INTEGRATING COMPLIANCE, CLEANLINESS, AND SAFETY IN CONTROLLED ENVIRONMENTS CONTROLLED ENVIRONMENTS MANAGEMENT SERVICES

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1 INTEGRATING COMPLIANCE, CLEANLINESS, AND SAFETY IN CONTROLLED ENVIRONMENTS CONTROLLED ENVIRONMENTS MANAGEMENT SERVICES

2 Because Clean is Critical Technological advancement, rapid change, and high quality are the hallmarks of today s high-tech industries. Everchanging technologies and exceptional quality standards require specially cleaned processing and production environments to keep pace with biocontamination-free production demands. Controlled environments meet these needs by precisely controlling air, water, gases and chemicals to prevent contamination of products and processes that are utilized in a number of industries including: Aerospace Semiconductor Microelectronics Printed circuit boards Medical device Pharmaceutical Food processing Controlled environments present many unique issues and requirements that extend beyond typical industrial and laboratory construction, maintenance, and operation practices. Compliance, certification, and training must also be addressed from initial planning through full operation. These activities require technical knowledge of industry-specific cleanroom requirements, regulations, safety procedures, and contamination control that often exceed the expertise of most project management firms. That is why Fisher Safety has teamed up with leading CE Management Services providers to offer solutions and services that will help you to protect your investment, your facility, and your workers.

3 Comprehensive Controlled Environments Management and Support Services Fisher Safety now offers services to facilitate your controlled environmental projects from new personnel training to certification to construction and renovation. These key services include: AUDITING Fisher Safety offers auditing services that aid in verifying compliance with federal, state, and local environmental and safety regulations, Standard Operating Procedures (SOP), current Good Manufacturing Procedures (cgmp), and other project-specific controlled environments protocols. Noncompliance issues and deviations from these regulations, procedures, and protocols are immediately reported to the onsite project supervisor, along with the potential for contamination. All issues and recommendations for corrective action are fully documented and tracked throughout the duration of the project. Additionally, auditing tasks specifically related to contamination monitoring in controlled environments can be conducted. Auditing tasks include: Static and dynamic multi-point particlecount monitoring of particles ranging from 0.1 to 7.0µm in size and tracking of collected data Audits of SOPs including gowning, product handling, and cleaning Cleanroom performance audits Airflow, pressurization, and HVAC dynamic consulting Microcontamination review CONTROLLED ENVIRONMENTS TRAINING All activities in controlled environments require minute-by-minute attention to prevent contamination, maintain high-quality standards, ensure worker safety, and support compliance with regulatory and controlled environments protocol. Today s businesses recognize not only the necessity, but also the competitive advantage of training employees, contractor personnel, and janitorial staff alike in these procedures. For many companies, training across-theboard from the parking lot to the shipping dock and ultimately to the customer has become the new standard in contamination control procedures. To help you meet your facility- and/or project-specific controlled environments practices and protocols, Fisher Safety provides customized training courses in the following areas: Personal safety guidelines in controlled environments Controlled environments practices and guidelines Introduction to airflow and control technologies Cleanroom operator and supervisor training Industry-specific cleanroom training Project-specific controlled environmental protocols

4 CERTIFICATION Through a network of regional NEBB Certified Supervisors, Fisher Safety provides the necessary services to review your project specifications and evaluate your certification needs from project kick-off to final certification. From upgrades to new construction to facility recertification, these Certified Supervisors ensure that your project complies with the applicable requirements set forth by the National Environmental Balancing Bureau (NEBB), Institute of Environmental Sciences and Technology (IEST), Federal Standard 209E, and the new global ISO 14644, Parts 1 and 2 standards (see table below). Specific capabilities include: Testing for sound and vibration Building for system commissioning Cleanroom performance testing Tooling certification Periodic recertification Recertification after tooling or facility changes Comparison of Cleanliness Classes for Cleanrooms and Clean Zones This table shows the maximum concentration limits (particles/m 3 ) for airborne particles equal to and larger than particle size shown. ISO ENGLISH SI 0.1µm 0.2µm `0.3µm 0.5µm 1.0µm 5.0µm CLASS (209 E) (209 E) M 1.5 1, M ,000 2,370 1, M ,000 23,700 10,200 3, ,000 M 4.5 1,000, , ,000 35,200 8, ,000 M ,000 83,200 2, ,000 M ,520, ,000 29, ,200,000 8,320, ,000 Note: On November 29, 2001, the United States General Services Administration announced that Federal Standard 209E had been cancelled and superseded by the global ISO standards for cleanrooms and controlled environments. As shown above, ISO changes to metric measure of air volume and adds three additional classes two "cleaner" than former Class M2.5 (Class 10) and one "dirtier" than former Class M6.5 (Class 100,000).

5 CE CLEANING SERVICES To ensure that your controlled environment meets the newest ISO standards for its intended use and class, Fisher Safety offers services such as continuous cleaning or precision microcleaning of walls, floors and ceilings, counters, and other equipment. Cleaning can continue throughout the tool entry phase from arrival on the dock to humidity and temperature control to final wipedown and placement in your controlled environment. For services performed by your employees or contractors, Fisher Safety also provides monitoring for compliance with regulations, SOP, cgmp, and protocols as well. Specific cleaning services include: Disinfection Microcleaning Janitorial services Parts cleaning CONSTRUCTION PROJECT MANAGEMENT To avoid costly and timely delays, construction activities must be carefully planned during the initial design phase. Aside from ensuring that design requirements are met for your controlled environments and process needs, the overall safety of contractors and employees is of the utmost importance when dealing with the number of hazardous substances usually found within these facilities. To avert such losses, Fisher Safety offers the services of a qualified representative to work directly with the construction project manager. These services include: Review design specifications Ensure compliance with clean construction protocol Certify work in accordance with applicable requirements Review and approve change orders Coordinate subcontractors RECOVERY MANAGEMENT With controlled environments, only a few hours of downtime can mean millions of dollars in losses. Contingency planning and rapid response can prevent downtime caused by contamination from vandalism, neglect, accidents, or natural disasters. In the world of high technology, such plans are manufacturing and financial necessities that protect against loss and reduce insurance rates. At Fisher Safety, we have the resources to rapidly deploy the products you need and the expertise to help you respond in the event that contingency plans must be implemented. Recovery management services available include: Rapid 24-hour response Project management Contamination assessment and monitoring Coordination with regulatory agencies, insurance companies, and contractors Remedial oversight

6 From Apparel to Wipers A Complete Line of Controlled Environments Products In addition to Controlled Environments Management Services, Fisher Safety offers a comprehensive selection of products that are compatible with virtually any class of controlled environment from ISO 1 to 9. Choose from the highest-quality gloves, apparel, bags and film, dispensers, particle counters, furniture, housekeeping supplies, mats, documentation paper and supplies, static control products, swabs, and wipers. Fisher Safety also provides other support and services you require, such as outsourced labor, laundry, point-of-use delivery, and racking design and automation. At Fisher Safety, we believe that Controlled Environments Management and Support Services are successful only when they address the unique requirements of your industrial or laboratory-controlled environment. We don t provide one-size-fits-all packages because no two controlled environments are exactly alike. Rather, we offer customized management and support services tailored to your controlled environment project specifications and the needs of your contractors and employees. For customer service, call To fax an order, use To order online: Fisher Scientific AP/MG 10M-HTR-9/02 Litho in U.S.A. BN Fisher Safety is America's leading distributor of occupational safety products, cleanroom supplies, and services. Fisher Safety represents almost 1000 of the leading safety product manufacturers and provides access to over 64,000 safety and cleanroom products. As a total solutions provider, Fisher Safety offers safety, health and environmental (SHE) consulting, onsite and online SHE training, mobile health testing and records management, and clean-build facilities management. Fisher Safety Protecting What Matters Most.