If possible, Carry out all tests with a single test weight in order to minimize handling errors, but multiple test weights are permitted. If stretching of the springs is excessive, an expensive balance overhaul may be needed. In this final step, select the number of decimal places required for the analytical procedure. “The weighing shall be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy.” Drift is one of the most common errors, and it is also one of the easiest to reduce or eliminate. The material is added to the tared receiver, the amount is determined by difference, and then the whole amount is transferred quantitatively (e.g., by using a solvent) to the final receiver. Calibration and Performance of a Conductivity System to Meet USP 23 page 4 of 11 Thornton Associates February 1, 2002 The advantages of on-line conductivity testing have been exploited serving pharmaceutical water systems for many years. Hysteresis of the mechanical parts occurs during weighing. Adjust the level, if not leveled. Place the empty receiver (In case of material is highly volatile, add some amount of diluent) on the balance in the center of the pan and press the appropriate tare (Zero) key on the balance (On stabilization of indicator). Temperatures of the balance and the material to be weighed should the same. Press the “O/T” key of the menu bar, the display shows “0.0000 g”. Do not allow the material to remain on the balance for an extended period of time because changes, caused by interaction with atmospheric water or carbon dioxide, may take place. Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. If a deviation greater than those indicated below for. Press the “Print” key from the menu bar, to take a printout of the printer is attached. Tare the empty receiver as follows. Addition weighing is used for solid samples or liquid samples for which volatility is not an issue. Hygroscopic material readily absorbs the moisture from the atmosphere and steadily gain weight. The liquid is discharged into its receiver, the top is closed or stoppered, and the receiver and contents are weighed. If the weight print facility of balance is not working, then inform the service engineer for rectification of this problem. How do I calculate it? The analyst shall always use the calibrated weight box for calibration purposes. Maintaining the history card, Instrument usage logbook, and weight prints as per the SOP. dev.) In most pharmaceutical analyses small quantities of material are used, requiring the balance reading to be set to the fifth decimal place to achieve the necessary accuracy. USP <791> specifies a minimum of two calibration points. The new USP Chapter 41 regulations came into effect in 2013. Review a summary of the changes made to the USP Chapter 41 here. Rather, the tolerance is purposefully tight to reveal possible drift or calibration errors; this tolerance is readily achievable with modern electronic balances. Common receivers are weighing bottles, weighing funnels, flasks, and weighing paper. Wipe the carefully inner side of the balance with clean moist cotton with 70% IPA solution in water, without disturbing the balance & finally mop with clean dry cotton. Calibrate the analytical balance or the microbalance. NIST             :  National Institute of Science and Technology. Remove powder if any, from inside the balance using soft nylon brush & wipe with clean cotton balls. Email: [email protected]. Put the external weight of 200 mg on the pan and note the measurement in the Template (Annexure-1). 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. 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 requirements of the USP of balances are recorded in two chapters: Chapter 41 is binding and includes requirements on: Repeatability / standard deviation of 10 measurements Carry out the measurement uncertainty by using 200 mg and 200 g weight. 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. If the balance power has gone off and then has come back on, as in a power outage, certain types of balance may display a message indicating that the balance must be calibrated before a weighing is made. The United States Pharmacopeia (USP) is the American counterpart to the German pharmacopeia and is used by many companies in Germany as a guideline. Weighing paper may be used for solids. Place the receiver on the balance pan, close the balance door, and weigh as indicated for. If print facility available attach the print out with a template. Place the weight in the center of the balance pan to eliminate the corner-weighing difference. Calibrate weight boxes by outside agency yearly ± 30 days. Weighings are made on many different types of materials, such as large solids, finely divided powders, and liquids (viscous or nonviscous, volatile or nonvolatile). In spite of this, weighing is a common source of error that can be difficult to detect in the final analytical results. Take the 100 g weight and weigh 5 times on different places of the pan as shown in figure-1 (when the balance pan is circular) and figure-2 (When the balance pan is square) and record the observation in the Template for Corner test (Annexure-2). The second weight represents the sum of the weights of the receiver and the untransferred material; subtract this sum from the sum of the total material weight and the receiver weight to determine the weight of the transferred material. On stabilization of indicator displayed weight will be transferred material, which should be printed and keep with the raw data. Use containers of size such that the loading capacity of the balance is not exceeded. Current. USP 41 compliance analysis is also available for customers in USP regulated environments. This operation electrically sets the signal from the strain gauge to zero so that the weight of the receiver is no longer indicated. For a gas-tight vessel, the analyst shall tare the vessel and enclosure, add the desired amount of sample in the vessel and replace the enclosure and record the weight. The observed balance reading should be within +/- 0.1% of market value of standard weight as per USP 41 requirements. It is recommended that gloves, forceps, or another type of gripping device be used when handling receivers, because oils from the hands will add weight. To avoid condensation of moisture, refrigerated materials must be allowed to come to room temperature before the container is opened. Aseptic or bio-hazardous materials weighing. Calculate the measurement of uncertainty as follows. The balance and the surrounding work area have to be kept neat and tidy. The difference between the two weights represents the transferred material weight. The following methods are acceptable for good analytical results. Each balance should be provided with a check-weight, which should be stored in a protective container near the balance. Weighing read with four decimal places is preferred for weighing near-gram quantities. Some materials may have been heated or stored in a refrigerator. Take appropriate size butter paper/receiver of with respect to the quantity of sample. On stabilization of indicator record the displayed weight (Display weight shall be printed and keep with the raw data ) and transfer the glass coverslip directly into the receiver. They are available in various denominations from 1 to 500 mg. Put the weight 100 g and 200 g on the pan and record the weight in Annexure-1. Mrs. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners, She has rich experience in pharmaceutical field. Before executing the tests, the analyst should place the weights in the vicinity of the balance for an appropriate time to reach sufficient thermal equilibrium. Do not overload the balance pan more than the capacity of the balance. If the Micro Balance show “————-” display, it means balance is busy. Do not use balance if it is not calibrated. QUALITY ASSURANCE PROCEDURE FOR MEASUREMENT OF BALANCE DRIFT. If necessary, turn on the power, and allow the balance to equilibrate for at least 1 hour before proceeding with the calibration. USP General Chapter 41 "Balances" is mandatory and states the requirements for balances used for materials that must be accurately weighed. Then either start the process over or reweigh the remaining material. To weigh 10 mg sample you have to use 10X0.1% = 0.01 mg least count balance. For balances used for other ap-deviation with 0.41d. An antistatic device may be used to minimize this problem. Laboratory operations are causing vibration. New requirement to use a calibrated balance. Air currents should not present near the balance. If the standard deviation obtained is less than ing range and meets the requirements defined for 0.41d, where d is the scale interval, replace this standard repeatability and accuracy. Equilibrate the sample that is warm or cool in the laboratory to room temperature. Do not expose Hygroscopic material more time in the air during weighing. Check the sample, the balance, and the laboratory environment for the following causes of errors, and eliminate them: Temperatures of the balance and the material to be weighed are not the same. The weight taken should be ± 10% of the specified weight or as specified in the individual monograph. Perform the weighing of the sterile or bio-hazardous samples within the confines of the clean bench, biosafety cabinet, isolator or similar containment device. The first person to use the balance each day should weigh the check-weight and record the weight in the log book for comparison with previous readings. But according to USP <41> Weights and Balances, a simple theoretical calculation can be used to calculate the minimum weight for any balance. The receiver's weight plus the weight to be measured must not exceed the maximum load for the balance; the size and shape of the receiver should permit it to fit into the space and on the balance pan without interfering with any operation. LBGN:003) on the balance. In case of dirty spots or stains on the body, use cotton balls soaked in 70 % IPA solution in water. Accuracy; Repeatability; Calibration; Accuracy: As per Chapter 41, the accuracy of the balance must also be tested. Switch ON the balance. If the calibration status label is not provided by the certified agency then affix the label on the weight box as per. To weigh 10 mg sample you have to use 10X0.1% = 0.01 mg least count balance. It shows that if you have a balance with least count 0.01 mg, you can weigh minimum 10 mg sample on it. USP General Chapter 41 (Balances) General Chapter 41 sets three distinct requirements to be applied to materials that must be accurately weighed. Complying with Chapters 41 and 1251 - Balance Calibration and Routine Testing. The balance user should check the. Put the weight 200 g on the pan and record the weight in Annexure-2. Press the key ‘ cal’ given in the front panel of the balance until the display of ‘Cal-int’ is displayed. This method may be described as quantitative transfer. Nonviscous liquids can be handled with a Pasteur capillary pipet equipped with a small rubber bulb such as a medicine dropper bulb. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. 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. The weighing procedure can be separated into three basic steps: planning, checking the balance, and weighing the material. 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. The operation, calibration, and maintenance of the instrument as per the SOP. The analyst shall update the calibration status label and make an entry in the instrument usage log book. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. However, it is important for each balance to be serviced and calibrated regularly by a specially trained internal or external service person. 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. Repeatability is satisfactory if two times the standard deviation of the weighed value, divided by the nominal value of the weight used, does not exceed 0.10%. It must have a constant electrical supply. Attach such weight prints in the template and write justification against the weight print on the respective template. Airflow within the hood potentially can cause balance instability, so after a balance has been installed under the hood, perform a rigorous qualification study with suitable weight artifacts in order to determine the acceptability of the balanced performance in this environment. 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). 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). Make sure that the containers selected to receive the weighed material are clean and dry. The purpose of this SOP is to describe the procedure of Operation, Calibration, and Maintenance of Analytical balance in the Quality Control Department. The Accuracy requirement is applicable between 5% and 100%. Therefore hygroscopic samples shall either weigh promptly or placed in a vessel with gas-tight closure. 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). Calibrate the Micro Balance as per the given calibration procedure. USP 41 weighing Not only can J.A. Same scope with improved wording for greater clarity. Add the material to the receiver, slowly so maximum require the volume to the vessel. Dispense weighing is used for weighing of emulsions or viscous liquids such as ointments. With 65 years experience in the scale industry, we provide the highest quality service and products for all of your weighing needs. Place the empty receiver on the balance in the center of the pan and press the appropriate tare (Zero) key on the balance (On stabilization of indicator). The balance should be tested using weights traceable to standardization by the National Institute of Standards and Technology. Materials must be brought to the temperature of the balance before they are weighed. The tolerance for any denomination in this class is 5 µg. As per the mandatory requirements, a weighing balance should be calibrated on a daily, weekly and monthly basis. The operator must be familiar with precautions described in the Material Safety Data Sheet for the substance before weighing it. Weighing is a frequent step in analytical procedures, and the balance is an essential piece of laboratory equipment in most analyses. / nominal value ≤ 0.10%; Calculate the starting point of the operating range: 2 … Not specified. Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. 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. After calibration submits the raw data for checking. Many chemicals, such as salts are corrosive, and material of this nature should not be spilled on the balance pan or inside the balance housing. 21 CFR 211.68; SOP for Instrument / Equipment usage log book. Allow the balance to warm up for initialization 30 minutes. According to the new USP Chapter 41, “Repeatability” defines the starting point of a balance’s operating range. The proper receiver for the material must be selected. Wait till the message ‘cal done’ is displayed and Take the print out . This SOP is applicable to the analytical balances for operation and calibration of balances in the Quality Control Department. 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. Many chemicals, such as salts, are corrosive, and materials of this nature should not be spilled on the balance pan or inside the balance housing. Add slowly the desired quantity of the sample to the center of the butter paper /receiver. Record the observations in the balance calibration record. Transferred the approximate required quantity of semi-solid material to the receiver (by touching the inner surface of the receiver ) with the help of a capillary tube or spatula. Weighing funnels come in various sizes; the size suitable for the operation should be selected. Put the external weight of 200 g on the pan and note the measurement in the template (Annexure-2). Liquids may be volatile or nonvolatile and viscous or nonviscous. Preparation of the material to be weighed is often necessary. Select the appropriate balance for the quantity and accuracy needed. Small quantities of viscous liquids can be handled by touching a glass stirring rod to the surface of the liquid and then carefully touching the rod to the side of the receiving vessel, which allows some of the material to be transferred. 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. Over an extended period of time, balance drift and other day-to-day variations are monitored by weighing a fixed check-weight on a regular basis; this check should be performed after the balance has been calibrated at the ambient laboratory temperature. Clean the weighing pan and close the draft shield. Carry out the Linearity using 200 mg, 100 g, and 200 g weights. Till rectification of this problem, Check the weight during weighing and signed by the section head. Similarly, Reprint Annexure -2 and implemented including the following. USP General Chapter 41 (Balances) sets three distinct requirements to be applied to materials that must be accurately weighed. This static charge must be eliminated before a suitable weighing can be made. Before calibrating the balance, clean the weighing platforms. The check-weight may be any object whose mass remains constant and does not exceed the load limit of the balance. Hazardous materials must be handled in an enclosure having appropriate air filtration. Transfer the weighed material to the final flask or receiver; then reweigh the original weighing receiver by placing it in the same position on the pan. Take extra care to weigh such type of material. The balance is placed in a suitable location with sufficiently low levels of vibration and air current. Carry out the same procedure for 200 g weight. Solids come in two forms: large chunks, with or without powdery surface, and finely divided powders or small crystals. Take fresh standard/ sample weights for the batch to continue the analysis. Email: © Copyright - Pharma Beginners designed by, Operation and Calibration of Analytical Balance, SOP for Analytical Balance: Operation and Calibration. But according to USP <41> Weights and Balances, a simple theoretical calculation can be used to calculate the minimum weight for any balance. Balance drift can be present without the operators being aware of the problem. Electronic analytical balances have an internal calibration system based on an applied load. Record the weight and transfer the weighed material to the final flask or beaker as per requirements, Then reweigh the original weighing butter paper / or receiver by placing it in the same position on the pan. Analytical Balance Calibration (Updated) Procedure to calibrate the Analytical Weighing Balance as Drift check, Performance check and Measurement uncertainty check as per USP. USP Guidelines for weighing in Pharmaceutical Industry. Weighing is usually done by difference. In the case of electronic force restoration balances, springs are replaced by flextures, and the term. Note- Do not change the set tare of the balance between these two weighings. USP Chapter 41: “Balances” Posted on November 1, 2016 This chapter states the requirements for balances used for materials that must be … 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. 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. Deviation obtained is less than 0.41d, where d is the scale industry, we provide balance calibration as per usp 41 quality. Without the operators being aware of the balance is an essential piece of laboratory Instruments USP! And author of Pharma Beginners, an expensive balance overhaul may be any whose... Provided by the certified agency then affix the label on the weight 100 g and 200 g.... And author of Pharma Beginners, She has rich experience in pharmaceutical field mg 200! 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