Consumables: The Essential Commodity
By Sheila Galatowitsch
Without a steady supply of gloves, masks, wipers and other consumables, the cleanroom as we know it would not exist. Consumables are vital to operating and maintaining a cleanroom, and in some industries, they have an even greater impact on the product being manufactured.
“You could contaminate your cleanroom if you are not using consumables that are clean enough, but it really boils down to the products you are manufacturing,” says Larry Ranta, director of M-Con Technologies (Mission Viejo, CA), a consumables testing laboratory. “Consumables have a significant affect on the quality of what you are making. In the case of gloves, which contact the product, transferred particles can affect how well the product functions and looks–just by touching it with a glove that is not clean enough.”
Users vary in listing price, availability or quality as their number one concern when purchasing consumables and deciding on a supplier. To Bob Burns, protocol manager of Environmental Cleaning Services, Inc. (Atlanta, GA), availability and service are preeminent. The company cleans cleanrooms during and after construction and has limited storage capacity at a construction site. Vendors must agree to have consumables in stock with a guaranteed delivery of three days or less, Burns says.
Nancy Bowers, cleanroom technologist at medical device manufacturer COBE Laboratories (Lakewood, CO), says that quality is first. Bowers oversees consumables used by 1,000 employees in the company`s four cleanrooms operating at Class 10,000. Products must pass two critical tests pertaining to pyrogen and cytotoxicity, and to ensure suppliers meet the requirements, COBE conducts vendor site audits. While emphasizing quality, Bowers must also balance price and availability concerns. “Sometimes it requires COBE to pay more for consumables because they have to pass those two tests,” Bowers says. Vendors must keep critical products in stock and provide a 24-hour delivery service. “The glove industry is the big nightmare,” Bowers says. “Everything else is readily available.”
Other users emphasizing quality and availability–with price as a secondary issue–include Pat Warton, senior technical staff member at Rockwell Semiconductor Systems (Newport Beach, CA), and Bart Bartelt, supplier quality engineer at Motorola (Mesa, AZ), who ensures the quality of consumable materials for 16 area fabs.
But for some users it all comes down to price. These users are looking for the lowest-cost consumables they can find–and in the process they sometimes wind up pitting vendors against each other in a price war, say some suppliers. This approach, however, could backfire on a company.
“Hopefully, a company`s management will take quality into account. Consumables have a definite impact on the reject rate of a product,” Ranta says. “If they can live with a 10 to 20 percent reject rate for visible particles, they can buy the lowest cost consumables. But to achieve a 1 to 2 percent reject rate, they would have to invest in a higher quality line of consumables.”
According to cleanroom industry consultant Chuck Berndt of C.W. Berndt Associates Ltd. (Highland Park, IL), consumables can be defined as disposable adjuncts to cleanroom garment systems that are designed to control human-sourced contamination. That definition covers gloves, face masks, hairnets, beard covers, bouffants, sleeveguards, aprons and disposable garment systems, including booties and coveralls. Users interviewed for this article referred to other products they consider to be consumables, such as swabs and wipers, hoods, finger cots, sticky mats, cleaning supplies, mops, HEPA filters and paper products.
Finding the right products
Finding just the right product is not always easy. Pharmaceuticals manufacturer Pharmacia & Upjohn (Kalamazoo, MI) has had a difficult time locating a presterilized mask with ties. After a long search, a supplier for a duck-billed mask with elastic bands was found through a manufacturer`s representative. A mask with ties still has not been located. The company is also searching for a presterilized nitrile glove that is individually wrapped. Most come packaged in bulk. “Eventually vendors will supply this kind of custom order, but it takes a number of months to find one,” says Steve Ball, manager of sterile operations.
The company has not been able to locate a substitute for a sponge supplied from outside the United States. Although the sponge has super absorbency and cleaning characteristics, it sheds. “We can`t find a substitute that works nearly as well, so we have to hand cut it, wrap it and sterilize it ourselves instead of buying presterilized sponges,” Ball says.
Functionality, low particle counts, sterility assurance and presterilization are the key quality features Pharmacia & Upjohn demands. “Then we will look at price and availability. If there is a significant difference in price, then that can be a factor, but price is normally not a big factor,” Ball says. “We focus more on producing good quality product with good yields that meet our time commitments. There is more money to be saved in that area than there is in cost savings in mop heads.”
As an example, Ball says the company uses only disposable gowns–at a yearly cost of more than $300,000–even though it could save money by switching to recyclable gowns. Any cost savings had better be significant to get the company to switch from proven products and suppliers. “Unless it has a sizable cost savings, I`m not willing to spend the time to make the change,” he says. “One of the big issues is resources. There`s some opportunity to save money on commodity items, but we need more people to do the research, investigation and follow-up. We are too busy fighting the day-to-day fires in a production environment.”
Another factor against penny-pinching is operator acceptability. Saving a dime per mask will be meaningless if operators dislike using a particular brand. And supplier loyalty means vendors will be more likely to respond quickly when problems occur. Pharmacia & Upjohn recently had problems with gloves ripping and mask bands breaking. In both cases, production personnel worked with the suppliers to solve the problems satisfactorily.
Quality takes priority over price of consumables at Boeing (Huntsville, AL), where cleanroom assembly of the International Space Station is beginning. Dale Albright, who leads contamination control and cleanroom operations, says the program requires high quality products. “Price should not be the deciding factor in choosing consumables,” Albright says. “Quality is number one.” The company does its own in-house testing to qualify cleanroom materials for use on the Space Station elements. “When we test wipers, for example, we look at particles and nonvolatile residue extractables. Once lab results come back and we get an approved material, we put it on an approved list of materials.”
Stockroom technicians can call for delivery of new items when the supply gets low. This system works well for the most part, Albright says, however, “one problem we encountered was the substitution of items that were not on the approved list. Items were being ordered that were thought to be equivalent, but were not.” To eliminate the problem, the company established a single-source supplier for cleanroom consumables.
Getting the right service
For Larry Mainers, president of TEC International (Atlanta, GA), “the issue comes down to price and service, and I would put service above price.” Mainers` company provides clean-build and sustainable cleaning services for cleanrooms, and in his view, “there is zero tolerance for not having consumables. If the fab needs them for service or production people, you can`t be without them.”
Mainers says he has been disappointed by vendors` lack of knowledge about where their products are and how quickly they can deliver them. Because cleanroom facilities do not always have the sufficient storage space for supplies, “we commonly run into situations where we need to have the right product delivered at the right time, and we have been amazed how very often people taking the orders are not familiar with the product and cannot guarantee delivery,” Mainers says.
“We`ve noticed that some of the largest clients will get first class service because of the volumes they are purchasing, but new fabs being built and fabs that don`t have millions of dollars in inventory don`t get that kind of service,” he says.
Mainers has had to “hunt out those companies willing to commit themselves to delivery,” and he often pays more to get the right service. He recommends that suppliers “remove order- takers from the loop,” while users should insist upon a dedicated salesperson who knows about your company`s needs and will ensure a smooth line of communication from order to delivery. “So when you have a problem, you don`t get a order-taker,” Mainers says. “You get someone who realizes the urgency.”
The business world in general is going away from stocking inventory to overnight delivery. “The cleanroom consumables industry is going to have to follow that lead and develop a way to ship product overnight to the customer,” he says. “It gets down to dollars. If vendors sense that their sales are going to be hurt, I think the industry will respond.”
Jeff Smith, president of consumables distributor Ultrapure Technology (Suwanee, GA), says he has seen an increased interest in “consigned inventories.” This level of service makes the supplier responsible for keeping proper levels of inventory stocked in a user`s storeroom. The user is billed only for what is used. The service`s main advantages are less waste and less over-ordering, Smith says.
Working with purchasing
Standing between consumable users and suppliers in many cases are the buyers–the purchasing groups in companies that sometimes clash with engineers over specs and with vendors over prices. Engineers report that buyers sometimes try to substitute nonequivalent items, and vendors claim that buyers lowball prices.
It is true there are problems, says one buyer from a filter manufacturer, who preferred not to be identified. His company has solved the problem in two ways. For one thing, each group now has its own budget, so the burden and responsibility for costs is more targeted. “By making [users] responsible for X amount of dollars, then that puts them into a position where they have to keep track of it,” the buyer says. “Before, it was chaos.”
The company has also involved purchasing in the product lifecycle from R&D to production. “In the past it was a problem because purchasing and R&D didn`t work together. But now, with the support of management, purchasing is involved in ordering supplies from the beginning of the product cycle to the end. The good companies will do that because they know purchasing will save a lot of money.”
All three entities have different roles but must work as a team, says Jon Martin, purchasing manager at Photronics (Brookfield, CT), a photomask manufacturer. If one player steps outside of his role, communication breaks down. “Suppliers sometimes don`t want to speak to a purchasing agent or a buyer. It`s easier to sell an engineer on the product, hoping it will be specified,” Martin says. “I`ve also seen engineering departments that call in suppliers they would prefer to deal with.”
“The ideal way is for engineering and purchasing to get together first. The purchasing department`s job is to buy what the engineer has specified. Then the purchasing department interviews suppliers and negotiates the price. Ultimately, my job is to get the highest quality product I can for the least amount of dollars.”
What bothers Martin, as well as many of the users interviewed for this article, is that there is no standard way to compare manufacturer`s quality claims. All measure their products differently, using different specifications and test methods.
Another user pet peeve is suppliers who describe a product as a certain class, such as “Class 100 gloves.” Classifications per Federal Standard 209E refer to the cleanliness levels in a cubic foot of air, not to products. A designation as a “Class 100 product” is meaningless and misleading, critics say. A better description would be “compatible for use in a Class 100 cleanroom.”
But what the industry really needs is to eliminate as many of the variables as possible in sample preparation and testing, says Martin Grossman, directory of laboratory services for Particle Measurement Technology (PMT; Ventura, CA), an independent testing laboratory. Although users will continue to develop test protocols specific to their industry and product, agreement on generic sample prep and testing methods will help give the industry a common interpretation of quality claims, he says. Grossman is a member of the Institute of Environmental Sciences` working group committee on consumables testing, which meets twice yearly to discuss test methods.
The committee is now considering a proposal that would require manufacturers to identify the method detection limits used in extractables testing. “Currently, if a supplier tests a product using a method detection limit of 100 parts per million and discovers nothing, they may state it has no detectable amount of materials without mentioning what the limit was,” Grossman says.
Meanwhile, another company could be testing extracted materials at 1 part per million and also reporting no detectable amount of extractables. Users are unable to determine which manufacturer has a lower detection limit, and therefore a better test result, because detection limits are not defined in product data sheets. The committee will discuss this proposal further at the Institute`s annual meeting this May.
New and proposed testing methods
The committee is also searching for a wet test that would replace the Helmke Drum method, the method currently used for testing garments and other consumable materials. Helmke Drum has several drawbacks, Grossman says. For one thing, it does not generate sufficient particulate matter to validate cleanliness levels. “A wet test can generate higher levels of particulates and give a better indication of cleanliness. All proposals are on the drawing board, but nobody has come up with a good method yet,” he says.
In addition, a new way to test swabs is under consideration, and several labs are now testing a new device proposed by swab manufacturer Texwipe. The device holds up to 16 swabs and spins them at a given rate in a beaker containing the solvent or liquid of interest. The device would help standardize swab testing results.
Most of the recent testing focus, however, has been on improving glove tests. The Institute of Environmental Sciences` committee adopted several new testing recommendations at its May 1996 meeting. The major change involved Recommended Practice (RP) 5.2, which now substitutes an orbital shaker for a biaxial shaker in the test formerly known as a biaxial shake test. This change reflects common practice and encourages the industry to standardize on the orbital shaker. Also added to RP 5.2 are a weight-based equivalency method to determine the surface area of a glove and a copper strip test for corrosion.
In addition, committee members are discussing several proposed test methods for near-zero mechanical stress tests on gloves. One is modeled on RP 4 for wipers. Gloves are placed in a photographic tray and soaked with extract water, which is then tested for the particulates it contains. PMT is using this tray method, but it has also developed a prototype device that will help eliminate variables in sample preparation. A fully operational unit will be demonstrated at the May meeting, where committee members are expected to vote on a near-zero mechanical test method. A microorganisms test for gloves is also under discussion.
The Institute`s RP already includes a chemical compatibility test to demonstrate how gloves react to various free agents, such as DI water, strong acids, bases and solvents. The compatibility test looks for glove swelling, shrinkage and other signs of degradation. But PMT and other labs have initiated a chemical permeation test that goes a step further, Grossman says. It subjects gloves to an eight-hour exposure to various free agents to determine the material`s ability to resist permeation. For example, nitrile gloves are showing no permeation after eight hours, while certain latex gloves don`t last more than a few seconds, Grossman says. The labs are continuing to use the test on both gloves and wipers to establish valid statistics.
The testing community is also using a scanning electron microscope (SEM) to identify certain types of particulates on the surface of any consumable product. Semiconductor and disk drive manufacturer protocols require identification of certain particles, such as magnesium silicate, Grossman says. Attaching an energy dispersive X-ray (EDX) probe to the SEM lets users simultaneously detect all the elements on the periodic table above atomic number five, boron. Another method capable of identifying specific contaminates is the Fourier transform infrared analysis (FTIR) test, which can detect the presence of silicone oils or primary amides.
Better testing methods will help prove the overall quality of consumables, but experts also recommend that users conduct manufacturer and distributor site audits. “It`s very important to ensure that what you are getting meets your specifications,” says consultant Berndt. “Users need to see supplier facilities, how they operate, and that they are in fact capable of delivering what they say they can deliver.” Pharmaceutical companies conduct more site audits because the industry is regulated, but many other users fail to schedule what can be an expensive and time-consuming–but extremely important–yearly ritual.
Conducting a site audit
Site audits are based on ISO 9001-9002 procedures, says Hank Eaton, vice president of the consumable group at Prudential Cleanroom Services (Milpitas, CA). Process consistency is the key. Once a manufacturer has agreed to meet user specifications, any deviation from the process could cause a problem in the product.
After confirming that a manufacturer has established ISO procedures, users should verify that these procedures are being followed. Start from the beginning of the process, and ensure that the raw materials used in manufacturing meet specifications and are stored properly. The raw materials may be tested onsite or samples collected for laboratory testing.
Track the ISO procedures through the entire process to the manufacturer`s outgoing quality assurance. Verify that material safety data sheet information meets your specifications, and arrange for additional product testing if necessary. Audit your distributor to ensure that the company is performing incoming inspection lot sampling and testing, and that the product is handled and stored appropriately for the climate.
During a site audit, visually examine a supplier`s facility and organizational structure. How are raw materials received, stored and inspected? What are the quality assurance standards? How clean is the facility? Are production personnel dressed appropriately for the work? Suppliers must be able to demonstrate a track record of consistently following established quality assurance standards–not just on the day of your visit, but a well documented policy that proves this is an ongoing practice.
Regular site audits by major users have improved quality for the entire user base, Eaton says. They also help build communication and trust between users and suppliers–two key ingredients that help users get the right consumables at the right price and time. n
Cleanroom apparel is offered by Connecticut Clean Room Corp.
Another consumable is Contec`s Edgeless Mop.
Cleanroom computer paper is another consumable from Connecticut Clean Room.
Texwipe`s black wiper–a consumable/disposable product.
Glove liners from Berkshire.
Contec`s Quiltec wiper.
CT International is unveiling their newest glove, the Clean Class Nitrile glove.
Worklon`s frocks and smocks.
Quality may be the number one concern among users, but companies still like to save money.
Following are some tips culled from users and suppliers to help control costs of the essential commodity–consumables.
Get more than one– preferably three–quotes on supplies. It may sound simple, but it`s a good practice to follow.
Get volume pricing rates by using one supplier for all your consumable needs.
Order the right supply in the right amount. Some companies order equal amounts of consumables in incremental sizes, but certain supplies and sizes are very rarely needed or used.
Build an accurate profile of the volumes and sizes needed for your cleanroom, and order based on the profile. Consumables purchased but not used eventually become unusable. Ordering exactly what is needed will pay off in long-term savings.
Don`t automatically accept a price increase. Sometimes a price increase cannot be avoided, but always determine the reasons for the increase.
Investigate consumables that are also recyclable. They cost more initially, but some suppliers say reusable consumables can save a company 30 to 40 percent over the long haul.
Consolidate shipments and invoices to avoid cutting multiple checks.
Ask your supplier for suggestions on ways to reduce costs and alternatives to costlier products.
A good supplier can find ways to save you money. –SG
Niche consumables market growing
There is no hard data to support it, but the consumables market is growing. A survey of major research firms turned up no information on this small segment of the cleanroom market. Company data is also scarce because most consumables manufacturers and distributors are privately owned and reluctant to provide data for competitive reasons. Therefore, the growth claims are based primarily on anecdotal evidence; for example, all the companies interviewed for this article report increasing use of these products.
The consumables niche is growing because the industries using cleanrooms continue to grow, says cleanroom industry consultant Chuck Berndt. Stalwart cleanroom users, such as the critical assembly, pharmaceutical and semiconductor industries, are experiencing either stable or surging growth, and new industries are starting to implement cleanroom operations. “The food industry in particular is beginning to wake up to using contamination control technologies,” Berndt says.
The implementation of automation and isolation technologies–effectively removing people and consumables from the cleanroom–will have an impact on the market, but not for several years. “The use of isolation technology is in its infancy in the pharmaceutical industry and controversial in the semiconductor industry,” Berndt says. “Its impact will be slow to come.”
Pharmacia & Upjohn, one of the first U.S. companies to install isolator-based aseptic processing lines, will switch from traditional consumables to half-suits and glove ports for the new technology. As isolators become more pervasive, “there will be no gowns, no mops, and not a tremendous amount of air handling to deal with,” Steve Ball says. “But we have a long way to go before that takes affect.” –SG