USP 41 compliance analysis is also available for customers in USP regulated environments. Both tests have tolerances of 0.10%. In some cases, drift due to hysteresis can be eliminated by allowing the balance to stand without weighing long enough for it to recover. As per the mandatory requirements, a weighing balance should be calibrated on a daily, weekly and monthly basis. The balance is placed in a suitable location with sufficiently low levels of vibration and air current. This static charge must be eliminated before a suitable weighing can be made. Each balance should be provided with a check-weight, which should be stored in a protective container near the balance. 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). Weighing read with four decimal places is preferred for weighing near-gram quantities. 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. dev.) Put the weight 100 g and 200 g on the pan and record the weight in Annexure-1. Press the key ‘ cal’ given in the front panel of the balance until the display of ‘Cal-int’ is displayed. No repairs should be made to any balance by anyone other than a qualified validation person. 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. This method may be described as quantitative transfer. Take extra care to weigh such type of material. 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. Put the external weight of 200 mg on the pan and note the measurement in the Template (Annexure-1). Carry out the Sensitivity by using 200 g weights. Assemble the necessary chemicals if solutions or reagents are required. Extreme care is essential when materials of this nature are being weighed. formed using a balance that is calibrated over the operat-0.10%. 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. They are available in various denominations from 1 to 500 mg. 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. It is important that the receiver be clean and dry. This operation electrically sets the signal from the strain gauge to zero so that the weight of the receiver is no longer indicated. shall be reprinted and implemented including following. (Microbalances may require up to 24 hours to reach equilibrium.) 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. 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 Hysteresis of the mechanical parts should not occur. Perform the weighing of the sterile or bio-hazardous samples within the confines of the clean bench, biosafety cabinet, isolator or similar containment device. There are two required tests in Chapter 41, Accuracy and Repeatability. Email: [email protected]. 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 ). 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. Liquids may be volatile or nonvolatile and viscous or nonviscous. If the calibration status label is not provided by the certified agency then affix the label on the weight box as per. 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). 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. 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. No repairs should be made to any balance by anyone other than a qualified maintenance person. To avoid condensation of moisture, refrigerated materials must be allowed to come to room temperature before the container is opened. The operator should know this limit so that the balance will not be damaged. Release the key. All other things being equal, a vessel of low mass should be chosen when small amounts of material are to be weighed. 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). Some materials may have been heated or stored in a refrigerator. Calibrate the Micro Balance as per the given calibration procedure. Nonviscous liquids can be handled with a Pasteur capillary pipet equipped with a small rubber bulb such as a medicine dropper bulb. The balance should be tested using weights traceable to standardization by the National Institute of Standards and Technology. Gloves should be used to prevent any contact with the skin. Air currents are present in the laboratory. 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. Make sure that the containers selected to receive the weighed material are clean and dry. USP General Chapter 41 "Balances" is mandatory and states the requirements for balances used for materials that must be accurately weighed. Allow the balance to warm up for initialization 30 minutes. 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%. USP<1251> Weighing on an analytical balance. Weighing is usually done by difference. SOP for Maintenance of Laboratory Instruments. The observed balance reading should be within +/- 0.1% of market value of standard weight as per USP 41 requirements. 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. 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]. 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) sets three distinct requirements to be applied to materials that must be accurately weighed. The material may require grinding or drying. 21 CFR 211.68; SOP for Instrument / Equipment usage log book. As if warm samples weighed then apparent weight is smaller than the true weight because of heat convention. If we are working with butter paper/container, place it on the weighing pan, close the glass draft shield, then press the “O/T” key to tare the scale. 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. 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. How do I calculate it? Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. Take appropriate size butter paper/receiver of with respect to the quantity of sample. Hygroscopic material readily absorbs the moisture from the atmosphere and steadily gain weight. Many chemicals, such as salts are corrosive, and material of this nature should not spill on the balance pan or inside the balance housing. Perform the following procedures to reduce balance errors and the possibility of an incorrect reading because of drift: Make certain that the electrical power to the balance is on and that the level bubble is in the center of the indicator. Defines ‘the requirement for balances used to weigh analytes for quantitative measures’. Switch ON the balance. Where “ d” is the scale interval (readability ) of the balance. Place the receiver on the balance pan, close the balance door, and weigh as indicated for. The instrument performs calibration automatically. If stretching of the springs is excessive, an expensive balance overhaul may be needed. Laboratory operations are causing vibration. Many substances are extremely toxic, are possibly allergenic, and may be liquids or finely divided particles. Materials must be brought to the temperature of the balance before they are weighed. With 65 years experience in the scale industry, we provide the highest quality service and products for all of your weighing needs. 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. Box containing standard weights Traceability of calibration weight standards In addition, the tolerance does not correspond to the value of 0.1%, specified under Weights and Balances 41, for weighing material accurately. Similarly, Reprint Annexure -2 and implemented including the following. The tolerance for any denomination in this class is 5 µg. In spite of this, weighing is a common source of error that can be difficult to detect in the final analytical results. To weigh 10 mg sample you have to use 10X0.1% = 0.01 mg least count balance. 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. The weight class chosen for the calibration should be such that the tolerance of the weights used does not exceed 0.1% of the amount weighed. Temperatures of the balance and the material to be weighed should the same. Note- Do not change the set tare of the balance between these two weighings. Current. Before weighing or calibration, the balance should exactly in a horizontal position (check the level indicator, which should be in the center). 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