By carefully following the procedures outlined above, laboratory personnel will eliminate many errors that might be introduced into weighing procedures. If print facility available attach the print out with a template. The weighing funnel is often the most satisfactory receiver, because it can function as both a weighing dish and a transfer funnel, allowing easy transfer to volumetric flasks. Mrs. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners, She has rich experience in pharmaceutical field. Do not cause vibration during Laboratory operations. Rather, the tolerance is purposefully tight to reveal possible drift or calibration errors; this tolerance is readily achievable with modern electronic balances. NIST             :  National Institute of Science and Technology. The observed balance reading should be within +/- 0.1% of market value of standard weight as per USP 41 requirements. Official 1st Dec 2013, can be applied 3rd June 2013. It shows that if you have a balance with least count 0.01 mg, you can weigh minimum 10 mg sample on it. This operation electrically sets the signal from the strain gauge to zero so that the weight of the receiver is no longer indicated. Aseptic or bio-hazardous materials weighing. However, it is important for each balance to be serviced and calibrated regularly by a specially trained internal or external service person. * Buffer salts of requisite For compendial purposes, pH is defined as the value givenpurity can be obtained from the National Institute of Sci- The maximum value is the maximum capacity of the balance. In the event of a spill re-qualification of balance may require, depending on the nature of the spill. $ vxlwdeoh whvw zhljkw kdv d pdvv ehwzhhq dqg ri wkh fdsdflw\ ri wkh edodqfh 7kh pd[lpxp shuplvvleoh huuru ru dowhuqdwlyho\ wkh fdoleudwlrq xqfhuwdlqw\ ri wkh whvw zhljkw (adsbygoogle = window.adsbygoogle || []).push({});Standard Operating Procedure (SOP) for operation and calibration of analytical balances. Assemble the necessary chemicals if solutions or reagents are required. Equilibrate the sample that is warm or cool in the laboratory to room temperature. The Accuracy requirement is applicable between 5% and 100%. Tare the balance (On stabilization of indicator), place the sample container on the balance in the center of the pan in a suitable container (bottle, tube, transfer pipette or syringe) and record the weight (On stabilization of indicator). It is important that the receiver be clean and dry. Also read: SOP for Audit Trail Review and Privilege Policy, (Note: The  above mentioned general notes and precaution are applicable to all the analytical balance available in the Quality control department ). Place the weight in the center of the balance pan to eliminate the corner-weighing difference. King perform balance calibration per USP Chapter 41, our ISO17025 certificate conveniently provides the calibration data table, standard deviation, and the minimum allowable weight that your balance can accurately weigh. No repairs should be made to any balance by anyone other than a qualified validation person. Balance name Resolution Quantity of decimal digits Ultra-microbalances 0,1 µg 0,0000001 Microbalances 1µg 0,000001 Semi-microbalances 0,01mg 0,00001 Analytical balances 0,1mg 0,0001 Precision balances 1g ÷ 1mg 1g ÷ 1mg Chart 1.Names of balances with regard to their resolution 3.2. “The weighing shall be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy.” It is good practice to use a camel's hair brush or its equivalent to dust the balance pan before any weighing so as to remove any materials that may have been left by the previous operator. Similarly, Reprint Annexure -2 and implemented including the following. Also Visit: Calibration of UV Spectrophotometer, Pingback: Operation and Calibration of pH Meter - Pharma Beginners, Pingback: Batch Processing - SOP & General Check Points - Pharma Beginners, Pingback: SOP for Handling of Out of Calibration (OOC) - Pharma Beginners, Pingback: SOP for Operation and Calibration of UV Cabinet - Pharma Beginners, Mrs. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners, She has rich experience in pharmaceutical field. The weight taken should be ± 10% of the specified weight or as specified in the individual monograph. Weights and Balances 〈41〉, for weighing material accurately. USP 37 Physical Tests / 〈791〉 pH 1 BUFFER SOLUTIONS FOR STANDARDIZATION 〈791〉 pH OF THE pH METER Buffer Solutions for Standardization are to be prepared as directed in the accompanying table. Make sure that the containers selected to receive the weighed material are clean and dry. Weighing is a frequent step in analytical procedures, and the balance is an essential piece of laboratory equipment in most analyses. Many of these instruments also have own USP general chapters, for example: •21> Thermometers, 31> Volumetric apparatus, 41> Weights and balances As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. If stretching of the springs is excessive, an expensive balance overhaul may be needed. The operator must be familiar with precautions described in the Material Safety Data Sheet for the substance before weighing it. Email: Purified Water Loop – Operation & Maintenance SOP, Dissolution Apparatus – Operation & Calibration SOP, Refrigerator – Operation & Performance Check, Sampling of Packaging Materials – Procedure, Acceptable Quality Level (AQL) – SOP and Chart, Isolation and Identification of Microorganisms, Process Standardization and Validation – SOP, Stability Study Protocol and Specification – SOP, Handling of Returned Raw & Packing Material – SOP, User Requirement Specification (URS) Handling SOP, SOP for Review of Analytical Report and Raw Data, Microbiologist Qualification : SOP & Protocol, Analytical Method Validation (AMV) Procedure / Guide, Swab Test analysis of Equipment / Instrument – SOP. Each type of material requires its own special handling. Extreme care is essential when materials of this nature are being weighed. In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP General Chapters—Physical Analysis Expert Committee intends to revise General Chapter <41> Balances to correct a problem detected with the Repeatability test. Add the material to the receiver, slowly so maximum require the volume to the vessel. In this case, repeatability is satisfactory if two times 0.41d, divided by the nominal value of the weight use… The spilled material must be properly disposed of and must not be swept out onto the balance table where other operators may come in contact with the chemical. The analyst shall always use the calibrated weight box for calibration purposes. SOP for Instrument / Equipment usage log book. Transfer the desired amount of material to the final flask or beaker as per requirements, then reweigh the sample container by placing back on the pan of balance [ Note- Do not change the set tare of the balance between these two weighings]. The liquid is discharged into its receiver, the top is closed or stoppered, and the receiver and contents are weighed. Take appropriate size butter paper/receiver of with respect to the quantity of sample. In some cases, drift due to hysteresis can be eliminated by allowing the balance to stand without weighing long enough for it to recover. Till rectification of this problem, Check the weight during weighing and signed by the section head. Record the weight, and transfer the weighed material to the final flask or receiver; then reweigh the original weighing receiver by returning it to the same position on the pan. Defines ‘the requirement for balances used to weigh analytes for quantitative measures’. Weighing should be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy. Solids come in two forms: large chunks, with or without powdery surface, and finely divided powders or small crystals. Before weighing or calibration, the balance should exactly in a horizontal position (check the level indicator, which should be in the center). According to the new USP Chapter 41, “Repeatability” defines the starting point of a balance’s operating range. If the standard deviation obtained is less than 0.41d, where d is the scale interval, replace this standard deviation with 0.41d. Complying with Chapters 41 and 1251 - Balance Calibration and Routine Testing. If the empty receiver is not going to be tared, add the material to the receiver, and place the receiver on the balance in the center of the pan. Where “ d” is the scale interval (readability ) of the balance. Temperatures of the balance and the material to be weighed should the same. If large chunks with a powdery surface are to be weighed, at least a piece of weighing paper must be placed on the balance pan to protect it from damage. After the receipt of the calibrated weight box along with the calibration certificate limit for allowable tolerance limit (for external calibration) should be calculated as minimum and maximum weight from the limit in terms of % mentioned in Attachment-1 for all the weight which require for the calibration. Micro Balance – Operation and Calibration SOP, SOP for Audit Trail Review and Privilege Policy, Non-Recoverable Recovery – Handling & Destruction, SOP on Internal Audit and Self Inspection, Roller Compactor Machine – Operation & Cleaning, Operation and Calibration of pH Meter - Pharma Beginners, Batch Processing - SOP & General Check Points - Pharma Beginners, SOP for Handling of Out of Calibration (OOC) - Pharma Beginners, SOP for Operation and Calibration of UV Cabinet - Pharma Beginners. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. Release the key. Email: © Copyright - Pharma Beginners designed by, Operation and Calibration of Analytical Balance, SOP for Analytical Balance: Operation and Calibration. How do I calculate it? Calibrated Balance. Check the level of the balance with the help of spirit level. MONTHLY CALIBRATION Set the standard weights for various balances based on the capacity of the balance as mentioned in table – I. 6.9.2 Acceptance Criteria: Deviation: Standard Weight ± 2 x Least Count % RSD: NMT 0.5 % 6.10 If all the parameters fall with the acceptance criteria limit, affix the calibration tag (no. Air currents should not present near the balance. Large nonreactive chunks that have no powdery surface may be placed directly on the pan (for example, a coated tablet). Every four readings (other than central reading) should lie in the range of ± 0.05% of central reading and actual mass value of weight. The balance has been recently moved but has not been allowed to equilibrate to its surroundings or has not been recalibrated. Place the receiver on the balance in the center of the pan, and press the appropriate tare key on the balance. Clean the weighing pan and close the draft shield. Press the key ‘ cal’ given in the front panel of the balance until the display of ‘Cal-int’ is displayed. Gloves should be used to prevent any contact with the skin. If the weight print facility of balance is not working, then inform the service engineer for rectification of this problem. Common receivers are weighing bottles, weighing funnels, flasks, and weighing paper. Place the clean and dry glass coverslip on the balance in the center of the pan and press the appropriate tare (Zero) key on the balance (On stabilization of indicator). The United States Pharmacopeia (USP) is the American counterpart to the German pharmacopeia and is used by many companies in Germany as a guideline. Balance drift can be present without the operators being aware of the problem. The material may require grinding or drying. Then either start the process over or reweigh the remaining material. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. Analytical Balances for Laboratory Analytical Lab Weighing requiring 0.1 mg to 10 µg readability from AND Weighing, Adamlab, Mettler-Toledo, Ohaus, Sartorius, Scientech analytical balance manufacturers. Record the observations in the balance calibration record. Pick up the weight with a forceps, place it carefully on the pan. All the weights taken should be ± 10% of the target weight as specified in the individual monograph. If the standard deviation is less than 0.41 digit (0.041 milligram (mg) for an analytical balance with a readability of 0.1 mg), replace it with 0.41 d so you can achieve the smallest possible starting point of an operating range of up to 820 d (2 * 0.41*1,000). Weighing read with four decimal places is preferred for weighing near-gram quantities. If possible, Carry out all tests with a single test weight in order to minimize handling errors, but multiple test weights are permitted. Air currents are present in the laboratory. Laboratory operations are causing vibration. This SOP is applicable to the analytical balances for operation and calibration of balances in the Quality Control Department. In case the weight prints taken are not considered in the calculation ( e.g due to  unclear  visibility, misprinting, not as per defined statistics mode or weighing mode, etc.). If any unevenness is observed in its location. e.g. 4.0 RESPONSIBILITY : If solids are spilled, remove the receiver, and sweep out all of the spilled material from the balance. The new USP Chapter 41 regulations came into effect in 2013. Review a summary of the changes made to the USP Chapter 41 here. If the operator touches the balance bar, the message may be cleared and the balance may display zeros; however, the balance will not give the correct weighing until it has been calibrated. Switch on the main power supply of the balance. Weighing paper may be used for solids. In spite of this, weighing is a common source of error that can be difficult to detect in the final analytical results. Microbalances are very sensitive to overload and shock. The following methods are acceptable for good analytical results. / nominal value ≤ 0.10%; Calculate the starting point of the operating range: 2 … Add the material to the receiver, and record the weight. Hygroscopic material readily absorbs the moisture from the atmosphere and steadily gain weight. Remove powder if any, from inside the balance using soft nylon brush & wipe with clean cotton balls. Remove weighing pan & wipe it with a soft nylon brush, if required, wipe with clean cotton soaked in 70 % IPA solution & dry the pan with cotton balls completely before mounting. If the Micro Balance show “————-” display, it means balance is busy. formed using a balance that is calibrated over the operat-0.10%. In the revised version of Chapter 41 of the USP, the working range of a balance needs to be determined instead of the minimum initial weight. Chapter 41. Preparation of the material to be weighed is often necessary. SOP for Preparation of internal and external (Third Party) Calibration schedule and calibration practices. shall be reprinted and implemented including following. Correct it by turning leveling feet until the level bubble is in the center of the indicator. In the next step it is important to remember that, unless the balance is checked before each weighing operation is performed, errors can easily occur, resulting in faulty analytical data. Place the empty butter paper / or receiver on the balance in the center of the pan, and press the appropriate tare (Zero) key on the balance (On stabilization of indicator). Addition weighing is used for solid samples or liquid samples for which volatility is not an issue. Select the appropriate balance for the quantity and accuracy needed. To avoid condensation of moisture, refrigerated materials must be allowed to come to room temperature before the container is opened. To weigh 10 mg sample you have to use 10X0.1% = 0.01 mg least count balance. Each balance should be provided with a check-weight, which should be stored in a protective container near the balance. Many substances are extremely toxic, are possibly allergenic, and may be liquids or finely divided particles. Fine powders have a tendency to pick up static charge, which will cause the particles to fly around. Switch ON the balance. After the symbol disappears, press the “>0<” key to get zero on display. If necessary, turn on the power, and allow the balance to equilibrate for at least 1 hour before proceeding with the calibration. Repeatability should not be more than 0.001 or 0.10% and the measurements should be within ± 10% or 0.0010. of the actual weight. The check-weight may be any object whose mass remains constant and does not exceed the load limit of the balance. Brady Systems is one of the largest distributors representing METTLER TOLEDO in North America. Electronic analytical balances have an internal calibration system based on an applied load. A mask that covers the nose and mouth should be within +/- 0.1 % of the distributors! Equipped with a check-weight, which should be made to the USP Chapter 41, the display shows 0.0000. Balance door should not be open during weighing Sensitivity, Repeatability ( Uncertainty ), and weigh indicated. The butter paper /receiver it means balance is an essential piece of laboratory in. 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A weighing balance should be used to weigh 10 mg sample you have a tendency to up.