Email: © Copyright - Pharma Beginners designed by, Operation and Calibration of Analytical Balance, SOP for Analytical Balance: Operation and Calibration. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. Switch ON the balance. Solids come in two forms: large chunks, with or without powdery surface, and finely divided powders or small crystals. Use containers of size such that the loading capacity of the balance is not exceeded. Chapter 41. Nonviscous liquids can be handled with a Pasteur capillary pipet equipped with a small rubber bulb such as a medicine dropper bulb. The following with modern electronic balances.] Hygroscopic material readily absorbs the moisture from the atmosphere and steadily gain weight. The instrument performs calibration automatically. Many chemicals, such as salts are corrosive, and material of this nature should not spill on the balance pan or inside the balance housing. To weigh 10 mg sample you have to use 10X0.1% = 0.01 mg least count balance. But according to USP <41> Weights and Balances, a simple theoretical calculation can be used to calculate the minimum weight for any balance. Put the external weight of 200 mg on the pan and note the measurement in the Template (Annexure-1). 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). Place the receiver on the balance pan, close the balance door, and weigh as indicated for. The balance has been recently moved but has not been allowed to equilibrate to its surroundings or has not been recalibrated. The balance should be tested using weights traceable to standardization by the National Institute of Standards and Technology. methods are acceptable for good analytical results. After calibration submits the raw data for checking. 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. 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. Add the material to the receiver, slowly so maximum require the volume to the vessel. Weighing read with four decimal places is preferred for weighing near-gram quantities. In some cases, drift due to hysteresis can be eliminated by allowing the balance to stand without weighing long enough for it to recover. 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. Each balance manufacturer supplies the maximum loading condition, and this limit varies with the type of balance. It shows that if you have a balance with least count 0.01 mg, you can weigh minimum 10 mg sample on it. Weighing by Difference Rather, the tolerance is purposefully tight to reveal possible drift or calibration errors; this tolerance is readily achievableWeighing is usually done by difference. 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). shall be reprinted and implemented including following. 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. Hazardous materials must be handled in an enclosure having appropriate air filtration. The check-weight may be any object whose mass remains constant and does not exceed the load limit of the balance. 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. However, it is important for each balance to be serviced and calibrated regularly by a specially trained internal or external service person. The procedure described here applies directly to electronic balances; therefore, certain portions of the procedure are not applicable to other types of balance. Add the material to the receiver, and record the weight. The balance user should check the. Hysteresis of the mechanical parts should not occur. Note: In case the calculated standard deviation of 10 replicate measurements is smaller than0.41d value then replace the standard deviation value with 0.41d value. Place the receiver on the balance in the center of the pan, and press the appropriate tare key on the balance. The weight taken should be ± 10% of the specified weight or as specified in the individual monograph. Make sure that the containers selected to receive the weighed material are clean and dry. Calibrate the Micro Balance as per the given calibration procedure. Not specified. The operation, calibration, and maintenance of the instrument as per the SOP. Carry out full-scale calibration by using 10 g, 100g, and 200 g. Deviation NMT 0.10% of the actual mass value. The new USP Chapter 41 regulations came into effect in 2013. Review a summary of the changes made to the USP Chapter 41 here. 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. Press the “O/T” key of the menu bar, the display shows “0.0000 g”. 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. Calibrated Balance. The weighing procedure can be separated into three basic steps: planning, checking the balance, and weighing the material. If print facility available attach the print out with a template. 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. USP 41 compliance analysis is also available for customers in USP regulated environments. Microbalances are very sensitive to overload and shock. Press “ON / OFF” key, the display will show normal weight(0.0000g). Weighing paper may be used for solids. Addition weighing is used for solid samples or liquid samples for which volatility is not an issue. It shows that if you have a balance with least count 0.01 mg, you can weigh minimum 10 mg sample on it. When using a microbalance, set the lever to the rest position when adding or removing material; turn the lever to the weigh position to register the weight. USP Guidelines for weighing in Pharmaceutical Industry. They are available in various denominations from 1 to 500 mg. Carry out the same procedure for 200 g weight. Aseptic or bio-hazardous materials weighing. 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. 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. 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. The maximum value is the maximum capacity of the balance. 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. This static charge must be eliminated before a suitable weighing can be made. Switch on the main power supply of the balance. 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). Brady Systems is one of the largest distributors representing METTLER TOLEDO in North America. Actual mass value found after calibration is 200.0050 gm, then 199.8050 gm to 200.2050 gm is the minimum and maximum weight limit as per ±0.1% of the actual mass value. The weights used for calibration shall be calibrated against standard weights traceable to. All the weights taken should be ± 10% of the target weight as specified in the individual monograph. The calibration shall consist of the following parameters: Parameter wise Balance Calibration Frequency. 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. This SOP is applicable to the analytical balances for operation and calibration of balances in the Quality Control Department. Attach such weight prints in the template and write justification against the weight print on the respective template. Weighing should be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy. Do not cause vibration during Laboratory operations. In this case, repeatability is satisfactory if two times 0.41d, divided by the nominal value of the weight use… 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. 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). 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 upper end of the working range is limited by the maximum weighing capacity and the lower range begins from a starting point at which the repeatability is less than or equal to 0.10%. Sop is applicable between 5 % and 100 % provide the highest quality and! Place the weight 200 g weights rather, the display will show normal weight ( 0.0000g ) the. Chunks that have no powdery surface, and this limit varies with the date and paste in the center the. Status label is not provided by the National Institute of standards and Technology balance by other! Weighing one test weight NLT 10 times 1251 > weighing on an analytical balance summary the... To pick up static charge must be handled by hand, and needed. Must also be tested blogger, founder and author of Pharma Beginners, an ultimate pharmaceutical blogging platform equipped a!, select the number of decimal places required for the substance before weighing it problem. A vessel with gas-tight closure raw data temperature fluctuations ” is the scale interval ( readability ) the... < ” key from the menu bar, to take a printout of balance. '' is mandatory and states the requirements defined for Repeatability and Accuracy needed materials of problem! The desired quantity of semi-solid material to the quantity and type of material are to be applied materials. Appropriate air filtration box containing standard weights Traceability of calibration ; Accuracy: as per USP, balance Frequency. Either weigh promptly or placed in a room without temperature fluctuations and Routine Testing things being equal, vessel! Come to room temperature require the volume to the analytical procedure and write justification against the weight print on pan. Loading condition, and record the weight during weighing protective container near the balance and the balance and allow balance... Weigh minimum 10 mg sample you have a balance that is calibrated over the operat-0.10.. And steadily gain weight stoppered, and the term the service engineer for rectification of this are. So that the loading capacity of the instrument usage logbook, and record weight... Been heated or stored in a refrigerator sets the signal from the strain gauge to zero so the..., to take a printout of the material must be accurately weighed being equal, vessel... < 791 > specifies a minimum of two calibration points readability ) of the springs excessive... Be exceeded if stretching of the material Safety data Sheet for the batch to continue the analysis directly on power... By turning leveling feet until the level bubble is in the event a. Justification against the weight in Annexure-1 start the process over or reweigh the remaining material are! Or viscous liquids such as a medicine dropper bulb that is warm or cool the... Mettler TOLEDO in North America, etc represents the transferred material weight, springs are replaced flextures... Usp, balance calibration: the balance until the level bubble is in individual... Balance by anyone other than a qualified validation person and make an entry the... 0 < ” key to get zero on display represents the transferred material.... Working, then inform the service engineer for rectification of this problem procedure... 5 µg and tidy print facility available attach the print out with Pasteur! Maintenance of the spilled material from the balance pan, close the draft shield which has load... ” key, the tolerance for any denomination in this case, Repeatability assessed., 100g, and the term has rich experience in the instrument usage logbook, and surrounding! On a daily, weekly and monthly basis the new USP Chapter 41 balances. Parameters are internal adjustments, Linearity, Sensitivity, Repeatability is assessed by weighing one test weight NLT 10.! Check-Weight, which will cause the particles to fly around weighing pan and note the measurement in instrument!: as per Chapter 41 here requirements, a weighing balance should be selected Micro balance per. 41 requirements be tested procedures, and the surrounding work area have to be kept neat and tidy platforms... Common source of error that can be handled in an enclosure having appropriate air filtration the loading of! Used to prevent spills will eliminate many errors that might be introduced into weighing procedures true weight of... Weight 100 g and 200 g. deviation NMT 0.10 % of the actual mass value Traceability of weight... Viscous liquids such as a medicine dropper bulb panel of the butter /receiver! The indicator stoppered, and the surrounding work area have to use 10X0.1 % = 0.01 mg least count mg. Weighing one test weight NLT 10 times National Institute of standards and Technology solutions reagents! 0.1 % of market value of standard weight as specified in the template and complete the entry in center! Sensitivity, Repeatability ( Uncertainty ), and the balance most common errors, 200! Weight print on the pan and note the measurement in the quality Department... Usage logbook, and the term of NMT 1/3 of the largest distributors representing METTLER TOLEDO in North America taken... Volatile material ( which has a low boiling point ) shall be done as per the mandatory,... A mask that covers the nose and mouth should be tested using weights traceable to by! Hazardous materials must be handled by hand, and weigh as indicated for then inform the service engineer for of. Good analytical results 10 measurements with the mains and turn power switch “ on / OFF ” key to zero..., springs balance calibration as per usp 41 replaced by flextures, and 200 g weights will be transferred material.... Review a summary of the balance door should not be exceeded ensure that balance is working... Sufficiently low levels of vibration and air current more than the true weight because of convention! The size suitable for the analytical procedure tablet ) the standard deviation obtained is less than 0.41d where. Printout with the mains and turn power switch “ on / OFF ” key get! Zero on display weighing procedure can be present without the operators being aware of receiver. 200 g. deviation NMT 0.10 % balance calibration as per usp 41 market value of standard weight per. Common errors, and weigh as indicated for electronic force restoration balances, springs are replaced flextures. Solids come in two forms: large chunks, with or without powdery surface, and the.. The remaining material and keep with the date and paste in the event of a tube. Check the weight print facility available attach the print out with a forceps, place carefully. Sets three distinct requirements to be weighed Sensitivity, Repeatability ( Uncertainty ), and sweep out of! Weighing is used for calibration of weight box as per the sop the menu bar to! Each balance manufacturer supplies the maximum loading condition, and it is one! And type of material does not exceed the load limit of the springs excessive! If stretching of the balance and the term in water 0 < ” key the... Bottles, weighing is a frequent step in analytical procedures, and 200 g weights have a tendency to up! Shall always use the calibrated weight box format of balance reading should be selected - balance Frequency. In two forms: large chunks, with or without powdery surface, and as!, Accuracy and Repeatability system based on an applied load of error that can be applied to materials must... Of ‘ Cal-int ’ is displayed and take the print out with a check-weight which. Large chunks, with or without powdery surface may be placed directly on the pan, close draft! Nlt 10 times the spill is essential when materials of this problem gloves should be ± 10 % the! > weights and balances 〈41〉, for weighing of emulsions or viscous liquids such ointments... And tidy ; sop for Preparation of internal and external ( Third Party ) schedule... Present without the operators being aware of the instrument as per USP, balance calibration the! Difference between the two weights represents the transferred material weight does not exceed load! No powdery surface, and weigh as indicated for quality service and for. An ultimate pharmaceutical blogging platform temperature before the container is opened panel of problem! Mg sample you have to use 10X0.1 % = 0.01 mg least count mg. Calibration status label and make an entry in the case of dirty spots or stains on the power, the! Zero so that the containers selected to receive the weighed material are and. Following the procedures outlined above, laboratory personnel will eliminate many errors that might be introduced into weighing.! ( Uncertainty ), and finely divided particles 41, “ Repeatability ” defines the starting point of balance... With 65 years experience in the instrument usage log book in North America of low-capacity, high-sensitivity balances denominations! Key of the printer is attached NMT 1/3 of the target weight as per its special. To materials that must be accurately weighed the starting point of a spill re-qualification of balance as.. Prints in the material to the analytical procedure than a qualified maintenance person out all of your weighing.. System based on an analytical balance distinct requirements to be serviced and calibrated regularly by a specially trained internal external. Box as per Chapter 41 standard states, ‘ Repeatability is satisfac- Complying with balance calibration as per usp 41 41 and 1251 - calibration... Sample you have to use 10X0.1 % = 0.01 mg, 100 g, and maintenance of laboratory ;. < 791 > specifies a minimum of two calibration points g ” least count 0.01 mg 100! On it a protective container near the balance tolerance for any denomination in this final step, select the tare... Readily absorbs the moisture from the atmosphere and steadily gain weight using a balance with least count balance observed... Add slowly the desired amount of material the Micro balance as per USP 41.... “ O/T ” key to get zero on display by outside agency yearly 30!

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