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E-raamat: Developments in Surface Contamination and Cleaning, Volume 7: Cleanliness Validation and Verification

Edited by (Editor, Reviews of Adhesion and Adhesives, USA), Edited by (National Aeronautics and Space Administration, Houston, TX, USA)
  • Formaat: EPUB+DRM
  • Ilmumisaeg: 18-Nov-2014
  • Kirjastus: William Andrew Publishing
  • Keel: eng
  • ISBN-13: 9780323311458
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Developments in Surface Contamination and Cleaning, Volume 7: Cleanliness Validation and VerificationSuurem pilt
  • Formaat: EPUB+DRM
  • Ilmumisaeg: 18-Nov-2014
  • Kirjastus: William Andrew Publishing
  • Keel: eng
  • ISBN-13: 9780323311458
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As device sizes in the semiconductor industries are shrinking, they become more vulnerable to smaller contaminant particles, and most conventional cleaning techniques employed in the industry are not as effective at smaller scales. The book series Developments in Surface Contamination and Cleaning as a whole provides an excellent source of information on these alternative cleaning techniques as well as methods for characterization and validation of surface contamination. Each volume has a particular topical focus, covering the key techniques and recent developments in the area. The chapters in this Volume address the sources of surface contaminants and various methods for their collection and characterization, as well as methods for cleanliness validation. Regulatory aspects of cleaning are also covered. The collection of topics in this book is unique and complements other volumes in this series. Edited by the leading experts in small-scale particle surface contamination, cleaning and cleaning control, these books will be an invaluable reference for researchers and engineers in R&D, manufacturing, quality control and procurement specification situated in a multitude of industries such as: aerospace, automotive, biomedical, defense, energy, manufacturing, microelectronics, optics and xerography.

This Volume complements other volumes in this series and:

  • Provides a state-of-the-art survey and best-practice guidance for scientists and engineers engaged in surface cleaning or handling the consequences of surface contamination
  • Addresses the continuing trends of shrinking device size and contamination vulnerability in a range of industries, spearheaded by the semiconductor industry and others
  • Includes new regulatory aspects

Arvustused

"This volume comprises five chapters, some covering a wide subject area, others very sharply focusedIn Chapter 4, we return to a broader treatment 'Methods for Verifying Medical Device Cleanliness'...This chapter is highly recommended for those involved in manufacture of medical devices..." --Galvanotechnik

Muu info

Provides a state-of-the-art reference for all major areas in surface contamination and cleaning for industries ranging from semiconductor fabrication to space exploration.
Contributors ix
Preface xi
About the Editors xv
1 Sources and Generation of Surface Contaminants and Their Impact 1(50)
Rajiv Kohli
1 Introduction
1(1)
2 Surface Cleanliness Levels
2(9)
3 Sources and Generation of Contaminants
11(16)
3.1 Particles
15(5)
3.2 Thin Film or Molecular Contamination
20(2)
3.3 Ionic Contamination
22(2)
3.4 Microbial Contamination
24(3)
4 Impact of Contaminants
27(11)
4.1 Particle Contamination
27(6)
4.2 Molecular Contamination
33(1)
4.3 Ionic Contamination
34(2)
4.4 Microbial Contamination
36(2)
5 Summary and Conclusions
38(1)
Acknowledgment
38(1)
Disclaimer
38(1)
References
38(13)
2 Mid-IR Spectroscopy as a Tool for Cleanliness Validation 51(18)
Mary A. Thomson
1 Background
51(2)
2 Principles of Grazing-Angle FTIR
53(1)
3 Description of the Method
54(3)
4 Advantages and Disadvantages
57(1)
4.1 Direct, Real-Time Method
57(1)
4.2 Detect Anything With An IR Spectrum
58(1)
4.3 Automation
58(1)
4.4 Access to Small Spaces/Flat Surfaces
58(1)
5 Results and Applications
58(6)
5.1 Aerospace
58(1)
5.2 Manufacturing
59(1)
5.3 Pharmaceutical Applications
60(1)
5.4 Explosives and Chemical Warfare Agents
61(1)
5.5 Tank Trials
62(1)
5.6 IRRAS by Direct Reflectance
63(1)
6 Future Developments
64(1)
7 Summary
65(1)
References
65(4)
3 Optically Stimulated Electron Emission: A Powerful Tool for Surface Cleanliness Monitoring 69(40)
Mantosh K. Chawla
1 Introduction
69(2)
2 OSEE Principle
71(11)
2.1 Resolution
74(1)
2.2 Repeatability and Reproducibility
74(1)
2.3 Calibration
75(1)
2.4 Factors Affecting OSEE
76(6)
3 Photoemitting Materials
82(5)
3.1 Substrate Emitting and Contaminant Nonemitting
82(3)
3.2 Substrate Nonemitting and Contaminant Emitting
85(1)
3.3 Both Substrate and Contaminant Emitting
85(2)
3.4 Both Substrate and Contaminant Nonemitting
87(1)
4 Applications of OSEE
87(18)
4.1 Surface Cleanliness Monitoring
87(13)
4.2 Detecting Absence/Presence of Films/Coatings
100(2)
4.3 Measuring Thickness of Thin Films/Coatings
102(3)
5 Summary
105(1)
References
106(3)
4 Methods for Verifying Medical Device Cleanliness 109(20)
David E. Albert
1 Background
109(2)
2 Cleaning Issues and Concerns with Medical Devices
111(2)
3 Extraction Techniques
113(2)
4 Cleaning of Metal and Ceramic Components
115(2)
5 Device Compatibility-Types of Tests and Description
117(2)
6 Test Methods to Identify Contaminants in Extracts
119(1)
6.1 Chromatographic Analysis
119(1)
6.2 Spectrophotometric Analysis
119(1)
6.3 Total Organic Carbon
120(1)
6.4 Gravimetric Analysis
120(1)
7 Setting Limits and Biological Safety Assessment
120(2)
8 Validation
122(1)
9 Sources of Contamination
123(1)
10 Cleanliness Standards, Nonviable Contamination
124(1)
10.1 Setting Allowable Limits
124(1)
10.2 Extraction and Gravimetric Analysis
125(1)
10.3 Quality Management Systems
125(1)
11 Future Developments
125(1)
12 Conclusion
126(1)
References
127(2)
5 Cleaning Validation and Its Regulatory Aspects in the Pharmaceutical Industry 129(58)
S. Lakshmana Prabu
T.N.K. Suriya Prakash
R. Thirumurugan
1 Introduction
131(3)
1.1 Purpose
132(1)
1.2 Reasons
132(1)
1.3 Contaminant
133(1)
2 Good Manufacturing Practice in API Manufacturing
134(2)
2.1 Designing the Cleaning Process in Manufacturing Plants
134(1)
2.2 Equipment in the Manufacturing Plant
134(2)
2.3 Personnel
136(1)
2.4 Heating, Ventilation, and Air Conditioning System
136(1)
2.5 Clothing and Footwear
136(1)
3 Establishing the Acceptance Limits
136(5)
3.1 Doses
137(1)
3.2 Approaches in Establishing the Acceptable Carryover Quantity
137(1)
3.3 Limits Based on Medical or Pharmacological Potency of the Product
138(1)
3.4 Limits Based on Toxicity of the Residue
139(1)
3.5 Risk Levels in Cleaning Validation
140(1)
3.6 Use of ACQ for a Level 0 or Level 1 Changeover
141(1)
4 Cleaning of Equipment
141(7)
4.1 Cleaning Methods
141(1)
4.2 Cleaning Mechanisms
141(4)
4.3 Grouping of Products
145(1)
4.4 Cleaning Process
145(1)
4.5 Cleaning Porous Equipment
146(1)
4.6 Cleaning Frequency
146(1)
4.7 Product Attributes
147(1)
4.8 Postcleaning Equipment Storage
147(1)
4.9 Microbiological Considerations
147(1)
4.10 Documentation
148(1)
4.11 Inspection and Sampling Plan
148(1)
5 Sampling Methods for Cleaning Validation
148(3)
5.1 Swabbing Technique
148(1)
5.2 Rinse Sampling
149(2)
5.3 Placebo Sampling
151(1)
5.4 Microbiological Sampling
151(1)
6 Cleaning Method Specificity
151(3)
6.1 Recovery in Swab Sampling
151(1)
6.2 Stability Issues in Cleaning Method
152(2)
7 Solvents Used for Cleaning
154(3)
7.1 Builders
155(1)
7.2 Cleaning Cycle
155(2)
8 Cleaning Agents
157(2)
8.1 Grouping of Cleaning Agents
157(1)
8.2 Selection of a Cleaning Agent
158(1)
8.3 Water
158(1)
8.4 Alkaline Agents
158(1)
8.5 Acidic Agents
159(1)
9 Analytical Methods
159(7)
9.1 Specific Methods
161(1)
9.2 Nonspecific Methods
161(1)
9.3 Various Analytical Techniques in Cleaning Validation
162(4)
10 Cleaning Development Phase
166(2)
10.1 Standard Operating Procedures
166(1)
10.2 Operator
167(1)
10.3 Operator Training
167(1)
11 Cleaning Validation Protocol
168(9)
11.1 A Model Cleaning Validation Protocol
168(9)
12 Validation Report
177(1)
13 The FDA Cleaning Validation Guideline
177(2)
13.1 FDA Requirements
178(1)
13.2 Acceptance Criteria
178(1)
14 Effective Cleaning Validation Maintenance Program
179(2)
14.1 Equipment Cleaning Validation and Maintenance
179(1)
14.2 Overview of Cleaning Validation Program
180(1)
14.3 Cleaning Validation Lifecycle Management
180(1)
14.4 Cleaning Validation Chart
181(1)
15 Summary
181(1)
References
182(5)
Index 187
Dr. Rajiv Kohli is a leading expert with The Aerospace Corporation in contaminant particle behavior, surface cleaning, and contamination control. At the NASA Johnson Space Center in Houston, Texas, he provides technical support for contamination control related to ground-based and manned spaceflight hardware, as well as for unmanned spacecraft. His technical interests are in particle behavior, precision cleaning, solution and surface chemistry, advanced materials and chemical thermodynamics. Dr. Kohli was involved in developing solvent-based cleaning applications for use in the nuclear industry and he also developed an innovative microabrasive system for a wide variety of precision cleaning and micro-processing applications in the commercial industry. He is the senior editor of this book series Developments in Surface Contamination and Cleaning”; the first ten volumes in the series were published in 2008, 2010, 2011, 2012, 2013 (Volumes 5 and 6), 2015 (Volumes 7 and 8), and 2017 (Volumes 9 and 10), respectively. The second edition of Volume 1 was published in 2016. Volume 11 and Volume 12 (this volume) are expected to be published in 2019. Previously, Dr. Kohli co-authored the book Commercial Utilization of Space: An International Comparison of Framework Conditions”, and he has published more than 270 technical papers, articles and reports on precision cleaning, advanced materials, chemical thermodynamics, environmental degradation of materials, and technical and economic assessment of emerging technologies. Dr. Kohli was recognized for his contributions to NASAs Space Shuttle Return to Flight effort with the Public Service Medal, one of the agencys highest awards. Dr. Kashmiri (Kash) Mittal was associated with IBM from 1972 to 1994. Currently, he is teaching and consulting in the areas of adhesion science and technology and in surface contamination and cleaning. He is the founding editor of the Journal of Adhesion Science and Technology and is editor of more than 130 published books, many of them dealing with surface contamination and cleaning. In 2002, the Kash Mittal Award was inaugurated for his extensive efforts and significant contributions to the field of colloid and interface chemistry. Among his numerous awards, Dr. Mittal was awarded the title honoris causa by the Maria Curie-Sklodowska University in Lubin, Poland in 2003. Currently, he is teaching and consulting in the areas of surface contamination and cleaning and in adhesion science and technology.
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