To U.G., or not U.G. On the safety of Underground Labs by William Llewellyn

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buff guy double dumbbell curlingIn case you haven’t noticed, underground labs are everywhere these days. If you are unfamiliar with the term, an “Underground Lab” is a steroid manufacturing operation that produces drugs illegally, not under government license. As such, these drugs are made without any type of regulation or oversight, and are produced solely for sale on the black market. Many years ago we would simply refer to these as counterfeits, but things have changed. Many of these underground labs operate with unique brand names, and have earned themselves good reputations among bodybuilders. Indeed, many of these labs have loyal customer bases, often buying their products almost exclusively. These consumers tend to look at their favorite underground lab more as a rogue production company than a bootlegger or counterfeiter. The popularity of this sentiment only seems to be growing.

The purpose of this article is not to introduce you to the various manufacturers that operate in the world of underground steroids. There are already many good places to find this information if you so wish. Instead, I’d like to discuss a side of underground drugs that, in my opinion, is too often dismissed or overlooked by consumers: the safety risks. The main concern here is the purity and sterility of the drug products being sold. Here in the United States, human and veterinary drugs alike are made under very strict conditions of sterility, conditions outlined by the Food and Drug Administration. Most developed countries outside of the U.S. have similarly stringent systems in place, at least for human medicines. Underground labs, by their very nature, do not have to adhere to such regulations. Before one dismisses these regulations as trivial, it might be a good idea to find out exactly what they call for, and perhaps give some thought to how closely they may be followed (informally) when your favorite underground lab is producing their gear.

Aseptic Processing

The term Aseptic Processing refers to the manufacture of drug products free of contamination by harmful bacteria, viruses, or microorganisms. This is especially important with injectable medications, as the human body’s normal defenses against infection are bypassed when a drug is introduced directly into the body. The theoretical risks of injecting a contaminated drug product are innumerable, and range from simple injection-site infection, to life threatening allergic reactions or illness. The FDA takes drug manufacturing very seriously, and years ago had instituted what it calls Good Manufacturing Practice (GMP) regulations to assure the general public was protected from such risks. These GMPs provide strict requirements for assuring global aseptic processing and satisfactory product purity and sterility – all U.S. drug companies must adhere to these very strict regulations. The exact regulations are many, such that charting them all here would require dozens of pages of text. I have, instead, summarized and highlighted the key points from each of the general sections. As you will see, producing a certified sterile and pure drug product in the United States is no simple matter.

Clean Rooms

One of the fundamental requirements for aseptic drug manufacturing is the isolation of clean manufacturing rooms. These rooms are supplied with HEPA filtered air under positive pressure to prevent outside air from leaking in. Filtered air must be regularly monitored for microbiological and particulate content. Airflow is strictly controlled, so that there is no turbulence, eddy currents, or stagnant air in the room. Temperature, humidity, and lighting are also strictly controlled. All exposed surfaces in the room must be smooth and unbroken, in order to minimize the shedding of particles and facilitate disinfection. Ledges, shelves, cupboards, and unnecessary equipment are generally excluded from clean rooms, and doors are designed so that all surfaces are easily disinfected. False ceilings are sealed to prevent contamination from the space above, and all pipes, ducts, and other utilities are installed in ways that do not create recessed (hard to clean) surfaces. No sinks or drains are allowed in clean rooms. General room sanitation is strictly outlined and documented, and the disinfectants themselves must even be periodically monitored for contamination. All of these requirements are designed to minimize the introduction of biological or other harmful contaminants, or the generation of particles that can serve as vehicles for biological contamination.

The FDA requires that only sterile and pure ingredients be used in the manufacture of drug products. The standards for such assurance are set forth by the United States Pharmacopeia (USP), which is an independently owned and funded organization comprised mainly of health care professionals. USP’s standards are recognized and used in many other countries, some of which have established their own similar organizations. In the United Kingdom, for example, one can find the organization British Pharmacopeia (BP). You have probably seen these abbreviations before. If you look at an ingredients list for a drug in the U.S., for example, it should list something like “testosterone enanthate, USP”. This should look something like “testosterone propionate, BP” if the paperwork were for a British drug. USP/BP guidelines are fairly complex, but in general assure that each ingredient item is manufactured, filtered, sterilized, and validated to specific high standards. Ingredients that meet USP/BP standards are more costly to procure than those that meet lesser standards of “food grade” ingredients, which are often used to make dietary supplements.

Sterile Components

All containers used for the packaging of a drug product in the U.S. must be sterile, airtight, and tamperproof. If the container is the type that is opened on more than one occasion, it must be designed so that it remains airtight after each closing. The container itself must be made of inert, non-shedding, sterilizable, and cleanable materials, such as glass, plastic, aluminum, or stainless steel. All components in the container closure system must be inspected for proper seal. First, the compatibility of the various components and ingredients must be demonstrated beforehand by experimentation. This is to be validated with a microbiological penetration test. Any component with visible manufacturing flaw must be discarded. Any cleaning process used with the containers and closures must also be validated for sterility, and all final assembly of sterile components must take place inside a sterile (clean) room. Containers should be closed immediately after filling and sampling to avoid contamination and the uptake of moisture. Automated production equipment is used to apply the proper seals, which itself is rigorously sterilized between uses.

Personnel and Clothing

GMP guidelines also call for strict requirements regarding the education and dress of personnel that work in the clean room. To begin with, only the minimum number of employees necessary for any given operation should be in the clean room. Training for each clean room operator will include proper hygiene and to the basic elements of microbiology. Clean room personnel are instructed to report any health condition that may cause the shedding of microorganisms, and are required to undergo periodic health checks for such conditions. Changing and washing follow a written procedure designed to minimize contamination of clean area clothing. Wristwatches, make-up and jewelry cannot be worn in clean areas. Headgear is worn to totally enclose hair, including beard and moustache. A facemask must be worn to prevent droplets of saliva from contaminating sterile materials. Sterilized non-powdered rubber or plastic gloves are worn on the hands at all times in the clean room. Gloves are to be regularly disinfected during operations, and will be changed every working session. Clean sterile protective garments are provided for every new work session. Clean room garments are designed to shed virtually no fibers, and will protect sterile materials from the shedding of particles from the body.

Post-Production Testing

Even in the face of all of these requirements to assure sterility during manufacture, the drug product is inspected again at the conclusion of production for possible particulate or biological contamination. A single vial or bottle of contaminated product will be cause for a full investigation of the line. During such investigation, the entire production lot will be quarantined. Depending on the size of the production run and nature of the contamination, often a single unsatisfactory test will be deemed sufficient cause for the destruction of the full production run.

As we see, there is a great deal of regulation controlling the sterile manufacture of drug products in the United States. These regulations are taken very seriously, and right they should. So what about your favorite underground lab? How are things manufactured there? Do you think they manufacture with USP grade ingredients, and assemble their products and components in clean rooms? Chances are, they don’t, not even close. Below is a quick rundown of the true good, bad, and ugly of underground steroid manufacturing.

The Good

An extremely small percentage of underground labs have their steroids manufactured by contract at offshore pharmaceutical production facilities that adhere to FDA (or similar) guidelines for sterility. I must emphasize that the number of such labs is low, and virtually all of them reside outside the United States. It is, for all intents and purposes, impossible for an underground operation inside the United States to have access to a domestic production facility that is licensed for drug products, and willing to risk all its business, and its own existence, by taking in completely illegal and undocumented underground work like this. It simply doesn’t happen, not here, not in today’s world of steroid hysteria and criminalization.

Short of this, your underground lab may be one that “brews at home” but still tries to take sterility seriously. To accomplish this, they may first be diligent that their ingredients, though perhaps not always up to USP standards, are as pure as possible. Pre-production testing of raw materials is considered a standard practice. Next, they will likely fill their products in as close to sterile conditions as possible without a clean room. A colleague of mine, Ronny Tober, has been consulted by certain underground operations, and usually recommends the implementation of a closed filling system called Nalgene. The Nalgene system filters the steroid in a vacuum through a 20 micron filter. Because this is a closed system, the steroid product has almost no contact with the open air, decreasing the chance of contamination. If I could not obtain drugs made in a true pharmaceutical facility, drugs made in a closed system like Nalgene may provide the next best alternative. Unfortunately, the number of labs using such a system is also very small.

The Bad

The majority of underground labs make their injectable products in the following manner. Food grade pharmaceutical ingredients are obtained and mixed in a glass bowl with sterile oil and antimicrobial agents (usually benzyl alcohol and benzyl benzoate). The oil is filtered by hand before placed in the vials with the use of a simple syringe filter, which is attached to the end of a normal syringe. The vial, which is likely not sterile itself, is filled and then sealed with a simple hand-crimping machine. The greatest attempt at sterility is made by the inclusion of the anti-microbial agents, which when present in the correct quantity will kill a majority of biological contaminants. To spite this, underground products made like this are absolutely not considered to be sterile, nor are they considered made to any acceptable pharmaceutical standards. This is simple crude home brewing at its most mediocre. Odds are that if you are buying underground, this is what you are using.

The Ugly

Some underground labs are even worse than the above. They will make many dangerous mistakes, starting with the purchase of whatever food grade ingredients they can find at a good price. The raw materials are not tested for purity or contamination before use, and are instead introduced immediately into production. These ingredients are mixed in a bowl with food grade oil and anti-microbial agents, and purified only with crude coffee filters before the vials are sealed with a hand-crimping machine. Very little attention is paid to sterility and contamination, as the end focus is solely on the production of as much sellable product as can be made. Unfortunately, underground labs of the ugly category are all too common.

In Conclusion

I read somewhere that underground labs are the best to buy from because their owners take their own products. While I can appreciate where this logic is coming from, I find it to be fatally flawed. The fact that someone is injecting their own non-sterile home-brewed products doesn’t necessarily make me feel comfortable about injecting them too. Personally, I have come to appreciate the stringent requirements set forth by the FDA for drug manufacturing, and would administer nothing less than a sterile government-licensed pharmaceutical product myself. I don’t want this article to be cause for major alarm, however. Admittedly, the number of dangerous reactions to underground products is small. But these issues are still very worthy of consideration, in my opinion. You may want to give the stringent requirements of the FDA’s Good Manufacturing Practice regulations some thought the next time you are popping the cap off your favorite underground gear. Don’t get me wrong. There are certainly some decent underground companies out there; some that take sterility (at least general cleanliness) seriously. If you are into underground gear, the question now should be simple; is your favorite lab one of them?

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