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To U.G., or not U.G. On the safety of Underground Labs
by: William Llewellyn
In case you havenâ€™t noticed, underground labs are everywhere these days. If you are unfamiliar with the term, an â€śUnderground Labâ€ť 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, Iâ€™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.
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.
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.
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<
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