC). This is a document that confirms that the lab has complied with all of the manufacturing specifications for Super Pak.
Super Pak’s tablets and softgels are received at the packaging lab in bulk, usually in drums or corrugated boxes, which protect them from the environment. After being released into inventory they are loaded into a machine at one end of the production line. It is responsible for forming, filling and sealing the packets. This is one of the few times during which the tablets and softgels are exposed to the environment. Once sealed, the machine sends the packets down a conveyor belt in groups of 30.
As the packets make their way down the conveyor belt they pass line inspectors whose job it is to critique the packets, making sure they are sealed properly and the internal count (number of tablets and softgels) is correct before placing them in the consumer box. Filled boxes are placed on a table where each is weighed (check weighing) to verify that it contains the correct number of packets. Upon successfully passing inspection, each box is stamped on its inside flap. A production run of 5,000 boxes of Super Pak takes about 2.5 days.
Check weighing can’t be relied on to detect a missing tablet or softgel, but it can detect a missing packet. It is the job of the line inspector to prevent the former from happening. In the unusual instance that he or she were to find and remove a defective packet and not replace it, the consumer box would be short a packet. It is at the check weighing station where this would be revealed.
Super Pak’s quality is also controlled through random testing of finished boxes. Here, line inspectors randomly grab a box, open it up and compare it against standards established over years of packaging this product. If something is found to be amiss, it is promptly recorded and resolved. Thus, quality is something that is policed throughout the packaging process rather than only at the beginning or end. This way if there is a problem the line can be stopped and machinery can be adjusted, for instance.
With a combined total of 9 tablets and softgels, Super Pak is considered a "high-count" packet. The higher the count, the more things that can go wrong. Indeed, the biggest challenge facing the packaging lab is getting the correct number of tablets and softgels inside every packet. The lab director explains:
"The consumer doesn’t care if we only produce, say, 5 defective packets for every 1,000,000 of them made. While manufacturers might consider this to be a very low level of defects, if you happen to be the consumer who purchases the defective product, then you will be unhappy. Thus, our job is to make sure that every unit of Super Pack is perfect. This is possible because of our time-tested procedures, our highly trained personnel and because we design, build and maintain all of our own packaging equipment. With a lower-quality product you might see missing packets, defective seals, broken tablets, or holes in the consumer box. These types of things are not acceptable in a BI product."
It would be very difficult if not impossible to purchase the type of equipment used to make the Super Pak packet. BI’s lab was at the forefront of this style of packeting back in the 1970s. It currently has in the range of 15-20 different packet lines and a huge assortment of tooling and spare parts. If the lab was to buy a machine that was made in Korea or Italy, for instance, and it broke down, it might be out of operation for several days. As it is, the lab can shift over to another piece of equipment or pull a replacement part off the shelf and have the Super Pak production line running again in a very short period of time. The lab director adds:
"Having our own equipment gives us numerous advantages. We intimately understand how it works, how to tool it and keep it online. Our strong engineering staff keeps up with technical changes in the industry. Over the years the basic design of the machines has remained fairly constant, though as new technological developments have appeared -computerized controls, state-of-the art sensors, etc.- we have incorporated them when and where appropriate. This has allowed our operation to remain highly efficient, versatile and dependable. If, say, BI wanted to change one of its Super Pak tablets to address a particular consumer need, then we could do this very efficiently. Our machines are very adaptable."
Operating and maintaining all of this custom-made packaging equipment comes at a price, of course. Labor is in fact the most expensive aspect of the Super Pak packaging process.
Protection of Potency
The tablets and softgels are exposed to the environment only briefly before being packaged. Super Pak packets are made of an acrylic-coated polypropylene film that has a low moisture-vapor transmission rate (MTVR). The lower the MVTR, the greater the barrier to moisture. The packets are sealed with a "4-fin seal" which offers another level of protection to the micronutrient cargo inside.
Convenience & Cost-Effectiveness
BI’s research and development team decided to use packets for Super Pak because they felt it was the most convenient and cost-effective way to produce a micronutrient supplement consisting of several different components. While blister packs may have a "pharmaceutical" look and feel to them, they are typically only used for products consisting of one or more copies of the same component (e.g. 10 tablets of vitamin C). Making Super Pak in a blister pack format would require a more expensive custom application that might ultimately result in higher prices for consumers. BI’s decision to not print colors or logos on the packet also allows it to reduce costs and pass along the savings to consumers.
Like the tablet manufacturing lab, the Super Pak packaging lab is free of banned substances. This doesn’t rule out the possibility of cross-contamination with other substances, of course. The lab minimizes this risk by rigorously adhering to GMP. For instance, at the end of each production run something known as line clearance is performed. This involves clearing the area of any previously manufactured product, taking down and sanitizing equipment, and so forth. The segregation of packaging equipment in discrete rooms, proper training of personnel, accurate documentation –these and other procedures allow the lab to drastically reduce the likelihood of cross-contamination, if not avoid it entirely.
Non-Toxic Inks, Recyclable Box
The Super Pak consumer box is shipped ready-made to the packaging lab. The box printer is Chain-of-Custody certified by the Forest Stewardship Council. For more information, visit www.fsc.org. The Super Pak box is printed with non-toxic soy-based inks. It is also recyclable.
It is rare that anyone takes a behind-the-scenes look at the manufacturing of a dietary supplement, let alone a micronutrient supplement. However, it seems warranted for a micronutrient supplement as exceptional as BI’s Super Pak. Assembling super-dietary quantities of over 40 ingredients into a single packet is no simple engineering feat, particularly when the goal is to consistently achieve the highest level of quality possible in the finished product.
In light of the attention to detail that goes into the manufacturing Super Pak, it might come as a surprise that its suggested retail price is only $40. You may not be surprised, on the other hand, when you encounter BI’s "No Nonsense" 100% satisfaction guarantee printed on the outside of the box:
"If ever you are not completely satisfied with your purchase, you may return the unused portion for a full refund. No questions asked…ever."
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