Mt. Prospect, IL – Two new recommended practices from the Institute of Environmental Sciences and Technology (IEST) do more than deliver information to the masses. The documents provide cleanroom professionals with critical guidance that boasts good form and function.
Released in late spring, RP-CC034.1 updates and combines three separate recommended practices on leak tests for HEPA and ULPA filters [RP-CC001.3: HEPA and ULPA Filters; RP-CC002-86: Laminar Flow Clean Air Devices; and RP-CC006.2: Testing Cleanroom] into a single resource. New RP-CC027.1: Personnel Practices and Procedures in Cleanrooms and Controlled Environments is arranged in a similar fashion. It too compiles and expands known facts into one guide, which is intended to serve inexperienced cleanroom owners, users and managers.
With contamination control-related industries growing by leaps and bounds, uniformity is essential, according to Bruce McDonald, a principal scientist for air filtration at Donaldson Co. Inc. (Minneapolis). He spearheaded the efforts of the IEST working group that wrote RP-CC034.1: HEPA and ULPA Filter Leak Tests.
“The more we can accomplish in terms of making information easier for users to access, the better off we are,” McDonald contends.
He says the three documents that serve as the basis for RP 34 were in a state of revision under three separate committees, which meant that changes related to existing sections concerning filter leak tests didn't always match. To provide users with consistent guidelines, the filter leak test portions were pulled out and assigned to a single working group. The result, McDonald and his fellow group members believe, is a document that meets the technical challenges associated with present-day manufacturing.
A key component, they cite, is a section that talks about leak tests at the filter manufacturers' facilities and after installation. “The criteria [for testing] changes as you go from the factory where [filters] are manufactured to the area where they are applied,” McDonald points out. “When you combine all the information in the same document, you can make it more consistent and easier to explore the differences between testing at the factory and after you've installed 500 filters in a cleanroom ceiling.”
Another advantage of RP 34 is that it introduces new ideas. For example, the document offers clean bench manufacturers recommended methods of introducing challenge aerosols and it discusses choice of test to help users select the appropriate ones for their applications.
“It's a real benefit to industry to have all these usable procedures in one document, and this is one of the most comprehensive RPs I've seen to date,” claims IEST veteran Gary Rolf, president of Cleanroom Sciences (Phoenix, AZ) and a member of working group 34, who has been involved in the creation of recommended practices since 1982.
“It has more scientific data in it than other [RPs] related to cleanroom technology. What I like about the document is that it is based on mathematically proven facts and within the limits of the instrumentation used today,” he notes.
One reservation Rolf has about RP 34, however, is its complicated vernacular. “We're highly in tune with the [technical] building blocks we need to get us where we need to be,” he says. “[Yet] there are those who would rather see the information summarized in a form that companies could more easily understand.”
User-friendly document
By contrast, this perceived need for “user-friendliness” is the cornerstone on which RP-27 was drafted, according to working group chair Gary Knoth, who is also a senior principal contamination control engineer at Western Digital Corp. (San Jose, CA).
Knoth says the document organizes and adds to information on cleanroom personnel practices and procedures that is available, but not easily accessible.
“The approach we took was to lay out the document in the order you need to start a usable program,” he explains.
RP 27 defines terms used in relation to cleanroom personnel systems in microelectronics and precision assembly, but much of its content can also be applied to pharmaceutical and biomedical facilities. However, Knoth notes that the document does not specifically address aseptic concerns. Its main topics, outlined in a logical progression, include hiring procedures; training and compliance; hygiene and health; gowning; cleanroom entry; behavior in the cleanroom; change room and garment storage design; monitoring and auditing the cleanroom and personnel; gowning system management; and cleanroom exiting and evacuation.
RP 27 also offers insight into current guidance. “For example,” Knoth says, “RP 3 has some garment information, but not specifics like what to consider when hiring a laundry or the differences between leasing and owning garments. Our document does. We spell out everything.”
The real boon associated with this document, Knoth believes, is that it was written by 15 to 20 leading cleanroom professionals from the user and supplier communities.
“Experts in specific areas wrote the sections and then I flowed the parts into a single source,” he says. “It puts both user and supplier groups on an even footing.”
Based on calls from people requesting the information, Knoth says RP 27 serves a real need. Observations from the field tout the document as a means to offset operational or procedural shortcomings.
John Plata, who is employed as a member of Texas Instruments' (Dallas) worldwide construction fab design group, says that his experience has shown him that every fab has its own way of doing things.
“Fabs base their operations on best practices, but management teams pick and choose how they want to comply,” Plata contends. “There's not a lot of cross-referencing available. I'd say there's about a 50 percent correlation between fabs and procedures, so having this kind of a formalized reference guide is going to be important to industries.”
To date, the IEST has sold 13 copies of RP 27 and 18 copies of RP 34. Representatives say those figures are in line with demand. The average number of copies of a recommended practice sold is 27.
“We're going to start selling our publications on-line and we expect to see more interest and interaction at that time,” says Roberta Burrows, senior editor/special projects of the Journal of the IEST.
For more information or to order recommended practices, call the IEST at (847) 255-1561 or visit its Web site at www.iest.org.
Master plans and bottom lines affect drug deliveries
New Haven, CT- “The pharmaceu-tical industry is speculative and mistakes are costly so a good master plan is critical to the health of a business,” explained Kenneth Crowell, manager of engineering services for Bayer Corp.'s pharmaceutical division, at the International Society for Pharmaceutical Engineering (ISPE) New England chapter's May meeting.
The meeting featured a presentation by senior managers from Bayer (New Haven, CT), who discussed the rewards of integrating master site planning with business objectives.
Paul Planz, manager of project engineering for Bayer's pharmaceutical division, adds that for years the company has utilized master plans to manage its growth, including a major site expansion started in the late 1980s.
Both claim the concept has allowed Bayer to keep pace with projected industry activity, while reducing risk. For example, to meet its business goal of increased market share, a fact-finding process incorporated into its master planning efforts allowed the pharmaceutical division to determine drivers of office growth. As a result, specific facility, infrastructure and capital requirements were identified, such as an immediate need for extra lab space.
Attendee Jonathon Savona of Siemens Building Technologies Inc. (Cromwell, CT) believes this type of dialogue between companies is practical, especially among industries that consider most information proprietary.
“You get a lot of good hints,” he says of business-related seminars. “There are a lot of things that can't be shared in pharmaceuticals, but this (kind of discussion) is needed in an industry that moves forward in such a rapid fashion.”
Preparing for Y2K
Top chipmakers complete tool fixes
AUSTIN, TX – The world's top semiconductor manufacturers have met a self-appointed deadline of June 30 to update equipment software with Year 2000 fixes.
With the help of research consortia Sematech (Austin, TX) and International Sematech, such companies as Intel, Motorola and Hyundai have completed cleanroom equipment remediation and are now looking ahead to contingency plans for the New Year rollover.
The effort to fix equipment software bugs began two years ago, says Harvey Wohlwend, program manager of Sematech's external Y2K project. As requested by its member companies, 14 of the world's leading manufacturers, Sematech compiled a database of front- and back-end equipment currently in use in fabs, identified the suppliers of the tools, then solicited Y2K status from those suppliers.
The consortium also defined a “consistent, minimum set of test scenarios to run against test equipment and made those publicly available on the Sematech Web site so that companies could download and use them,” Wohlwend says.
In a typical fab, about 55 percent of the tools required fixes. “For newer fabs with more software, more functionality and more factory automation, 90 percent of the tools needed remediation,” he says.
With tool updates completed, the industry is now turning to Y2K public infrastructure issues, such as potential electrical disruptions. Sematech is tracking utility preparedness, working with manufacturers and suppliers on contingency planning, and brainstorming “what-if” scenarios.
Wohlwend says that rather than developing Y2K-specific contingency plans, most fabs are relying on plans already in place for incidents like power disruptions and chemical spills. As a further precaution, however, some manufacturers may put equipment on standby during the New Year rollover to minimize wafer loss in case of a power disruption. Others are weighing the business issues of building up a backlog of product.
By mid-May, Intel (Santa Clara, CA) and the Semiconductor Products Sector of Motorola Inc.(Austin, TX) had completed remediation on more than 95 percent of critical and priority manufacturing systems. External power, water and gas infrastructure stability and availability now top Y2K priorities, both companies say.
“We still have a lot of work to do – working with customers, the entire supply network and infrastructure suppliers,” says Bill Calder, Intel spokesperson on Y2K issues. “We are looking at all the backup systems, assessing where we may have issues with power, water and transportation, and developing plans in those locations where some of the infrastructure suppliers may not be ready. And at the same time, we are trying to get them ready.”
Most of Intel's dozen fabs will rely on backup power already in place. “We have made a thorough assessment of the readiness of power suppliers in those areas. If we find a power supplier is not ready, we may install additional backup,” Calder says. Intel typically places its fabs into a warm-down mode during New Year rollovers and will continue the practice this year. Motorola also plans to idle fabs during the rollover.
Motorola does not plan to generate enough power on-site to keep fabs fully operational, says Gary Kleinkopf, vice president and director for the Y2K Initiative. “We do, however, have EHS [environmental health and safety] generation capacity at all of our manufacturing sites and also have backup where there is a need for uninterruptible power at other critical sites, such as mainframe computer facilities.”
Fabs in developing countries are of greater concern, Kleinkopf says. “It is generally understood that developing countries are not progressing as rapidly as might be necessary to become Y2K ready. Where we have concerns, we are urging the infrastructure providers in those countries to accelerate their Y2K efforts.”
Whatever the outcome of the software-induced millennia problem, Wohlwend says that Sematech member companies have taken great pains to be prepared. And, there's still time to plan. More information on Sematech's Y2K project is available at www.sematech.org.
Insurance companies take preventive stand
JOHNSTON, RI – Worldwide, the “millennium bug” may cause devices run by computerized equipment, or those containing miniscule date-sensitive microprocessors housing embedded logic, to malfunction or fail when clocks tick from one century to the next. Within a second – amazing potential for astounding damage. Although there are no reliable statistics, worst case, this Y2K bug has the potential to cause billions of dollars in damage.
Rather than concentrate on the loss, FM Global (Johnston, RI), insurer of nearly half of the top 20 semiconductor manufacturers, puts its efforts into prevention. In January 1999 FM Global put into action a dedicated effort to alleviate problems. After providing additional training to its field engineers who work at a facility level, and account engineers specializing in corporate risk management, FM began to entice parties to join forces to combat Y2K uncertainty in its customers' cleanrooms.
“Although we are visiting customer locations, we aren't conducting inspections,” says Paul Higgins, a semiconductor specialist in the FM Global network. “We aren't doing audits of Y2K – telling clients what they're doing wrong. Rather, we are loss prevention experts, and our clients are production experts. There are certain things from a loss-prevention standpoint that we bring to the fore to see if these issues have already been addressed. We also discuss the elements of an effective contingency planning program.”
Meeting contingencies
Within a semiconductor fab, a major concern given Y2K is the disruption of electrical power. Within the U.S. and other developed countries, disruptions in quality and voltage of a few minutes' duration are expected. In developing countries, however, blackouts may occur for several days.
The question becomes not how long the power will be off, but what would a loss of electrical power do to production equipment, air handling systems, control systems for hazardous material, including flammable or toxic gases and liquids? And how will each company deal with the loss of power?
The important thing about contingency plans is that they be rehearsed. The major issues in the plans should be complete loss of electrical power; chemical spills; losing heat in cold climates; and security.
Assessment
Assessment should begin with a review of existing control systems, production equipment and required versus available emergency power. Are any of the control systems, for example, date-aware? If they fail, would a hazardous situation result, such as opening up valves for gases or chemicals and releasing them directly into the cleanroom or into equipment not prepared to receive them, or cause overflow in tanks?
Second is concern for damage to production equipment. If power is lost, a stepper, for an electrical furnace may be damaged. When a furnace cools too quickly, quartz tubes may be damaged. Steppers, if they lose cooling and a supply of clean dry air, optics may cloud over and alignment devices may potentially lose their alignment or “fix.” Some such situations may take a long time to recalibrate, or in some cases, the tools may need to be returned to the manufacturer to be fixed.
In the course of checking the controls between smoke detection systems and emergency smoke exhaust fans, in a few cases FM found, for example, that someone had disconnected the two. The smoke exhaust system wouldn't have worked. That's not something that ordinarily would be checked from one end to the other.
Most plants retain some form of emergency power, normally sufficient to support life safety systems – keep emergency lights on and hazardous fume exhaust running to some level, if not full capacity. Very few plants, however, have enough emergency power to generate capacity enough to keep the equipment warm and calibrated, supply inert gases, etc. And no one has enough emergency power on site to keep air-handling systems running.
Recommendations
FM Global recommends companies take additional steps for safety. In the case of a stepper, if the exposure is such that it loses clean, dry air, then FM suggests hooking up an emergency supply of compressed air from cylinders to last a few days, to keep the optics section dry and clean. In some cases, site managers rent emergency generators to park on site that are large enough to keep air handling systems running – if not at full capacity, at least to maintain a fair degree of cleanliness, humidity and temperature.
“There are a lot of issues we bring up that most companies haven't considered,” says Higgins. “They tend to put their focus on production equipment compliance – rather than a functioning safety system. In several cases, companies we've talked with haven't considered checking their fire and security alarm systems. Specifically in developing countries, representing approximately half of the semiconductor fabs in existence, this means putting extra security in place.
If possible, it makes sense for fabs to be placed in a safe, idle state during the New Year rollover, taking an opportunity to perform annual preventive maintenance. In most cases, during an annual shut down, the main electrical switch gear is taken offline to test circuit breakers, clean out panel boards, etc. And, normally, mobile generators feed directly into air handlers, lights and critical tools.
Results
“Initially reception to FM's Y2K program was slow,” says Higgins. “A lot of companies were hesitant to talk about Y2K given the sensitivity of product liability. Now that the companies understand we aren't conducting an audit, and that we're helping in a meaningful way, the reception is very good.”
Qualifying cleanroom products
STUTTGART, GERMANY – The Fraunhofer Institute for Manufacturing Engineering and Automation IPA (Stuttgart, Germany) is seeking incorporation of its cleanroom product-suitability qualification test procedures and requirements into Germany's Association of German Engineers (VDI) 2083 Guidelines. The IPA is currently participating in discussions with the VDI taskforce regarding the establishment of a national testing standard for products suitable for cleanrooms use.
The question of product-suitability testing standards and procedures, whether conducted by suppliers, third-party laboratories, or end-users continues to be a hot topic throughout the cleanroom industry (see “Third-party testing lab certifies cleanliness levels, CleanRooms, May 1999, page 1), but by working through the VDI and ultimately the International Organization for Standardization (ISO), the IPA hopes to help solve the problem by encouraging the adoption of international standards and guidelines.
For a number of years, the IPA has been testing the suitability of products for use in such clean manufacturing environments as measuring instruments, process equipment, robots, lights, furniture, and so on. Recently, however, in response to customer requests, it also began supplying certification documents and an IPA seal of approval that manufacturers can affix to their products.
According to Jochen Schliesser, group manager for cleanroom manufacturing, the appearance of the IPA seal on a product indicates that it has undergone “reliable and independent testing and that the results have been documented and evaluated relative to its suitability to cleanroom use.” Each seal identifies the specific classification of the product tested as well as the IPA report number upon which it is based.
As Schliesser points out, the determination of cleanroom suitability can be a complex problem. “When you talk about cleanroom suitability, you have to consider the potential contamination hazards for each and every product type being manufactured. As a result, the question of cleanroom suitability often becomes more of an issue of the product being manufactured than a particular cleanroom class.”
For example, whereas a Class 100 cleanroom used in the manufacture of electronics may be particularly concerned about particulates and electrostatic discharge, a Class 10 pharmaceutical room will be more concerned with biocontamination. “We have to consider the contamination-control concerns for each potential manufacturing environment,” says Schliesser. To meet industry needs, the IPA conducts its testing and reports its results relative to the restrictions of all potential cleanroom classes or product manufacturing environments in which the product may be used.
The certification process begins with a discussion of the qualification procedures between the IPA and the potential customer, followed by a written proposal of the testing to be performed and its cost, Schliesser describes. The cost of IPA qualification can vary depending on the type of equipment and the level and extent of testing required, ranging from as little as 2,000 DM ($1,100) to 50,000 DM ($26,800) for certain process equipment. But, according to Schliesser, “In the last few months, we've been inundated with requests for product qualification, which gives us a good indication that our costs are in line with expectations.”
In addition to the IPA qualification seal and certificate, the institute now also provides customers with an extensive test report and documentation package. Included in the kit is the “IPA Qualification Toolbox,” which aids manufacturers in using the report materials in the sale and marketing of their products. On request, customers can also receive confidential detailed analyses of any weaknesses found in their products or recommended areas for improvement. Documentation and tools are provided in both hard copy and digital (CD-ROM) format.
The IPA is also now seeking agreement with its service subscribers to post test data and documentation on the IPA Web site. “This will allow anyone looking for a particular cleanroom-suitable product to come to a central location and see what products have already been tested and qualified,” notes Schliesser. The goal is to have the information on-line by the end of the year.
The most recent meeting of the VDI Taskforce was held on June 24. If adopted, the cleanroom product suitability standard would initially become part of Germany's VDI 2083 guidelines, but down the road, Schliesser hopes the work could also evolve into an international ISO standard.