Tag Archives: Clean Rooms

The U.S. Food and Drug Administration (FDA) is requesting nearly $2.4 billion “to protect and promote public health” as part of the President’s fiscal year 2009 (FY09) budget. This amount would be a 5.7 percent increase over the budget that FDA received for the current fiscal year. The FY09 request covers the period of Oct. 1, 2008 through Sept. 30, 2009.

The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes funds to cover cost of living increases for FDA employees that perform the agency’s scientific and highly specialized public health mission.

“The FDA is committed to protecting and promoting the health of the American people,” says Andrew C. von Eschenbach, M.D., Commissioner of FDA. “This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.”

During FY09, FDA will experience a full-time equivalent staff increase of 526. The FY09 budget supports additional staff for priority areas such as food defense and food safety, as well as drug, blood, and human tissue safety programs. FDA will also work to ensure the safety of domestic and imported food and medical products by conducting more domestic and foreign inspections and more inspections of high-risk foods.

FDA’s key proposed budget increases support the following:

  • Protecting America’s food supply ($42.2 million). FDA’s Protecting America’s Food Supply initiative integrates food safety and food defense and uses a comprehensive, preventative, and risk-based approach to safeguard the food supply and the American homeland (see “Food Safety Plan Emphasizes ‘Effective Action’ to Prevent Food Supply Contamination,” CleanRooms magazine, December 2007, p. 8).

    The foundation of the plan is to increase its focus on prevention, to identify potential food threats to the food supply, and counteract them before they harm consumers. The FY09 increase will allow the agency to focus on the most important food defense and food safety issues throughout the entire life cycle of foods, from production through consumption. In FY 2009, FDA will devote more workforce and resources to food production and handling sites, whether they are located in the United States or abroad.

  • Medical product safety and development ($17.4 million, $79.0 million user fees). This initiative provides targeted resources to improve the safety of human and animal drugs, blood, human tissues, and medical devices. FDA says the resources will strengthen its ability to effectively monitor the safety of medical products, including imported products. The agency will also help medical product manufacturers develop new technologies to treat life-threatening diseases and conditions.

    In 2007, Congress enacted the Food and Drug Administration Amendments Act (FDAAA). The FY09 budget implements new drug and medical device safety programs in FDAAA that are funded by user fees. As a result, FDA will strengthen its ability to regulate medical products and ensure their safety and effectiveness for the American public.

  • Management efficiencies. The FY09 budget also captures the productivity savings (

ATMI, Inc. has acquired LevTech, Inc., a provider of disposable mixing technologies to the biotechnology and pharmaceutical industries, in a $27 million cash transaction. Based in Lexington, KY, LevTech will be combined with ATMI’s existing LifeSciences business focused on single-use bioprocess containers and processes for the biopharmaceutical industry. Company executives expect the deal to be accretive by late 2008.

Contract manufacturers are realizing that risk assessments demonstrating the absence of cross-contamination between products are essential for regulatory inspection.

By George Miller

Regulators are raising the bar for the majority of drugs in development, causing some problems for manufacturers but wreaking havoc with contract manufacturing organizations. CMOs

A cleanroom should be planned as an environmental control system for best results

By Thomas E. Hansz, Facility Planning & Resources, Inc.

Not too long ago, I sat down with a prominent researcher in advanced materials to discuss his upcoming cleanroom requirements. He was currently working in an ISO 6 or Class 1000 laboratory. I asked him to describe the critical nature of the contamination control required for his research. His response was, “I need Class 100.” All right, but what about the type, size, and concentration of “killer particles” that would negatively affect his work? Again, his response was, “I need Class 100.” It took quite a while to convince him that cleanroom design does not begin with designing to the next higher level of cleanliness, but that understanding the contamination characteristics detrimental to the process leads to determining the appropriate level of cleanroom classification. We finally concluded with a sound understanding of his needs.

This example is not uncommon. When one equates cleanroom quality with cleanroom classification levels, it can become a very expensive trap. One of the main objectives of a cleanroom design should be to establish and maintain the appropriate level of contamination control. This will be a recurring theme in both this article and the next part on ISO 7 cleanrooms.

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Like art, the condition of “cleanliness” depends on the point of view of the cleanroom user. So it is important to bear in mind that there are no absolutes for cleanliness. Think of a cleanroom as an environmental control system (part fixed facility and part continuous process) that, once in use, requires regular monitoring and strict adherence to defined operational protocols for the life of the facility.

Therefore, unlike other facility types, there are three critical aspects required in establishing a successfully functioning cleanroom:

  1. Defining the cleanroom program (identifying contaminants; determining size and concentrations; establishing contamination control criteria; identifying process services; and defining facility systems)
  2. Developing design and construction (proceeding from a thoroughly developed definition; coordinating process systems with facility systems; developing operational protocols; and coordinating intent with realization)
  3. Implementing/operating the cleanroom (finalizing operational protocols; developing an appropriate cleaning and maintenance program; and instituting effective management over cleanroom operations)

Who needs an ISO 5 cleanroom?

So, how does all this apply to an ISO 5 cleanroom and who needs one? Generally, the aerospace/defense, microelectronics, and semiconductor industries have been the primary users of ISO 5 cleanrooms. This is by and large due to the scale of their work with silicon-based wafer fabrication. During the 1970s and into the 1980s, protecting silicon-based products during the fabrication process relied primarily on reducing the number of 0.5-

isolators


February 1, 2008

Isolators play an important role in reducing contamination through exposure to airborne particles and human contact. Developers of enclosed environment equipment must not only focus on the cleanliness of the internal atmosphere, but also keep in mind how the design will affect user experience and safety.

Compiled by Jason Andrukaitis

Built-to-order isolation equipment

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Clean Rooms International has been providing built-to-order isolation equipment since 1982 and has developed the expertise necessary to provide flexible solutions for customers. The company develops creative products for adding clean air, extracting contaminants, isolating major problem areas, and more. An isolator can mean many different things, so Clean Rooms International provides customization of isolation equipment. Customers produce the requirements, and the company will develop an approach that is unique to each business. For product questions, estimates, or to place an order call 616-452-8700 or e-mail sales@clean
roomsint.com.

Clean Rooms International

Grand Rapids, MI
www.cleanroomsint.com

Stent coating isolator

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EnGuard Systems, an established leader in the design and manufacture of isolators, has developed a stent coating isolator for use as an integral part of the safe and efficient development of coronary artery stents. In this custom application, the company’s ability to understand the process resulted in ergonomic integration of the process, the equipment, and the isolator. The stent coating isolator employs multiple safety devices and a process logic controller for the complex management of hazardous gases and interlock systems. EnGuard’s practical approach to isolation technology was developed from many years of hands-on pharmaceutical manufacturing experience. In addition to this application, the firm provides isolators for totally contained processing of potent compounds, aseptic applications, and parenteral products. EnGuard’s portable enclosures provide maximum interaction with the process while protecting the product and the personnel. EnGuard Systems provides complete isolator service from initial concept to validation support.

EnGuard Systems
Indianapolis, IN
www.enguardsystems.com

Controlled atmosphere gloveboxes

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Precise™ controlled atmosphere gloveboxes offer high-end construction and features at economical prices. These gloveboxes maintain a leak-tight, controlled condition environment for applications such as organometallic chemistry, alternative energy cells, and hydrophilic chemicals. The boxes are capable of maintaining low levels of oxygen (as low as 5 ppm) or moisture (as low as 50 ppm). Features include a one-piece molded, medium-density polyethylene shell, which is chemical-resistant and easy to clean; a viewing window of 1/4-inch thick laminated safety glass; and six manual valves for purging, filling, and drying train connections. Space-saving inner and outer transfer chamber doors that pivot upward are counterbalanced and equipped with quick-latches and pressure relief valve. The generous 13 ft3 interior of the main chamber meets Class 1 atmosphere conditions for leak rate per ISO 10648-2 test methods. The transfer chamber is 11 inches long and also features a pressure gauge with readings from 0 to

New Products


February 1, 2008

Compiled by Jason Andrukaitis

Wireless temperature monitoring system

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Accsense’s wireless monitoring system helps medical, pharmaceutical, and laboratory personnel keep track of temperatures, CO2 levels, humidity, and other measurements. The system works well with refrigerators, freezers, and incubators, keeping automated logs and sending alarm notifications via e-mail, phone, or pager. The system can be set up quickly with no additional hardware or software. An internet connection is all that is required to run the system. The device complies with USP 797, CLIA, JCAHO, FDA, AABB, and other industry regulations.

Accsense, Inc.
Santa Barbara, CA
www.accsense.com

Two-component mixing packages

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APS’s Meg-A-Pak™ is now available in 800-g packs for two-component reactive adhesives and sealants in flexible pouches. The package is simple, safe, and easy to use, and provides a combination packaging/mixing burst seal container for a variety of resin systems such as epoxies, acrylics, urethanes, silicones, conductives, polysulfides, adhesives, and other materials. For more information call 800-222-1117.

Adhesive Packaging Specialties, Inc.
Peabody, MA
www.adhesivepackaging.com

Stainless-steel overbraided PTFE hose

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AdvantaPure is now offering stainless-steel overbraided PTFE hose in six variations. Called APFOS, the hose offers the purity of PTFE fluoropolymer with the durability and enhanced pressure carrying capabilities of stainless steel. The hoses can be used for applications in the chemical, food and beverage, pharmaceutical, and other high-purity industries. The core provides non-restrictive flow and an inert surface to transport critical fluids. The hose handles temperatures ranging from

Contamination control is an international industry. And, as you read this special show issue of CleanRooms magazine, there can be no doubt as to the international breadth and scale of the contamination control profession. Being distributed at this year’s CleanRooms Europe Conference and Exhibition, CleanRooms magazine is proud to be at the forefront in advancing and disseminating the very latest in contamination control technology and expertise to users and providers around the globe.

A quick scan of this year’s all-new comprehensive conference program for CleanRooms Europe gives a good indication of the health and vitality of the contamination control industry, covering both long-established user industries like microelectronics and pharmaceutical manufacturing as well as rapidly emerging opportunities in new industries such as photovoltaics, biotechnology, and automotive manufacture. In addition, there is continuing cross-over and penetration into the infection control arena with new solutions for hospital health care and hospital pharmacies. Europe continues to be both a major marketplace and center of new contamination/infection control technology development and production. You can read all about it in the special “European Contamination Control Market-place” supplement also being distributed at the show and to be mailed with your March issue.

The broad international circulation of CleanRooms magazine is itself a testament to the global scope of contamination control science. In addition to our wide circulation in the Americas and Europe, Asia is, of course, one of the most rapidly growing geographic regions for industries requiring advanced contamination control technology. Our CleanRooms China publication is one information product specifically targeted to this market with Chinese (Mandarin) language editorial content and distribution to thousands of contamination control professionals in mainland China. CleanRooms China provides both an informational and educational vehicle for China’s growing contamination control community as well as a unique product and service exposure opportunity for contamination control companies around the globe interested in penetrating this critical market.

Going forward, CleanRooms will continue to cover the entire world scene of contamination control science and technology. Whether through our on-line directories and buyers guides, our informational web site, our print and digital publications and newsletters, CleanRooms is committed to meeting the information needs of the worldwide contamination control community. If you’re not already a subscriber, make sure you join our family of informed professionals today. We look forward to serving you.

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John Haystead,
Publisher & Editor

Electronic documentation could make keeping up a little less daunting

By Gregg Mosley, Communications Vice President, and Roberta Burrows, Executive Director, IEST

Do you ever feel lost in trying to keep up with new and revised international standards and recommended practices? If feedback from our many colleagues is a good indicator, you are not alone in wishing there was something akin to a GPS system to guide you through the ever-changing landscape of standards. While the GPS system may be wishful thinking, the Institute of Environmental Sciences and Technology (IEST) is working the roadway to both increased standards awareness and improved standards access.

In the not-so-distant past, Fed. Std. 209 was the main document used in the United States in contamination control operations and contracts. The revisions moved along the alphabet from “A” to “E,” making it easy to keep up with any changes. We now live in a world dominated by global events, global businesses, and global economies. Standardization is not only integral but necessary, resulting in the need for publication of generic guidance documents (ISO standards) and more specific Recommended Practices (IEST RPs). As of this writing, ISO Technical Committee 209, Cleanrooms and Associated Controlled Environments (ISO/TC 209), has ten published International standards, one document under development, and four published documents under revision. IEST has 27 published recommended practices and standards with many more in various stages of development.

To steer you down the express lane to the official ISO standards, IEST will soon be providing all ISO cleanroom standards in searchable electronic format. No more worrying about where you left your dog-eared printed copy of contamination control’s cornerstone ISO 14644-1, Cleanrooms and Associated Controlled Environments