Sources and Financial Impact of Microbial Contamination
Every day contamination costs biotech, pharmaceutical, medical device and high-tech companies money. If a product is contaminated, it can’t be sold. When this occurs, not only is the investment in raw materials and labor to make a microchip or heart valve lost, but the company has to start all over again and duplicate costs. In such situations, it is for the best to find a professional company that provides the best computer room cleaning services. And, yes, you also need them for access floor cleaning.
Pharmaceutical, biotech and medical device companies with histories of contamination issues also risk delays in meeting Food and Drug Administration (FDA) regulations. Such delays can jeopardize competitive market advantages, put employees into costly, unproductive work holding patterns and give a company’s reputation a black eye. When products aren’t getting out of the factory door, companies bleed money.
Organizations experiencing contamination issues may also find it more difficult to retain the all-important certification of their systems by the International Organization for Standardization (ISO). Moreover, most customers won’t accept products from a company that isn’t ISO certified. Quite simply, contamination poses series financial risks to a company’s bottom-line.
There are two sources of contamination: particulate and microbial. Despite best efforts, contaminants frequently manage to penetrate cleanrooms. How? Some specific common vehicles include humans (cells, hair) and environment factors such as dust, fumes, smoke, mistorequipment (lab equipment, cleaning equipment, wiping techniques). Contamination can occur due to personnel and environmental factors or process-related activities. When you think about all of these things, it kind of makes sense to hire someone to handle computer room cleaning, not to mention access floor cleaning.
The most common vector is humans. Even with themost stringent gowning and operating procedures, people improperly or untrained on cleanroom best practices are the biggest threat of contamination.Employees who fail to follow cleanroom guidelines religiously are a high risk. After all, part of training is to ensure that the training is actually followed. A single employee doing one thing incorrectly, or forgetting a step, is all it takes to contaminate an entire cleanroom. Companies with low to zero contamination rates continually monitor and update their training.
Another major source of contamination is tools and equipment.If a cart or a piece of machinery is only given a cursory wipe before entering the cleanroom the odds are it will bring in microbes with it. Oftentimes, the staff does not realize that equipment on wheels rolls across contaminated floors on its way to the cleanroom. Airflows used to be a common cause of contamination, but HVAC systems for cleanrooms are so good now that they no longer pose a major threat. The highest levels, and most frequent sources of contamination, remain humans. You should think about the importance of computer room cleaning and access floor cleaning services, choosing the best people out there for the job.
Sources and entry paths for contaminants do not vary significantly by industry. However, there are some industry differences in terms of tolerable versus intolerable levels of contamination. For example, a manufacturer of an ingestible tablet doesn’t need to maintain the same degree of cleanliness as a maker of an injectiblethat is inserted directly into the body.
Pharmaceutical manufacturers have less tolerance for microbial contamination than high-tech manufacturers. Technology manufacturers make microscopic products that cannot accept any particulate contamination whatsoever. A tinyspeck of dust would look like a boulder on top of a microchip. But high-tech companies only care about the sterility of the chip or cell phone they’re making; they don’t care about mold, fungus or other forms of contamination. On the other hand, pharmaceutical firms areconcerned with all viable and non-viable microbials.
Pharmaceutical is the industry most affected by contamination because they have to adhere to strict FDA and Good Manufacturing Practice (GMP) regulations. Not only must drug makers ensure their products are microbial-free, they also have to verify their produce a paper trail for everything,a high-tech device simply has to pass the company’s own internal checks. If a laptop or television setworks, then it ships. It’s not so simple for pharmaceutical companies. That’s why it’s critical for organizations to have, use and document cleanroom procedures.
Enlisting an experienced outside professional cleanroom team is helpful because internal staff do not like the burden of having to painstakingly clean all of their equipment in their lab at the end of a long day; they want to go home.Pegasus Data Center Cleaning Services understands how critical controlling contamination is to the success of medical device, nanotechnology, pharmaceutical, biotech and semiconductor companies. Expertly trained technicians, and the latest technologies, are employed to make 100% certain that cleanroom environments exceed the industry’s highest regulations for contamination control, cleanroom control, maintenance and safety in line with federal and ISO standards compliance (providing computer room cleaning and access floor cleaning on the spot). For a Cleanroom audit, contact Pegasus Data Center Cleaning Services at 800-734-3878 or visit www.pegasusdatacentercleaning.com to learn more about our services, expertise and experience.
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