Oversight of High-Containment Biological Laboratories: Issues for Congress

The federal government responded to the September 11, 2001, terrorist attacks and the subsequent anthrax attacks with increased focus on and funding for biodefense. A key consideration in this response was addressing shortages in diagnostic, clinical, and research laboratory capacity.

Several departments and agencies have increased or are in the process of increasing their laboratory capacity. High-containment laboratories play a critical role in the biodefense effort, offering the hope of better responses to an attack and a better understanding of the threat posed by bioterrorism. However, they also could increase the risk of a biological attack by serving as a potential source of materials or training. Indeed, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommends tightening government oversight of high-containment laboratories.

Policymakers have become increasingly interested in the oversight of these facilities following reports of accidents, regulatory noncompliance, and community resistance. The increase in highcontainment laboratory capacity has raised new policy questions and emphasized existing ones. How much laboratory capacity is enough? What is the necessary federal investment? Should laboratories be consolidated or dispersed? What plans exist to coordinate multiple agency efforts to expand high-containment laboratory capacity? Does increasing laboratory capacity increase the risk of accidents and the opportunity for purposeful misuse? What is an acceptable balance between the benefits these laboratories provide and the risks they pose? Interested Members of Congress might take action to address some or all of these concerns.

Alternatively, they might defer action until efforts currently under way assess and make recommendations regarding the existing regulatory structure. If Congress chooses to enhance oversight, it might require a survey of existing facilities and their use and a national needs assessment, perhaps barring further construction until these are complete. Stakeholders could focus on enhancing self-regulatory activities such as improving or standardizing laboratory worker training or building a mechanism for sharing lessons learned. Rather than relying on selfregulation,
policymakers might enhance oversight through additional regulation of ighcontainment facilities, requiring laboratory or personnel certification, or by broadening the Select Agent Program. Which agencies should implement any new mandates remains an open question.

Biocontainment technologies are widely used by scientists around the world. Efforts to increase control of U.S. high-containment laboratories may put domestic industry at a competitive disadvantage and inhibit international academic collaboration. Absent international harmonization, the United States can only partially address the threat of a high-containment laboratory being the source of a bioterror weapon.

A key task for policymakers is to define their goals for enhancing oversight of high-containment laboratories. The focus of the oversight effort may affect which policy issues are addressed. For example, focusing on a registry of existing high- containment laboratory capacity may improve planning, coordination, and efficiency of use but provide relatively limited security benefits.

Similarly, a rigorous oversight program including facility and personnel licensure, mandatory training, and restricted construction of new facilities may provide security benefits at the cost of regulatory burden, increased federal expenditures, and impeded scientific progress in countermeasure research, bioforensics, and public health. When weighing options to address these complex policy issues, policymakers may have to reconcile many competing and potentially conflicting national needs.

Frank Gottron
Specialist in Science and Technology Policy

Dana A. Shea
Specialist in Science and Technology Policy

May 4, 2009

Technologies Impact on Medical Device Clean Rooms

Over the years, medical device cleanrooms have become more cost effective in both initial cost and operating cost due to advances in technology and methods.

My first experience with cleanrooms was in 1967 with the first laminar flow room built for Honeywell's Solid State Electronics Center in Plymouth, Minnesota. That room has been in constant use for 39 years. There were no filter changes in those 39 years. The system was upgraded with ULPA (ultra low penetration air) filters in 2004 even though the HEPA(high efficiency particulate air) filters were not loaded.

Then in the early 1970s, Medtronic built their headquarter campus on the north side of the Twin Cities. Manufacturing was moved from St. Anthony to the new campus and a new cleanroom. This room was the first cleanroom for medical device manufacturing in the area. It was a "unidirectional" cross flow design. It has been in continuous use since it was constructed. In the beginning, a cross flow design was selected because all the manufacturing was done in one room, with the dirtier operations in the return end and the final assembly, cleaning and packaging near the supply wall.

Throughout the next 15 years or so, rel=nofollow [http://www.gerbig.com]medical device cleanrooms used ducted modular HEPA filter systems and walls constructed of gypsum and coated with epoxy paint. The Class 10,000 room was the norm for medical device manufacturing. The filtration system began to change in the 1980s with the introduction in 1983 of the fan-filter unit by Envirco, Inc. in Albuquerque, NM. At first, it was thought this system would be too noisy for most operations, but over time this objection disappeared as the new unit proved to be very quiet. Today, over 90% of medical device cleanrooms use the fan-filter system. The reasons are straightforward:


Lower first cost.
Lower energy consumption.
Easier to add or subtract HEPA filtered airflow to any space.
Easier to take the investment in filtration to a new location.


Fan-filter units today have two basic motor-drive systems: a) permanent split capacitor motor and b) DC motor with built-in rectification from AC supply voltage. The DC motor option lowers energy consumption while maintaining airflow throughout the life of the HEPA filters. The motor automatically adjusts rpm to deliver constant flow through the HEPA filter. One change in medical device cleanrooms that we are beginning to see in our market area is the use of a low cost control system that offers unoccupied set-back of the system airflow. For systems with 40 hours per week peak flow usage, this system pays back the investment quickly. The system also identifies units that are not working and allows for setting individual fan speed from the control console.

Another change we have seen in the past eight years in medical device cleanrooms is the use of modular wall systems. Typically, a large manufacturing area is defined by occupancy separation walls with interior walls being constructed of a cleanroom panel system. This technique is being used because the device manufacturer can't afford down time for changes to the wall systems. One large manufacturer of implantable devices modifies their wall systems about 20 times per year. Walls are added, moved, and removed all while the cleanroom maintains the cleanliness rating. Technicians are gowned up appropriately and all materials and tools cleaned outside the room before the wall modification begins. By using a modular wall system, the cost of the walls disappears when compared to shutting down a large manufacturing operation for a day or so due to dust created by gypsum walls and painting.

rel=nofollow [http://www.gerbig.com/Workstation_Home.html]The Clean Workstation

The class 10,000 room has be the standard for medical device manufacturing for the past 30 years or so. But this too may be changing. About four years ago, Medtronic asked Gerbig Engineering to develop and manufacture a clean workstation specifically for medical device assembly. After a couple of prototypes were constructed the design was finalized. The new workstation offered many new ideas in device assembly.


Double sided airflow with two fans and two HEPA filters. More assembly area per dollar invested.
Smaller HEPA filter area; only the first few inches above the work surface has HEPA filtered airflow. This reduces heat gain and total energy, but still offers contamination protection superior to conventional assembly stations.
Putting the airflow at the work surface means fewer HEPA units in the ceiling. In our prototype test, particle counts below 3000 were recorded in an office environment. Less than 100 particles were measured in a Class 10,000 room. Using the clean workstation approach, the room could be designed as a Class 100,000 or unclassified with HEPA filters in the air handling system, while the work area itself can be class 10,000 or better.
The assembly workstation has quick connects for compressed air and electrical circuits to pass from station to station eliminating drops from the ceiling.
Using a shorter HEPA filter allows for storage or monitors to be mounted at a more usable height.


Today, with the advances in clean room construction and controls, a manufacturer needs to make sure that they are considering all options before investing in a clean room. A little time researching and using an expert system designer work out the specifications, one could realize thousands of dollars in startup as well as on going costs,.

Fred T. Gerbig, PE, has been involved with both the cleanroom industry and HVAC systems for the past 33 years. In 1985, Fred started Gerbig Engineering Company specializing in contamination control. The Company designs, builds, and certifies cleanrooms. In addition, the company performs validation work for GMP facilities and designs high purity gas and water systems. Mr. Gerbig has a Bachelor of Science in Mechanical Engineering and Bachelor of Science in Electrical Engineering, both from Iowa State University (1964).

As an active member of the Institute of Environmental Sciences (IES), he was the secretary of subcommittee RP-50 for updating Federal Standard 209B to 209D and was the Secretary for IES subcommittee RP-006 to standardize the testing of cleanrooms. Mr. Gerbig was awarded the 1986 "James R. Mildon Award" for outstanding contributions to the Institute of Environmental Sciences Contamination Control Division. He holds a patent in the field of air filtration.

Article Source: [http://EzineArticles.com/?Technologies-Impact-on-Medical-Device-Clean-Rooms&id=568004] Technologies Impact on Medical Device Clean Rooms