Handbook for Critical Cleaning

Barbara Kanegsberg is president of BFK Solutions LLC, Pacific Palisades, California, an independent consulting company established in 1994. BFK Solutions is the industry leader in critical cleaning. As a recognized consultant in the areas of critical cleaning, contamination control, surface quality, and process validation, she helps companies optimize manufacturing cleaning processes, improve yield, resolve regulatory issues, and maintain trouble-free production. She has participated in projects that include aerospace/military equipment, electronics assembly, medical devices, engineered coatings, metals, pump repair, and optical and nanotechnological devices. She has also participated in a number of product development- and intellectual property-related projects for manufacturers of cleaning chemicals and industrial equipment. Barbara is a recipient of the U.S. EPA Stratospheric Ozone Protection Award for her achievements in implementing effective, environment-friendly manufacturing processes. She has numerous publications to her credit in the areas of surface preparation, contamination control, critical cleaning, method validation, analytical techniques, and regulatory issues. Ed Kanegsberg is the vice president of BFK Solutions, Pacific Palisades, California. He is also a chemical physicist and engineer who troubleshoots and solves manufacturing production problems. Ed is a recognized advisor and consultant in the areas of industrial cleaning process design and process performance. He uses his four decades of practical experience along with his background in physics and engineering to help companies solve production problems and optimize their cleaning and contamination control processes.

Part I: Process Implement and Control

Evaluating, Choosing, and Implementing the Process: How to Get Vendors to Work with You. Cleaning Agent Balancing. Blunders, Disasters, Horror Stories, and Mistakes You Can Avoid. Cleaning Practices and Pollution Prevention. Basis of Design for Life Science Cleanroom Facilities. Validating and Monitoring the Cleanroom. Cleanroom Management, Validation of a Cleanroom Garment System, and Gowning Procedure. Principles of Wiping and Cleaning Validation. Overview to Analytical and Monitoring Techniques. Practical Aspects of Analyzing Surfaces. How Clean Is Clean? Measuring Surface Cleanliness and Defining Acceptable Levels of Cleanliness. Cleaning Validations Using Extraction Techniques. Biomedical Applications: Testing Methods for Verifying Medical Device Cleanliness. Material Compatibility.

Part II: Applications

Clean Critically: An Overview of Cleaning Applications. Cleaning Validation of Reusable Medical Devices: An Overview of Issues in Designing, Testing, and Labeling of Reusable Devices. Critical Cleaning for Pharmaceutical Applications. Cleaning in the Food Processing Industry. Electronic Assembly Cleaning Process Considerations. Precision Cleaning in the Electronics Industry: Surfactant-Free Aqueous Chemistries. Contamination-Induced Failure of Electronic Assemblies. Surface Cleaning: Particle Removal. Cleaning Processes for Semiconductor Wafer Manufacturing (Aluminum Interconnect). Advanced Cleaning Processes for Electronic Device Fabrication (Copper Interconnect and Particle Cleaning). The Cleaning of Paintings. Road Map for Cleaning Product Selection for Pollution Prevention. Wax Removal in the Aerospace Industry. Implementation of Environmentally Preferable Cleaning Processes for Military Applications.

Part III: Safety and Regulations

Worker Protection and the Environment: Current Editorial Observations. Health and Safety. Critical Cleaning and Working with Regulators: From a Regulator’s Viewpoint. Momentum from the Phaseout of Ozone-Depleting Solvents Drives Continuous Environmental Improvement. Screening Techniques for Environmental Impact of Cleaning Agents.