Current Strategies for Engineering Controls in Nanomaterial Production and Downstream Handling Processes/Appendix B
APPENDIX B
Sources of Guidance for Control Design
The American National Standards Institute (ANSI) and American Industrial Hygiene Association (AIHA)
ANSI/AIHA Z9.2-2007—Fundamentals Governing the Design and Operation of Local Exhaust Systems. This standard establishes minimum requirements for the commissioning, design, specification, construction, and installation of fixed industrial LEV systems used for the reduction and prevention of employee exposure to air contaminants [ANSI/AIHA 2007].
ANSI/AIHA Z9.5-2003—Laboratory Ventilation. This expanded standard, first published in 1992, includes new chapters on performance tests, air cleaning, preventive maintenance, and work practices, as well as five appendices, such as “Selecting Laboratory Stack Designs,” and an audit form [ANSI/AIHA 2003].
ANSI/AIHA Z9.7-2007—Recirculation of Air from Industrial Process Exhaust Systems. This standard established minimum criteria for the design and operation of a recirculating industrial process exhaust ventilation system [ANSI/AIHA 2007].
ANSI/AIHA Z9.9-2010—Portable Ventilation Systems. This standard discusses portable ventilation equipment and systems used for the reduction, control, or prevention of exposure to hazardous atmospheres or airborne substances, and for comfort to employees [ANSI/ AIHA 2010].
BSR/AIHA Z9.13—Design, Operation, Testing, and Maintenance of Laminar Flow Fume Hoods. This standard applies to laminar flow fume hoods (LFFH) that use filtered supply air and ducted exhaust to protect products inside the hood from external contamination and exhaust hazardous effluents from the building. This standard provides guidelines for design, operation, testing, and maintenance of laminar flow fume hoods [BSR/AIHA 2010].
The American Society of Heating, Refrigerating, and Air-conditioning Engineers (ASHRAE)
2009 ASHRAE Handbook—Fundamentals. This handbook covers basic principles and data used in the HVAC industry. The ASHRAE technical committees that prepare these chapters strive to provide new information, clarify existing information, delete obsolete materials, and reorganize chapters to make the Handbook more understandable and easier to use [ASHRAE 2005].
2007 ASHRAE Handbook—HVAC Applications. This handbook covers a broad range of facilities and topics and is written to help engineers design and use equipment and systems described in other Handbook volumes [ASHRAE 2007].
ANSI/ASHRAE Standard 110-1995—Method of Testing Performance of Laboratory Fume Hoods). The purpose of this standard is to specify a quantitative and qualitative test method for evaluating the containment of a laboratory fume hood.
The American Conference of Governmental Industrial Hygienists
Industrial Ventilation. A Manual of Recommended Practice. This IH standard reference of ventilation system design and evaluation is made up of two volumes. The first is related to the design of ventilation systems including templates for specific operations. The second provides guidance on the operation and maintenance of ventilation systems and includes information on system performance evaluation.
British Health and Safety Executive (HSE)
COSHH Essentials Control Guidance Sheets. The Generic COSHH Essentials model assigns intervention approaches (i.e., control bands) to workplace tasks after the completion of a semi-quantitative risk assessment. A combination of a substance’s toxicity and its inhalation exposure potential determine the desired level of control. After completing this assessment online, users are directed to the appropriate fact sheet. To download the Control Guidance Sheets related to Generic COSHH Essentials go to http://oehc.uchc.edu/news/ Control_Guidance_Factsheets.pdf and insert the sheet number in the space indicated. An index to these sheets is shown at that Web site.
The International Organization for Standardization (ISO)
ISO 14644-7:2004—Cleanrooms and associated controlled environments—Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments). ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test, and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.
The International Society for Pharmaceutical Engineering (ISPE)
ISPE is the world’s largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry.
ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment. This guide provides a standard methodology for use in testing the containment efficiency of solids handling systems used in the pharmaceutical industry under closely defined conditions. It covers the main factors that affect the test results for specific contained solids-handling systems, including material handling, room environment, air quality, ventilation, and operator technique.
Knowledge Brief: Containment Hierarchy of Controls. This brief explains the basics of the Containment Hierarchy of Controls, as described in ISPE’s Baseline® Guide: Volume 1—Active Pharmaceutical Ingredients. Information beyond the hierarchy described in the Baseline Guide has been added to illustrate alternative considerations typically contained in other versions of hierarchies, such as those used in industrial hygiene or risk-based manufacture of pharmaceutical products (Risk-MaPP) [Brock 2010].
The National Institute for Occupational Safety and Health
NIOSH is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology. This research focuses NIOSH’s scientific expertise and its efforts on answering the following central questions:
- How might workers be exposed to nanoparticles in the manufacturing or industrial use of nanomaterials?
- How do nanoparticles interact with the body’s systems?
- What effects might nanoparticles have on the body’s systems?
NIOSH has created a field research team to assess workplace processes, materials, and control technologies associated with nanotechnology. Research laboratories, producers, and manufacturers working with engineered nanomaterials have the opportunity to participate in a cost-free, on-site assessment that will give information about the potential for employee exposure, sources of emissions, as well as applicable engineering controls. The NIOSH control technology research program conducts engineering control studies. The field-study portion of this research is documented in workplace survey reports.