On-line resource to help bridge user industries
NEW YORK — While process and procedure advancements in contamination control are burgeoning, real-time access to newly published standards and multi-industry advancements in progress is all but impossible. The sheer deluge of data, spanning multiple industries, is staggering. Often, it`s a case of the right microelectronics-gloved hand not knowing what a left pharmaceuticals-gloved hand is doing. Simply, there hasn`t been one viable mechanism in place to share data. Today, that mechanism may be at hand.
A potential solution
In June 1998, American National Standards Institute (ANSI) announced an online information service, NSSN: A National Resource for Global Standards to provide electronic access to standards.
“The idea behind NSSN,” says Ken Peabody, director, NSSN Services, “is that it is a communications tool, designed to bring people responsible for standards together with the people who need to use them. At its foundation is a 280,000-record data
base listing standards from approximately 600 organizations worldwide. A unique service, NSSN maintains a comprehensive list, then points or leads the user back to the source. For example, if IEEE or ASTM is the standards developer, the specific standard is listed, as is information on the development organization and how to contact it.”
The first production version came out in February of 1997, with 160,000 records in the database. In 1998, NSSN began to offer electronic access, where available. Today approximately 11,000 standards are available for direct download — and that number is growing. “We`re also close to having mil-specs available — another 40,000 documents, and access to European norms. We`re converting all of the 10,000 ISO documents right now. The majority of these will be done in June this year,” says Peabody.
The subscription portion of the service, STAR — Standards Tracking and Automated Retrieval, gives subscribers four profiles of their choosing. Instead of just performing a real-time search against the current database, STAR stores requests and, as updates are made and new data comes in, an e-mail is generated listing new activity — identifying the standard title, document number and what prompted the alert. A URL returns the user to NSSN and provides a full bibliographic record. NSSN is open to any standards development organization wanting its information on the site.
Peabody says, “Within the next six months there will be a major transition in the service. Today the actual hosting of the site and the maintenance of the database is done by an outside vendor. We`ll be moving that in house — expanding the search capabilities of the system.
“I have people calling me saying `I`m downloading this standard, and it`s taking 20 minutes.` A year ago it would have taken two weeks. We`re trying to meet their changing needs in cooperation with all of the US standards developing organizations and international organizations,” says Peabody.
A variety of needs and challenges
Why is this type of access important? A variety of organizations focus on contamination control. IEST`s Working Group 9, for example, publishes a compendium of standards, practices, methods and similar documents. The document, close to 70-pages long, includes information provided by such groups as the American Association of Textile Chemists, ANSI, ASTM, ASWP, Space Industries Association, Institute of Aeronautics, American Institute of Chemical Engineers, ASME, NASA, and National Fluid Power. Sources are American, Australian, Belgian, Canadian, Chinese, English, French, German, Japanese, Swedish, and Swiss agencies.
Al Lieberman, chairman of the IEST Working Group, when asked about the sharing of molecular contamination information between industries, replied, “Naturally you hear about molecular contamination challenges more in the electronics industry than in other industries, such as pharmaceuticals, for example. However, in the pharmaceutical industry where it`s assumed there`s no real problem with molecular contamination, there is.”
Tom Barber, technical director at Baxter Labs (Round Lake, WI), says, “He`s right that we`re more conscious of organic deposition in pharmaceutical manufacturing today. The contamination source is our testing of HEPA filters with an oil-based fog that ultimately deposits on work surfaces. Although we`re looking for a better way to test filters, there isn`t a dry method available for us yet unless you use a particle counter — which is what the microelectronics industry typically does.
Barber continues, “There`s a barrier between microelectronics, aerospace and pharmaceuticals because of the focus and procedures being different. I`ve deliberately avoided saying that we`re lagging microelectronics, we`re not. Our requirements for cleanliness are not the same. For example, we`re concerned with a special class of molecular contamination — potent materials or chemotherapy agents. People are making toxic dosage forms, yet can`t be exposed to the drugs. In this context, we`re very concerned about small amounts of contamination. Our concern is that a tiny particle of a chemo agent would get out of a containment room or isolator and into somebody`s respiratory tract.”
“Medical devices represents the best link between our [pharmaceutical] industry and microelectronics. Pacemakers and other sophisticated implantable items contain chips. The FDA is now seriously looking at this. When assembling a pacemaker, it may be important to do so under conditions approaching those that the microelectronics industry uses,” says Barber.
“One area of overlap within IEST is gloves,” Barber continues. “We`re very concerned with gloves for different reasons. They don`t want powder to come off and get chips dirty. We don`t want particles to carry latex from gloves into people. We want to have an IEST method to show the FDA that — here`s how we regulate the particles in our gloves.”
Bob Spector, technical vice president for IEST`s contamination control division says, “You`d like to believe that there`s a cross-section somewhere of all industries, but it does not happen. Not talking to each other has a lot to do with NIH — not invented here. Some aren`t willing to say that someone else has done work and we can adopt it — it`s hard to justify your existence if you`re adapting someone else`s work.”
NSSN can be found online at www.nssn.org.