Cleanroom gowning, to the layman, would seem one of those simple, rote tasks of daily existence—like brushing your teeth or walking the dog. How tough could it be?
Professionals who work in sterile environments, however, know gowning to be a science, or even an art. It’s something to take seriously and do by exact protocol, lest you be the one that introduces contaminants into what is supposed to be a sterile environment.
“The dirtiest thing to enter the cleanroom is the person,” says Damon Larkin, scientific apparel and mask category manager at Kimberly-Clark Professional. “You want to do absolutely everything possible to protect the process from the person.”
Kimberly-Clark, known for its cleanroom apparel, has made an effort to gather more data on what it is that cleanroom professionals really want. In a nutshell, says Larkin, they want more comfort, more protection, and better performance.
The company has spent the past two years visiting cleanroom operators at their workplaces and interviewing them regarding features and functions of traditional sterile cleanroom gowns (from various manufacturers). Some of the most intriguing findings include:
- The sterile cleanroom gowning process takes between 5 and 10 minutes for the vast majority of cleanroom operators.
- Donning coveralls takes an average of 30 percent of the entire gowning process time.
- Operators dispose of an average of 10 percent of their sterile garments due to exterior contamination during the gowning process.
- Most new cleanroom operators need 30 hours of initial training on cGMP donning procedures before they are allowed in the cleanroom itself, and an average of 6 hours of ongoing training each week.
- More than 50 percent of cleanroom operators reported garments ripping out or billowing due to poor fit.
- More than 40 percent of cleanroom operators report the need to exit the cleanroom due to overheating on a regular basis.
Not surprisingly, Kimberly-Clark is trying to meet these demands in its Kimtech Pure line of disposable garments. Regarding comfort, it has introduced more breathable materials, such as the SMS (Spunbond Meltblown Spunbond) fabric in its A5 coveralls (photo), that contrast with suits designed to create a moisture barrier between operator and outside. “It’s a bit like walking around in a HEPA filter,” says Aaron Smith, research scientist for the company’s Product & Technology Development group. Indeed, in research, 100 percent of operators preferred this material to other “hot, sweaty and plastic-feeling” gowns.
The data also showed that professionals have trouble making sure that they touch only the inside of the garment when they open up a sealed package. In response, gowns are now folded and packaged with the outsides in, and open up so that cleanroom professionals can step into them easier, Larkin says.
In terms of performance, Larkin notes that clients are looking more to disposables, choosing to forego any risk that product or bacteria may remain in laundered materials. This may especially be true in the contract manufacturing sector. “If you’re going to be manufacturing a variety of drugs in your facility, you’re going to do everything you can to make sure there’s no cross-contamination,” he says.
Protective Clothing: The Swine Flu Factor
It’s been widely reported that there has been a spike in sales, and thus production, of hand sanitizers and face masks since the inception of the H1N1 flu pandemic. Kimberly-Clark Professional has seen a “significant uptick” in demand for its masks, gloves, and other protective garments, says Larkin. In North America, demand peaked near the end of April, the time when the flu season is usually ending, he says.
Larkin and colleagues are now closely monitoring what’s happening in the southern Hemisphere as winter and the flu season set in there, and will be watching North America again closely this fall. Larkin recommends that manufacturers be prepared: Encourage good health and hygiene practices amongst employees in advance of the flu season, and stockpile a fair amount of supplies that might be needed should the pandemic flare up again.
Many manufacturers, with and without scruples, are seeking to profit from the flu scare. Added Value Pharmaceutical Services, for instance, has just launched two new masks which were developed for pharma purposes, but have been cleared by FDA for use by the general public and are thus being marketed for pandemic preparedness—you can find them at the fear-mongering www.truthaboutflu.com.
Off the Cuff: Another cleanroom apparel problem: the dreaded glove cuff rolldown. In response, GloveLock brand is marketing glove sealing tabs (photo) with no adhesive-to-garment contact. The tabs, for use with thin latex, vinyl, or nitrile gloves, have a peel-away liner that, after a bit of pressing and maneuvering on the part of the gowned operator, keep gloves and garment sealed together and, the company says, is less bulky and more effective than double-cuff garments.
For those looking to match safety gloves with a particular chemical, Cole Parmer has just made available its safety glove chemical compatibility database, at: www.coleparmer.com\safetychemguide. The interactive database contains permeation and degradation ratings of glove materials for up to 160 chemicals.
Style Meets Safety: They may not be for highly sterile environments, but for those who like style with their safety, Gateway Safety has introduced the 4X4 Sport safety goggles (photo), which it says provide “high-end sunglass styling” and “rough-and-tough impact protection and 99.9% protection from eye-damaging ultraviolet (UV) radiation that comes from the sun.” Think of them as the Oakleys for the lab and plant crowd.
Bug Spray: Another means that manufacturers are applying to keep cleanrooms and other work areas even cleaner is antimicrobial coatings, in particular silver ion coatings. Terra Universal, a provider of cleanroom and laboratory equipment, began offering AgIon coatings to benches, glove boxes, work stations, cleanroom pass-throughs and other stainless steel products after seeing the technology catch on in hospitals, says Terra’s Mike Buckwalter. Many customers prefer the coatings for small-scale stainless products, and some are asking for entire stainless steel rooms to have it as well. Some clients prefer it for aesthetic reasons as well, he says, since silver ion provides a non-smudge, matte-like finish.
The silver ion chemical substance is sprayed on the surface of equipment and baked, notes Buckwalter. Thus, mixed-material objects (such as those that contain plastic) cannot be treated.
Does it work? Buckwalter supports the notion that the coatings inhibit the spread of infectious bacteria among workers and generally promote an aseptic environment, but says there is inconclusive data as to whether they eliminate all bacterial, viral and fungal agents equally well. (Author’s note: Consultant and microbiologist Michael Miller, PhD, informs us that most manufacturers will shy away from using the coating for production equipment, since current aseptic processing environments provide ample sterility, and some may fear that the silver might leach into the process environment.)
Just Add Water: The Clean Air Trakker from Clean Air Solutions is a portable, stainless steel fogger that helps you see airflow patterns in a cleanroom environment. The fog completely dissipates afterwards, leaving no residue.
Gimme Shelter: Safety Storage specializes in the design and construction of buildings for materials management and cleanroom purposes, both free-standing structures and those adapted to an existing facility.
Explosion-proof and temperature-controlled, the systems can serve as labs, production facilities, storage areas, and air-lock suit-up chambers.