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April 25, 2017

Rise of the Bugs – How Can We Win the Battle for the Cleanroom?

Bug Black Vector Silhouettes Illustration

 

According to the Smithsonian Institution, the world’s largest museum and research institution, there are more than 10 quintillion insects alive at any given moment.(1) That’s an estimate, of course, and quintillion – for those of us unfamiliar with the scope of the term – refers to 10 to the 19th power, or 10,000,000,000,000,000,000. While we know of approximately 900,000 different, uniquely described species – comprising around 80% of our global biological diversity – the true figure for the number of individual species may be closer to 2 million, the largest terrestrial biomass of all. And to couch this in slightly more approachable numbers this is approximately 200 million insects to each and every human being.

Yikes. So that means at any given time, we are all personally surrounded by – and outnumbered by – bugs. In studies cited by the Smithsonian, soil samples across the U.S. yielded massively different insects per acre figures, with North Carolina offering a seemingly paltry 124 million bugs per acre to Pennsylvania’s much more generous 425 million.

So given the number of critters with whom we share the planet, is it any surprise that we also tend to share our homes with an assortment of them too? And even in the most well-maintained and tended property, this can be a problem. There are some for whom we cut some slack – most folks, for example, can peacefully coexist with a friendly house spider and actually we’ve been doing it for millennia. As Rod Crawford of the Burke Museum of Natural History & Culture in Seattle, WA, notes:

‘Some house spider species have been living indoors at least since the days of the Roman Empire, and are seldom to be found outside, even in their native countries. They usually spend their entire life cycle in, on or under their native building.’(2)

And given that spiders – as arthropods – developed around 300 million years ago, in the interests of fairness it must be acknowledged they were here first. Be that as it may, we don’t necessarily want lots of them in the house and, requiring only 1/16th inch gap to enter, this can be a problem. Similarly, cockroaches – those new darlings of the foodie circuit – see the same 1/16th inch gap as our way of rolling out the ‘welcome mat’ to our homes, and termites need only 1/64th inch as encouragement to take up residence. Along with a couple million of their closest friends and relatives.(3)

…how do insects gain entry and, perhaps more importantly, how can we prevent it?

So apart from the usual points of entry – open doors and gaps around windows – how do insects gain entry and, perhaps more importantly, how can we prevent it? Air conditioning vents and utility pipes, wires, and cables offer easy access points to tiny creatures as do cracks in a building’s foundation. But, as far as it goes, the good news is that theses are almost always fixable using something as mundane as a squirt of sealant. Removing overhanging branches that can form ‘land bridges’ between trees and roofs or exterior walls is also an easy fix to thwart the ingress of the undesirables seeking refuge from climate change, cooler temperatures, or a lack of water. And just as we bug-proof our homes, we also have a responsibility to insect-proof our contamination-controlled environments. For example, let’s look at hospitals…

Infested with bedbugs

The most common pest in hospitals and healthcare facilities is not, as you might imagine, that well-known patient, the Medical Malingerer, but is in fact a group of bugs that includes ants, flies, and cockroaches. This is according to a 2013 survey by the Association for the Healthcare Environment (AHE) as reported by Health Facilities Management, a publication of the American Hospitals Association, which also noted the increasing prevalence of bed bugs within hospital environments.(4) Horrifyingly, a single female bed bug can lay as many as 100 eggs and her offspring are sexually mature within just a few short months. Ant colonies housing as many as 100,000 individuals can be found nesting in walls, and cockroaches favor the sewers and drains for direct routes into the hospital. And because no building is immune to the presence of at least some form of unwanted multi-legged visitor, it is incumbent upon facilities to formulate their own customized integrated pest management (IPM) plan.

In an article published this month, Health Facilities Management lists four apparently easy steps to pest management, including exclusion, sanitation, landscaping, and the formulation of an ongoing inspection schedule.(5) Exclusion includes sealing up gaps and installing double doors and air curtains. Sanitation covers the removal of dirt, webs, food, spills, garbage, and standing water that offers both sustenance and breeding opportunities. Intelligent landscaping allows a facility to create a natural – and often aesthetically pleasing – barrier to unwanted guests, discouraging creatures that struggle in the open. This includes not only the obvious ones such as mice and rats but also termites, which need to construct an earth tunnel to move from place to place. And finally, the ongoing inspections can serve to prevent pest infiltration before it becomes a problem.

All of which sounds a lot like common sense and can be readily applied to another area in which pest infestation is absolutely not to be tolerated: the cleanroom.

Cleanrooms are, by their very nature, contamination-controlled environments. Whether they consist of a simple room in a research lab, a dedicated area, or a gigantic purpose-constructed facility to service the aerospace or semi-conductor industries they all have one thing in common: sterility. In this environment there is no place for dirt, dust, fungus, bacteria, hair, skin cells, clothing fibers, volatile organic compounds (VOCs), microbes, insects, coughs, colds, or sneezes. Contamination and particulate matter in all its myriad forms is absolutely non grata.

And, in the main, contamination is kept out by the diligent adherence to Standard Operating Procedures (SOPs) and Hazard Analysis and Critical Control Procedures (HACCP). SOPs are documented processes that ensure goods or products are created and delivered consistently, while HACCPs offer a systematic approach to ensuring safety in production processes by instituting checkpoints along the way. But they both have an Achilles Heel – their reliance upon the human willingness to conform. But let’s assume that your personnel follow the SOPs and that your company pursues HACCPs proficiently. Does that mean insects are never found in cleanrooms? Sadly it does not. Despite the protection of airlocks, filtration systems that ‘scrub’ air, air showers, and air pressure systems, bugs can occasionally find their way in. Common culprits include flies and gnats, midges and mayflies, plaster beetles and springtails, and the all too common ant. Given that many cleanroom facilities exist within a manicured campus situation where landscaping surrounds the buildings, nature will usually find a way in – whether stepping through an open door or blown in on an air current. So what do we do in the event of an infestation?

Within our domestic environments we have a couple of choices. We can make the routine home improvements to thwart entry, use natural deterrents, or we can opt to deploy the ‘nuclear option’ by bringing in the pest control specialists with their arsenal of chemical weapons. In a contamination-controlled environment, it’s just not that easy and their elimination represents the ultimate challenge for pest management specialists. Space around and within a cleanroom is considered sealed off against pests but occasionally it’s possible for some to be sneaking ‘past the filters that scrub incoming air, or they may be breeding in a damp void area caused by a water leak, bad drainage, improper landscaping, or some other deficiency.’(6) And these are hard to eradicate because the solutions routinely deployed by pest managers are themselves a significant threat and source of potential contamination to the quality of the air within the treated area. So what can we do?

…the bottom line must be an insistence upon a zero tolerance policy – both when it comes to pests and to pest control materials in the cleanroom.

In an article by Jay Bruesch and Pat Hottel, published in Pest Control Technology, the bottom line must be an insistence upon a zero tolerance policy – both when it comes to pests and to pest control materials in the cleanroom.(7) Perceiving the problem somewhat holistically, the authors call for pest management professionals to partner with cleanroom managers to advise on fundamental issues of sanitation, maintenance, and even of design and construction of future facilities. Bruesch and Hottel are firm believers in Benjamin Franklin’s ideal that an ounce of prevention is worth more than a pound of cure, and also underline the notion that there can be no room for error.

But in the real world errors do persist. Even in the most unlikely of places. But let’s first take a look at the case of the Federal Drug Administration versus Wells Pharmacy network, LLC…

In August and September of last year, representatives of the Federal Drug Administration (FDA) inspected the premises of Wells Pharmacy Network LLC in Ocala, FL. Wells Pharmacy Network is the producer of sterile drug products such as the injectable Progesterone in Sesame Oil and lyophilized Mitiomycin, a chemotherapy drug designed for use with cancer patients. But according to the FDAs report and warning letter, despite preparing compounds intended to be injected into the human body, Wells Pharmacy Network failed to comply with basic contamination control procedures in its ISO 5 aseptic production area.

Yet it is really not that difficult to understand – and abide by – federal regulations. They are all detailed in the Code of Federal Regulations Title 21, with the most salient points being in Chapter 1, Subchapter C, Part 205, Sec. 205.50(a)(5): ‘All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall […] Be free from infestation by insects, rodents, birds, or vermin of any kind.’(7)

Moreover, in specific reference to the development of lyophilized products, the FDA’s guidelines are clear:

‘Products should be transferred under appropriate cleanroom conditions. For example, lyophilization processes include transfer of aseptically filled product in partially sealed containers. To prevent contamination, a partially closed sterile product should be transferred only in critical areas. Facility design should ensure that the area between a filling line and the lyophilizer provide for Class 100 (ISO 5) protection. Transport and loading procedures should afford the same protection.’(8)

But, in a warning letter dated 09/13/2016, inspectors highlighted the inadequate segregation of hazardous and non-hazardous drug products. Although the letter makes no mention of whether lyophilized products were found outside of critical areas, it does clearly state that ‘adequate containment, segregation, and/or cleaning of work surfaces, utensils, and or personnel to prevent cross-contamination’ was not provided.(9)

And then there was also the matter of other ‘nasties’ in the ISO 5 and 7 environments. In addition to microbial contamination by Penicillium, Cladosporium, a hyaline fungus, and an unidentified basidiomycete, investigators also noted the presence dead insects. Dead insects in an aseptic environment – let’s just take a moment to consider that.

…FDA inspectors found insects in light fixtures

Unfortunately Wells Pharmacy Network, LLC was not alone in hosting bugs within its facilities. In a February 2016 action by the FDA, Baxter International, Inc. of Deerfield, IL, was forced to pull a product widely used in hospitals. According to the recall notice, the Sodium Chloride Irrigation solution was found to contain ‘particulate matter, identified as an insect.’(10) Furthermore in arguably the most shocking case, a pharmacy that made drugs for clinical trials by the National Institutes of Health (NIH) was closed down ‘out of an abundance of caution’ when injectable albumin was found to harbor a fungal contaminant. According to an article in Nature, the International Weekly Journal of Science, an anonymous complaint led to an FDA inspection of the Pharmaceutical Development Section in Bethesda, MD, which uncovered serious infractions. These included ‘lab employees wearing garments that left parts of their arms, faces or necks exposed. Some rested their arms on work surfaces, and one lab worker had exposed facial hair.’(11) And, perhaps most egregious of all was the fact that in ‘two ‘clean rooms’ intended to operate under strict contamination controls, FDA inspectors found insects in light fixtures.’(12)

Frankly, it leaves us scratching our heads in bewilderment as to how this could happen, right under the metaphorical nose of an organization of such a high caliber as the NIH. But perhaps it just shows that no organization – however powerful – is immune. And it also serves as a call to vigilance; a warning that we must always be at the top of our game, perpetually alert to the threats our (otherwise lovely) natural world presents to the integrity of our sterile, aseptic, and contamination-controlled environments. It’s a challenge we have always promised to meet.

Have you ever found bugs in a cleanroom environment? Do you have a documented IPM plan? Are you looking for a starting point? If so, please download our Technical Brief – Auditing Conformance to Standard Operating Procedures. And as always, we welcome your comments.

References:

  1. https://www.si.edu/encyclopedia_si/nmnh/buginfo/bugnos.htm
  2. http://www.mnn.com/your-home/at-home/blogs/8-facts-about-misunderstood-house-spider
  3. https://entomology.ca.uky.edu/ef641
  4. http://www.hfmmagazine.com/articles/2816-diagnosing-health-facility-pest-activity
  5. http://www.hfmmagazine.com/articles/2817-pest-prevention-tips-for-health-care-facilities
  6. http://www.pctonline.com/article/no-margin-for-error/
  7. ibid
  8. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=205.50
  9. https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf
  10. ibid
  11. https://www.fda.gov/Safety/Recalls/ucm486687.htm
  12. http://www.nature.com/news/contamination-shuts-down-nih-pharmacy-centre-1.17703
  13. ibid
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