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Overview
Process and Product Contamination Investigations
Chemical, particulate, and biological (bioburden) contamination events are frequently associated with plant shutdowns and product recalls. Problems can result from mechanical failures, contaminated raw materials (BPI), materials deterioration, design defects, or improper SOP instructions. Exponent scientists and engineers have extensive experience in contamination investigations: when needed, a multidisciplinary team can be deployed to identify the point source(s) of contamination and develop effective remedial recommendations. Our staff works closely with client facilities engineers, QA/QC professionals, and production staff to investigate process and product contamination events. We are familiar with the relevant cGMP’s and can conduct confidential audits to ensure that client SOPs are properly developed and implemented.
Compendial Water System Contamination Investigations
Biological contamination of compendial water systems continues to present significant challenges to the pharmaceutical, biotechnology, and medical device industries. Bacteria, in particular, are well adapted to survival in purified water systems. Their presence leads to the contamination of process equipment, raw materials, and in some cases, product adulteration leading to recalls. Effective control of bioburden in compendial water systems requires an understanding of those factors that promote microbial growth and biofilm formation. The presence of biofilms associated with wetted surfaces gives rise to both bioburden and associated endotoxin (pyrogen) contamination. While increased assimilable organic concentrations are often associated with bioburden development, the role of surface topography, materials of construction, and fluid hydraulics in microbial attachment are less well understood. Exponent scientists and engineers have extensive experience in characterizing issues of bioburden (and other contaminants), reviewing system designs, and developing targeted preventive and treatment strategies.
Our professional team includes: Microbiologists, Toxicologists, Materials Engineers, Building Technology Specialists, Civil/Structural Engineers, Corrosion Engineers, Environmental Engineers, Epidemiologists, and Physicians.
Exponent professionals have the breadth of experience and access to necessary resources to assess the risk of process/product contamination, and develop targeted remedial strategies. Exponent takes a multidisciplinary approach to problem solving, incorporating the expertise of microbiologists, materials scientists, and a variety of professionals from different scientific and engineering disciplines. For every project there is a project manager who is the lead scientist/engineer, and that manager may bring in other experts on an “as needed” basis as required by the issues involved and the budget. Our staff has experience directing contamination and process failure investigations for a wide variety of industries.
The professionals at Exponent often work in complex regulatory environments, and have carried out significant projects in North America, Europe, and Asia.
اضافه جديده
Following up on yesterday’s post, where I talked about a law in San Francisco that attempts to minimize the external costs of fast/junk food and that has met with staunch rebukes from the GOP, there is another measure in front of the San Francisco Board of Supervisors that equally makes Republicans and the companies that fund them nervous. It revolves around the externalized cost of end-of-life disposal for unused pharmaceutical drugs.
The pharmaceutical industry currently has no legal requirement to take back drugs when they pass their expiration dates or are no longer useful for other reasons. As a result, one of two things happens: the drugs are improperly disposed of and end up in waterways and even drinking water, affecting human health in a wide variety of ways, or the taxpayer pays for proper disposal of the drugs. In the former case, some of the most common effects result from hormone-mimicking compounds that can affect our sexuality, reproduction, and general health. The endocrine disruption caused by hormone mimics was covered in great detail by scientists in the book Our Stolen Future. The end product in many cases of this type of pollution is wildlife populations that have lost the ability to reproduce, either because penises were greatly shrunken in male offspring (Florida alligators), or homosexual behavior was witnessed and documented for the first time ever in bird populations that mate for life with one partner (Great Lakes water birds).
Either way, the pharmaceutical companies get away with an externalized cost that helps them keep their margins healthy. The new measure, if passed, would require pharmaceutical companies to pay for disposal of their unused medications. This is a terrifying concept for pharmaceutical companies, and their knee jerk response has been predictable. “We are asking for the pharmaceutical industry to wise up and be a good corporate partner, to be a good neighbor,” said Democratic San Francisco Supervisor Ross Mirkarimi. Drug companies responded that the grand majority of drugs in the water supply are actually from human secretions, not from drugs being flushed down the toilet or thrown in the trash.
Studies cited by Marjaneh Zarrehparvar, manager of the department’s hazardous waste program, show that landfills leach everything from painkillers to steroids to antidepressants. In all likelihood, the rate of infection of drinking water would be much higher when those pharmaceuticals are flushed down a toilet or poured into a sink and thereby sent directly to wastewater treatment plants.
End-of-life disposal is a key externality that companies often don’t have to pay for. In this case, the cost is borne by taxpayers when pharmaceutical take-back programs are put in place by municipalities. And, of course, the cost is borne by people exposed to high levels of endocrine disrupting chemicals that have dissolved from pharmaceutical products. Drug companies counter that the extra regulation would just mean higher prices passed on to the customer.
How much would it actually cost? “All we’re asking for,” said Mirkarimi, “is a bucket with a lid that is regulated so that people can have a controlled environment to bring back their medications to dispose of prudently–that’s it.”
Response by San Francisco Supervisor Sean Elsbernd was typical of shortsighted policymakers everywhere who would like to keep externalities off the balance sheet of polluting industries. Elsbernd called SF’s program another example of “the long arm of San Francisco” trying to solve a national problem, according to an article in the San Francisco Chronicle.
It is my firm belief that policies like this, which help make large polluters accountable, are exactly why the Republican party and other conservative politicians can count on large contributions from oil, gas, coal, pharmaceutical, and other industries that continue to rely on lax regulations that help them keep costs off their balance sheet–and make them the burden of the taxpayer, the general public, the individual…
Why not a creative solution? That bucket Mirkarimi is asking for? Why not put a Viagra ad on it and post it up for safe disposal at every pharmacy? Call it a marketing expense, and all of a sudden, you’ll watch pharmaceutical companies line up to internalize those external costs and become good corporate citizens. Taxpayers stop paying for what should rightfully be the pharmaceutical companies’ costs, and people get lower exposure to chemicals in their food and drinking water.
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