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UPDATE ON NEW AND REVISED IEST DOCUMENTS

"As very active participants in several IEST Working Groups 1, 2, 6, 7, 12, 13, 14, 19, 23, 28, 34 and 36, Micro-Clean is proud to announce that several new publications have been released for publication. These Recommended Practices are published by the Institute of Environmental Sciences and Technology to advance engineering and technical sciences relating to Contamination Control."

These Recommended Practices are available through www.iest.org.


IEST-RP-CC001.5 “HEPA AND ULPA FILTERS” [October 2009]

This document covers the basic provisions for HEPA and ULPA filters for applications requiring extremely high filter efficiency (99.97% or higher) for submicrometer particles. The RP provides performance information for 11 filter types, defines six construction grades, and includes a very-handy and expanded Filter Selection Guide that lists typical industry applications and their appropriate filter types. While this table tries to help lessen the confusion over filter selection, if you still have questions, contact our technical or sales staff for any help in this area.

IEST-RP-CC002.3 “UNIDIRECTIONAL FLOW CLEAN-AIR DEVICES” [March 2009]

This Recommended Practice spells out the construction, design, and factory/field testing requirements for Unidirectional Flow Devices or “Clean Benches”. New features in this publication include an expanded and modernized illustration section for the different styles and configurations of “Clean Benches” and a testing matrix table that Micro-Clean contributed to the document.
IEST-RP-CC034.3 “HEPA and ULPA Filter Leak Test” [October 2009] ("Required reading" for pharmaceutical and biotechnology organizations)
This expanded Recommended Practice covers definitions, equipment, and procedures for leak testing HEPA and ULPA filters in the factory, at the job site before installation, and as-installed in cleanrooms and in unidirectional-flow, clean-air devices. The document also includes guidelines for selecting the appropriate leak-test method and procedures for measuring the uniformity of the aerosol challenge approaching the filter under test.

OTHER STANDARDS AND RECOMMENDED PRACTICES

NSF/ANSI 49 – 2009 Biosafety Cabinetry: Design, Construction, Performance and Field Certification

Once again updated after nearly-annual revisions to this standard coming out in 2007, the 2009 edition is the current version in use. Many changes have come since 2002 when the standard had not changed for 10 years. Some of the substantial changes since 2002 include, but aren’t limited to:

• Type A1 cabinets can no longer be manufactured with exposed positive pressure plenums.
• Stronger wording for converting A1/A2 hard-duct connections to canopy ducting.
• Concurrent balance values for type B1 and B2 cabinets.
• Addition of chlorine dioxide procedures as a method of gas decontamination (compliments of research and validation involving Micro-Clean personnel).
• Exhaust interlocks are now required on new B1 cabinets.
• Recommended reporting information on testing and certification reports.
  

ISO 14644-1 Cleanrooms and associated controlled environments-Part 1: Classification of air cleanliness updated standard is scheduled to be released in 2011. Some of the expected changes are:

• the abandonment of the statistical analysis calculations,
• the number of locations will be changed from a formula to a table resulting in more particle count locations,
• changes to the particle count classification limits table doing away with small limit numbers such as ISO Class 5 at 5.0 µm size
  

ISO 29463-1 through 29463-5 High Efficiency Filters and Filter Media for Removing Particles from Air is currently past the Committee Draft (CD) phase and now in the Draft International Standard (DIS) format undergoing vote and comment from national review bodies and awaiting reconciliation of the comments. The five documents will provide filter manufacturers, suppliers and users with a single group of standards to classify and specify factory testing of the filters ranging from efficiencies of 95% to 99.999995%. The goal of the standard was not to exclude any testing methods, but to recommend one primary test method and provide information of other available methodologies used worldwide. The standards are broken out into five sections:

1-Classification, performance, testing and marking
2-Test equipment
3- Testing of the flat sheet filter media
4-Constructed filter scan test method
5-Constructed filter efficiency test method

 

Animal Lab News CASE STUDY:
Chlorine Dioxide Gas Decontamination of the University of Pennsylvania’s George D. Widener Large Animal Hospital Intensive and Neonatal Care Units
Case Study, Mark A. Czarneski, Paul Lorcheim, Thomas Boyle, Helen Aceto, Barbara Dallap, Donald Munro, Michael A. Regits, and Henry S. Luftman, May/June 2005

"After a salmonellosis outbreak, the 170,000 cubic foot C. Mahlon Kline building remained under quarantine until a successful decontamination program was implemented...
The decontamination process using chlorine dioxide gas was determined to be an unqualified success. Swab tests for Salmonella taken for two months post decontamination produced no positives. The University of Pennsylvania’s C. Mahlon Kline Intensive and Neonatal Care Units was lifted from quarantine and declared fully operational."

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