This presentation provides an overview of control banding (CB), a method for determining control measures for nanoparticles in laboratories. CB involves assigning hazards to exposure "bands" and recommending controls. The authors discuss how CB has been applied at Oak Ridge National Laboratory's Center for Nanophase Materials Sciences, including developing a risk assessment process using CB. Research studies show CB can effectively control exposures, though some hazard bands may require narrower safety margins. The authors propose using initial CB assignments and exposure validation to determine a process's control status, allowing continued operation if sufficiently controlled.
This document summarizes an empirical study on optimizing the speed of high performance liquid chromatography (HPLC) while maintaining separation quality. The key findings are:
1) Increasing separation speed requires both increasing the velocity of flow through the column and using smaller particle sizes. However, practical limitations are reached due to rising pressure and limitations of injection processes.
2) The injection process, not mass transfer efficiency in the column, is now the limiting factor for separation speed and efficiency in HPLC. Injection processes can dilute samples 20-50 fold, accounting for 80% of observed peak variance.
3) To optimize speed within these limitations, temperature must be increased along with velocity as particle size decreases. Column
1. This document describes Standard Test Method D 92 for determining the flash point and fire point of petroleum products using a Cleveland open cup apparatus.
2. The test method involves heating oil samples in an open cup at a controlled rate and applying an ignition source to determine the temperatures at which the samples will flash or sustain combustion for 5 seconds.
3. Flash point and fire point values indicate a material's flammability hazard and are used in shipping and safety regulations to classify flammable and combustible materials. The test method is applicable to petroleum products with flash points between 79°C and 400°C except for fuel oils.
qualification of analytical instruments..M pharmacy 1st year.validationSohailPattan
The document discusses the qualification and calibration of analytical instruments like electronic balances and UV-Visible spectrophotometers. It provides details on the various tests and parameters to be checked during qualification of these instruments to ensure they meet performance requirements. These include tests for baseline flatness, wavelength accuracy, transmittance, absorbance, emission lines, stray light, resolution and photometric linearity. The document also outlines the recommended frequency of qualification and calibration.
This document discusses quality management systems in medical laboratories. It defines key terms like quality control, accuracy, precision, and quality assurance. It describes the goals of internal and external quality control. The document also explains sources of error like pre-analytical, analytical, and post-analytical phases. It provides details on Levey-Jennings charts, including how they are used to evaluate quality control results over time using statistical process control rules like Westgard rules.
This presentation discusses gas detection calibration and accuracy requirements. It notes that while performance standards for gas detectors are good, calibrations can vary in quality depending on the equipment and process used. To help ensure safety until calibration standards are improved, it recommends comparing readings from multiple gas detection methods, including fixed detectors, handheld detectors, tube bundles, and gas samples, and treating the highest reading as most accurate. The presentation also discusses hypothetical scenarios where one detector reads higher or lower than others, to illustrate the challenges of relying on a single calibrated detector. It concludes the best approach is to work on improving calibration reliability and standardization.
qualification of instrument(UV & FTIR) BY Bhumi Suratiya, M.Pharm sem 2.pptxBhumiSuratiya
So, Here it's presentation on Qualification of instrument(UV & FTIR) BY Bhumi Suratiya, M.Pharm sem 2. Qualification of analytical instruments. it also includes design qualifications (DQ), Installation qualification(IQ)
Operational qualification(OQ)
Performance qualification(PQ).
Measuring Comparability of Conformation, Heterogeneity and Aggregation with C...KBI Biopharma
"Measuring Comparability of Conformation, Heterogeneity, and Aggregation with Circular Dichroism and Analytical Ultracentrifugation", invited talk, State of the Art Methods for the Characterization of Biological Products and Assessment of Comparability, NIH, June 2003
This document summarizes an empirical study on optimizing the speed of high performance liquid chromatography (HPLC) while maintaining separation quality. The key findings are:
1) Increasing separation speed requires both increasing the velocity of flow through the column and using smaller particle sizes. However, practical limitations are reached due to rising pressure and limitations of injection processes.
2) The injection process, not mass transfer efficiency in the column, is now the limiting factor for separation speed and efficiency in HPLC. Injection processes can dilute samples 20-50 fold, accounting for 80% of observed peak variance.
3) To optimize speed within these limitations, temperature must be increased along with velocity as particle size decreases. Column
1. This document describes Standard Test Method D 92 for determining the flash point and fire point of petroleum products using a Cleveland open cup apparatus.
2. The test method involves heating oil samples in an open cup at a controlled rate and applying an ignition source to determine the temperatures at which the samples will flash or sustain combustion for 5 seconds.
3. Flash point and fire point values indicate a material's flammability hazard and are used in shipping and safety regulations to classify flammable and combustible materials. The test method is applicable to petroleum products with flash points between 79°C and 400°C except for fuel oils.
qualification of analytical instruments..M pharmacy 1st year.validationSohailPattan
The document discusses the qualification and calibration of analytical instruments like electronic balances and UV-Visible spectrophotometers. It provides details on the various tests and parameters to be checked during qualification of these instruments to ensure they meet performance requirements. These include tests for baseline flatness, wavelength accuracy, transmittance, absorbance, emission lines, stray light, resolution and photometric linearity. The document also outlines the recommended frequency of qualification and calibration.
This document discusses quality management systems in medical laboratories. It defines key terms like quality control, accuracy, precision, and quality assurance. It describes the goals of internal and external quality control. The document also explains sources of error like pre-analytical, analytical, and post-analytical phases. It provides details on Levey-Jennings charts, including how they are used to evaluate quality control results over time using statistical process control rules like Westgard rules.
This presentation discusses gas detection calibration and accuracy requirements. It notes that while performance standards for gas detectors are good, calibrations can vary in quality depending on the equipment and process used. To help ensure safety until calibration standards are improved, it recommends comparing readings from multiple gas detection methods, including fixed detectors, handheld detectors, tube bundles, and gas samples, and treating the highest reading as most accurate. The presentation also discusses hypothetical scenarios where one detector reads higher or lower than others, to illustrate the challenges of relying on a single calibrated detector. It concludes the best approach is to work on improving calibration reliability and standardization.
qualification of instrument(UV & FTIR) BY Bhumi Suratiya, M.Pharm sem 2.pptxBhumiSuratiya
So, Here it's presentation on Qualification of instrument(UV & FTIR) BY Bhumi Suratiya, M.Pharm sem 2. Qualification of analytical instruments. it also includes design qualifications (DQ), Installation qualification(IQ)
Operational qualification(OQ)
Performance qualification(PQ).
Measuring Comparability of Conformation, Heterogeneity and Aggregation with C...KBI Biopharma
"Measuring Comparability of Conformation, Heterogeneity, and Aggregation with Circular Dichroism and Analytical Ultracentrifugation", invited talk, State of the Art Methods for the Characterization of Biological Products and Assessment of Comparability, NIH, June 2003
Acceptance sampling is a quality control technique where samples are taken from a production lot to determine whether to accept or reject the entire lot. It involves taking a sample, inspecting it for defects, and using pre-defined acceptance criteria based on the sample results to decide whether to accept the lot. The key advantages are that it reduces inspection costs and improves overall quality by eliminating poor quality lots. There are different types of sampling plans like single, double, and multiple sampling based on attributes or variables.
Stress stability testing is designed to determine a molecule's intrinsic stability by establishing degradation pathways and validating analytical procedures. The document discusses guidelines, importance, experimental design, common issues, and industry approaches for stress testing. Key points include: conducting tests like hydrolysis, thermal, oxidation, and photolysis; analyzing degradation pathways and products; and using results to support development and meet regulatory requirements. Stress testing helps ensure quality but industry practices vary in testing design, activities, and organization.
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
The analyst is required to analyze a number of QC samples throughout the run where there are decisions to be made based on a window of acceptance for each QC sample analyzed.
This document outlines statistical quality control techniques for evaluating manufacturing and service processes. It discusses measuring and controlling process variation using variables like mean, standard deviation and control charts. Key aspects covered include process capability analysis using metrics like Cpk, acceptance sampling plans to determine quality levels while balancing producer and consumer risks, and operating characteristic curves.
Calibration of hematology analyzers is necessary to ensure accurate and consistent test results. The document discusses the definition of calibration, why it is needed, recommended calibration frequency according to the manufacturer, and documentation requirements. Quality control is important for monitoring the analyzer's performance but does not replace the need for periodic calibration adjustments. Common quality control methods involve rules and Levey-Jennings charts to detect errors and ensure the analyzer remains in control.
QUALITY ASSURANCE TESTS OF REMOTE AFTERLOADING BRACHYTHERAPY UNIT 1.pptxTaushifulHoque
Quality assurance tests are important to ensure the safe and proper functioning of remote afterloading brachytherapy units. The summary describes the key types of quality assurance tests for brachytherapy units:
1. Mechanical tests check the functioning of sensors, couplings between components, and source positioning accuracy and speed. Electrical tests evaluate interlocks, displays, and console functions.
2. Radiation tests include checks for source leakage and contamination, positioning accuracy and uniformity, temporal accuracy, and source strength verification.
3. Treatment planning system tests assess digitization accuracy and calculation algorithms. Radiation safety tests monitor gamma radiation levels and unit leakage to ensure radiation limits are not exceeded.
The document discusses parametric tolerance interval tests for assessing delivered dose uniformity of orally inhaled products. It provides details on:
- What parametric tolerance intervals and the FDA-proposed two one-sided tolerance interval test are
- How the test determines if a pre-specified proportion of doses fall within the target interval limits with a certain confidence level
- Operational characteristics and acceptance criteria for the two-tiered test approach
- Challenges and advantages of the parametric tolerance interval and alternative counting tests
The document discusses factors to consider when selecting appropriate calibration intervals for measuring instruments. It explains that calibration intervals should account for the instrument type, usage conditions, measurement uncertainty requirements, and risk of exceeding error limits. The document reviews various interval methods including fixed intervals, automatic adjustment based on past calibration results, in-use time tracking, and control charts which can help predict when recalibration is needed to maintain control. Selecting calibration intervals involves balancing calibration frequency against costs while ensuring measurement accuracy and quality.
The growth of, and the confidence in, hemp products will require applicable testing to ensure product quality and safety. Chromatography technology will play a large role in this as the technique is used for potency testing. This study optimizes a quantitative chromatographic determination of 15 cannabinoids using the Shimadzu Hemp Analyzer.
The document discusses phase appropriate method validation. It provides guidelines for validating analytical methods based on the intended use and stage of product development. Validation requirements become more extensive in later phases, from proof of concept in Phase I to full validation in Phase III. Key validation characteristics discussed include specificity, selectivity, range, accuracy, precision, detection limit, quantitation limit, linearity and robustness. The document also covers stress studies, system suitability criteria, and the differences between stability indicating and specificity methods.
This document discusses an eco-friendly and energy efficient biological nitrogen removal process that produces minimal greenhouse gas emissions. It outlines the importance of nitrogen removal from wastewater. It then describes the nitrification process carried out by ammonia oxidizing bacteria through multiple pathways that can produce nitrous oxide. The document also presents a model for the bacteria's behavior in oxic and anoxic conditions and simulations of the model in a continuous bioreactor. It discusses observability testing and state estimation using an extended Kalman filter to estimate unobserved states. Finally, it proposes using a model predictive controller to control the aeration rate based on optimization to meet nitrogen removal goals while minimizing energy use and nitrous oxide emissions.
This document discusses condition monitoring techniques including vibration analysis and acoustic emission. It provides details on:
1. Vibration analysis involves using transducers and signal analyzers to monitor vibration levels in machines. This can identify improper maintenance issues or production practices.
2. Acoustic emission detects mechanical waves and can be used for airborne or direct contact ultrasound testing. It is useful for monitoring boilers, heat exchangers, condensers, steam traps and detecting electrical, bearing, lubrication or mechanical faults.
3. Condition monitoring provides inspection results and reports that are most useful when all monitoring data is correlated. It can indicate potential problems but not necessarily active failures, and good diagnosis requires reference data.
This document discusses analytical method validation and cleaning validation in pharmaceutical manufacturing. It defines validation and outlines key parameters assessed in analytical method validation, including linearity, range, specificity, precision, accuracy, detection and quantitation limits, robustness, and system suitability. It also discusses objectives of cleaning validation, levels of cleaning, validation of cleaning processes and equipment, sampling methods, establishment of limits for residues, and documentation requirements. The overall purpose of validation is to demonstrate that processes can consistently produce products meeting specifications.
This document discusses quality control in clinical laboratories. It outlines objectives related to establishing analytical goals, quality control schemes, and identifying quality control charts and roles. It describes using control charts like Levey-Jennings charts to monitor quality control data over time and evaluate if tests are in or out of control. It also discusses Westgard rules, a multi-rule quality control procedure used to determine if an analytical run is in or out of statistical control.
Measurement of Respirable Suspended Pm10 ParticlesECRD IN
This document provides a detailed method for measuring respirable particulate matter (PM10) in ambient air using a cyclone flow technique. Key steps include:
1) Drawing air through a size-selective inlet and filter to collect particles under 10 micrometers.
2) Weighing the filter before and after to determine the mass of collected particles.
3) Calculating the PM10 concentration by dividing the weight gain by the sampled air volume.
4) Specifying equipment such as the high volume air sampler, cyclone inlet, and controlled environment for filter weighing.
The document provides details on measuring respirable suspended particulate matter (PM10) in ambient air using a cyclone flow technique. It describes how air is drawn through a size-selective inlet that collects particles under 10 micrometers in diameter on a filter. The mass of collected particles is determined by the difference in pre- and post-sampling filter weights, and concentration is calculated based on sampled air volume. The document outlines the equipment, procedures, calibration standards, and quality controls for accurate PM10 measurement according to this standardized method.
This document provides a method for measuring respirable suspended particulate matter (PM10) in ambient air using a cyclone flow technique. Air is drawn through a size-selective inlet that collects particles under 10 micrometers in diameter on a filter. The mass of collected particles is determined by weighing the filter before and after sampling. The concentration of PM10 is calculated by dividing the weight gain by the volume of air sampled. The method involves equilibrating, weighing, and processing filters in a controlled environment, then collecting samples in the field using high-volume air samplers fitted with cyclonic inlets.
The document outlines an agenda for a presentation on building better laboratories. The presentation will discuss project roles and definitions, and provide examples of thinking like a user, including engaging maintenance staff in design, cleanliness perceptions, means and methods, BIM value, hoteling concepts, commissioning integration, and always seeking new solutions. The purpose is to explain key concepts for a successful lab project from a builder's perspective and identify what end users and facility managers should know and expect.
Yale University has transformed its former pharmaceutical campus into a research hub known as Yale West Campus. The 136-acre campus contains over 1.6 million square feet of research labs, administrative offices, and specialty storage facilities. Yale aims to establish interdisciplinary institutes that bring together faculty from across the university to work on challenges in health, environment and energy. The director of research technology discusses challenges in integrating the new campus, developing its identity and vision, and planning state-of-the-art research facilities. Several case studies highlight how old buildings have been repurposed and new centers designed to foster collaboration among researchers.
Acceptance sampling is a quality control technique where samples are taken from a production lot to determine whether to accept or reject the entire lot. It involves taking a sample, inspecting it for defects, and using pre-defined acceptance criteria based on the sample results to decide whether to accept the lot. The key advantages are that it reduces inspection costs and improves overall quality by eliminating poor quality lots. There are different types of sampling plans like single, double, and multiple sampling based on attributes or variables.
Stress stability testing is designed to determine a molecule's intrinsic stability by establishing degradation pathways and validating analytical procedures. The document discusses guidelines, importance, experimental design, common issues, and industry approaches for stress testing. Key points include: conducting tests like hydrolysis, thermal, oxidation, and photolysis; analyzing degradation pathways and products; and using results to support development and meet regulatory requirements. Stress testing helps ensure quality but industry practices vary in testing design, activities, and organization.
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
The analyst is required to analyze a number of QC samples throughout the run where there are decisions to be made based on a window of acceptance for each QC sample analyzed.
This document outlines statistical quality control techniques for evaluating manufacturing and service processes. It discusses measuring and controlling process variation using variables like mean, standard deviation and control charts. Key aspects covered include process capability analysis using metrics like Cpk, acceptance sampling plans to determine quality levels while balancing producer and consumer risks, and operating characteristic curves.
Calibration of hematology analyzers is necessary to ensure accurate and consistent test results. The document discusses the definition of calibration, why it is needed, recommended calibration frequency according to the manufacturer, and documentation requirements. Quality control is important for monitoring the analyzer's performance but does not replace the need for periodic calibration adjustments. Common quality control methods involve rules and Levey-Jennings charts to detect errors and ensure the analyzer remains in control.
QUALITY ASSURANCE TESTS OF REMOTE AFTERLOADING BRACHYTHERAPY UNIT 1.pptxTaushifulHoque
Quality assurance tests are important to ensure the safe and proper functioning of remote afterloading brachytherapy units. The summary describes the key types of quality assurance tests for brachytherapy units:
1. Mechanical tests check the functioning of sensors, couplings between components, and source positioning accuracy and speed. Electrical tests evaluate interlocks, displays, and console functions.
2. Radiation tests include checks for source leakage and contamination, positioning accuracy and uniformity, temporal accuracy, and source strength verification.
3. Treatment planning system tests assess digitization accuracy and calculation algorithms. Radiation safety tests monitor gamma radiation levels and unit leakage to ensure radiation limits are not exceeded.
The document discusses parametric tolerance interval tests for assessing delivered dose uniformity of orally inhaled products. It provides details on:
- What parametric tolerance intervals and the FDA-proposed two one-sided tolerance interval test are
- How the test determines if a pre-specified proportion of doses fall within the target interval limits with a certain confidence level
- Operational characteristics and acceptance criteria for the two-tiered test approach
- Challenges and advantages of the parametric tolerance interval and alternative counting tests
The document discusses factors to consider when selecting appropriate calibration intervals for measuring instruments. It explains that calibration intervals should account for the instrument type, usage conditions, measurement uncertainty requirements, and risk of exceeding error limits. The document reviews various interval methods including fixed intervals, automatic adjustment based on past calibration results, in-use time tracking, and control charts which can help predict when recalibration is needed to maintain control. Selecting calibration intervals involves balancing calibration frequency against costs while ensuring measurement accuracy and quality.
The growth of, and the confidence in, hemp products will require applicable testing to ensure product quality and safety. Chromatography technology will play a large role in this as the technique is used for potency testing. This study optimizes a quantitative chromatographic determination of 15 cannabinoids using the Shimadzu Hemp Analyzer.
The document discusses phase appropriate method validation. It provides guidelines for validating analytical methods based on the intended use and stage of product development. Validation requirements become more extensive in later phases, from proof of concept in Phase I to full validation in Phase III. Key validation characteristics discussed include specificity, selectivity, range, accuracy, precision, detection limit, quantitation limit, linearity and robustness. The document also covers stress studies, system suitability criteria, and the differences between stability indicating and specificity methods.
This document discusses an eco-friendly and energy efficient biological nitrogen removal process that produces minimal greenhouse gas emissions. It outlines the importance of nitrogen removal from wastewater. It then describes the nitrification process carried out by ammonia oxidizing bacteria through multiple pathways that can produce nitrous oxide. The document also presents a model for the bacteria's behavior in oxic and anoxic conditions and simulations of the model in a continuous bioreactor. It discusses observability testing and state estimation using an extended Kalman filter to estimate unobserved states. Finally, it proposes using a model predictive controller to control the aeration rate based on optimization to meet nitrogen removal goals while minimizing energy use and nitrous oxide emissions.
This document discusses condition monitoring techniques including vibration analysis and acoustic emission. It provides details on:
1. Vibration analysis involves using transducers and signal analyzers to monitor vibration levels in machines. This can identify improper maintenance issues or production practices.
2. Acoustic emission detects mechanical waves and can be used for airborne or direct contact ultrasound testing. It is useful for monitoring boilers, heat exchangers, condensers, steam traps and detecting electrical, bearing, lubrication or mechanical faults.
3. Condition monitoring provides inspection results and reports that are most useful when all monitoring data is correlated. It can indicate potential problems but not necessarily active failures, and good diagnosis requires reference data.
This document discusses analytical method validation and cleaning validation in pharmaceutical manufacturing. It defines validation and outlines key parameters assessed in analytical method validation, including linearity, range, specificity, precision, accuracy, detection and quantitation limits, robustness, and system suitability. It also discusses objectives of cleaning validation, levels of cleaning, validation of cleaning processes and equipment, sampling methods, establishment of limits for residues, and documentation requirements. The overall purpose of validation is to demonstrate that processes can consistently produce products meeting specifications.
This document discusses quality control in clinical laboratories. It outlines objectives related to establishing analytical goals, quality control schemes, and identifying quality control charts and roles. It describes using control charts like Levey-Jennings charts to monitor quality control data over time and evaluate if tests are in or out of control. It also discusses Westgard rules, a multi-rule quality control procedure used to determine if an analytical run is in or out of statistical control.
Measurement of Respirable Suspended Pm10 ParticlesECRD IN
This document provides a detailed method for measuring respirable particulate matter (PM10) in ambient air using a cyclone flow technique. Key steps include:
1) Drawing air through a size-selective inlet and filter to collect particles under 10 micrometers.
2) Weighing the filter before and after to determine the mass of collected particles.
3) Calculating the PM10 concentration by dividing the weight gain by the sampled air volume.
4) Specifying equipment such as the high volume air sampler, cyclone inlet, and controlled environment for filter weighing.
The document provides details on measuring respirable suspended particulate matter (PM10) in ambient air using a cyclone flow technique. It describes how air is drawn through a size-selective inlet that collects particles under 10 micrometers in diameter on a filter. The mass of collected particles is determined by the difference in pre- and post-sampling filter weights, and concentration is calculated based on sampled air volume. The document outlines the equipment, procedures, calibration standards, and quality controls for accurate PM10 measurement according to this standardized method.
This document provides a method for measuring respirable suspended particulate matter (PM10) in ambient air using a cyclone flow technique. Air is drawn through a size-selective inlet that collects particles under 10 micrometers in diameter on a filter. The mass of collected particles is determined by weighing the filter before and after sampling. The concentration of PM10 is calculated by dividing the weight gain by the volume of air sampled. The method involves equilibrating, weighing, and processing filters in a controlled environment, then collecting samples in the field using high-volume air samplers fitted with cyclonic inlets.
The document outlines an agenda for a presentation on building better laboratories. The presentation will discuss project roles and definitions, and provide examples of thinking like a user, including engaging maintenance staff in design, cleanliness perceptions, means and methods, BIM value, hoteling concepts, commissioning integration, and always seeking new solutions. The purpose is to explain key concepts for a successful lab project from a builder's perspective and identify what end users and facility managers should know and expect.
Yale University has transformed its former pharmaceutical campus into a research hub known as Yale West Campus. The 136-acre campus contains over 1.6 million square feet of research labs, administrative offices, and specialty storage facilities. Yale aims to establish interdisciplinary institutes that bring together faculty from across the university to work on challenges in health, environment and energy. The director of research technology discusses challenges in integrating the new campus, developing its identity and vision, and planning state-of-the-art research facilities. Several case studies highlight how old buildings have been repurposed and new centers designed to foster collaboration among researchers.
The document summarizes the role and activities of the Director of Research Technology (DoRT) at Yale University. It discusses how DoRT supports research by managing shared research instrumentation, facilitating relationships with faculty and vendors, assisting with facilities planning, and providing other services. It also gives examples of DoRT's work, such as acquiring and inventorying lab equipment from a new research campus and providing a 5-stage process for integrating new faculty into the research environment at Yale within 1 year.
The document summarizes OSHA's Hazard Communication Standard 1910.1200. It outlines the purpose and definitions of key terms to ensure chemical hazards are evaluated and communicated. It describes requirements for written hazard programs, labels, safety data sheets, and employee training. It provides details on hazard classification and the changes made to harmonize with the global standard including new definitions, pictograms, and safety data sheet format.
The document discusses a new Chemical Hazard Use Authorization (CHUA) online application that will allow principal investigators to register high hazard chemicals and obtain Hazard Control Plans. The CHUA aims to provide predictable and effective management of high-risk materials through cooperative management between campus entities, promotion of active safety management, rigorous oversight and accountability, and tools to help safely manage high-risk activities.
The document describes a technique called Lab-HIRA (Hazard Identification and Risk Analysis) for identifying and assessing hazards associated with chemical synthesis in a research laboratory. Lab-HIRA involves identifying hazards using data on the physical, chemical and health properties of reactants and reactions. Once hazards are identified, appropriate risk minimization measures can be implemented. The document provides examples of how Lab-HIRA classifies hazard data and identifies hazardous characteristics and reaction types.
Using transparency to increase awareness of chemical hazardsDIv CHAS
This document summarizes a study on how to make chemical hazard information on the internet more useful for researchers and workers at universities. It tested the relevance, compatibility, and accessibility of various chemical safety websites using ratings from students and laboratory staff. Websites from the Agency for Toxic Substances and Disease Registry (ATSDR), New Jersey Right to Know program, and International Chemical Safety Cards were rated most highly. The study found that for chemical safety sites to be useful, they need relevant and easily accessible content, as well as high search engine rankings like on Google.
Chemistry involves exposure to hazardous chemicals, but exposure can be managed by keeping it below recognized limits and informing workers of risks. While universities produce chemists for industry, government, and academia, textbooks often omit teaching students how to safely handle concentrated acids/bases and toxic chemicals. This misses opportunities to explain dilution, hazard assessments, risk evaluations, and safe waste disposal. Instructors should introduce concepts like hazard, risk management, and chemical substitution to help students respect chemical risks and safely handle hazardous materials as future professionals.
This document discusses lessons learned from designing an interactive safety training course. It covers how people learn, including the difference between working and long-term memory. It also presents models for instructional design, like the ROPES model of review, overview, presentation, exercise and summary. Specific techniques are discussed like varying activities every 20 minutes and interacting every 8 minutes. The document concludes by outlining the implementation of safety lessons for different chemistry courses.
This document summarizes a presentation on challenges and solutions for research operations at Oak Ridge National Laboratory. It discusses defining an operations philosophy focused on directly supporting research. It also addresses developing a team approach with expertise at all levels, from subject matter experts to local support staff. Finally, it outlines taking a plan-based approach to focus areas to continuously improve operations while keeping research progressing efficiently.
The document discusses the role of managing the interface between research organizations and teams involved in designing, constructing, and moving facilities. It focuses on minimizing research downtime by having a research representative embedded throughout the process to facilitate efficient planning, communication, and timely resolution of conflicts. The role involves listening to researcher needs, balancing those with flexibility, and negotiating communication between all parties.
This document discusses the challenges and solutions for research operations at a premier aerospace and defense company that works with high-risk energetic materials. It outlines the organizational structure, business challenges including budget constraints, and technical challenges of working with explosives and propellants. Solutions discussed include organizational checks and balances between research and operations, implementing hazard recognition and risk management processes, taking a lifecycle approach with operational discipline, using tracking tools, and ensuring leadership engagement. Recent successes highlighted effective planning and preparation, establishing new processes safely, and growing business lines.
This document discusses fire codes and chemical limits for scientific facilities. It provides examples of how infrastructure affects maximum allowable quantities of hazardous materials. Specifically, it compares a 1950s facility with one constructed in 1999. The older facility had inadequate fire barriers and a single chemical control area, limiting it to lower quantities. The newer facility has proper fire barriers and 10 separate chemical control areas, allowing storage of much greater amounts divided among the areas. The document emphasizes that chemical storage limits depend on the occupancy classification, safety features of the building, and requirements of the building and fire codes.
Developing effective safety training for a changing audienceDIv CHAS
The document discusses developing effective safety training for a changing audience. It notes that effective training incorporates visual, auditory, and kinesthetic learning modalities and encourages active learning. Examples of training methods discussed include instructor-led training using objectives, worksheets, and demonstrations, as well as online or computer-based training using video, audio, and interactivity. The goal is to develop training that meets different learning needs and engages learners through problem-based scenarios.
Princeton University has rigorous lab safety training requirements for all individuals working in its over 600 laboratories. The training includes a 3-hour classroom session covering topics like health hazards, emergency procedures, and risk assessment. Undergraduate science majors must complete this training, as well as additional in-lab training, to ensure they are prepared to work independently in future research projects. Graduate students also receive mandatory safety training tailored to their programs. The goal is for all laboratory workers to have a strong base of safety knowledge no matter their role at the university.
Using transparency to increase awareness of chemical hazards.pptxDIv CHAS
This document summarizes a study on how to make chemical hazard information on the internet more useful for researchers and workers. The study tested how 35 participants rated the relevance, compatibility and accessibility of various chemical safety websites in responding to hypothetical chemical exposure scenarios. Websites from government agencies like ATSDR and NIOSH rated highly according to these criteria. The findings suggest that for chemical safety information online to be truly useful, sites need relevant and easy-to-understand content as well as high searchability in engines like Google.
This document discusses efforts to improve chemical safety culture at Texas Tech University's Department of Chemistry and Biochemistry following a laboratory explosion in 2010. It provides background on Texas Tech University and the chemistry department. It then outlines the response to the explosion, which included reorganizing safety committees, requiring safety training and personal protective equipment, and increasing regulatory oversight of laboratories. It describes additional changes made by the chemistry department such as implementing peer safety reviews, developing incident reporting processes, and emphasizing safety in graduate education and faculty evaluations. Finally, it discusses lessons learned about the challenges of ensuring chemical safety culture.
Safety culture and academic laboratory accidentsDIv CHAS
The document summarizes Miriam Weil's research on safety culture in academic laboratories. It details accidents that occurred at UCLA, Northwestern, and Dartmouth and how each institution addressed laboratory safety after the incidents. Weil conducted interviews and literature reviews to analyze the key elements of safety culture. Her research identified management commitment to safety, communication of safety information, and trust as the three most critical values of an effective safety culture.
This document describes a hazard identification and risk analysis (Lab-HIRA) technique for chemical research laboratories. The Lab-HIRA technique involves identifying hazards of planned chemical syntheses using data on reactants, reactions, and experimental conditions. This includes assigning hazard indices to discrete property values and characteristic hazards. Once hazards are identified, appropriate risk minimization measures can be implemented. The document provides examples of applying the Lab-HIRA technique to sample chemical properties, characteristics, reaction types, and conditions.
Chemistry involves exposure to hazardous chemicals, but exposure can be managed by keeping it below recognized limits and informing workers of risks. While universities produce chemists for industry, government, and academia, textbooks often omit teaching students how to safely handle concentrated acids/bases and toxic chemicals. This misses opportunities to explain dilution, hazard assessments, risk evaluations, and safe waste disposal. Instructors should introduce concepts like hazard, risk management, and chemical substitution to help students respect chemical risks and safely work with hazardous materials as future chemists.
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[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Unlock the full potential of the MECE (Mutually Exclusive, Collectively Exhaustive) Principle with this comprehensive PowerPoint deck. Designed to enhance your analytical skills and strategic decision-making, this presentation guides you through the fundamental concepts, advanced techniques, and practical applications of the MECE framework, ensuring you can apply it effectively in various business contexts.
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1. Applying control banding in the
determination of control
measures in laboratories using
nanoparticles
Scott Hollenbeck, John Jankovic, Randy Ogle
Center for Nanophase Materials Sciences,
Oak Ridge National Laboratory
The 234th ACS National Meeting,
Boston, MA, August 21, 2007
2. This presentation:
• Overview of basics of Control Banding
• How Control Banding has been applied
to Operations at the Center for
Nanophase Materials Sciences
• Examples of other uses of Control
Banding in the R&D Environment.
3. Control Banding
Control Banding - increased national and international
attention
– as a practical approach to controlling hazardous agents in a
changing world;
– an approach complementary to the traditional methods of air
sampling and analysis.
– Provides a formal process for incorporating professional
judgment and monitoring.
• The concept - initially developed by the pharmaceutical
industry and later adapted for use by small businesses
and developing countries, an approach that was
appealing to many large industries involving chemical
manufacture.
• NIOSH leads U.S. efforts
4. “Control Banding 101”, NIOSH
http://www.cdc.gov/niosh/topics/ctrlbanding/
• Control banding - a process in which a single
control technology is applied to one range or
band of exposures to a chemical (such as
1−10 mg/m3) that falls within a given hazard
group (such as skin and eye irritants or
severely irritating and corrosive).
• Four main control bands have
been developed for exposure
to chemicals by inhalation
5. “Control Banding 101”, NIOSH cont.
• The most developed CB model for control banding has been
established by the Health and Safety Executive (HSE) of the
United Kingdom.
– http://www.coshh-essentials.org.uk/
• “Easy & qualitative”, First applied to dangerous
chemicals, chemical mixtures, and fumes.
• Emphasizes the controls needed to prevent
hazardous substances from causing harm to people
at work.
• The greater the potential for harm, the greater the
degree of control needed to manage the situation and
make the risk “acceptable.”
6. CB can be applied to categories of chemicals or
their mechanism of toxicity (Table 1 =Inhalation)
Application can be prospective, based on
anticipated exposures; or retrospective based on
measured exposures; and should be periodically
be re-evaluated
From NIOSH
7. Does control banding work?
YES
• The German authority (Bundesanstalt für
Arbeitsschutz und Arbeitsmedizin - BAuA) evaluated
the system based on about 1,000 personal
measurements from field studies in 18 industrial
applications. They found that for solids (dusts and
powders) and medium-scale use (liter quantities) of
liquids, exposures were within the range predicted by
the CB process.
• A study of another control banding tool, the
International Labor Organization (ILO) Toolkit, was
conducted in the United States. The study found
small safety margins for the hazard bands that
included high-potency chemicals.
8. Design and Application of Controls Center for
Nanophase Materials Sciences (CNMS)
• CNMS Laboratories, designed to provide high level of control
• Designed for nanotechnology R&D hazards
• For normal R&D operations the goal is to achieve a control status
of 2 or less
9. CNMS method for CB in
prospect
• Research Safety Summary (RSS)
process, flag priority chems.
• At project planning, do CB (or other
hazard analysis) and determine need
for IH monitoring.
• Document in RSS, IH handles informing
employees
10. A Conceptual Idea for Conducting Exposure Assessment as
Part of the CNMS Work Control Process Using Control
Banding to Achieve a Desired Control Status
WORK CONTROL
CONTROL
BANDS
EXPOSURE
EXPOSURE
ANALYSIS
CONTROL
11. A Control Band (CB) designation reflects a belief about the level of
control for a particular process. Validation of the process’s CB
designation determines the actual control status (CS).
CS (0)
No Exposure Potential CB(0)
CS (1) Remote (<< 10% OEL) CB (1)
CS (2) Highly unlikely (< 10% OEL) CB (2)
CS (3) Unlikely (10% < 50% OEL) CB (3)
CS (4) Possible (50% < 100% OEL) CB (4)
Likely (100% + OEL or Unk) CB (5)
CS (5)
Assignment of a CB of 3 or less
Validation as a CS of 3 or less permits start-up and interim
permits continued operation of a operation of a process under
process.
surveillance.
12. The initial CB designation may be assigned on the basis of process
knowledge, exposure data from a similar exposure group/task, modeling,
or a combination thereof.
Belief (exp
potential +
toxicity)
Belief (process
knowledge,
exposure data,
modeling)
Add to specified controls to
achieve a CB designation of 3 or
lower.
Specified Set
of Controls
Control Band
Assignment
13. Once a control band is validated it
Initial represents the control status of the
Control Band operation. Only a CS of 3 or lower is
Assignment acceptable for routine process
(0 – 3) operation. The control status is
reevaluated on a periodic basis
commensurate with the CS level.
Feedback
Validate
Control
Band
CB becomes
Selection Control Status.
Document and
Determine
Reevaluation
Schedule
14. Developing belief about a process/activity based on:
Sampling data Cutting and Cold Forming Cadmium Sheet Metal
ORNL bldg. 7012 sheet metal working (1991-1995)
Date Sample Time Cadmium TWA Cnct’n. Sheets of cadmium were sheared,
(min) (µ g) (µ g/M3)
bent, and rolled to specified sizes
7/26/91 176 ND <1.1
and shapes for use as shielding in
7/26/91 165 ND <1.1 HFIR fuel storage containers. Six
8/21/91 440 ND <1.1 (approx 2' x 4') sheets of cadmium
8/21/91 400 ND <1.1 metal were cut and formed using a
1/11/95 400 ND <1.1 sheet metal shear and a hand
1/11/95 400 ND <1.1
operated break. Breathing zone
exposure monitoring was conducted
Detection limit for Cd was approximately 1 µ g
during this activity.
Assign a CB of 1
15. Developing belief about a process/activity based on:
Process Cutting and Cold Forming Cadmium Sheet Metal
Knowledge is not a likely mechanism to produce cadmium
fume or aerosolize respirable particulates
Assigned CB activity exposure
1 cutting 5% of the exposure limit
1 Bending/shaping <1% of the exposure limit
1 installing <1% of the exposure limit
16. Selection of initial control band (process knowledge and prior
monitoring)
Bayesian analysis of the
sampling data combined
with professional judgment
suggests the control band.
Control Status determination drives
additional assessment
Control Status 1 calls for:
• samples per sampling cycle
2
• 4 month sampling interval
2
• -10% of SEG/SET per cycle
5
• xposures < 10% of OEL = no change
e
in control status
17. EXAMPLE
Decision Probability
Prior Initial Process knowledge
1
0.8
0.6 Control Band and monitoring from
0.6
0.4
0.2
0.14
Assignment similar ops is used to
0.04
(1)
0.02
0.2
0 assign an initial CB
0 1 2 3 4
Exposure Rating
Decision Probability
Previous monitoring of process indicates CB as 1-2 Likelihood
1 0.677
location activity time job 8 h 2d average % of 0.8
(min) concentration AL 0.6 0.315
0.4
0.006
employee # 922470 cutting 290 1.72 gCd/m3 0.51 gCd/m3 2 0.2
0.001 0.000
0
employee # 924275 installing 245 no Cd detected <0.10gCd/m3 <0.4 0 1 2 3 4
Exposure Rating
on wall inside tank installing 516 no Cd detected < 0.14 gCd/m3 <0.6
Decision Probability
Posterior
0.901
1
0.8
0.6
0.4 0.098
0.000 0.001 0
0.2
0
0 1 2 3 4
CB 1 becomes CS 1
Exposure Rating
+
Sampling combined with
process knowledge verifies
CB 1 designation
18. Process control band validation feeds back into data
bases ensuring initial designations reflect actual work
places and practices.
19. For future use from the book of control bands:
Manual Cutting and Cold Forming Cadmium
Control Band Sheet Metal is not a likely mechanism to produce
1 cadmium fume or aerosolize respirable
particulates
Decision Probability
Posterior
0.901
1
0.8
0.6
0.4 0.098
0.000 0.001 0
0.2
0
0 1 2 3 4
Exposure Rating
Controls flow both into and from control band designation
AZCOM is required in the JHA process.
H
nitial monitoring is not required for the planned operation.
I
et wiping the cadmium sheets before handling is desirable but not required.
W
espiratory protection is not required for the planned operation.
R
ersonal hygiene and the use of gloves (cotton is acceptable)
P
and washing before eating or smoking.
H
rovision of company clothes or coveralls is desirable but not required.
P
Note: Conclusions are based on the assumption that the task to be preformed will involve cutting with shears and cold
forming. Any activities that might abrade or otherwise produce cadmium particles which could become airborne are
outside the scope of this assessment.
20. Two CB examples, from the
CNMS
• First example is a polymer processing
system and determining if CB/Controls
are sufficient.
• Second, is application of CB to carbon
nanotube synthesis
21. Similar Exposure Polymer Collection using solvent systems in fully
Group or Task enclosed process system. Minimal personnel
Control Band 0
(exposure belief < < OEL)
contact during fills and decanting. System and
work takes place in laboratory hood.
General Process Description: Polymers are formed in an enclosed system. Various
solvents contained in the same system are used to separate reacted polymeric
material. The system is opened for filling/recharge, final collection of polymer, and
disposal of spent solvents. Skin/eye contact with solvents is possible during
solvent transfer steps.
Other possible hazards include glass apparatus manipulations involving cutting
and heating with open flame torch.
Solvent exposures in breathing zone are expected to be << 10% of the OEL as task
concentrations without time weighting.
22. Monitoring to validate control band designation and associated controls.
Table 1. Results of air monitoring
location activity time job concentration % of AL
(min)
Researcher BZ standing at hood face- Monitoring/adjusting 5 ND (<0.1 total VOC) ND
arms occasionally inside hood opening. apparatus
Researcher BZ standing at hood face – Opening glass vessel <5 ND (<0.1 total VOC) ND
head occasionally inside plane of hood
opening.
Researcher BZ standing at hood face– Pouring off solvent <5 ND (<0.1 total VOC) ND
head occasionally inside plane of hood
Decision Probability
Decision Probability
Decision Probability
opening.
Prior Likelihood
0.945 0.988
Posterior
1 1 1
0.6
0.8 0.8 0.8
0.6 0.6 0.6
0.2 0.15
0.4 0.4 0.4
0.04 0.01 0 0 0.038 0.017 0 0 0.01 0.001
0.2 0.2 0.2
0 0 0
0 1 2 3 4 0 1 2 3 4 0 1 2 3 4
Exposure Rating Exposure Rating Exposure Rating
23. Monitoring to validate control band designation
combined with belief about process control indicates
control band 2 for this task. This change reflects the
low exposure limit (high toxicity) of benzene, and
the high detection limit of the monitoring equipment.
Similar Exposure Polymer Collection using solvent systems in fully
Group or Task enclosed process system. Minimal personnel
Control Band 2
(exposure belief < < OEL)
contact during fills and decanting. System and
work takes place in laboratory hood.
Minimum controls: Hazcom, PPE to prevent skin contact, and general
ventilation. Process enclosure is recommended but not required.
Resample within 24 months / 3 samples / acceptable control demonstrated if
results < 50% or OEL. More sensitive analytical method may allow for reduction
of control band.
25. Industrial Hygiene Controls
HEPA vacuum used to move all nano
material from quartz tube into collection
chamber.
Collection chamber removed, ends
covered – highest potential for employee
exposure during this step.
TWA = 120 particles/cc
530 p/cc limit
(OSHA limit for graphite)
Justification described
in corresponding poster.
26. Industrial Hygiene Controls
Harvesting nano materials by enclosing
collection chamber in bag and working in
hood
Overall process TWA = 310 p/cc
Traditional industrial hygiene controls
(clean room under HEPA filtration, local
exhaust ventilation, process enclosure,
HEPA vacuum) effectively control
inhalation exposure.
27. Hazard Assessment
Nano material
created is larger
than 100 nm
Therefore, majority of material
is deposited in head airways
rather than penetrating deep
into the lungs.
28. Ensuring Exposure Control for a New Process
nitial hazard assessment initiated in research safety summary –
I
a document created jointly with researchers and occupational
health professionals that describes process, risks, and controls
preliminary control band is assigned based on similar task
A
group
ontrol bands incorporate requisite controls based on
C
toxicity, exposure potential, monitoring capability, process
stability, and professional judgment
ontrol band designation is validated by process monitoring and
C
changed as appropriate
alidated control band incorporates air sampling at requisite
V
resample frequency to ensure continued process control
29. Similar Laser ablation nano particle generation
Exposure
& harvesting
Group or
Task Control Band 2
Decision Probability
Decision Probability
Professional judgment Process evaluation
Likelihood
Prior 1
0.8 0.52 0.48
+
1
0.6 0.6
0.8
0.4
0.6 0 0 0
0.17 0.17 0.2
0.4
0.03 0.03 0
0.2 0 1 2 3 4
0 Exposure Rating
0 1 2 3 4
Exposure Rating Decision Probability
combined
Posterior
0.765
1
0.8
0.6
0.235
0.4
0 0 0
0.2
0
0 1 2 3 4
Exposure Rating
30. Summary for laser ablation
• rocess is controlled using existing methods (clean room, HEPA
P
vacuum, enclosure, local exhaust ventilation).
• nhalation hazard is low for agglomerated particulate as size is less
I
than 100 nm; therefore, does not penetrate into lungs.
• perational exposure limit (530 p/cc) is protective and achievable.
O
• onitoring results combined with professional judgment using
M
Bayesian techniques confirm control band 2 is justified for operations
whenever controls as specified are implemented.
• esample every year or with any change in process by performing a
R
spot check (three breathing zone measurements). If median is less
than or equal to 265 p/cc process is considered to continue as well
controlled.
31. Conclusions
• Efficient and effective method for hazard
analysis in the R&D environment
• Provides a formal process for incorporating
pre- and post judgment regarding a task
• Ranks tasks based on degree of hazard
control
• Provides a method of conducting and
documenting hazard assessments