This document discusses good weighing practices in quality control laboratories. It emphasizes the importance of accurate weighing and describes the types of balances needed, including their minimum weights and calibration requirements. Factors that can influence weighing accuracy, such as vibration, temperature, sample properties, and location are examined. Calibration tests including repeatability, linearity, eccentricity and sensitivity are defined.
This document discusses analytical balances and their classification, accuracy, and performance testing. It provides:
1) A classification system for balances based on their number of decimal places and accuracy class. The smallest and most precise are ultra microbalances while technical balances have the lowest precision.
2) Requirements for accuracy and repeatability testing according to the USP General Chapters. Accuracy must be within 0.1% of the test weight and repeatability must have a standard deviation below 0.1% of the smallest intended weight.
3) Guidelines for other performance tests including sensitivity, linearity, eccentricity, and criteria for acceptance. Tests should ensure the balance meets tolerance requirements for intended uses.
Analytical balances have been used since 5000 BC, with the modern version originating in the mid-18th century developed by Joseph Black. There are several types of balances including analytical, micro, and top-load balances, which differ in capacity and sensitivity. Proper use and calibration of balances is important for accuracy and includes factors like location, temperature/humidity control, cleaning, and calibration schedules using certified weights.
Good weighing-practices-a.9421999.powerpoint (1)Nop Pirom
Weighing is a key activity in quality control laboratories. The type of balance used and weighing practices can impact the accuracy and quality of test results. Analytical, semi-micro, and micro balances with desired resolution, accuracy, and repeatability should be selected based on the minimum weight needed to reduce error and meet compliance standards. Factors like balance repeatability, required precision, and sample mass are considered to determine minimum weight, below which measurement error increases and results become unreliable.
The document discusses calibration procedures for an analytical balance, including drift check, performance check, and measurement uncertainty check. Key steps include using weights of 1mg, 2mg, 5mg, 10mg, and 20mg to ensure measurements are within 0.1% of the actual mass value, calculating measurement uncertainty as the standard deviation times 3 divided by the actual mass value, and ensuring calibration is performed daily and after maintenance or relocation. Environmental factors like temperature, humidity, and static electricity are also discussed as important to control drift.
The document discusses calibration, including defining calibration as checking the accuracy of measuring instruments against a standard. It describes various calibration laboratories and standards in India such as NPL, ERTL, and ETDC. It explains the importance, purpose, and types of calibration, as well as requirements for calibration management systems and common instrument calibrations.
Analytical balances are highly sensitive weighing devices used to measure small masses in the sub-milligram range. They have an enclosed weighing pan inside a transparent draft shield to prevent dust and air currents from affecting measurements. Analytical balances must be calibrated regularly and located in areas free of vibration and electromagnetic interference to provide accurate readings. Proper weighing technique requires taring the balance, centering samples on the pan, and allowing readings to stabilize before recording results.
This document provides guidelines and formulas for calibrating analytical balances according to chapters 41 and 1251 of the USP and chapter 2.1.7 of the EP. It discusses important terms and how to test a balance's repeatability, accuracy, sensitivity, linearity, and eccentricity. The tests involve loading standard weights in different locations and calculations to evaluate the balance's performance against specified acceptance criteria.
This document discusses measurement uncertainty. It defines measurement uncertainty as a parameter included with any measurement result that accounts for possible errors. It describes sources of uncertainty like sampling, storage conditions, and personal effects. The document outlines methods of calculating uncertainty using the standard deviation, and explains why assessing uncertainty is important for interpreting results and ensuring measurement quality. Measurement uncertainty is a key component of any measurement result.
This document discusses analytical balances and their classification, accuracy, and performance testing. It provides:
1) A classification system for balances based on their number of decimal places and accuracy class. The smallest and most precise are ultra microbalances while technical balances have the lowest precision.
2) Requirements for accuracy and repeatability testing according to the USP General Chapters. Accuracy must be within 0.1% of the test weight and repeatability must have a standard deviation below 0.1% of the smallest intended weight.
3) Guidelines for other performance tests including sensitivity, linearity, eccentricity, and criteria for acceptance. Tests should ensure the balance meets tolerance requirements for intended uses.
Analytical balances have been used since 5000 BC, with the modern version originating in the mid-18th century developed by Joseph Black. There are several types of balances including analytical, micro, and top-load balances, which differ in capacity and sensitivity. Proper use and calibration of balances is important for accuracy and includes factors like location, temperature/humidity control, cleaning, and calibration schedules using certified weights.
Good weighing-practices-a.9421999.powerpoint (1)Nop Pirom
Weighing is a key activity in quality control laboratories. The type of balance used and weighing practices can impact the accuracy and quality of test results. Analytical, semi-micro, and micro balances with desired resolution, accuracy, and repeatability should be selected based on the minimum weight needed to reduce error and meet compliance standards. Factors like balance repeatability, required precision, and sample mass are considered to determine minimum weight, below which measurement error increases and results become unreliable.
The document discusses calibration procedures for an analytical balance, including drift check, performance check, and measurement uncertainty check. Key steps include using weights of 1mg, 2mg, 5mg, 10mg, and 20mg to ensure measurements are within 0.1% of the actual mass value, calculating measurement uncertainty as the standard deviation times 3 divided by the actual mass value, and ensuring calibration is performed daily and after maintenance or relocation. Environmental factors like temperature, humidity, and static electricity are also discussed as important to control drift.
The document discusses calibration, including defining calibration as checking the accuracy of measuring instruments against a standard. It describes various calibration laboratories and standards in India such as NPL, ERTL, and ETDC. It explains the importance, purpose, and types of calibration, as well as requirements for calibration management systems and common instrument calibrations.
Analytical balances are highly sensitive weighing devices used to measure small masses in the sub-milligram range. They have an enclosed weighing pan inside a transparent draft shield to prevent dust and air currents from affecting measurements. Analytical balances must be calibrated regularly and located in areas free of vibration and electromagnetic interference to provide accurate readings. Proper weighing technique requires taring the balance, centering samples on the pan, and allowing readings to stabilize before recording results.
This document provides guidelines and formulas for calibrating analytical balances according to chapters 41 and 1251 of the USP and chapter 2.1.7 of the EP. It discusses important terms and how to test a balance's repeatability, accuracy, sensitivity, linearity, and eccentricity. The tests involve loading standard weights in different locations and calculations to evaluate the balance's performance against specified acceptance criteria.
This document discusses measurement uncertainty. It defines measurement uncertainty as a parameter included with any measurement result that accounts for possible errors. It describes sources of uncertainty like sampling, storage conditions, and personal effects. The document outlines methods of calculating uncertainty using the standard deviation, and explains why assessing uncertainty is important for interpreting results and ensuring measurement quality. Measurement uncertainty is a key component of any measurement result.
Method Validation - ICH /USP Validation, Linearity and Repeatability labgo
1. The document provides an overview of method validation requirements from various regulatory bodies and guidelines. It discusses key validation parameters such as specificity, linearity, range, accuracy, precision, detection limit, and quantitation limit.
2. Validation is required to demonstrate that analytical methods are suitable for their intended purposes. It identifies potential sources of error and quantifies errors in the method. Validation includes parameters like linearity, range, accuracy, and precision.
3. The document provides details on establishing various validation parameters according to regulatory guidelines from ICH, FDA, and USP. It also discusses considerations for validating methods like instrument qualification and defines method life cycles.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
This document provides information on calibrating and qualifying various analytical instruments. It discusses the importance of calibration and qualification to ensure proper functioning and accurate results. It describes the different types of qualification including design, installation, operational and performance qualification. It then provides details on specific calibration procedures for various instruments like electronic balances, pH meters, UV-Vis and IR spectrophotometers, and HPLC. The calibration procedures ensure the instruments meet parameters for accuracy, resolution, wavelength verification and flow rate consistency.
QA and QC are related but distinct concepts in quality management. QA refers to the overall system that aims to prevent defects through processes, while QC tests products to identify defects. QA is a preventative system involving all employees to ensure quality standards are met throughout development. In contrast, QC is reactive and conducted by a specialized team to detect defects in finished products before release. Both work together to continually meet customer requirements, with QA focusing on building quality in from the start and QC checking for quality along the way.
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.
Qualification of analytical instrumentsFaris ameen
This document provides guidelines for qualifying analytical instruments including electronic balances, pH meters, and UV-Visible spectrophotometers. It discusses the various levels of qualification including: Level I which involves selecting instruments and suppliers; Level II which involves installation and releasing instruments for use; Level III which involves periodic checks; and Level IV which involves in-use checks. Specific guidelines are provided for qualifying balances, pH meters, and UV-Visible spectrophotometers, including recommended tolerance limits for various parameters, calibration procedures, and qualification frequencies.
The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
This document provides standard operating procedures for cleaning equipment, facilities, and cleaning-in-place (CIP) at a pharmaceutical company. It outlines two types of equipment cleaning - Type A which requires dismantling equipment parts for cleaning, and Type B which is surface cleaning without dismantling. Critical areas for cleaning facilities are also identified. CIP is described as a method for cleaning pipes and vessels internally without disassembly using circulation of cleaning solutions. A typical CIP cycle involves pre-rinse, caustic wash, intermediate rinse, acid wash, and final rinse steps. Factors like temperature, concentration, contact time and pressure/turbulence are noted to impact cleaning effectiveness.
The document discusses the qualification of an FTIR analytical instrument. It describes various parameters used to ensure instrument quality such as validation, calibration, and maintenance. Qualification involves collecting evidence that the instrument is suitable for its intended purpose and includes design qualification, installation qualification, operational qualification, and performance qualification phases. The document then discusses specific tests and acceptance criteria for qualifying an FTIR, including tests for resolution, wave number accuracy and reproducibility, transmittance reproducibility, and other tests to evaluate the instrument over time according to ASTM standards.
The document discusses pharmaceutical validation including definitions of qualification and validation. It provides details on types of qualification including design, installation, operational and performance qualification. Validation types such as prospective, concurrent and retrospective validation are summarized. The importance of validation master plan and validation protocols are highlighted. Key aspects of streamlining validation operations are also covered such as the importance of parallel development of API, analytical methods and drug product.
This document provides standard operating procedures for qualifying various laboratory equipment used in pharmaceutical quality control testing. It includes procedures for calibrating hardness testers, friability test apparatus, tap density testers, disintegration testers, and dissolution test apparatus. The qualification process involves design qualification, installation qualification, operational qualification, and performance qualification to ensure equipment is properly installed, works correctly, and provides expected results. Calibration procedures are also described to verify equipment meets specifications.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
Reference standards in Pharmaceutical Industriesbhavanavedantam
This presentation is brief introduction about reference standards that are using in pharmaceutical industries for calibration of different instruments, methods and pharmaceutical chemicals...
The document discusses calibration, including definitions and objectives. It provides details on calibration procedures, including typical contents and development. Key aspects of a calibration system are outlined, such as traceability, environmental controls, and personnel requirements. Validation of calibration methods and general calibration techniques are also summarized. The document provides an overview of important concepts and considerations for calibration.
The document discusses in-process quality control (IPQC) for parenteral products. IPQC involves controlling manufacturing procedures from raw materials to finished product release. Key IPQC tests for parenterals include clarity testing to detect particulate matter using visual or automated methods, leakage testing of packaging, testing fill volume and pH, and sterility testing. The document outlines various physical, chemical, biological, and microbiological tests performed during IPQC to ensure product quality.
This document provides an introduction to metrology, which is the study of measurement. It defines key terms like measurement and discusses the importance of making good measurements. It explains that a good measurement is one where the standard is accurately defined and the method and instruments used are reliable. Sources of error in measurements are also outlined, including systematic, random and gross errors. Statistical analysis methods for measurements are introduced.
analytical method validation and validation of hplcvenkatesh thota
The document summarizes a seminar on analytical method validation and validation of HPLC. It discusses parameters for method validation according to USP, BP, and ICH guidelines such as accuracy, precision, linearity, range, specificity, detection limit, and quantitation limit. It also covers validation of typical HPLC systems through qualification, design, installation, operational, and performance qualification. Key parameters evaluated during HPLC method validation are discussed, including system suitability tests involving retention factor, relative retention, theoretical plates, resolution, and tailing factor.
Method Validation - ICH /USP Validation, Linearity and Repeatability labgo
1. The document provides an overview of method validation requirements from various regulatory bodies and guidelines. It discusses key validation parameters such as specificity, linearity, range, accuracy, precision, detection limit, and quantitation limit.
2. Validation is required to demonstrate that analytical methods are suitable for their intended purposes. It identifies potential sources of error and quantifies errors in the method. Validation includes parameters like linearity, range, accuracy, and precision.
3. The document provides details on establishing various validation parameters according to regulatory guidelines from ICH, FDA, and USP. It also discusses considerations for validating methods like instrument qualification and defines method life cycles.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
This document provides information on calibrating and qualifying various analytical instruments. It discusses the importance of calibration and qualification to ensure proper functioning and accurate results. It describes the different types of qualification including design, installation, operational and performance qualification. It then provides details on specific calibration procedures for various instruments like electronic balances, pH meters, UV-Vis and IR spectrophotometers, and HPLC. The calibration procedures ensure the instruments meet parameters for accuracy, resolution, wavelength verification and flow rate consistency.
QA and QC are related but distinct concepts in quality management. QA refers to the overall system that aims to prevent defects through processes, while QC tests products to identify defects. QA is a preventative system involving all employees to ensure quality standards are met throughout development. In contrast, QC is reactive and conducted by a specialized team to detect defects in finished products before release. Both work together to continually meet customer requirements, with QA focusing on building quality in from the start and QC checking for quality along the way.
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.
Qualification of analytical instrumentsFaris ameen
This document provides guidelines for qualifying analytical instruments including electronic balances, pH meters, and UV-Visible spectrophotometers. It discusses the various levels of qualification including: Level I which involves selecting instruments and suppliers; Level II which involves installation and releasing instruments for use; Level III which involves periodic checks; and Level IV which involves in-use checks. Specific guidelines are provided for qualifying balances, pH meters, and UV-Visible spectrophotometers, including recommended tolerance limits for various parameters, calibration procedures, and qualification frequencies.
The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
This document provides standard operating procedures for cleaning equipment, facilities, and cleaning-in-place (CIP) at a pharmaceutical company. It outlines two types of equipment cleaning - Type A which requires dismantling equipment parts for cleaning, and Type B which is surface cleaning without dismantling. Critical areas for cleaning facilities are also identified. CIP is described as a method for cleaning pipes and vessels internally without disassembly using circulation of cleaning solutions. A typical CIP cycle involves pre-rinse, caustic wash, intermediate rinse, acid wash, and final rinse steps. Factors like temperature, concentration, contact time and pressure/turbulence are noted to impact cleaning effectiveness.
The document discusses the qualification of an FTIR analytical instrument. It describes various parameters used to ensure instrument quality such as validation, calibration, and maintenance. Qualification involves collecting evidence that the instrument is suitable for its intended purpose and includes design qualification, installation qualification, operational qualification, and performance qualification phases. The document then discusses specific tests and acceptance criteria for qualifying an FTIR, including tests for resolution, wave number accuracy and reproducibility, transmittance reproducibility, and other tests to evaluate the instrument over time according to ASTM standards.
The document discusses pharmaceutical validation including definitions of qualification and validation. It provides details on types of qualification including design, installation, operational and performance qualification. Validation types such as prospective, concurrent and retrospective validation are summarized. The importance of validation master plan and validation protocols are highlighted. Key aspects of streamlining validation operations are also covered such as the importance of parallel development of API, analytical methods and drug product.
This document provides standard operating procedures for qualifying various laboratory equipment used in pharmaceutical quality control testing. It includes procedures for calibrating hardness testers, friability test apparatus, tap density testers, disintegration testers, and dissolution test apparatus. The qualification process involves design qualification, installation qualification, operational qualification, and performance qualification to ensure equipment is properly installed, works correctly, and provides expected results. Calibration procedures are also described to verify equipment meets specifications.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
Reference standards in Pharmaceutical Industriesbhavanavedantam
This presentation is brief introduction about reference standards that are using in pharmaceutical industries for calibration of different instruments, methods and pharmaceutical chemicals...
The document discusses calibration, including definitions and objectives. It provides details on calibration procedures, including typical contents and development. Key aspects of a calibration system are outlined, such as traceability, environmental controls, and personnel requirements. Validation of calibration methods and general calibration techniques are also summarized. The document provides an overview of important concepts and considerations for calibration.
The document discusses in-process quality control (IPQC) for parenteral products. IPQC involves controlling manufacturing procedures from raw materials to finished product release. Key IPQC tests for parenterals include clarity testing to detect particulate matter using visual or automated methods, leakage testing of packaging, testing fill volume and pH, and sterility testing. The document outlines various physical, chemical, biological, and microbiological tests performed during IPQC to ensure product quality.
This document provides an introduction to metrology, which is the study of measurement. It defines key terms like measurement and discusses the importance of making good measurements. It explains that a good measurement is one where the standard is accurately defined and the method and instruments used are reliable. Sources of error in measurements are also outlined, including systematic, random and gross errors. Statistical analysis methods for measurements are introduced.
analytical method validation and validation of hplcvenkatesh thota
The document summarizes a seminar on analytical method validation and validation of HPLC. It discusses parameters for method validation according to USP, BP, and ICH guidelines such as accuracy, precision, linearity, range, specificity, detection limit, and quantitation limit. It also covers validation of typical HPLC systems through qualification, design, installation, operational, and performance qualification. Key parameters evaluated during HPLC method validation are discussed, including system suitability tests involving retention factor, relative retention, theoretical plates, resolution, and tailing factor.
This document provides guidelines for qualification of analytical balances and pH meters used in official medicines control laboratories (OMCLs). It discusses the requirements for selection, installation, calibration and ongoing testing of balances and pH meters. Key points include checking that balances are installed in stable, vibration-free locations with controlled temperature and humidity; calibrating balances and pH meters upon installation and on a defined frequency; and conducting tests to verify accuracy, precision, linearity and other performance characteristics. Proper management and calibration of pH electrodes is also covered. The document aims to ensure analytical instruments are qualified and meet performance standards for their intended use in chemical and biological testing.
The document provides information on calibrating analytical balances. It discusses parameters to check such as accuracy, linearity, precision, and corner load tests. The calibration procedure involves placing standard weights on the balance and recording readings to ensure they are within acceptance criteria. Types of balances and common issues like drift due to temperature, static electricity, and air currents are also outlined. Regular evaluation of balance performance through tests of repeatability, cornerload, and linearity is recommended to identify any issues.
The document provides information about calibrating various analytical instruments. It discusses:
1. Calibrating a UV-VIS spectrophotometer involves calibrating for wavelength accuracy, absorbance measurement, gratings performance/stray light test, and resolution power. Specific procedures are outlined for each.
2. Calibrating an HPLC involves parameters like pump calibration, injector calibration, system precision, and detector calibration. Details are given for calibrating the pump flow rate, injector linearity and volume accuracy, and detector linearity.
3. Calibrating a balance involves checking accuracy with standard weights, linearity, precision, and performing a corner load test. Acceptance criteria for each parameter are
How to Comply with the new USP41 Standard.pdfmaruthiprasadK1
This document provides an overview and review of the USP General Chapter <41> on balances. It discusses the new version compared to the old version. Some key points:
- The scope has been expanded from applying only to assays to applying to almost all weighing processes. Two key tests are required - repeatability and accuracy.
- The repeatability test involves weighing a test weight 10 times. The standard deviation calculation has changed from a factor of 3 to 2. There is now a lower limit of 0.41d for the standard deviation.
- The accuracy test tolerance has changed from 0.1% to 0.10%. Only one suitable test weight is needed between 5-100% of the balance's
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
Validation is the process of confirming an analytical method is suitable for its intended purpose. The key steps in validation include assessing accuracy, precision (repeatability and reproducibility), specificity, linearity, range, detection limit, and robustness. Accuracy demonstrates closeness between true and measured values. Precision expresses the degree of variation in measurements. Specificity ensures only the intended analyte is measured. Linearity evaluates the relationship between concentration and response. Range confirms acceptable accuracy and precision within the method's measurable concentrations. [END SUMMARY]
The document discusses the key characteristics and performance parameters of measuring instruments. It describes:
1) Static characteristics relate to constant or slowly varying inputs over time and include parameters like accuracy, precision, resolution, sensitivity, and linearity.
2) Dynamic characteristics relate to rapidly varying inputs over time and are represented by differential equations.
3) Measuring instruments are evaluated based on both their static and dynamic characteristics, with static characteristics being most important for time-independent signals.
This document discusses instrumentation and measurement. It defines measurement as a quantitative comparison between a standard and unknown quantity. There are direct and indirect methods of measurement. Instruments must be calibrated by comparing them to primary or secondary standards.
The key components of an instrument are the primary sensing element, variable conversion element, variable manipulation element, data transmission element, and data presentation element. Instrument performance is characterized by static and dynamic characteristics. Static characteristics include linearity, sensitivity, repeatability, hysteresis, threshold, resolution, and readability.
Methods of force measurement include direct methods using balances and indirect methods measuring acceleration. Proving rings can also measure force by relating deformation to applied force using transducers like strain gauges and LV
This document discusses evaluating meter test data that does not follow a normal distribution. It provides an overview of ANSI/ASQ Z1.9 sampling procedures and requirements for normal data. Non-normal data distributions are common for electronic and digital meter test results. Tools for assessing normality include Anderson-Darling tests and normal probability plots. If data is non-normal, transformations like Box-Cox and Johnson may be applied, but often do not work for meter data. Alternative statistical analyses may be needed for non-normal data.
- Reliability is a measure of reproducibility of a test when repeated, quantifying random error. Validity is how well a test measures what it intends to, requiring comparison to a criterion.
- Reliability is typically quantified by the typical error or intraclass correlation. Validity uses correlation and error of estimate from regression of the test on a criterion.
- Both reliability and validity should be high for a test to accurately track small individual changes over time and distinguish individuals. Ideal values are >0.96 for reliability and validity correlations and typical/estimate errors <20% of between-subject standard deviation.
This document discusses key principles of calibration, including defining calibration as comparing a measuring instrument to a higher accuracy standard. It describes maintaining traceability through an unbroken chain of comparisons to national standards and evaluating uncertainty through factors that affect accuracy. The key characteristics of a calibration discussed are specifying a tolerance, using an accuracy ratio of 4:1 between the instrument and standard, and documenting traceability.
This document discusses key principles of calibration, including defining calibration as comparing a measuring instrument to a higher accuracy standard. It describes characteristics like calibration tolerance, accuracy ratio, traceability, and uncertainty. The goal is for readers to understand calibration requirements and best practices for technicians.
This document discusses the static and dynamic characteristics of instruments. It defines static characteristics as those pertaining to a system where quantities are constant or vary slowly over time, such as temperature. Key static characteristics discussed include accuracy, precision, repeatability, reproducibility, tolerance, range, span, linearity, sensitivity, threshold, resolution, hysteresis, and drift. Dynamic characteristics relate to how an instrument responds to rapidly changing quantities over time and are not defined in this document.
quality control in clinical laboratory DrmanarEmam
The document discusses quality control, quality assurance, and quality assessment in medical laboratories. It defines each term and describes their related but distinct roles. Quality control refers to statistical processes used during each test run to verify test accuracy and precision. Quality assurance describes the overall program that ensures correct final test results. Quality assessment challenges the quality programs through proficiency testing to evaluate the quality of reported results. The document provides details on quality control measurements and rules to monitor test performance over time and determine if tests are in or out of control.
This document defines instrumentation and describes the fundamental measuring process and key performance characteristics of instruments. It states that instrumentation is the technology of using instruments to measure and control physical and chemical properties. The fundamental measuring process involves comparing a measurand (quantity to be measured) to a standard of known quantity. Key elements of a measurement system are the primary sensing element, data conditioning element, and data presentation element. Performance characteristics include static characteristics like accuracy, precision, tolerance, range, linearity, and threshold, and dynamic characteristics.
This presentation discusses the importance of testing meters and the best practices and test equipment to do so. This presentation was given at MEUA Meter School. 03.03.20
Drug Discovery path
Pharma R & D –overview
Discovery & Development
Preclinical research
Clinical Trial
NDA and FDA Approval
Post marketing data
References
This document discusses quality metrics and their importance in measuring and improving pharmaceutical quality. It defines quality metrics as standards used to assess efficiency, performance, and quality. Quality metrics help ensure what is measured gets recorded, monitored, controlled, and improved. The document outlines key quality metrics like batch acceptance rate, product complaint rate, and invalid OOS rate. It also discusses FDA's guidance around voluntary submission of quality metrics data and the benefits this can provide manufacturers. Overall quality metrics are presented as an important tool for continual improvement and assurance of patient safety.
Optical Rotation and Polarimeter by Dr. A. AmsavelDr. Amsavel A
Isomers and enantiomers
Specific Optical Rotation
Polarimeter
Instrumentation and Operation
Factors affect the Optical Rotation
Calibration
Application Specifically Pharmaceutical Industries
Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
Awareness on Cancer
what are the causes for cancer
Terminology
Classification of Cancers
Signs and Symptoms
Stages of Cancers (TSM)
Types of Cancer Treatments
Surgery, Chemotherapy, Radiation Therapy etc
Side effects on treatment
Palliative care
FTIR SPECTROSCOPY,
Principle, Theory, Instrumentation and Application in Pharmaceutical Industry
IR Spectroscopy- Absorption Theory
Type of Vibrations & Vibration Energy level
FTIR Spectrophotometer-Instrumentation
Operation of the Spectrophotometer
Qualification & Calibration
IR Absorption by Organic compounds
Application
FDA citation in FTIR Analysis-Pharmaceutical Industries
UV -Vis Spectrophotometry- Principle, Theory, Instrumentation and Application...Dr. Amsavel A
UV -Vis Spectrophotometry- Principle, Theory, Instrumentation and Application in Pharmaceutical Industry Dr. A. Amsavel.
UV &Visible Spectroscopy-Absorption Theory
Electronic Transitions
Beer- Lambert Law
Chromophores & Auxochrome
Factors Influence the Absorption
UV-Vis Spectrophotometer-Instrumentation
Operation of the Spectrophotometer
Qualification & Calibration
Application
Handling of Refernce Standards_Dr.A.Amsavel Dr. Amsavel A
Definition
Requirements
Guidelines
Pharmacopiea
Types of Reference Standards
SOP for handling of Reference Standards
Qualification of Secondary Standards
Assigning Potency, Storage and Use
Documents & Records
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
Handling of Customer Complaint_Dr.A.AmsavelDr. Amsavel A
Reference Guideline
Definitions
GMP Requirement: 21 CFR § 211.198 and ICH Q7
Procedure for Handling of Complaints
Complaint Investigation
Remedial action and CAPA
Report preparation
Response to customer
Verification of CAPA effectiveness
Review of Complaints
Handling of Reserve Samples Dr.A. AmsavelDr. Amsavel A
This document provides guidelines for reserve/retention samples of active pharmaceutical ingredients (APIs) and drug products according to various regulations. It discusses:
- Requirements for reserve samples under 21 CFR 211.170 including quantity, packaging, and retention period.
- ICH Q7 guidance on reserve/retention samples including storing samples in the same or better packaging than marketed.
- Details on developing standard operating procedures for handling, packing, labeling, storing, examining, and destroying reserve/retention samples according to cGMP regulations.
- Responses to common questions about reserve/retention sample requirements.
Review of Quality Control Record and Analytical Data by Dr. A. AmsavelDr. Amsavel A
Review of Quality Control Record and Analytical Data
Objective and Requirement for Analytical data review
Role of Analyst and reviewer,
Procedure and checklist for review of records/data
Review of traceable /associated documents
Review of calibration, Reference standard record, sampling reports,
Review of Audit trail
Role of Analyst & Reviewer
Review of chromatograms& audit trail,
Data Integrity & Good Record Practice
FDA Citations
Deviation, OOS & complaint investigation and CAPADr. Amsavel A
This document discusses deviation, out-of-specification (OOS), and complaint investigations and corrective and preventive action (CAPA). It defines key terms like nonconformity, corrective action, and preventive action. It describes the requirements for investigations per 21 CFR regulations. Common investigation tools like root cause analysis, 5 whys, fishbone diagrams, and fault tree analysis are explained. The document stresses identifying the root cause, avoiding focus on individuals, and verifying the effectiveness of CAPA.
Volumetric Analysis
Titration Basics
Reaction, End point & Indicators
Types of Titrations
Acid – Base Theory & Principles
Acid Base titration
Non- Aqueous Titration
Precipitation Titration
Complexometric Titration
Oxidation- Reduction Titration
Calculation
General Information
Errors
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
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There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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2. Content
• Significance of balances in the QC Laboratories
• Types of Balances
• Definition
• Minimum weight
• Location for installation Balances
• USP requirement
• Performances test
• Calibration
– Repeatability
– Linearity
– Eccentricity
– Sensitivity
• Factor influence the accuracy of weight
• Types of samples and handling
• Precaution to be taken while weighing
3. Impact of Weighing in Analysis
• Weighing is a one of key activities in all the QC laboratories
• Most of the time, our understanding is not at sufficient level
• Its importance or complexity is underestimated.
• Quality of weighing determines the Quality & Accuracy of final• Quality of weighing determines the Quality & Accuracy of final
test result.
• The USP specifically requires highly accurate results when
weighing analytes for quantitative measures
• Right choice of balances (Analytical/semi-micro/micro ) with
desired resolution, accuracy & repeatability is essential to
reduce the error and meet the compliance
4. Type of balances
Balance name Resolution Quantity of
decimal digits (gm)
Ultra-microbalances 0.1 µg 0.0000001
Microbalances 1 µg 0.000001
Semi-microbalances 0.01mg 0.00001
Analytical balances 0.1mg 0.0001
Precision balances 1g ÷ 1mg 1g ÷ 1mg
7. What is minimum weight ?
• Minimum weight is the minimum sample quantity required to
perform an accurate quantitative analysis is based on the
measurement error of the balance used
• In order to satisfy the required weighing tolerance, when
samples are weighed the amount of sample mass (i.e., the net
weight) must be equal to or larger than the minimum weight.
• The minimum weight applies to the sample weight, not to the
tare or gross weight.
• If the sample quantity is too small, the measurement error will be
huge and result of the analysis will be unreliable.
8. Calculation of Minimum Mass
Minimal mass value of balance can be established based on
repeatability
- analysis required precision 0,1%,
- standard deviation (Balance specification)
Eg Max 220g; d=0.01mg/0.1mg; s = 0,025mg; k = 2; A = 0.1%
• Minimal weighing for the balance is 50mg, if analysis is supposed to
be performed with precision 0.1%.
9. Definition:
Accuracy
• Closeness of agreement between a measured quantity value and a
true quantity value of a measurand. VIM *
• Difference between measurements average value and the real value
according to USP
PrecisionPrecision
• Closeness of agreement between indications or measured quantity
values obtained by replicate measurements on the same or similar
objects under specified conditions. VIM
Trueness
closeness of agreement between the average of an infinite number
of replicate measured quantity values and a reference quantity value
(*) VIM – International Vocabulary of Terms in Legal Metrology
(**) USP – United States Pharmacopeia
11. USP General Chapters
• Measurement is stated to be 'accurately measured' or
'accurately weighed',
– (41) Balances
– (1251) Weighing On An Analytical Balance– (1251) Weighing On An Analytical Balance
12. Understand the USP Requirement
USP General Chapter <1251>:
"In order to satisfy the required weighing tolerance, when
samples are weighed, the amount of sample mass (i.e.,
the net weight) must be equal or larger than the minimumthe net weight) must be equal or larger than the minimum
weight.
The minimum weight applies to the sample weight, not to
the tare or gross weight.
13. Requirement of Balances
Select the appropriate balance based on the accuracy,
repeatability, stability, access control, printout or connect to
other instrument or LIMS etc.
URS
Select Correct accuracy and repeatability Select Correct accuracy and repeatability
Qualification
Installation at right place / location
Operation qualification
Performance qualification / Calibration
Password protection, Access control , printer, etc
14. Balances Requirement - USP
REPEATABILITY USP General Chapter <41>
Repeatability tolerance 0.10%
Expansion factor, K 2
Acceptance criteria 2 x SD/N ≤ 0.10%
Smallest possible sample
weight/lowest starting point
820 d (in optimal conditions)
weight/lowest starting point
Operating Range (2 x SD x 1000) to max capacity or
(2 x 0.41d x 1000) to max capacity (if SD < 0.41d)
ACCURACY USP General Chapter <41>
Tolerance Satisfactory if its weighing value is within 0.10% of
the test weight value
Test weight Between 5% and 100% of the balance's capacity
Calibration uncertainty of the
weight
Must be ≤ 1/3 of 0.10%
15. Location : Installation of Balances
• Install the balance on anti- vibration table &
• non-magnetic surface and grounded to prevent static
electricity
• Room should be temperature and humidity controlled
• vibration, air currents,
• Should be free of drafts and away from air conditioner or fans
or windows to avoid strong air current or direct sunlight
• Away from magnetic fields (magnetic stirrer), electromagnetic
radiation eg RF generators/communication devices and
electric motors,
• Away from Corrosive materials are used nearby.
16. Operational Qualification
OQ has to cover following, but not limited to;
• Control of stable indication
• Mechanical mobility of all moveable parts
• Manually triggered or automatic adjustment by means of• Manually triggered or automatic adjustment by means of
built-in weights.
– Automatic adjustment reduce the drift of the balance.
• Operation of ancillary equipment
• Tare function
• Calibration part of OQ
17. Performance Test
Prop-
erty
Definition Acceptance
Criteria
ExamplesSensitivity
Change in weighing value divided by
the change in load, usually measured
between zero and the capacity of the
balance.
NMT 0.05% deviation
where 〈41〉 is
applicable. For other
uses, respective
tolerance requirement
divided by 2.
The test load at or
sufficiently close
to the capacity of
the balance.
Sensitivity
divided by 2.
Repeat-ability
Ability of a weighing instrument to display
identical measurement values for repeated
weighings of the same objects under the
same conditions, e.g.,
the same measurement procedure,
operator, measuring system, operating
conditions, and same location over a short
period of time. Repeatability usually is
expressed as the standard deviation of
multiple weighings.
Requirement from 〈41〉
where applicable. For
other uses, user
specified requirements
will apply.
10 replicate
weighings (test
weight -few
percent of the
nominal capacity
of the balance).
18. Performance Tests
Pro
perty
Definition Acceptance
Criteria
Examples
Linearity
Ability of a balance to follow the linear
relationship between a load and the
indicated weighing value. Nonlinearity
usually is expressed as the largest
magnitude of any linearity deviation
within the test interval.
NMT 0.05% deviation
where 〈41〉 is
applicable. For other
uses, respective
tolerance
requirement divided
From 3 to 6 points
over the range of the
balance.
Linearity
within the test interval. requirement divided
by 2.
Eccentricity
Deviation in the measurement value
caused by eccentric loading—in other
words, the asymmetrical placement of
the center of gravity of the load relative
to the load receiver. Eccentricity usually
is expressed as the largest magnitude of
any of the deviations between an off-
center reading and the center reading
for a given test load.
NMT 0.05% deviation
where 〈41〉 is
applicable. For other
uses, respective
tolerance
requirement divided
by 2.
Performed in the
center of gravity & 4
quadrants (
Test load usually
should be 30% of the
capacity of the
balance or higher
19. Accuracy <41>:
Accuracy:
• The accuracy is satisfactory if its weighing value, is within 0.10%
of the test weight value.
• A test weight is suitable if it has a mass between 5% and 100% of• A test weight is suitable if it has a mass between 5% and 100% of
the balance's capacity.
• maximum permissible error (mpe) or uncertinity shall 1/3 of the
applied test ie 0.03%. (ASTM E617)
Note: A readability of 0.1 mg of balance is believed as “accurate to 0.1 mg” as
misconception.
20. Balance Calibration
According to USP General Chapter <41> “Balances”, for
substances to be accurately weighed, the balance used must
be calibrated over the operating range
The most important are ;
Repeatability (RP),
Eccentricity (EC),
Linearity (L) and
Sensitivity (SE),
21. Repeatability
• Why Repeatability is so important?
• It will have significant impact on all the quantitative analysis
• Ability of a weighing instrument to display identical
measurement values for repeated weighings of the same
objects under the same conditions, e.g., the sameobjects under the same conditions, e.g., the same
measurement procedure, same operator, same measuring
system, same operating conditions, and same location over a
short period of time.
• Systematic deviations normally can be prevented if
Repeatability is performed.
22. Repeatability :
Repeatability :
Individual measurement deviation from average value does not exceed
standard deviation, that is ~ 0,0003g with probability 68,5%.
Individual measurement deviation does not exceed three standard
deviations, that is ~ 0,0009g with probability higher than 99,7%, so very close
to certainty.
23. Repeatability test <USP 41>
• Perform 10 measurements with the same reference weight
• Calculate the Standard Deviation [SD]
Repeatability is satisfactory if
– 2 x SD/Nominal reference weight used is ≤ 0.10 %
• If the standard deviation obtained is less than 0.41d, (d-is the scale interval),• If the standard deviation obtained is less than 0.41d, (d-is the scale interval),
replace this standard deviation with 0.41d.
– 2x SD x 1000 If SD < 0.41d,
• In this case, repeatability is satisfactory if two times 0.41d, divided by the
nominal value of the weight used, does not exceed 0.10%.
– 2x SD (0.41d) x 1000 = 820d
– analytical balance with a readability of 0.1 mg, this means the
starting point yielded is 82 mg.
24. Linearity test
• Linearity: To ensure that balance is
accurate at the desired level in the
operating range
• Ability of a balance to follow the linear
relationship between a load and the
indicated weighing value.
• Non-linearity usually is expressed as the
largest magnitude of any linearity deviation
within the test interval.
• Perform 3 to 6 points over the range of the
balance.
• Limit: NMT 0.05% deviation where 〈41〉 is
applicable. For other uses, respective
tolerance requirement divided by 2.
It is a deviation of balance real curve
from straight line joining two points
A:B – ideal weight.
25. Eccentricity Test
• Deviation in the measurement value caused by eccentric loading— in other
words, the asymmetrical placement of the center of gravity of the load
• Eccentricity usually is expressed as the largest magnitude of any of the
deviations between an off-center reading and the center reading for a given
test load.
• In practice, a difference is defined between indication when mass standard is• In practice, a difference is defined between indication when mass standard is
put at central point of weighing pan and indication when the same mass
standard is located at another place on the weighing pan.
• Performed in the center of gravity and the four quadrants
• Test load usually should be 30% of the capacity of the balance or higher.
Limit: NMT 0.05%
Deviation where (41) is applicable.
26. Sensitivity Test
• Change in weighing value divided by the change in load,
usually measured between zero and the capacity of the
balance.
• Use certified weights with an appropriateUse certified weights with an appropriate
weight class
• Perform as performed for repeatability test
• Limit: NMT 0.05% deviation where 〈41〉 is applicable. For
other uses, respective tolerance requirement divided by 2.
27. Testing of Balance parameters
• How often balance parameters should be tested?
Intervals defining balance calibration/testing shall be based on
range of operation, their intensity, balance stability in time
and expected weighing process measurement precision.
• Assuming that external conditions are stable, following• Assuming that external conditions are stable, following
balance parameters control periods can be fixed:
– Calibration annually
– Repeatability & centricity monthly
– Sensitivity change weekly
– Verification/ adjustment daily
28. Factors affects the weighing Accuracy
There are several external factors influence the accuracy of weighing;
• Ambient area and people influence result of weight measurement;
• Major balance external factors are ;
– Oscillations, vibrations
– Breeze of air
– Temperature drifts– Temperature drifts
– Electrostatics
– Evaporation and absorption phenomena (hygroscopicity)
– Magnetism
• Other factors is nature of sample ,
• Both balance and the sample will influence the accuracy of results
• To prevent any such issue , need to identify the reason properly
– Is it due to Balance – external factor or sample – external factor?
29. Impact of Vibration & Strong Air
• Oscillations – vibrations are transmitted by the ground and
walls that are generates and affects weighing balance
– Effect is longer measurement time and higher indication
dispersion.
– Prevent vibrations by keep away from vibration area
– Keep on anti-vibration table. Anti vibration double rubber– Keep on anti-vibration table. Anti vibration double rubber
console, to suppress vibrations
• Breeze of air influence to instability and long weighing time.
– Balance workstation should not be located close to doors or
windows.
– Closeness to devices such as air-conditioning, fans, should be
avoided.
30. Impact due to Temperature
How Temperature affect the weighing;
• Weighing room temperature should be maintained at constant
level. Eg variation must not more than 0.5°C/hour.
• Equilibrate the sample to room temperature before weighing ,
will give error due to heat convection ( hot sample will be lesswill give error due to heat convection ( hot sample will be less
than true value)
• Precaution/ aspects for weighing process:
pick up the samples with use of tweezers or other holders
should not put their hands into weighing chamber
Touched with hands, samples –may change their
temperature
31. Hygroscopic samples
Sample nature influence the weighing accuracy:
Hygroscopic samples absorbs the moisture from ambient
air and steadily gain the weight
Measured weight will have higher mass than actual
Weighed promptly Weighed promptly
Use the hermetic vessels or a gas-tight enclosure.
Weighing vessel should be clean & dry and easily
transferable
Add the desired amount of sample, and replace the
enclosure
32. Volatile or hygroscopic samples
Sample nature influence the weighing accuracy:
Volatile liquids (low boiling solvents or solid with volatile
solvents ) can undergo evaporation during weighing
Balance indicates fluctuation / drift; ie weighing continuously
decrease while measurement
Use appropriate weighing vessels, like bulbs with narrow necksUse appropriate weighing vessels, like bulbs with narrow necks
or vessels with top cover.
Weighing of Volatile samples:
Weighing of low boiling liquid point in a vessel with a gas-tight
enclosure of small diameter.
Close immediately after transfer of material
After the balance display stabilizes, the analyst records the
specimen weight
33. Corrosive and Bio-hazardous Samples
Aseptic or Biohazardous Samples
• Weighing the samples in the confines area / bio-safety cabinet
/isolator, or similar containment device.
• Care should be taken if airflow in the hood may cause balance
instabilityinstability
Corrosive Materials
• Extra care is essential when materials of this nature are
weighed.
• Use sealed containers such as weighing bottles or syringes
34. Samples with Electrostatics
Effect of electrostatic presence.
o Slow drift of weighing result,
o Large dispersion of weighing results in a series of measurements,
and
o No return to zero if a load is taken off the weighing pan.
Possible source:
– Dry, finely divided powders may be charged with static electricity– Dry, finely divided powders may be charged with static electricity
– The static charge may develop due to low relative humidity, clothing
worn and gloves used
How to prevent:
Antistatic weigh boats, antistatic guns, and antistatic screens
Placing the container in a metal holder
Balances with a built-in antistatic device is available (piezoelectric
components or low amount of a radioactive polonium) to generate a
stream of ions that dissipate
35. Magnetism as interfering factor
• If magnetic load is measured, electromagnetic field of a
balance is disturbed or weighed sample is influenced by
magnet installed in a balance.
• It will lead to incorrect mass reading of a weighed
sample.sample.
• High resolution balances are constructed on basis of
electromagnetic sets which include a force-motor and
magnet.
• How to avoid: Increasing a distance between a sample
and balance mechanism. Use under-hook weighing with
application of special racks or hooks made of aluminum.
36. Precaution while weighing
• All receivers must be clean, dry, and inert.
• weighing uncertainty for small samples, i.e., net weights with a
mass determined around repeatability.
• Receivers should be nonmagnetic used at ambient
temperature
• Weighing dishes should be polymer or aluminum. Antistatic
and compatible with the liquid sample.
Safety measures:
• Use proper PPEs gloves , mask, goggles etc during a weighing to avoid exposure
• Hazardous materials should be handled in an enclosure that has appropriate air
filtration.
Many toxic— and possibly allergenic— substances are present as liquids or finely
divided particles.
37. Reference
• US Pharmacopeia- 42
• General Chapter <41> Balances,
• General Chapter <1251> Weighing on an Analytical
Balance,Balance,
• Reichmuth, A., Weighing Small Samples on Laboratory
Balances, 13th International Metrology Congress, Lille
(F), 2007