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Summarizing Sanitation

AIDP

Clean is lean. Strict sanitation processes are the lasting cornerstone of safety, notably for products meant to be ingested into the human body.

We all tend to cringe when we hear of recalls of natural foods (lettuce, etc.) due to nefarious bacteria nestled on a batch; this is usually found after someone (or more than one) got sick and their physicians finger the E. coli or salmonella (foodborne) that have caused the acute symptoms.

So “clean is lean” means that companies invested in working with suppliers and manufacturers that take the GMPs (good manufacturing practices), sanitation and sterilization very seriously—thus providing higher degrees of product safety—can run a more lean business that doesn’t have to pay high costs of legal representation for product recalls or mounting adverse event reports, or worse.

With the advent of GMPs and the necessary rigorous standards they impose, the industry should be ensuring safety. According to Warren Majerus, NSF CFR 111 compliance auditor, NSF, the dietary supplement regulation USFDA 21 CFR 111 mentions “sanitation” in several places in the regulation as well as in its preamble. The rule defines “sanitize,” which means to adequately treat cleaned equipment, containers, utensils, or any other clean contact surface through a process that is effective in destroying vegetative cells of public health significance and in substantially reducing numbers of other microbes, but without adversely affecting the product or the safety for the consumer.

“But,” he warned, “what the regulation does not do is to define what specifically this means. Inspectors seem to be looking for evidence that testing has been done after cleaning/ sanitizing to verify that there is no residual product and that there are no viable pathogens on the sanitized equipment. ‘Sanitize’ does not mean ‘sterilizing,’ so zero micro counts is not necessarily expected.”

“The GMPs are pretty big on sanitation; sanitation and process control are very important—you cannot obtain the level of sanitation required or desired without good process control,” expressed George Pontiakos, president and CEO, BI Nutraceuticals. “It is imperative that you maintain not only a sterile and clean factory but one that precludes cross contamination.”

For example, if you are milling echinacea in one mill and saw palmetto in another, you want to ensure you do not have airborne particulate from either one affecting the other. Then, you have to have a very good laboratory element within the factory, to not only test and maintain good process control, but to test incoming product (raw materials) to determine and know what you are starting with. If you are starting with very dirty product to begin with, it is important to know what you are working with to adjust the sterilization methodology to ensure workable material is clean and spec compliant. “It’s a necessary function—all raw material coming from a field is dirty, it can contain E. coli and a variety of naturally occurring contaminants such as lead, so you must ensure that your lab component baselines all material. Once you have it baselined, it tells you how much sanitization you have to put in the raw material to make it spec compliant,” Pontiakos explained.

BI Nutraceuticals had developed and implements its own process called Protex Steam that uses high heat and low moisture steam. Raw botanicals are brought into a large chamber and are sanitized in the whole form, the actual biomass, which, he said is very unique. Once the biomass is brought up to temperature, it is hit with a short duration of high heat low moisture steam. This process is specific to each plant material, so that its distinctive color, efficacy or volatile oils contained within are not affected. “You want the attributes of the plant to benefit the consumer,” he explained. “Some plants are very resistant and others sensitive, so we need to be very careful how we sterilize and sanitize raw material coming in. Biomass coming in from a different field in the same area can exhibit significant variations.”

He continued that the difference between Protex Steam and others is that factories that use steam methodologies have to mill biomass into powder, and because moisture is inherent in steam, it causes clumping, which may cause problems in running it through machinery. That may lead to downtime and further expense.

A significant challenge seen by NSF auditor Majerus is consistency of the sanitization process. “A verification test with swabbing after sanitization can confirm that a defined process is effective, but with changing environments and personnel, possible time constraints, sometimes the sanitization step may get modified or lessened,” he observed.

When he audits, he reviews several key aspects to ensure sanitation processes are properly in place.

• The cleaning process is sufficient to remove any residual material (residual material i.e., dirt cannot be sanitized)

• Verification of the sanitization process should be challenged at time zero, and also at time intervals that cover the normal down time before the equipment would need to be resanitized. (Satisfactorily sanitized equipment does not stay sanitized forever because of environmental contamination). This typically could cover from one day to perhaps up to a week, depending on the environment, sanitizers, etc.

• Sanitizers should be changed periodically (from a quat. To a chloride, for example) so that resident microbes do not become resistant.

“If sanitation rules are not followed any product run in that environment would be considered to be ‘adulterated’ by FDA (U.S. Food and Drug Administration) standards so any product run in those conditions would not be fit for human consumption,” he warned.

As many new brands seek to enter the ever-growing dietary supplement industry with product, Pontiakos advised to ensure dealing with suppliers and companies that are GMP certified, and that can trace the origins of material, often difficult or impossible to do when dealing with some middle agents or brokers. Even responsible manufacturers can encounter problematic recalls. “For example, Peanut Corp. of America, the largest in the world, passed all types of GMP audits and ended up with a huge salmonella problem where people died. Also, Menu Foods of Canada had melanine in the raw materials it uses for pet foods. So if you are buying from an aggregator who does not have control over its supply chain, your product may be more open to recalls and you are responsible. You don’t want to have to endure a GMP audit and find out that your supplier doesn’t have good process hygiene—or any.”

He added that if your supplier bemoans GMPs or doesn’t have the technical acumen and/or capital strength to invest in the GMP program, “run away!”