Issue



Contamination control consulting


05/01/2007







Contamination control is a critical factor in research and manufacturing facilities. It helps to have experts on hand to demystify standards and focus on the most pressing issues involved in the engineering and design, equipping, and maintenance of critical environments. This month, we bring you a selection of consulting firms specializing in the contamination control sector.

Compiled by Carrie Meadows

Full range of project, analysis, and training services
William R. Acorn, P.E., FASHRAE, is founder and president of Acorn Consulting Services, LLC. Building on more than 30 years of engineering consultation and project design and delivery services for projects ranging from institutional laboratories to cleanroom facilities for the semiconductor industry, he now provides focused consulting in the following areas:

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  • Project consulting-as an owner’s agent or design/build team member
  • Forensic analysis-evaluation of facility systems that perform below expectations or involve litigation, including alleged personnel exposure to hazardous materials in the work environment
  • Mentoring, coaching, and training-related to facility design, project management, or code compliance and permitting

Acorn is registered as a professional mechanical engineer in the states of Arizona, California, Colorado, Illinois, Nevada, New Mexico, New York, Oregon, Texas, and Utah. He is also registered with the National Council of Examiners for engineering and surveying.

Acorn Consulting Services, LLC
Tucson, AZ
www.acs-eng.com

‘Design and build’ cleanroom contractor

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Clean Air Technology, Inc. is a leading “design and build” cleanroom contractor and manufacturer for modular cleanrooms and biocontainment facilities. The Cleanroom Division specializes in the turnkey design, engineering, pre-fabrication, installation, startup, and testing for ISO Std. 14644 Class 1 to Class 8 and superseded U.S. Fed. Std. 209E Class 1 to Class 100,000 modular cleanrooms. The Bio-Containment Division specializes in BSL P2 and P3 biohazard containment laboratories and research facilities, following the guidelines of the U.S. National Institutes of Health and other agencies. Portable 20-foot and 40-foot containerized P3 labs and truck-mounted labs are also built and ready to ship worldwide, plug in, and go to work as medical emergencies require. The company supplies its products and services to the pharmaceutical, medical, electronics, semiconductor, and aerospace industries worldwide.

Clean Air Technology, Inc.
Canton, MI
www.cleanairtechnology.com

Cleanroom design and construction

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Clean Rooms West, Inc. (CRW), an established firm specializing in the design and construction of cleanrooms, provides consulting services for the microelectronics, semiconductor, medical, food, and pharmaceutical industries. CRW’s services include design/build (modular and conventional); GMP fully flush modular systems; low RH cleanroom and energy-efficient designs; portable made-to-ship cleanroom systems; process exhaust/utility and electrical systems; cleanroom system evaluation; architectural/structural systems; cleanroom construction protocol; validation support services; and certification. CRW has more than 20 years of experience in the cleanroom industry, designing and constructing more than 900 cleanrooms, from ISO 14644 Class 4 to Class 8 [Fed. Std. 209E Class 10 to 100,000]. Our team of mechanical, architectural, structural, controls, and process systems professionals allows us to design and build facilities that meet the customer’s requirements in a cost-effective manner.

Clean Rooms West, Inc.
Tustin, CA
www.cleanroomswest.com

Liability-limiting specialists

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At CleanAir Solutions, Inc., our cleanroom consultants promote the design-build approach because it limits our customers’ liability from potential errors in their own pre-written specifications and places the responsibility back on “the specialists” to provide the best design solution. Our consultants use a needs analysis worksheet to accurately assess your requirements and ensure that we do not inadvertently create guidelines that impact the overall goal of your project. We offer solutions that deliver significant benefits beyond the initial area in which your product or service operates. As specialists in cleanroom technology, we carefully analyze your process to ensure your program has been properly evaluated and consider the various factors affecting your overall cleanroom performance. Our design experts specialize in integrating your existing site conditions into our construction plans.

CleanAir Solutions, Inc.
Fairfield, CA
www.CleanRoomSpecialists.com

Expert in new cleanroom product introductions

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Cleanroom Consulting, LLC, specializes in cleanroom design and applications, cGMP cleanroom compliance, contamination control consultation, cleanroom and contamination control audits, and new cleanroom product introductions. Cleanroom Consulting provides contamination control services including requirements development and acting as owner’s representative for new controlled environment projects and troubleshooting for existing operations. Cleanroom Consulting also provides training in cleanroom operations, maintenance, gowning, housekeeping, and clean construction protocols. Among the services the firm offers are project planning and basis of design; cleanroom conceptual designs; cleanroom applications engineering; process isolation and minienvironments; troubleshooting and corrective actions; airborne and surface contaminant testing and analysis; compatibility testing for components and consumables; construction claims arbitration; and training.

Cleanroom Consulting, LLC
Rochester, NY
www.cleanroom-consulting.com

Testing and consulting services

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Controlled Environmental Regulatory Testing Services (C.E.R.T.S.) is a leader in full-service testing and certification of cleanrooms, aseptic fill suites, and related equipment. C.E.R.T.S. serves many industries including medical, pharmaceutical, electronics, and food services. In addition to standard testing and certification services, we offer cleanroom evaluation and standards compliance, contamination/protocol consulting, standard operating procedures, contractor performance verification, and on-site troubleshooting and repairs. Our experienced technicians have advanced training to help customers comply with the following standards and practices: ISO 14644-1, Fed. Standard 209e, NSF 49, Title 8, IEST, and customer specifications. C.E.R.T.S. has more than 10 years of experience providing HEPA filter leak tests and replacements, particle counts, air balance/velocity testing, parallelism smoke tests, temperature/humidity checks, hood and cabinet maintenance, decontamination, and filter/motor repair and replacement.

Controlled Environmental Regulatory Testing Services (C.E.R.T.S.)
Tustin, CA
www.cleanroomcertification.com

Acoustics and noise/vibration control

The consulting team at Colin Gordon & Associates (CG&A) has broad experience providing and evaluating low-vibration environments for advanced technology facilities, as well as acoustics and noise control consulting. Team members are noted for their ability to create high-quality vibration environments supported by slab-on-grade floors, isolated slabs, and suspended waffle slabs. Accurate and sophisticated measurements are an essential component of the services that CG&A provides. The firm uses portable, battery-operated systems for collecting both sound and vibration data in operating facilities and buildings on “greenfield” sites as well as in residential neighborhoods. A hammer-based system is used to document support properties such as dynamic stiffness for scanners and other similar systems. Our vibration monitoring systems, customized to the needs of vibration-critical facilities, can track and archive conditions over periods of weeks, months, and years and provide warnings when preset limits are exceeded. Our range of acoustical instrumentation includes an intensity analyzer that allows us to quantify the sound power radiated by fans, pumps, and other machines.

Colin Gordon & Associates
San Bruno, CA
www.colingordon.com

Comprehensive cleanroom services

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Controlled Contamination Services, LLC (CCS) is a leader in the contamination control industry offering a variety of services for cleanrooms and controlled environments, such as cleanroom cleaning, testing, protocol development, documentation support, and design consulting and contamination control training for specific customer applications. CCS uses cleanroom-approved materials, equipment, and methods for maintaining cleanroom environments as specified by IEST, ISO, and a variety of application-specific governing organizations. CCS trains its personnel in GMP and proper cleanroom protocol. The training program consists of three levels of certification as well as enhanced training for specific customer requirements. All training is documented and maintained to ensure that customers’ needs are met. CCS also provides contamination control and gowning training designed for customers’ needs and their unique applications. CCS performs various methods of quality assurance inspections to validate the cleaning and ensure the cleanroom integrity. CCS has the added ability to provide periodic environmental testing as required by its customers.

Controlled Contamination Services, LLC
Los Angeles, CA
www.cleanroomcleaning.com

Contamination control industry expert

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We are consultants offering a variety of services in human-sourced contamination control. This includes relevant cleanroom operations as well as assisting with establishing applicable contamination control cultures through education and training. We also offer services related to cleanroom garmenting with a specialty in sterile environments. We are well recognized in the industry and can focus our expertise effectively in improving critical operational environments so as to maximize profitability through informed contamination control problem resolution. Charles Berndt is the principal in C.W. Berndt Associates, Ltd., and serves on the editorial advisory board of CleanRooms, is chairman of the editorial board of the Journal of the Institute of Environmental Sciences and Technology, is both a Fellow of IEST and communications vice president, serves on the executive board, and has recently been elected to the office of president elect of the IEST. Berndt is the former chairman of Working Group 003, Garment system considerations for cleanrooms and other controlled environments (IEST-RP-CC003.3).

C.W. Berndt Associates, Ltd.
Highland Park, IL
E-mail: cwberndt@aol.com

‘Green building’ services and certification

Porter Industries offers GMP, HHPC, quality cleaning programs (TQM), green cleaning, training, LEED projects, and other consulting and contracting services. The company has more than 30 years of experience with cleanroom operations and maintenance and builds a comprehensive strategy to help organizations attain safe, healthy, high-performance facilities. Cross-contamination prevention programs both inside and outside cleanroom areas help ensure maximum containment. Easy to understand training materials provide support for best practice cleaning strategies, procedures, and guidelines to be maintained. The company also offers environmentally preferable purchasing guidelines for selecting janitorial chemicals, paper, liners, tools, and equipment. Porter Industries provides a pathway to earn credits toward certification under the LEED for Existing Buildings Green Building (LEED-EB) Rating System™ from the U.S. Green Building Council.

Porter Industries, Inc.
Loveland, CO
www.porterindustries.com

Low bio-burden designs

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Technovation provides design, consulting, and construction services to achieve energy-efficient cleanrooms and bio safety laboratories for the pharmaceutical, biotech, tissue and life sciences, hospital (USP <797> pharmacies), and microelectronics industries. Technovation designs utilizes the Bio Plus® bactericidal, ultralow-pressure drop HEPA filters and its optimized bypass air handling system to achieve low bio-burden, energy savings, and low operating costs without any penalty in initial costs. Additional energy savings are also achieved by utilization of Technovation’s dilution and transient analysis models, coupled with CFD computer models to achieve optimum airflow rate designs. Technovation has expertise in conducting and developing DQ/IQ/OQ documentation that is compliant with FDA cGMP requirements. Technovation has significant expertise in aerosol science, contamination control and fluid mechanics, and heat transfer along with expertise in mechanical, electrical, and structural engineering.

Technovation
Midlothian, VA
www.CleanroomSys.com

Regulatory, engineering, and scientific perspective addressed in every project

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Over the past 25 years, Vectech Pharmaceutical Consultants, Inc. has established a consultation philosophy based on sensible, scientific solutions to the complex problems faced by regulated industries. Our consultation approach involves a blend of science and engineering, practical and theoretical, which affords us a flexibility and perspective that most companies do not have. With industry experienced scientists and engineers, as well as a full-service architectural department, Vectech can bring unique options to any project. Our team of experts consists of recognized leaders in their fields, who stay abreast of technological and regulatory trends so that we can offer you practical solutions that meet federal and international regulations and guidelines. Among the many services we offer are confidential audits, sterilization processes, expert witness, design review, facility and validation master plans, transfer of technology programs, pre-approval inspections, and aseptic filling.

Vectech Pharmaceutical Consultants, Inc.
Farmington Hills, MI
www.vectech.com