8:00 - 10:00 a.m.

Strategies for USP<797> Compliance in Sterile Compounding Pharmacies
Chair: Sandeep Kalelkar, Texwipe Corporation
Co-chair: Gordon Ely, WuXi AppTec, Inc.
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This session will discuss best practices to successfully implement the recommendations of USP<797> in Sterile Compounding Pharmacies.

• USP <797> Controlled Environments Specifications - Richard Pitre, Allometrics, Inc.
• Cleaning Protocols in the Sterile Compounding Pharmacy, Texwipe Corporation

10:15 a.m. - 12:15 p.m.

The Goals and Choices Associated with Cleanroom Performance Testing
Chair: Les Miller, Micro Filtrations, Inc.
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1:00 - 3:00 p.m.

Latest Developments in the ISO Cleanroom Standards
Chair: Anne Marie Dixon, Cleanroom Management Associates
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This session will give a brief overview of ISO Technical Committee 209, followed by a discussion of the progress of four TC 209 Working Groups (WGs): WG 1, which is finalizing new DIS versions of ISO 14644-1 and ISO 14644-2; WG 2, Biocontamination; WG 3, Metrology and WG 10, Nanotechnology.

• Introduction to ISO Cleanroom Standards
• ISO/TC 209 Working Group 1: Airborne Particulate Cleanliness Classes, ISO/TC 209 Working Group 3: Metrology and Test Methods, ISO/TC 209 Working Group 4: Design and Construction - Robert Mielke, Abbott Laboratories
• ISO/TC 209 Working Group 2: Biocontamination and ISO/TC 209 Working Group 5: Cleanroom Operation - Anne Marie Dixon, Cleanroom Management Associates

3:15 - 5:15 p.m.

Specifying Energy Contamination Parameters in Nanotechnology Facilities
Chair: Hal Amick, Colin Gordon & Associates
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The intent of this session is to present an overview of the next set of Recommended Practices to be developed under the NANO aegis: Vibration; Acoustic Noise; Electromagnetic Interference (EMI/RFI); and Temperature. These specialty disciplines will be addressed individually with RPs intended to define the appropriate units, measurement methods, reporting methods, and typical criteria. Each one is in a different point in planning. This session will have four separate presentations giving an overview of the current stage of each, and where the organizers expect to head with each effort. They will proceed from the most evolved (in terms of RP development) to least evolved.

• Introduction and Overview of Energy Contaminants Affecting Nanotechnology - Hal Amick, Colin Gordon & Associates
• Vibration - Hal Amick, Colin Gordon & Associates
• Acoustic Noise - Michael Gendreau, Colin Gordon & Associates
• EMI/RFI - Lou Vitale, Vitatech Electromagnetics
• Temperature
• Where Will We Go From Here - Hal Amick, Colin Gordon & Associates

8:00 - 10:00 a.m.

The Next Small Thing
Chair: Steve Kochevar, Particle Measuring Systems
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Join us for presentations that will discuss the latest technology for detecting the smallest things: Sub-micron and nanoparticles! Recognized professionals from the leaders in particle counting technology will provide fascinating insights into modern particle-counting technology, as well as, a foreboding glimpse toward the end of optical particle counting.

• Are you Prepared? Regulatory Updates on Cleanroom Particle Counting and Instrument Calibration - Joe Gecsey, Hach Company
• Particle Counting Technology: The End of Optical Particle Counting - Mark Berdovich, Particle Measuring Systems, Inc.
• Development of a Small, Battery-Operated Nanoparticle Sizer - Tim Johnson, TSI, Inc.

10:15 a.m. - 3:00 p.m.

No conference sessions are scheduled. Please visit the exhibitors and make sure to attend one of the Vendor FAQ Sessions.

3:15 - 5:15 p.m.

Cleanroom Design and Energy Conservation
Chair: Wei Sun, Engsysco, Inc.
Sponsored by Engineered Air

The seminar objectives are to introduce the latest design practices, research findings and energy conservation efforts to cleanroom design architects, engineers, and professionals in cleanroom operation, construction and maintenance. Some basic steps will be presented which illustrate how to coordinate systems performance with operational protocols, and how to get the most out of the involvement of designers and contractors. Strategies on design (architectural, mechanical and electrical), operation, and material selection will also be discussed aiming at substantial reduction on overall energy consumption.

New technologies about cleanroom airflow rate modeling and demand flow control will be further presented. The seminar will discuss the problems in the existing practice that air change rate (ACR) is manually selected solely based on cleanliness classification, it will illustrate a new determination method which based on multiple variables such as room particle generation rate, AHU filters’ combined efficiency, room HEPA efficiency, particle deposition, outdoor particle concentration, and outdoor air/supply air ratio, etc. It will further illustrate the demand flow control technique by utilizing multi-stage or variable speed method on fans based on the feedback from continuous particle sensors.

• The First Steps in Cleanroom Design - Thomas Hansz, Facility Planning and Resources, Inc.
• Cleanroom Variable Airflow Design - Vincent Sakraida
• Cleanroom Mechanical System Selection Energy Efficiency - Joseph McGill, Engineered Air

8:00 a.m. - 10:00 a.m.

Basics of Nanotechnology
Chair: Dr. R. Nagarajan, IIT Madras

In this session, the attendees will be given an introduction to nano-materials, nano-science and nano-technology, with the differences delineated. Bottom-up and top-down methods of synthesizing nano-particles will be presented and contrasted with respect to their plus- and minus-points. In particular, the low-cost, high-throughput, high-purity technique of sono-fragmentation will be reviewed in detail. Characterization of the properties of nano-materials is a critical aspect of nano-process development and optimization. In order to produce nano-particles of required morphology (shape and size), structure (crystallinity), chemical composition (organic and inorganic), transport (diffusion, phoresis, cohesive flow) and functional properties, it is important that qualitative and quantitative analysis be carried out in an appropriate manner. Relevant techniques are presented here and explained in detail.

10:15 a.m. - 12:15 p.m.

Cleanroom Garments and Laundries
Chair: Mike Rataj, Aramark Cleanroom Services
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This session will discuss the latest developments in cleanroom garments and laundries, including garment recycling.

• Greening your Production Environment: Reducing Cleanroom Waste and Garment Recycling Solutions - Shena Weeks, Kimberly-Clark Corporation
• Processing Consideration for Cleanroom Garments - Rob Speice, White Knight Engineered Products

1:00 - 3:00 p.m.

Static Electricity - Generation, Discharge, and Mediation
Chair: Larry Levit, LBL Scientific
Sponsored by Transforming Technologies, Inc.

Cleanrooms and clean environments are enabling technologies required for the manufacture of many products that have exacting contamination control requirements in order to achieve defined yield and reliability targets. Clean manufacture is required in the semiconductor, hard disk drive, flat panel display, and pharmaceutical industries, to name a few. This session will focus on factory electrostatic charge generation, measurement and control issues in cleanrooms and designing for ESD immunity.

• Creating Ionization in Nitrogen - Tom Watkins, Transforming Technologies, Inc.
• Airborne Molecular Contamination Monitoring and Mapping using Air Ionizer Tip Deposits, and SEM/EDS Analysis - Larry Levit, LBL Scientific
• Utilizing Electrostatic Charge Monitoring and Discharge Detection as Predictive Maintenance Tools - Andrew Rudack, SEMATECH
• Eliminating Equipment Downtime Caused by Electrostatic Attraction - Roger Diener, Analog Devices, Inc.

3:15 - 5:15 p.m.

Airborne and Surface Molecular Contamination
Chair: Victor Chia, Balazs NanoAnalysis
Sponsored by Balazs NanoAnaylsis, Inc.

This session will include case studies, baseline programs and advances in monitoring technologies for airborne molecular contamination (AMC) and surface molecular contamination (SMC). Topics may be related to issues and solutions experienced in the cleanroom, production environment, minienvironment, wafer carrier systems, packaging and in-tool and chamber components.

• From Microns to Nanometers: The ITRS and AMC Control - Chris Muller, Purafil
• Process Tool Organic Case Study Utilizing IEST-RP-CC031 - Victor Chia, Balazs NanoAnalysis
• Applying AMC Filtration and Ionization to Fan Filters - Jim Harris, Technical Equipment Sales, Inc.