Because harmful contamination can occur at any point in the manufacturing and packaging process, no single step can be taken to eliminate the risk entirely.
Avoiding contamination is a major priority in the pharmaceutical field, where the stakes are exceptionally high. Medications tainted with foreign matter can cause adverse side effects and lead to costly recalls and law suitslawsuits.
Pharmaceutical Contamination: How the Consumer Is Affected
When it comes to the pharmaceutical industry, contaminated products can have different effects on the patient to whom the drug is administered, depending on the degree and nature of contamination.
Micro Contamination: When a medication is contaminated with microorganisms like bacteria or fungus, the consequences can range from harmless to fatal. For nonsterile drugs taken orally, the effects may be less likely to be dire, as our gastrointestinal tracts provide a highly acidic, unhospitable environment that can kill most microorganisms. However, medications that are administered intravenously or in the form of eye drops, must be completely sterile. Any contaminant can find its way directly into the bloodstream, causing sepsis or even death.
- Cross Contamination: Cross contamination occurs when particulates of one product or ingredient are inadvertently mixed with another. This can occur when the same equipment and/or componentsor components are used to process multiple products and are not adequately cleaned prior to mixing new solutions, or when multiple product lines are operating in close proximity to one another. Because different drugs interact differently, cross contamination will negatively impact the drug’s efficacy, cause other health problems, or trigger an allergic reaction in the patient. Even contamination via particle buildup from a single substance can cause problems by altering the intended dosage of the product.
- Foreign Particulate Contamination: Contamination can also take place via the unintended introduction of a foreign substance, such as dust, dirt, rust, or metal particulates, into the product. Many of these contaminants are essentially harmless, but the FDA has a zero-tolerance policy related to unplanned contamination by foreign materials in the pharmaceutical industry, due to the severity of potential adverse effects. The risk is heightened for injectable drugs, as the contaminant has direct access to the bloodstream and may block a capillary. Particulates in oral medications could cause damage to the teeth if chewed, wear away at internal organs, or pose a toxicological threat, with lead and chromium being the most dangerous in terms of poisoning potential.
The Many Aspects of Contamination Prevention
Because harmful contamination can occur at any point in the manufacturing and packaging process, no single step can be taken to eliminate the risk of contamination entirely.
Everything from the building’s layout and architecture, to cleaning supplies used, to employee regulations should be determined with the goal of contamination prevention in mind. The building layout must ensure minimal traffic in areas that have direct access to production lines, with only necessary employees granted access.
Stringent sanitation procedures should be in place for employees moving from one area of the facility to another, all with the goal of reducing the risk of contaminating the product.
Airborne contaminants pose a serious threat as well, so the heating ventilation and air conditioning (HVAC) system should be designed in such a way as to minimize the risk of insufficiently treated air coming into contact with products on the manufacturing line.
While cleanliness is paramount in the pharmaceutical industry, certain cleaning agents pose a threat and cannot be used on equipment. After cleaning, no cleaning agent should remain on any surface that could have direct contact with the product. Some equipment such as scrub brushes, for example, also generate dust and promote contamination, and should therefore be avoided.
Electropolishing to Treat Metal Components
Most componentsMost components used in the pharmaceutical industry are made of stainless steel, but it is possible during the manufacturing process for the parts to become contaminated with other metal particulates from the manufacturing equipment.
Carbon steel from machinery tooling is a common source of such contamination. Dirt, machine grease, and lubricants can also contaminate stainless steel surfaces during manufacturing. In addition, secondary processes such as grinding and mechanical polishing, which are intended to refine the surface, can compromise the passive film of the surface and introduce foreign particles.
Electropolishing is effectiveis effective in removing a very thin, uniform layer of metal from the surface, removing all contaminants and imperfections that may have accumulated during manufacturing or secondary processing procedures to produce a thoroughly clean and passive surface.
The resulting metal surface is extremely smooth, free of pitting and micro burrs, which greatly reduces the ability of a product or foreign material to adhere to it. Routine cleanings will bewill be more effective than they would be on an irregular surface that allows for the accumulation of debris. Finishing methods that leave a degree of pitting, such as picklingas pickling, provide an environment in which bacteria can thrive, and increase the risk of cross contamination.
Electropolishing is specified regularly for pharmaceutical equipment and components due to its compatibility and multiple benefits. The smoothThe smooth, oxygen, oxygen-rich, passive surface created with the electropolishing iselectropolishing is effective in improvingin improving cleanability and corrosion resistance, which reduces or eliminates conditions that can slow down or halt production.
About the Author
Tom Glass is President at Able Electropolishing. The ISO 9001 and 13485 certified company offers electropolishing, passivation, titanium anodizing, and laser marking services.