ISO 9000 has become an international reference for quality requirements in business to business dealings, and ISO 14000 looks set to achieve at least as much, if not more, in helping organizations to meet their environmental challenges.
Promoting the use of U.S. standards internationally. Playing an active role in the governance of ISO. Promoting the use of standards , including ISO9000, in the U.S.
Providing calibration services and primary standards for mass, temperature, humidity, fluid flow , and other physical properties. Providing more than 1300 standard references materials to be used in biological, chemical and physical assays. Performing research an development of new standards , including standards for biotechnology . NIST’s weights and measures services, a job assigned to the federal government in the Constitution, provide the basis for the fairness and efficiency of sales totaling more than $5 trillion—roughly half of the U.S. economy? Between 3 percent and 6 percent of the U.S. gross domestic product (GDP) is attributed to measurements and measurement-related operations that rely on NIST for accuracy, reliability, and international recognition? Eighty percent of global merchandise trade is influenced by testing and other measurement-related requirements of regulations and standards—and that U.S. companies increasingly depend on NIST to help ensure access to global markets that create new business and jobs? Without NIST, U.S. manufacturers of such products as glucose and cholesterol test kits—in vitro diagnostic (IVD) devices—wouldn’t be able to meet requirements of new European Union regulations and would have been shut out of the $7 billion European market where they now have more than 60 percent of the business?
Developing and publishing technical standards (eg., those covering the requirements for volume –measuring glassware). More than 100,000 ASTM standards are used worldwide. Providing technical publications and training courses.
Develop and enforce regulations: EPA works to develop and enforce regulations that implement environmental laws enacted by Congress. EPA is responsible for researching and setting national standards for a variety of environmental programs, and delegates to states and tribes the responsibility for issuing permits and for monitoring and enforcing compliance. Where national standards are not met, EPA can issue sanctions and take other steps to assist the states and tribes in reaching the desired levels of environmental quality. Product Quality—Standards and Verification USP establishes public standards to help assure good quality medicines, dietary supplements, and related products used to maintain health and treat disease. Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP's public standards, where such standards exist. Many other countries require the use of high-quality standards such as USP's to assure the quality of medicines and related products. USP disseminates its standards to pharmaceutical manufacturers, pharmacists, and other users through its USP–NF and other publications, official USP Reference Standards materials, and Pharmacopeial Education courses.
Members of the AOAC Laboratory Accreditation Criteria Committee (ALACC) have provided laboratory managers with the guidance they need to meet ISO 17025 requirements. AOAC also provides a number of key publications, hosts technical meetings and conferences, and offers training courses in the areas of laboratory management, quality assurance, accreditation, statistics, and measurement uncertainty.
Developing validated standards methods of analysis for pharmaceutical and health related products Publishing validated standard methods in the compendium the USP. Distributing references materials to be used with the methods outlined in the Pharmacopoeia USP operates two programs to promote safer care of patients who take medications and stay in hospitals. The Medication Errors Reporting Program allows healthcare professionals to directly report medication errors to USP. MEDMARX® , an Internet-based medication error and adverse drug reaction reporting program, is designed for use in hospitals and health systems. USP also uses its knowledge base to provide information that supports the healthcare community in the research and development of patient safety initiatives.
Certain transducers , such as strain gages and pressure transducers , have fatigue life that can change accuracy , depending on the duration and cyclic behavior of the mesurand. In some cases accuracy is not as the importance to detect small change (resolution) , as when quantities are being compared. Such an example is under ground tank testing , the interface between the liquid and the air can be located by observing a small temperature change between the air and liquid. Natural hazards : wiring and the connectors must be able to withstand the effects of exposure to in the required environment, dust, dirt high or low temperatures, water including salt water, humidity, solvents such as acids , bases. The transducer should not pose a hazard to the environment in which it is placed , including electrical problems such as explosion hazard or shock hazard. Power requirements are dependent on type of transducer. Passive transducers such as photocells , convert some of the incident source energy into electrical energy. An AC or DC source power leads can be come a potential problem if transducer operated in a noisy or remote environment. Signal conditioning : if the transducer produces a very small signal or located in a remote or noisy environment , amplification or other signal conditioning may be required at the transducer. The transducer output may need to be converted into a compatible fromate for the remainder of the instrument system. Physical requirements: the space available may be limited or the measurand may be limited over a limited rage. If the quantity to be measured is concentrated , such as in the case of a collimated light source. The physical sizes of the transducer can affect the output.
When Acids are added to water , they release hydrogen ions into solution. On the other hand when bases are added to water , they cause hydrogen ions to be removed from solution. Strong acids and strong bases completely dissociate when dissolved in water and therefore have a strong effect on the hydrogen ion concentrations. Wek acids and weak bases do not completely dissociate in water and therfore have a smaller effect on theconcentration ofhydrogen ions in the solution.
The human eyes receptors respond to wave of light, which we perceive as color. The human observer perceives only reflected light and sees material as color of the reflected wavelengths. White light (sun light) contain all wavelengths in roughly equal amounts . Before use the instrument is calibrated to 100% transmission (zero absorbance) by inserting a cuvette containing the pure solvent without light-absorbing solute. Cuvettes must be made from materials that is transparent to all wavelengths that might be used. Cuvettes are carefully made so that the light path is 1CM Glass is transparent to visible wavelengths but is opaque to ultra violet.
Calibration management system
Metrology Bob O’Brien Dave Miller NHCTC at Pease “ In theory, reality and theory are the same. In reality, they are not.”
Welcome to the E ggsentrix Annual Stockholder’s Meeting! Our mission: To meet or exceed our customer’s expectations for highest quality extra large eggs. Al Bumen, CEO Eggsentrix Inc.
The News <ul><li>Production costs up 48% </li></ul><ul><li>Extra Large egg yield down by 65% </li></ul><ul><li>However, medium and small egg production up by 65% offsets some losses </li></ul><ul><li>Customer satisfaction is up! </li></ul>$ Yield
Our Process <ul><li>Raise top quality laying hens </li></ul><ul><li>Collect eggs with a computerized egg handling system to ensure the freshest eggs </li></ul><ul><li>Classify eggs according to weight to assure consistency of extra large eggs </li></ul><ul><li>Package eggs in protective containers </li></ul><ul><li>Listen to our customers! </li></ul>
Customer Feedback! <ul><li>“ I used to use three eggs in my omelets, but with Eggsentrix eggs, two are plenty!” N. E. Juan </li></ul><ul><li>“ Eggsentrix eggs are the first and last things I can place in my shopping basket!” R. U. Serius </li></ul><ul><li>“ Two dozen Eggsentrix eggs feed my family of four for a week!” I.C. Yu </li></ul>
Recent Production Solutions <ul><li>Intensive selection of breeding stock to develop hens that lay extra large eggs </li></ul><ul><li>Development of specialized high yield feed </li></ul><ul><li>Utilization of custom packaging to handle the improved egg requirements </li></ul><ul><li>Continued engineering to find solutions to producing extra large eggs! </li></ul>
What do you think is the real problem? <ul><li>Are the eggs getting smaller? </li></ul><ul><li>Are the engineering methods effective? </li></ul><ul><li>What is the real issue? </li></ul>2005 2006 80 80
The Real Problem! <ul><li>Calibration of the balance scale! </li></ul><ul><li>Over time, the measurements of an instrument can become inaccurate. This can be from </li></ul><ul><ul><li>Wear </li></ul></ul><ul><ul><li>Misuse </li></ul></ul><ul><ul><li>Aging of components </li></ul></ul><ul><ul><li>Environmental changes </li></ul></ul><ul><ul><li>Stuff happens! </li></ul></ul>
Who Can Perform Calibrations <ul><li>Instrument user </li></ul><ul><li>Line supervisor </li></ul><ul><li>Internal calibration team </li></ul><ul><li>External calibration service </li></ul><ul><li>Instrument manufacturer </li></ul><ul><li>In all cases, proper training and documentation are required </li></ul>
Calibration Periods <ul><li>Manufacturer-recommended calibration interval. </li></ul><ul><li>Before a major critical measuring project. </li></ul><ul><li>After a major critical measuring project. </li></ul><ul><li>After an event. If your instrument took a hit </li></ul><ul><li>Per requirements. Some measurement jobs require calibrated, certified test equipment </li></ul><ul><li>Monthly, quarterly, or semiannually. </li></ul><ul><li>Annually. </li></ul><ul><li>Biannually. </li></ul><ul><li>Never. </li></ul>
Features of a CMS <ul><li>Identifies instruments that can be calibrated </li></ul><ul><li>Determines calibration requirements for instruments </li></ul><ul><li>Establishes calibration procedures </li></ul><ul><li>Develops corrective action procedures </li></ul><ul><li>Documents calibration results and activities </li></ul><ul><li>Supports audit trails for calibration system </li></ul>
Purpose of a CMS <ul><li>Defines: </li></ul><ul><ul><li>What is required? </li></ul></ul><ul><ul><li>Who is responsible? </li></ul></ul><ul><ul><li>When does it need to be done? </li></ul></ul><ul><ul><li>Why does it need to be done? </li></ul></ul><ul><ul><li>How it is accomplished? </li></ul></ul>
Important Definitions <ul><li>Calibration: The operations which assure that an instrument readings are accurate referenced to established standards. </li></ul><ul><li>Validation: Proving that a system (equipment, procedure, process, material) will yield expected results. </li></ul><ul><li>Qualification: Assuring that equipment can produce expected results. </li></ul><ul><li>Instrument: A device which measures a parameter. </li></ul><ul><li>Test Equipment: Devices used during the calibration of instruments. These devices must be traceable to known standards. </li></ul>
Requirements for a CMS <ul><li>Each instrument requires: </li></ul><ul><ul><li>Unique identification </li></ul></ul><ul><ul><li>A recorded history and current calibration status </li></ul></ul><ul><ul><li>Use appropriate for the function of the instrument </li></ul></ul><ul><li>Calibration procedures require </li></ul><ul><ul><li>Approved procedures for calibration </li></ul></ul><ul><ul><li>Schedule for calibration </li></ul></ul><ul><ul><li>Process range limits </li></ul></ul><ul><li>Calibration standards and test equipment </li></ul><ul><ul><li>Must be more accurate than the required accuracy of the instrument (typically 4 times more accurate) </li></ul></ul><ul><ul><li>Traceable back to national or international standards </li></ul></ul><ul><li>Personnel </li></ul><ul><ul><li>Proof of appropriate training </li></ul></ul><ul><ul><li>Perform within an established change management process </li></ul></ul>
Establishing a Calibration Management System <ul><li>Criticality assessment </li></ul><ul><li>Life cycle phases </li></ul><ul><ul><li>Project </li></ul></ul><ul><ul><li>Pre-Operational </li></ul></ul><ul><ul><li>Operational </li></ul></ul><ul><li>Training </li></ul><ul><li>Change control </li></ul><ul><li>Documentation </li></ul><ul><li>Electronic Records </li></ul><ul><li>Auditing </li></ul>
Criticality assessment <ul><li>Process owners, Engineering, and Quality Assurance establish for all instruments involved with the process and their respective criticality </li></ul><ul><ul><li>Identification, range, accuracy, history, capabilities </li></ul></ul><ul><ul><li>Criticality and calibration rationale </li></ul></ul><ul><ul><li>Categorization (product critical, process critical, safety critical, non critical) </li></ul></ul><ul><ul><li>Schedule for calibration service </li></ul></ul>
Life cycle phases <ul><li>Project: definines instruments to measure process variables. Ensure proper selection of instrumentation and procedures. </li></ul><ul><li>Pre-Operational: ensures transfer of calibration data and historical information to the operational phase. SOPs established. </li></ul><ul><li>Operational: calibration, cleaning, decontamination, and documentation of the process instrumentation. </li></ul>
Training <ul><li>Ensure that all personnel involved with calibration are properly trained </li></ul><ul><li>Training records must be maintained </li></ul><ul><ul><li>Personnel and identification records </li></ul></ul><ul><ul><li>Future training needs </li></ul></ul><ul><ul><li>Qualification records </li></ul></ul><ul><ul><li>Experience records </li></ul></ul><ul><ul><li>Competence records </li></ul></ul><ul><ul><li>Courses and presentations </li></ul></ul><ul><ul><li>certificates </li></ul></ul>
Change Control <ul><li>Updates and refinements of the calibration system must be done in a methodical and documented manner </li></ul><ul><li>The changes must be evaluated and approved by all stakeholders including users, Engineering, Quality Assurance, and Process Owner. </li></ul>User requests change Engineering defines detail QA approves change Change maker documents change Process Owner/Engineering/QA signs-off change & document archived
Documentation <ul><li>Documentation standards must be followed: </li></ul><ul><ul><li>Master document file </li></ul></ul><ul><ul><li>Approval procedures </li></ul></ul><ul><ul><li>Change procedures </li></ul></ul><ul><ul><li>Version control </li></ul></ul><ul><ul><li>Distribution control </li></ul></ul><ul><ul><li>Assure only current documents are deployed </li></ul></ul>
Electronic Records <ul><li>Management of electronic records for “paperless” calibration operations </li></ul><ul><li>FDA 21 CFR Part 11 standard for electronic records, electronic signatures, and time stamps </li></ul><ul><li>Key concepts: validation, audit trail, copies of records, record retention </li></ul>
Auditing <ul><li>Periodic audits assure that the calibration plan is being followed </li></ul><ul><li>Provides an opportunity to implement corrective action </li></ul><ul><li>Formal audit report documents audit process </li></ul>
Calibration Management Software <ul><li>Commercial software packages are available to: </li></ul><ul><ul><li>Automate calibration management tasks </li></ul></ul><ul><ul><li>Assure compliance with standards organizations </li></ul></ul><ul><ul><li>Comply with FDA 21 CFR Part 11 electronic signatures </li></ul></ul><ul><ul><li>Maintain documentation and instrument records </li></ul></ul><ul><ul><li>Trace standards used in calibration </li></ul></ul><ul><ul><li>Track changes with audit trail </li></ul></ul><ul><ul><li>Support “paperless” calibration management </li></ul></ul><ul><ul><li>Generate reports </li></ul></ul>
Standards Organizations <ul><li>ISO - International Origination for Standardization </li></ul><ul><li>ANSI - American National Standards Institute </li></ul><ul><li>NIST - National Institute for Standards and Technology </li></ul><ul><li>ASTM - American Society for Testing and Materials </li></ul><ul><li>CLSI (formerly NCCLS) - Clinical and Laboratory Standards Institute </li></ul><ul><li>US EPA – US Environmental Protection Agency </li></ul><ul><li>AOAC - Association of Analytical Communities </li></ul><ul><li>UPC - United States Pharmacopeia </li></ul>
ISO <ul><li>ISO International Origination for Standardization: worldwide federation of national standards bodies from 156 different countries that promotes the development of standards and related activities in the world with a view to facilitating the international exchange of goods and services. </li></ul><ul><li>Developing by consensus international standards including the ISO 9000 quality series Publishing and updating the SI metric systems of units. </li></ul>
ANSI <ul><li>ANSI the American National Standards Institute : administrator and coordinator of the united States private sector voluntary standardization system. ANSI does not itself develop American National Standards : rather it facilities their development by establishing consensus among qualified groups . ANSI is the sole U.S representatives to ISO. </li></ul>
NIST <ul><li>NIST the National Institute for Standards and Technology : A U.S. federal agency that works with industry and government to advance measurement science and development standards. Examples of measurement –related services provided by NIST. </li></ul>
ASTM <ul><li>ASTM, the American Society for Testing and Materials : coordinates efforts by manufacturers , consumers , and representatives of government and academia to develop by consensus standards of materials , products, systems, and services. Examples of measurement –related services provided by ASTM are: </li></ul>
CLSI <ul><li>CLSI: (formerly NCCLS) :The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. </li></ul><ul><li>Recognized worldwide for the application of a unique consensus process. </li></ul><ul><li>CLSI is based on the principle that consensus is an efficient and cost-effective way to improve patient testing and services. </li></ul>
U.S. EPA <ul><li>EPA employs 18,000 people across the country, including our headquarters offices in Washington, DC, 10 regional offices, and more than a dozen labs. Our staff are highly educated and technically trained; more than half are engineers, scientists, and policy analysts. In addition, a large number of employees are legal, public affairs, financial, information management and computer specialists. EPA is led by the Administrator, who is appointed by the President of the United States. </li></ul>
AOAC <ul><li>As the "Association of Analytical Communities," AOAC INTERNATIONAL is committed to be a proactive, worldwide provider and facilitator in the development, use, and harmonization of validated analytical methods and laboratory quality assurance programs and services. AOAC also serves as the primary resource for timely knowledge exchange, networking, and high-quality laboratory information for its members. </li></ul>
AOAC International Checklist <ul><li>Do you have an independent quality assurance department? Is your lab accredited with any organization? If so, which one(s)? Do you follow any published standard of good laboratory practices? </li></ul><ul><li>What information can I provide that will be helpful in the analysis of my product? </li></ul><ul><li>Will any of the sample testing be outsourced to another lab? </li></ul><ul><li>Please describe how you handle samples from the time of receipt, through lab analysis, report issuance, and data archiving. </li></ul><ul><li>Do you have written procedures and schedules for instrument and equipment maintenance and calibration? If so, how can you substantiate this? </li></ul>
AOAC International Checklist <ul><li>Do written valid test methods exist for the sample analysis? How do you assure that the test result(s) is both accurate and precise? </li></ul><ul><li>How much experience does your lab, and the analyst working on the sample, have in dealing with this analyte and matrix? </li></ul><ul><li>Do you record raw data in bound books (laboratory notebooks) or in other laboratory information systems? Is there a way to track a final report to the original raw data? What is the time period for retaining raw data and will you provide such data upon request? </li></ul><ul><li>Based on your experience with this test/matrix and the current lab workload, do you anticipate on-time delivery of the results? </li></ul><ul><li>What policies and procedures do you follow to assure that those results are valid? </li></ul>
USP <ul><li>The United States Pharmacopeia–National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. </li></ul>
References <ul><li>ISPE “GAMP Good Practice Guide, Calibration Management” </li></ul><ul><li>“ Rules and Guidance for Pharmaceutical Manufacturers and Distributors,” MCA, 1997 </li></ul><ul><li>US Code of Federal Regulations, Title 21, Food and Drugs </li></ul><ul><ul><li>21 CFR Part 211 – “Current Good Manufacturing Practice for Finished Pharmaceuticals” </li></ul></ul><ul><ul><li>21 CFR Part 11 – “Electronic Records, Electronic Signatures” </li></ul></ul><ul><li>Federal Standard 209E, “Airborne Particulate Cleanliness Classes in Clean Rooms and Clean Zones,” 1992, Institute of Environmental Science </li></ul>
Calibration physics and Example Instruments <ul><li>Temperature </li></ul><ul><li>Pressure </li></ul><ul><li>Weight/mass </li></ul><ul><li>pH </li></ul><ul><li>RPM </li></ul><ul><li>Electrical </li></ul><ul><li>Aseptic </li></ul><ul><li>Fluid flow </li></ul><ul><li>Humidity </li></ul><ul><li>Optical </li></ul><ul><li>Time </li></ul><ul><li>Volume </li></ul>
The buzz words (1) <ul><li>Data : Raw figures that are gathered </li></ul><ul><li>Information: knowledge that is extracted from data </li></ul><ul><li>Qualitative: data that is purely descriptive </li></ul><ul><li>Quantitative: magnitude or intensity of a physical phenomenon </li></ul><ul><li>Empirical data: values recorded directly from an experiment or observation </li></ul><ul><li>Processed data that has been analyzed </li></ul><ul><li>Analysis is the process of explaining results </li></ul><ul><li>Error is the difference between the true or best to be accurate if the error is small </li></ul><ul><li>Systematic: consistently appear in measurement in the same direction factors to look at : contaminated solution, malfunctioning instrument, and environmental inconsistencies. </li></ul><ul><li>Random: tend to vary in both directions from the true value, extremely or impossible to find and eliminate . </li></ul>
The buzz words (2) <ul><li>Gross errors : human mistakes </li></ul><ul><li>Accuracy refers to the comparison of the measured and accepted , or true value </li></ul><ul><li>Precision is a measure of the repeatability of a series of data points taken in the measure of some quantity, both resolution and stability </li></ul><ul><li>Stability freedom form random variations in the results </li></ul><ul><li>Repeatability is the precision of measurements made under uniform conditions repeated in successions.. </li></ul><ul><li>Reproducibility is the precision of measurements made under non-uniformed conditions , such as different locations. </li></ul><ul><li>Performance verification : is a process of checking that an instrument is performing properly. </li></ul><ul><li>Validation( instrument): is a comprehensive set of test done before an instrument is put into service that demonstrate that it will work within specified parameters and in the conditions under which it will operate. </li></ul><ul><li>Preventative maintence: is a program of scheduled inspections of instruments and the equipment that leads to minor adjustments and ensures that proper function of equipment or instruments. </li></ul>
Measurement <ul><li>If a parameter is not measured, it cannot be controlled </li></ul><ul><li>Measurement: is the process of association a number with a quantity by comparing the quantity to a standard. </li></ul><ul><li>Characterized by the sensitivity, dynamic range, and resolution of the measurement. </li></ul>Transducer Conditioning Signal Processing Signal Displayed Information interpretable by human or computer Simplified Measurement System Physical Quantity Transmission path
Statistics <ul><li>Method for handling data and drawing conclusions </li></ul><ul><li>Descriptive stats: deal with the collection processing and analysis of data to make it comprehensive. </li></ul><ul><li>Statistical inference goal is the interpretation of the data and drawing conclusions. </li></ul><ul><li>Frequency distribution number of occurrences for which measurement that lie with in some interval </li></ul><ul><li>Normal distribution error that is strictly random </li></ul><ul><li>X = X 1 +X 2 +X 3 +… +Xn </li></ul><ul><li>n </li></ul><ul><li>% Error= True Value- Measured Value(100%) /True Value </li></ul>
PM <ul><li>Ensure correct results are capable of being obtained </li></ul><ul><li>Identify weakened components that require replacement to maintain proper functioning. </li></ul><ul><li>Ensure instruments are safe to operate </li></ul><ul><li>Ensure that failing instrument will not result in major shut down or out of specification issue </li></ul><ul><li>Lower cost of repairs </li></ul>
Aseptic Practices <ul><li>Used while performing calibration to avoid inadvertently cross-contaminating: </li></ul><ul><ul><li>Biological pharmaceutical products </li></ul></ul><ul><ul><li>Buffers </li></ul></ul><ul><ul><li>Tools </li></ul></ul><ul><ul><li>Supplies </li></ul></ul>
Transducers <ul><li>Sensor selection is dependent on: measurement range required to perform, environmental conditions operated in </li></ul><ul><li>Conversation of a physical parameter into an electrical quantity: </li></ul><ul><li>Temperature, heat, stress, strain, pressure, displacement, velocity, and acceleration </li></ul><ul><li>Load cell: measures a force indirectly by deformation produced in a beam or other structure. The deformation is converted to a resistance change by a strain gauge that is bond ed to the surface of the beam. </li></ul><ul><li>Resistive transduction can be used to measure light and temperature. Constructed from platinum and their resistance increases as temperature increases. </li></ul>
Traceability <ul><li>Traceability describes the chain of calibrations that establishes the value of a standard or of a measurement. </li></ul><ul><li>In the U.S. traceability for physical and some chemical standards is often to NIST since NIST maintains primary standards. </li></ul><ul><li>Uncertainty of the standard used for calibration Intervals is dependent on various factors accuracy and confidence level , daily usage, predicted or actual drift performance check or verification . </li></ul>
Basic Principles of Weight Measurement <ul><li>Weight is the force of gravity on an object. </li></ul><ul><li>Balances are instruments used to measure this force. </li></ul><ul><li>Balance Range </li></ul><ul><li>Balance Capacity </li></ul><ul><li>Balance Sensitivity </li></ul><ul><li>Mechanical </li></ul><ul><li>Electronics </li></ul>
Weight vs. Mass <ul><li>Mass is the resistance of an object to a change in its motion, while weight is the gravitational force of attraction between the object and the Earth. Mass and weight even have different units. Nonetheless, the terms weight and mass are sometimes used interchangeably. </li></ul><ul><li>Weight = force of attraction between the Earth and an object = mass * acceleration due to gravity </li></ul><ul><li>Mass = Mass is the amount of matter in an object </li></ul>
Basic Procedures for Weight Measurement <ul><li>Make sure balance is level </li></ul><ul><li>Adjust balance to zero </li></ul><ul><li>Make sure the weight plan is clean and empty and chamber doors are in the closed position </li></ul><ul><li>Tare the weight container </li></ul><ul><li>Place the sample into the weighing pan and read the value for the measurement </li></ul><ul><li>Remove the sample </li></ul><ul><li>Clean the balance and area around it </li></ul>
Balance Basics <ul><li>The sample placed onto a balance weight boat on the pan pushes the pan down with a force equal to m g , where m is the mass of the object and g is the acceleration of gravity. </li></ul><ul><li>An electronic balance uses </li></ul><ul><li>electromagnetic force to return the pan to its original position. </li></ul><ul><li>3. Electric current required to generate the force is proportional to the mass, which is displayed on a digital readout on the balance. </li></ul>
Electronic Balance Ohaus Scout Pro Balance Internal overload protection ensures safety from damage caused by excessive weight Sudden impact protection eliminates the worry of dropping or being unexpectedly struck Multiple weighing units and built-in application modes Built-in calibration procedures
Balance Scale (Triple Beam) Ohaus Triple Beam Balances Precision-cast poises and deep notchs in beams for accurate values every time Precision-ground knife edges and self-aligning agate bearings provide maximum sensitivity and reproducibility Response time is quick and accurate Magnetic dampening minimizes oscillation Tare beam allows containers up to 225g to be balanced out
Autoclaves <ul><li>Autoclaves have instrumentation and control packages varying from relay controlled with simple pressure and vacuum gauges and a chart recorder to microprocessor controlled systems with full SCADA2 functionality. </li></ul><ul><li>Replace all of the air in contact with the load to be sterilized with steam of the right quality and of the right temperature and pressure for the correct length of time. </li></ul><ul><li>The critical parameters are steam quality, temperature and time. </li></ul><ul><li>The critical calibrations are temperature, pressure and time. </li></ul>
Calibration of an Autoclave <ul><li>Temperature calibration </li></ul><ul><li>Thermocouple is placed into chamber to allow same source location for both thermocouples </li></ul><ul><li>Correlation between the temperature gauge on instrument and gage on autoclave </li></ul>
Autoclave Tuttnauer Autoclaves An autoclave is a device that uses heat to sterilize equipment and other objects. This process inactivates all bacteria, viruses, fungi, and spores. Features slow and fast exhaust for steam sterilization of liquids, media, instruments and glassware Self-contained design with refillable reservoir allows control of the water purity for sterilization Drying cycle removes residual moisture after sterilization Temperature range: 100° to 134°C (212° to 273°F)
pH pH is a unit of measurement which describes the degree of acidity or alkalinity of a solution. pH refers to a combination of p for power and H for the symbol of the element hydrogen. pH is defined in chemistry as the negative log of the activity of the hydrogen ion: pH=-log10H+ pH is a measurement of the activity of hydrogen ions in a solution at a given temperature. Activity is a function of the availability of hydrogen ions and not their concentration in a solution. pH is measured on a scale of 0 to 14 where pH values less than 7 are considered acidic and values greater than 7 are alkaline.
pH of Common Substances <ul><li>pH Value Compound </li></ul><ul><li>0.3 Sulfuric acid </li></ul><ul><li>Wines </li></ul><ul><li>5-6 Purified laboratory water </li></ul><ul><li>Pure water </li></ul><ul><li>Sea water </li></ul><ul><li>8.4 Sodium bicarbonate </li></ul><ul><li>12.6 Bleach </li></ul><ul><li>14 1 M Sodium Hydroxide </li></ul>
pH Meter Oakton pHTestr 2 Compact, portable pH meter. Features of this meter include one-piece body design, microprocessor control with digital display, and automatic temperature control (ATC).
pH Meter Calibration (1) Calibration PH meters must be calibrated properly and regularly to provide accurate readings. The OAKTON pHTestr 2 uses up to three-point calibration (pH 4, 7,and 10) and automatically recognizes the selected buffer. 1. Turn the instrument on using the ON/OFF button. 2. Dip the electrode end of the unit into the selected buffer (pH 4, 7, or 10) up to the color band. Immersing the unit deeper into the test solution could damage electronic components in the instrument.
pH Meter Calibration (2) Calibration (cont’d) 3. Press the CAL button. The instrument is in calibration mode and “CA” will appear on the display. Calibration begins when a number close to the selected buffer starts to flash on the display. 4. After about 30 seconds confirm calibration by pressing the HOLD/CON button. If calibration is confirmed, “CO” will appear on the display. The buffer value reading will then be shown on the display. 5. The procedures listed in steps 2-4 are then repeated using the other two buffers, if desired. 6. Periodically check the calibration of the instrument to verify proper operation. Full calibration of the instrument should be performed daily. Confirmation of calibration with a known buffer solution should be performed before, and after the measurement of a set of samples.
Temperature <ul><li>In a qualitative manner, we can describe the temperature of an object as that which determines the sensation of warmth or coldness felt from contact with it. </li></ul><ul><li>When the thermal changes have stopped, we say that the two objects (physicists define them more rigorously as systems) are in thermal equilibrium . We can then define the temperature of the system by saying that the temperature is that quantity which is the same for both systems when they are in thermal equilibrium. </li></ul><ul><li>Celsius is more widely used that the Fahrenheit scale. Freezing point for water is 0 0 and boiling point is 100 0 Celsius </li></ul><ul><li>° F = 1.8° C + 32 </li></ul><ul><li>° K = ° C + 273 </li></ul><ul><li>° C = 1.8 ° F - 32 </li></ul>
Measurement of Temperature <ul><li>In industrial process controlled applications , temperature is one of the most frequency controlled and measure variable in biotechnology. </li></ul><ul><li>Transducers fall into two categories a direct connected or inserted into the body to be measured is a thermometer. </li></ul><ul><li>If the temperature is measured by observing the body to be measure through indirect contact is a pyrometer, by radiant heat or sensing the optical properties of the body. </li></ul>
Transducers/ RTD <ul><li>Calibration record: is the data taken during calibration. </li></ul><ul><li>Calibration curve is a line of connecting data points for a particular transducer. </li></ul><ul><li>Static calibration: a calibration in which the transducer is allowed to settle to a fixed value. </li></ul><ul><li>Dynamic calibration: is often a comparison of the transducer that is being calibrated and that of a know reference transducer. </li></ul><ul><li>Step-function response test : a rapid change is introduced 10%-90% of transducer range. The time it takes for the transducer to settle to new measured value is a measurement of the response time. </li></ul>
Thermocouples <ul><li>A thermocouple junction is created when two dissimilar metal wires are joined at one end. When the junction is heated , a small thermionic voltage that is directly proportional to the temperature appears between the wires. </li></ul><ul><li>Type J thermocouples containing iron are relatively inexpensive but limited range. </li></ul><ul><li>Type R and S thermocouples are (platinum-rhodium) are particularly stable . </li></ul><ul><li>Type E thermocouple has advantages for measurement of low temperatures but has a high non0linerarange. </li></ul><ul><li>Type –w (tungsten-rhenium) thermocouples are suited for very high temperatures. </li></ul><ul><li>Exposed-junction thermocouples are prone to corrosion and are fragile, to help prevent these problems probes are sheathed probes are made in metal or ceramic. </li></ul>
Thermocouple Meter Digi-Sense* DuaLogR* Thermocouple Meters Real-time datalogging with infrared output to transfer data to your computer. Logs up to 1000 readings in one second to 60-minute intervals. Thermometer measures minimum, maximum and differential readings using one to two probes. UL listed intrinsically safe for use in Class I; Groups A, B, C, and D Division 1 hazardous locations. Thermometer is also available with NIST certification
Thermometer Fisherbrand* Factory-Calibrated Thermometers Total immersion. Use to verify and calibrate routinely used thermometers including Liquid-In-Glass, RTD's, Thermistors, Thermocouples and Bi-Metal thermometers. Each thermometer is certified at points listed below. Calibrated to meet the requirements of ISO/EC Guide 25, ANSI/NCSL 2540-1-1994, ISO 9000/QS 9000 Series of Quality Standards, and MIL STD 45662A. Supplied with documentation to prove traceability to NIST.
Temperature Calibration Meter Omega CL20 High Precision Handheld Meter, Calibrator / Thermometer, Thermocouples, RTD's and Thermistors Simulate, measure and record RTD, ohm, thermocouple and thermistor signals–all in one meter. 0.3°C 0.5°F accuracy and in ambient temperatures from 18 to 28°C 64 to 82°F). Conform to the temperature/voltage tables of the National Institute of Standards and Technology (N.I.S.T.). OMEGA provides a free NIST Traceable Certificate of Calibration for your records.
Pyrometer Barnstead* Handheld Digital Pyrometer Measures temperature of solids, liquids or gases. Ambient operating temperature limits: 0–50°C. • Can be calibrated to NIST standards • Type K readout range: -200 to +1372°C/-328 to +2502°F; Type J: -200 to +1000°C/-328 to +1832°F
RTD Digi-Sense* ThermoLogR* RTD Thermometers Perfect for on-site documentation. Infrared output allows data transfer to your computer via the optional RS-232 adapter. Simultaneously monitor current, minimum, and maximum readings. CAL button enables you to field calibrate the meter. °F/°C selectable range is -330 to +2210°F (-201 to +1210°C). Resolution is 0.01°F/°C from -99.99 to 99.99°F/°C; 0.1°F/°C from -100.0 to -330°F/°C and from 100.0 to 999.9°F/°C; and 1°F/°C above 1000°F/°C. Accuracy is ±0.06°F (±0.03°C) from -99.99 to 99.99°F/°C; ±0.1°F/°C from -100.0 to -330°F/°C and 100.0 to 999.9°F/°C; ±1°F/°C above 1000°F/°C. Use probes (not included) with round, 3-pin locking connector.
Freezers, Refrigerators Fisher Isotemp* General-Purpose Refrigerator/Freezer Capacity: 17.9 cu. ft. (507L) (refrigerator, 12.9 cu. ft. [365L]; freezer, 5.0 cu. ft. [142L]) Temperature range from 2° to 13°C (refrigerator), -18° to -10°C (freezer) CFC-free R-134a refrigerant Manual or automatic defrost Yellow warning label reads: "Laboratory Refrigerator" Separate adjustment of refrigerator and freezer temperatures
Furnace Thermolyne Muffle Furnaces These laboratory muffle furnaces are ideal for the determination of volatile and suspended solids, drying and evaporating, ignition tests, gravimetric analysis, ashing organic and inorganic samples, and heat treatment operations. Stepless input controller holds any temperature from 100° to 1100°C. Direct reading pyrometer has °C and °F scales. All models are compensated for room temperature variations and molded with ceramic fiber insulation, offering excellent chemical stability and resistance to corrosive agents
Depyrogenation Oven HF4-2 SHEL LAB High Performance Oven Designed for continuous drying operations at temperatures up to 300°C. Factory-set over-temperature protection prevents control failure from damaging contents and guards against burnout. The temperature controller provides 24-step ramp and soak, 0.1°C control, multiple levels of operator access and automatic resumption of program following a power failure. Time and temperature are displayed in three-digit LED readout for fast and accurate setting.
Hot plate Cimarec Digital Hotplates and Stirring Hotplates LED indicates temperature settings, adjustable in 5° increments, from 5° up to 550°C (41° to 1022°F) Microprocessor-controlled feedback technology maintains consistent, repeatable temperature settings CSA approved Stirring models Microprocessor feedback control provides constant speed regardless of changes in viscosity and prevents runaway and magnetic decoupling Stirring speed ranges from 60 to 1200rpm
Incubator Lab-Line Incubators These incubators were specifically designed to meet the requirements of clinical and teaching laboratories. The educational model (not for clinical use) is designed for microbiological and biochemical studies. • Feature adjustable bimetallic thermostat control • Front light indicates when heaters are active
Pressure Calibration Meter Omega DPI603 Pressure Calibrators Enables pressure instrumentation to be serviced in remote locations. Features a built-in pump to generate pressures up to 300 psi. An optional pressure/ vacuum pump enables the hand pump to source pressure or vacuum down to 22 inHg. In addition to the pressure/vacuum measurement, can also measure voltage or current up to ± 50 Vdc or ± 55 mA dc.
Pressure measurement <ul><li>Each a square meter of the bottom area carries the same weight as every other square meter, force per unit area is defined as pressure. </li></ul><ul><li>P=F/A </li></ul><ul><li>P= pressure n/m 2 (Pa) </li></ul><ul><li>F= force , N </li></ul><ul><li>A+ area, m 2 </li></ul><ul><li>newtons per square meter = pascal (Pa) </li></ul><ul><li>Pounds per square inch (PSI) </li></ul><ul><li>Gage pressure (PSIG): reading difference between the atmospheric pressure. pressure readings that including the atmospheric contribution are called absolute pressures (PSIA); </li></ul><ul><li>Differential pressure :is the difference between two pressures </li></ul>
Electrical Terminology <ul><li>Analog signals or digital signals </li></ul><ul><li>Alternating current AC: electrical current that cycle between flowing first in on direction and then in the other direction. </li></ul><ul><li>Current: the flow of charge , may involve the movement of electrons in a conductor or ions in a solution. </li></ul><ul><li>Direct current: current that always flows in the same direction. </li></ul><ul><li>Discrete time signals </li></ul><ul><li>Current </li></ul><ul><li>Analog to Digital converters: device that converts analog to digital values. </li></ul><ul><li>Frequency : the rate at which alternating current cycles back and forth, measured in cycles / sec usually referred to as Hertz = 1Hz /1 cycle second. </li></ul><ul><li>Polarity: the characteristic of having a positive or negative charge. </li></ul><ul><li>Transformer: a device used to change AC voltages. </li></ul><ul><li>Signal: an electrical change that conveys information. For example, a change in voltage, current, or resistance. </li></ul><ul><li>Noise (electrical) Unwanted electrical interference which corrupts a signal. </li></ul><ul><li>Watts, W: unit of power . </li></ul>
Commonly Measured Electrical Parameters <ul><li>Electromotive force (Volts = Amps * Ohms) </li></ul><ul><li>Current (Amps = Volts / Ohms) </li></ul><ul><li>Resistance (Ohms = Volts / Amps) </li></ul><ul><li>Conductivity (Siemens = 1 / Ohms) </li></ul><ul><li>Capacitance and Inductance (The passive ability to store or release electrical energy in a circuit. Measured in units of Farads and Henrys respectively) </li></ul><ul><li>Frequency (Cycles per second of a time-varying signal) </li></ul>
VOM (Volt Ohm Meter) Digital Multimeter DMM <ul><li>Typically capable of measuring: </li></ul><ul><ul><li>AC voltage: Select an appropriate range higher than expected. Values displayed id the RMS value </li></ul></ul><ul><ul><li>DC Voltage :Select an appropriate range higher than expected </li></ul></ul><ul><ul><li>AC current: typically requires movement of probe leads into appropriate jacks along with appropriate range higher than expected. Meter must be connected in series with the electrical circuit under test. Values displayed id the RMS value </li></ul></ul><ul><ul><li>DC current: typically requires movement of probe leads into appropriate jacks along with appropriate range higher than expected </li></ul></ul><ul><ul><li>Ohms: the zero adjust should be verified at each use referred to as confidence test </li></ul></ul><ul><ul><li>Some meters will also measure other parameters such as temperature, frequency, or capacitance </li></ul></ul>
Digital Multimeter Fluke 189 Data Logging Multimeter The Multimeter and Software Combo Pack provides a practical, affordable approach to achieve significantly improved maintenance performance with the flexibility to monitor more than 20 different electrical functions plus temperature.
Conductivity Oakton Waterproof TDS/Conductivity Meters Microprocessor-controlled TDS or conductivity testers offer field durability, plus ±1% full-scale accuracy Automatic temperature compensation over the entire 0° to 50°C (32° to 122°F) range for quick response, even in fluctuating temperatures Unique electrode sensor-cup design allows use as a conventional dip-style tester or as a cup-style tester Calibrate using the one-point, push-button calibration feature
Environmental chamber Barnstead/Thermolyne Lab-Line Environmental Chambers Feature precise microprocessor-based PID control, an operating temperature range of 10° above ambient to 60°C, temperature control and uniformity of ±0.5°C, spray nozzles for humidification. Refrigeration system has a temperature range of 5° to 60°C for working at or below room temperature. Dehumidification feature maintains humidity at or below ambient conditions with ±5% humidity control. 10 in. (25.4cm), seven-day, two-pen chart recorder creates a permanent record of temperature and humidity.
Flow gage Gilmont* Industrial Correlated Aluminum Flowmeter Provides liquid or gas flow readings at capacity levels to 0.48gpm of water while maintaining an accuracy of ±5% of full scale. Includes calibration table for air and water. Certificate indicating instrument traceability to standards provided by NIST available on request.
Manometer Princo Bench Model Manometer Enclosed in glass jacket, with 5 in. diameter (12.7cm) metal base and 1/4 in. (0.6cm) nipple connections. Inner tube is filled with mercury and open to chamber. Scale is graduated upward and downward from center zero (1mm divisions). Absolute pressure is sum of readings for both columns. Constriction in manometer checks mercury surge if the vacuum is broken suddenly.
Fume hood Fisher Hamilton PaceAire Fume Hood Constant volume/bypass airflow system efficiently removes fumes and vapors while keeping the airflow and duct velocity constant. Two-speed integral blower allows the fume hood to operate at a lower mode to conserve energy and offers face velocity adjustment to coordinate with a wide range of duct conditions. Low-speed blower exhaust, 0.11sp at 75fpm face velocity (492cfm) high-speed blower exhaust, 0.28sp at 100fpm face velocity (657cfm).
Biological Safety Cabinet Pending GS certification to EN 12469 Product / Operator / Environment Protection ULPA Filters with typical efficiency at >99.999% at 0.12μm provide ISO Class 3 cleanliness within work zone. HPV-compliant for safe decontamination using BIOQUELL’s technology Isocide™ antimicrobial coated structure eliminates 99.9% of bacterial presence on external surfaces within 24 hours. Redundant fans Esco Infinity Class II Type A2 Biosafety Cabinet
Humidity Fisherbrand Digital Humidity/Temperature Meter Displays relative humidity from 10.0 to 95.0% with a resolution of 0.1% and an accuracy of 1.5% Temperature range is -40.0° to +104.4°C (-40.0° to +220.0°F) with a resolution of 0.1° and an accuracy of ±0.2°C (±0.4°F) Dew point range is -40.0° to +60.0°C (-40.0° to +140.0°F) An ISO 17025 certificate is provided to indicate instrument traceability to standards provided by NIST
IR Thermometer Fluke 572 Noncontact Infrared Thermometers Highly advanced portable IR thermometer reads surface temperatures at a distance. Broad temperature range of -30° to +900°C (-25° to +1600°F) Certifications: Available with a NIST DKD Calibration Certificate assuring its accuracy and indicating instrument traceability to standards provided by the National Institute of Standards and Technology (NIST).
Microscope University Series Microscopes This microscope series combines advanced features with superior optics. The Kohler illumination with field diaphragm helps to maximize resolution. Features and Specifications • The Seidentopf binocular head design provides superior optical performance • Calibration procedures for cleaning and maintenance • Objectives are available as standard Achromats, or Plan Achromats.
Spectrophotometers <ul><li>An instrument that measures concentration on the basis of the ability to absorb light in direct proportion to their concentration. Visible light occurs in a very narrow band of wavelengths approximately 400nm to 700nm. </li></ul><ul><li>Spectrophotometers that are designed for filters of colored glass are called colorimeters. </li></ul>
Spectrophotometer Spectronic 20+/20D+ Spectrophotometers Single-beam units are suitable for general colorimetric and spectrophotometric applications A detector covers the entire 340 to 950nm wavelength range, extending measurements into the near infrared and ultraviolet ranges Simple filter selection lever makes changing filters easy Automatically calculate standard curves by inserting sample and reading concentration When standard is unavailable, manually input the factor
Timers Traceable Lab Controller and Timer Three-channel alarm timer features clock; three timing alarms; audible and visual alarms; manual OFF; metric converter; calculator; repeat channel, memory channel, and stopwatch channel. Programmable for up to 224 ON/OFF switchings per day and 1568 per week Cycles equipment ON/OFF at any interval from 100 hours to one second Quartz crystal accuracy Supplied with serial-numbered certificate from an A2LA accredited ISO 17025 calibration laboratory to indicate traceability to standards provided by NIST.
Viscosity Haake VT02 Rotational ViscoTester Viscometer Speed-stabilized, rotor-driven motor measures the torque produced by the measured liquid, which directly correlates to viscosity. A scale indicates the deflection of the measuring spring. Calibrated for Newtonian substances, instruments indicate data in units of dPas. Typical testing time is only 1 min. Sample temperature range is up to 150°C (302°F). Rotational speed: 62.5rpm; reproducibility: ±2 full scale; comparability: ±7 full scale.
Pipette Gilson Pipetman P Individually calibrated ... a Performance Check Report is included with each Pipetman, along with an engraved Identification Number for traceability • Tip holder and tip ejector are fully autoclavable to avoid cross-contamination • P2 and P10 models are ideal for molecular biology techniques (PCR, DNA sequencing, etc.). Accurate and precise: P10 down to 1 µL and P2 down to 0.2 µL (0.1 µL with a good pipetting technique)
Tachometer Traceable Digital Tachometers Use the touchless sensor to get speed readouts in rpm, contact sensor for direct readout of surface speeds in feet per minute or meters per minute Detects speeds from 1 to 99,999rpm from a distance of 2 to 12 in. (5.1 to 30cm); resolution is 0.1 below 1000, and 1 above 1000 Contact sensor provides readouts from 1 to 19,999rpm, 0.05 to 1999.9m/min. or 0.2 to 6560 ft./min; accuracy, 0.05% ISO-17025 certificate is provided to indicate instrument traceability to standards provided by NIST
Centrifuge Eppendorf Models 5415D/5415R Microcentrifuges Capacity: 48mL (24 x 1.5/2.0mL) Maximum speed/force: 13,200rpm/16,110xG Digital display for time and speed (rpm or rcf); 5417R also displays temperature Timed-run (30 seconds to 99 minutes), adjustable short-spin and continuous-run modes Variable speed control to maximum in 200rpm increments Quick acceleration and deceleration
LABS <ul><li>Scout Pro Balance Scale Calibration </li></ul><ul><ul><li>Utilize internal calibration functions to zero set, span, and linear calibrate a Scout Pro. </li></ul></ul><ul><li>Autoclave Validation BT Sure Biological Indicator </li></ul><ul><ul><li>Utilize a biological indicator to validate proper operation of an autoclave </li></ul></ul>
Lab Procedures <ul><li>Review other documents operation SOP, maintenance SOP, calibration SOP (go over reasons for each, equipment intro) </li></ul><ul><li>Procedures generate work form </li></ul><ul><li>Fill out work form (calibration form 1) </li></ul><ul><li>Follow calibration SOP </li></ul><ul><li>File work form </li></ul><ul><li>Fill out and attach calibration stickers </li></ul>
Calibration of an Autoclave <ul><li>Temperature calibration </li></ul><ul><li>Thermocouple is placed into chamber to allow same source location for both thermocouples </li></ul><ul><li>Correlation between the temperature gauge on instrument and gage on autoclave </li></ul>