cGMP refers to the Current Good Manufacturing Practice regulations enforced by the U.S. Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, quality and purity of products by requiring that manufacturers adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining reliable testing laboratories. The problem with many supplements is that GMP certification is optional, which casts doubt on companies from consumers. A lack of strict regulation keeps supplement prices low, but also makes consumers highly wary of the manufacturing practices.
Last week’s article was aimed toward the production of whey protein, a popular food supplement used by athletes. While a relatively simple product, there are a number of issues that could arise at any time during the manufacturing process. This week we delve into the world of good bacteria and the processes involved in making a true cGMP certified facility.
The human intestinal tract is a bacterial Mecca since it is warm, dark and full of food. A cubic centimeter of prime real estate in the colon can hold over 100 billion bacteria –nearly 20 times the entire human population of earth! This isn’t as bad as it might sound though; many of these bacteria promote positive health through boosting the immune system, aiding in digestion and preventing infections. A growing number of people are taking these products in the wake of taking antibiotics and other medications, which throw intestinal flora out of balance.
Recent research suggests that most probiotics do not provide nearly enough CFUs (Colony Forming Units) in order to make a difference in one’s digestive health or immune system. Companies responded to this by improving their production standards and implementing creative ways to keep colonies as high as possible through to their expiration date. Many companies have taken it upon themselves to reach new cGMP standards and exceed them to accommodate consumers’ need for.
Manufacturers put the effort into finding the ideal environment and ingredients to produce a superior product. Cultures featured whole food bases, filled with antioxidant-rich fruits, vegetables and fiber to create an optimal environment for burgeoning cultures. Cultures also maintained humidity levels of 75% throughout the growing stages in order to produce supplements with over 100 billion CFUs, this is radically better than the 10 million CFU amounts seen by most companies a few years ago.
Another issue that companies had was ensuring the potency of a living, breathing product. Since probiotic cultures are ostensibly alive, the longer a culture is away from the mother culture, the more the culture dies off and becomes ineffective. Companies like Garden of Life, have incorporated overage practices, where more CFUs are placed in the capsule than are listed; so that even if a percentage of the product becomes inert, the number of live cultures will be at least what is listed on the package until the date of expiration.
The human stomach can occasionally drop down to a pH as low as 1 –an astounding 10 million times as acidic as water. This makes it tough to get probiotic capsules past the stomach unhindered. Enteric coating is a polymer barrier applied on oral medication. This helps by protecting drugs and supplements from the pH (i.e. acidity) of the stomach.
Most enteric coatings work by presenting a surface that is stable at the highly acidic pH found in the stomach, but breaks down rapidly at a less acidic (relatively more basic) pH. For example, they will not dissolve in the acidic juices of the stomach (pH ~3), but they will in the alkaline (pH 7-9) environment present in the small intestine. Materials used for enteric coatings include fatty acids, waxes, and plant fibers.
Probiotics are some of the most delicate supplements to manufacture, requiring highly stable, specific temperatures in order to maximize commercial output. The importance of proper temperature and humidity monitoring is something not to be overlooked. Cultures during production should never be exposed to temperatures below 70 degrees or above 95 degrees. This is because high temperatures quickly kill good bacteria, and low temperatures inhibit cell reproduction. Once the product is encapsulated and shipped out, temperatures need to stay cold and relative humidity close to 0%. This is done in order to exert a cryogenic effect on the product, preserving the culture until it’s bought for consumer use.
Companies can use temperature monitors to track changes in humidity, pressure, CO2, and temperature for cultures to ensure a stable, ideal environment for good bacteria. Sensor monitors can also monitor for flood issues, all through an integrated Cloud system. Temperature@lert’s Cellular Edition is an easy to install model that will continue to operate even in the event of a power outage, ensuring the most accurate data sent directly to your email or smartphone.
Stay tuned for next week’s piece, where we delve deep into the cold-pressing process and the manufacturing of fish oil!
Robert “Bobby” Rejek, Dreaming Dramatist
Boston local, Bobby is Temperature@lert's resident fitness and nutrition expert. Majoring in English and having earned Suffolk's Recognition Day Award for his contributions to Suffolk University, Bobby joins the Temperature@lert team as a content writer. He creates health-related blog posts, aids in marketing team initiatives, and helps maintain the technical content database. Outside of Temperature@lert, Bobby is a certified Personal Trainer through the NCSF and is working on his first fantasy novel. Because he's always on the go, Bobby's favorite temperature of 65°F reminds him to keep cool and stay breezy.