Know the impact of design specs and airflow patterns on your clean operations’ bottom line
We are faced with a unique business climate in the design/build of cleanrooms and other facilities. There is a shortage of capital and a high incentive to reduce energy and other operating costs. This means that the cleanroom designer must accomplish high energy efficiency preferably without increasing initial costs
Productive cleaning validation relies upon knowing medical device requirements and clearly defining processes
C leaning process validation is essential for the manufacture of many high-value products. The important steps in a cleaning validation program vary depending on the type of manufacturing as well as on the specific product under consideration. This article emphasizes considerations and principles that are important in medical device and other life-science area manufacturing processes; however, the approaches and principles can be used for many applications.
In many cases, the initial response to this question is something akin to “well, we are required to.” The correct, critical cleaning processes are essential to achieving the appropriate surface quality, attributes, and levels of contamination for the particular needs of the product and application. Validating the critical cleaning processes used in fabricating implantable medical devices is an important factor in successful interaction with regulators and in achieving a high-quality, high-performing product.
It is important to define internal customers and external customers, as well as current and future customers. Who is your “audience”? Manufacturers have to demonstrate and document quality and consistency in terms of product performance and product safety. Increasingly they also must demonstrate environmental acceptability.
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Used equipment may be the answer in difficult financial times
In difficult financial times it can become even more challenging to fund capital expansions. Plant managers, financial officers, and procurement departments may need to look beyond new capital acquisitions and consider purchasing used equipment with their limited funds in order to fulfill anticipated production needs. This option becomes particularly attractive with late-model used equipment increasingly available as many high-tech companies cut back on production and look for ways to raise capital by liquidating assets that are under-utilized or no longer needed.
When deciding whether to purchase used vs. new equipment, there are three major factors of equipment ownership, all with pros and cons, associated with used capital equipment.
Price: The market for used capital equipment would probably be 50 to 85 percent of the original selling price depending on age, condition, performance, and appearance. However, high-tech, performance-based equipment can be very difficult to appraise for fair market value. Settling for lesser quality in appearance or performance, thinking the equipment can be enhanced or upgraded it once in an operator’s possession, can prove to be more costly than anticipated. Original manufacturers’ parts and service may increase the overall cost to a final price greater than what the same system would have cost if new, then or even now.
Delivery: Once located, used capital equipment should be immediately available, although sometimes the seller may prefer to continue to use the equipment for a specific product run or timeframe. Buyers should make sure availability and final condition of the equipment is fully defined. Bear in mind that disassembly, packing, moving, reassembly, and recommissioning can be delicate, complicated tasks. Original packing cartons and documentation may not always be available. Extensive damage can result if critical components are not adequately protected in transit and properly reassembled.
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Usually, in this January column, I like to look ahead and talk about the outlook for the coming year. And as I look back at the last few of these that I’ve written, it seems I’ve usually been able to identify at least one
State-of-the-art laundering gets garments clean enough for strictest environments
Clothes make the man, the saying goes. The modern technological twist on that adage is that dirty garments can unmake the cleanroom. Since many of these garments are too expensive to be used only once, they have to be laundered. Now cleanroom operators in the Midwest have a new option, a recently completed facility that uses state-of-the-art techniques to get garments clean enough to help fabricate semiconductors, make pharmaceuticals, and paint cars.
Cintas Corp. (Cincinnati, OH) just opened up a new cleanroom laundry facility in Westland, MI. The 4,000-sq. ft. site has cleanrooms ranging in cleanliness from ISO Class 3 to 7, with different areas separated by process isolation controls. This arrangement is critically important, says Cintas corporate quality assurance manager Jan Eudy.
“You have a linear flow through your washing, drying, folding, and packaging process. But you want to be able to handle more than one customer’s garments at one point in time. So we have different process areas, depending upon the types of garments and the customer requirements,” she explains.
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Since human-generated contamination plays a large role in critical environments, special care must be taken to provide appropriate garments to minimize the human impact on the cleanroom. Other important factors include specialty fabrics to safeguard technicians, as well as proper laundering and care of reusable attire.
Compiled by Carrie Meadows
Ansell coat aprons offer medium- to heavy-duty splash protection specific to the food processing, laboratory, electronics, medical, pharmaceutical, and chemical processing industries. The series includes four versions that are made of the highest quality virgin vinyl in 6- and 8-mil thickness. Coat aprons are offered with dielectrically welded seams, which eliminate contaminant traps and permit cleaning to Fed. Std. 209E Class 100 standards. There are no exposed elastic or metal parts to create static or corrosion. Each garment has 40-mil PVC grommets permanently welded to the apron for greater strength and longer life.
Ansell
Red Bank, NJ
www.ansellpro.com
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Compiled by Carrie Meadows
Desco now offers its line of ESD three-ring binders with static-dissipative clear overlay pockets. Insert covers or documents in pockets on the front, back, and spine. Interior pockets allow additional storage for quick and easy access. Interior and exterior vinyl surfaces are static dissipative and are suitable for handling documents in ESD-protected areas; any charge will be removed when the binder is grounded. The format is 8 1/2
Construction subcontractors’ lack of awareness of their surroundings is perhaps one of the most frustrating issues, from a contamination control point of view, faced by health-care facility managers.
One example: “Information technology subcontractors will come in to string cable,” says Dennis Tremblay, senior scientist specializing in building and life safety issues at the environmental and engineering consultancy Environmental Health & Engineering (EH&E; Needham, MA). “They start lifting ceiling tiles without regard for containment of the site.”
Tremblay, who is also fire safety manager at Brigham & Women’s Hospital in Boston and a certified fire protection specialist, has penned the second release of the 2006 document Infection Control in the Healthcare Environment During Construction. In the document, he finds that it is possible to provide a “standardized and effective” infection control risk assessment (ICRA) program that causes a minimum of disruption in hospitals, which somehow always seem to be under construction. The key is a database that aids in program management by allowing all key personnel access to ICRA documents, and providing infection control training before contractors are allowed on site.
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What the heck are they teaching at the university business schools these days? Apparently, based on the brain trusts now running most of the world’s banks and corporations, it’s a curriculum pretty lean on economics and sound business practices and with a heavy emphasis on political science. I guess that only makes sense these days, though, since politicians are now pretty much calling the shots in our “free-enterprise system” anyway.
One thing I do know, however, is that whatever nonsense is being spun in the lecture halls, one simple truth will remain intact: Things have value, and some things have more value than others. A Japanese or German car, for example, has more value than an American car. That’s got nothing to do with nationalism or marketing, it’s just a fact, based on years of personal experience and comparison by consumers. And it’s a fact based on the conscious decision of American car executives to sacrifice quality and company reputations for a quick buck. Anyone remember the Vega, the Pinto, the K-car? Probably not too many. You’d have to have been around a while, because they didn’t stay on the road long.
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Merging contamination control technology with garment comfort and ease of use reduces the risks to cleanroom operations
When people are uncomfortable, they get annoyed. They fidget, they get distracted, and they adjust whatever is irritating them to make it go away. Anyone who’s ever worn a cleanroom bunny suit knows this is true. Although it has an impact on garment compliance, the makers of cleanroom garments have largely ignored this uncomfortable reality