An MD&DI February 1997 Feature
Device manufacturers are struggling to balance the need for quality cleanrooms with the increasing pressure to contain costs.
Domestic and international regulations, customer demand, competition, and the imperatives of quality assurance are all pressures that are pushing medical device manufacturers to adopt higher standards in their cleanroom manufacturing practices. At the same time, these manufacturers are feeling countervailing pressures from the public, medical practitioners, hospitals, insurance companies, and competitors to contain costs.
These two contradictory sets of pressures indicate the state of mind of many medical device manufacturers today as they consider their cleanroom options. This article presents a brief overview of how several of these manufacturers view their cleanrooms, why and how they use them, and some of the main issues that concern them, followed by some more general observations from various consultants, designers, and vendors.
IMPROVING CLEANROOM QUALITY
For many of today’s device manufacturers, the decision to upgrade their cleanrooms--or to build new ones--comes largely as a result of what they perceive to be an increasingly regulated industry. Ruth Semlak, manager of sterilization and laboratory services at St. Jude Medical, Inc. (St. Paul, MN), says her company recently went through a complete renovation of its cleanroom in large part because of an increasingly regulated environment. Semlak estimates that the upgraded cleanroom, which cost approximately $500,000 for a 4400-sq-ft Class 10,000 area, will take approximately $8000 a year to monitor and maintain once it’s up and running. The former cleanroom was totally gutted and new flooring and wall materials were installed during the remodeling. Additionally, the air-handling system was updated to better control the airflow rate, the number of gages was increased, and the monitoring of particulates and microbiological flora was upgraded.
Semlak says the renovation has been driven largely by the fact that "more and more auditors have been asking questions and reviewing environments. We’ve already been through a couple of audits from officials asking for supporting data. I anticipate this happening more, and more standards will come into play. Before, the cleanliness standards were driven by the semiconductor industry. But now they’re being specifically designed for our industry, especially standards relating to process control."
Documented process control is especially important at the time of an environmental disturbance, such as when hurricane Hortense affected St. Jude’s facility in Puerto Rico. "There were power outages and water shortages, and dirty air was getting into the clean environment, so we had to know everything that needed to be done to get the cleanroom up and running again," Semlak explains.
To ensure process control, a program has been set up to provide quarterly in-house monitoring, including checks such as leak testing and calculations of air changes per hour, with annual certification coming from an outside source. An important dynamic, Semlak says, "integrates the human element with the equipment. People need to understand what we are doing and why we are doing it."
Using videos to train cleanroom personnel--including those in remote sites and janitorial workers--has been very helpful, according to Semlak. "Janitors have usually been trained to clean schools or offices," she says. "But if they are trained to dry out equipment rather than store it wet and to notice things that could potentially contaminate the environment, they can be very helpful."
Nancy Bowers, cleanroom technologist at Cobe Laboratories (Lakewood, CO), a manufacturer of medical devices for heart/ lung surgery, kidney dialysis, and blood-component therapy, says her company is also concerned about improving cleanroom conditions. "We’ve worked to improve cleanliness by bringing in cleaner consumables and manufacturing materials, and by training our housekeeping personnel better."
Bowers reports that the company’s four cleanrooms have undergone dramatic improvement of cleanroom procedures, thanks to a much greater focus on training over the past year. "Training had previously brought about a gradual change, but it’s been greatly enhanced because of the International Organization for Standardization (ISO) requirements. The international mandates are forcing cleaner and cleaner manufacturing cleanrooms."
On the other hand, Darrell Otte, senior project engineer at Medtronic, Inc. (Minneapolis), says that regulatory and competitive factors are also important for his company. "The nature of our products has required us to manufacture in a controlled environment. We also take advantage of two of the controls. The first is control of temperature, which greatly improves employee comfort when wearing cleanroom attire. The second is humidity control, which is used to help control the electrostatic discharge that occurs in the fall and winter, when the temperature drops considerably in Minnesota."
Dick Mack, vice president of marketing and sales for Mid-State Plastics (Seagrove, NC), says that a combination of regulatory, competitive, and cost considerations is leading to "a major trend toward more complete assembly of parts." Previously, his company would send customers the unassembled components of its various devices (mostly blood filtration devices, oxygenators, and surgical saws), but now, Mack says, "we do everything through the assembly of the parts to the decorating of the packaging."
This also gives the company a competitive advantage, he says, allowing it to become a virtual one-stop center for his customers. "Our assembly costs are lower than our customers’ costs because of economies of scale. We can assemble 2 to 3 or 20 to 30 parts in the same room, saving our customers the costs that would be required to use their own cleanrooms."
Tim Ryan, director of engineering at McGaw, Inc. (Irvine, CA), says cleanroom procedures are necessary both to meet regulatory requirements and to ensure the consistency of product cleanliness of his company’s IV drug-delivery tubing sets. Ryan adds that, although cleanrooms can be expensive, they are much easier to set up and maintain now than they were in the past. "Now you can go to a catalog and order everything you need to operate a cleanroom. At one time this wasn’t so easy because a lot of things were not available. And when it comes to the machinery placed in the cleanroom, more manufacturers are aware of what’s needed in these controlled environments than they were in the past."
Thomas Brust, president of Micropure Medical, Inc. (St. Paul, MN), agrees that today’s regulatory environment has influenced manufacturers’ needs for quality cleanrooms. "The general consensus is that the cleanroom has become more necessary and prominent now that regulations have improved and people are looking for higher-quality products than they were a few years ago. Now there is a much greater focus on process rather than product. Rather than inspecting the product, you’re checking the process and process controls to make sure the product comes out consistently all the time."
According to Brust, this is especially important for contract manufacturers that do a wide variety of work, from small-lot implantables to high-volume disposables. Some of the key processes include bringing products into and out of the cleanroom, handling the products, preparing the work surfaces, physically separating various lots, and gowning and gloving. "Sealing and labeling are also key issues that can be easily overlooked," Brust adds.
Brust says most people don’t understand how cleanroom manufacturing and sterilization interact. "Anybody can build a product in a cleanroom, but the important thing is having all the processes and controls in place so that the product is protected beyond the cleanroom until it reaches the user. Most contract cleanroom manufacturers will put their product into a box and send it out for sterilization," he says. "We’re one of the few contract manufacturers that offer both services under one roof. And because we do the sterilization in-house, we control and monitor the process."
Following is a breakdown of cleanroom costs offered by Richard Matthews, president of Filtration Technology, Inc. (Greensboro, NC), and chairman of the International Organization for Standardization's Technical Committee 209 on cleanrooms and associated controlled environments. The numbers in column one refer to the amount of particles (0.5 µm in size and larger) per cubic foot of air.
|Type of Cleanroom||Cost (per sq ft)|
CLEANROOM OPTIONS VS. COST CONTAINMENT
The pressure to have better cleanrooms is growing, but so is the pressure to contain costs. For this reason, says Brust, "companies are looking to outsource many of their products, especially disposables, so they can concentrate on product development and distribution. Historically, we’ve always had small start-up companies coming to us for environmental controls. Now we’re seeing more midsized and larger ones. They’re looking for turnkey solutions because they’re discovering the hidden costs in maintaining good cleanrooms."
It’s the cost factor that is leading many device manufacturers to search for a modular, mobile style of cleanroom, according to Brian Weist, president of Innotech Products, Inc. (Minneapolis). "A flexible cleanroom allows the manufacturer to be flexible in altering or reconfiguring work processes, and helps a company minimize the size of the room and the cleanliness level needed for any particular product."
Modularity lets the manufacturer install islands of various levels of cleanliness to obtain the needed results. If a device maker does not require a climate-controlled situation, for example, then soft-wall cleanrooms or flexible curtains can be used instead of rigid walls. "As we get more involved in the global marketplace, people are constantly asking how they can become both more efficient and more cost-effective," Weist says.
St. Jude Medical, Inc. (St. Paul, MN), recently renovated its Class 10,000 cleanroom. The original cleanroom was totally gutted so that, among other things, new flooring and wall materials could be installed, the air-handling system could be updated, the number of gages could be increased, and the monitoring of particulates and microbiological flora could be updated.
Stephen Yellin, managing director of CMPA, Inc. (Grapevine, TX), a design/ build construction management firm, says, "It’s interesting to look at companies both inside and outside the United States in regard to the increasingly stringent standards. I recently went to Mexico City to see a manufacturer who wanted to ship a drug into the United States, but once he saw the basic cost of meeting FDA standards, he changed his mind. He said he will, however, continue to manufacture for other less-regulated countries."
U.S. medical product manufacturers, of course, can’t make such an arbitrary decision. But still, as Yellin (who is also president of the Institute of Environmental Sciences, Mount Prospect, IL) says, "What I’ve seen in the industry in general is that, unless a company is doing very well, it wants to meet the regulations at the lowest cost possible. In the semiconductor industry, people historically spent money on developing standards beyond what was needed. But in the medical device field, everybody is careful. They want us to develop designs that reflect the most efficient use of their funds. They’re not cheating, but they want to comply with the standards at the lowest possible level."
One anomaly of the cleanliness standards, explains Bob Pellizzi, systems analyst for Cordis Corp. (Miami), is that "there are no written regulations that say you even have to have a cleanroom, only that your operations and processes have to result in a safe, effective product. Unfortunately, there is no information that tells you whether or not you need a cleanroom. But once you decide you want one and commit yourself to a particular class of cleanroom, you’re held to the standards for that class and are required to have a periodic outside inspection to show you’re adhering to them."
One obvious way out of this dilemma is not to have a cleanroom if it is not absolutely necessary. And this, in fact, is a choice more and more device manufacturers are making. "What I’ve observed is that quite a few medical device manufacturers have stopped using a classified cleanroom in favor of a controlled or white space area," says Floyd Edwards, designer/analyst at Floyd Edwards, Inc. (Clarence, NY). "A problem occurred in that the European Community’s ISO specifications have become very tight for cleanrooms. I suspect that many products, such as devices that get into the bloodstream, will have even tighter controls than in the past. But there are more and more questions about what really requires manufacturing in a cleanroom and what does not."
Edwards suggests that many device products, such as the majority of surgical instruments, can simply be cleaned and sterilized prior to use. Only those that can become embedded with particulates, such as soft implants and delivery system components, for example, require clean controls during manufacturing. "Before, a lot of manufacturers would automatically put their products into a cleanroom and not ask questions. I see that less and less," he says.
Edwards says that "on the whole, the manufacturers are taking the issues of product quality and regulation seriously, since they might not survive if they don’t. But the industry is also extremely cost conscious. Whenever companies can cut costs, they do. And cleanrooms are one of the areas in which there is a lot of waste. The new Medicare rules will have an impact. They just address cost, not quality. So this is another reason why manufacturers will continue to look at just achieving the quality they need."
For this reason, agrees Anne Marie Dixon, managing partner of Cleanroom Management Associates, Inc. (Carson City, NV), more and more manufacturers are opting for the controlled space over the classified cleanroom. "Being conservative, I would estimate that manufacturers can save 10 to 15% on design and long-term expenses by choosing a controlled environment."
However, Dixon believes that there are a lot of competitive advantages in a manufacturer’s being able to advertise that it’s using a classified cleanroom. On the other hand, she says, "It’s extremely difficult to start off as a classified cleanroom and then back off. If you start with a controlled environment, you can always upgrade to a classified cleanroom if you need to. Starting with a controlled environment will give you flexibility and can save you money."
So what’s a device manufacturer to do? Unfortunately, there are no easy answers. As Dixon explains, "Right now there are a lot of discussions about what is really required and why," leaving individual manufacturers with the often-difficult task of evaluating what’s best for their particular situation.