Note: If balance is not calibrated within the time period, stop using the balance till satisfactory calibration is done. After the unstable mark disappears ‘O’, press TARE key >T< and the display shall be “0.0000 mg”. The weight taken should be ± 10% of the specified weight or as specified in the individual monograph. 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for calibration & handling of standard weights using for calibration of electronic weighing balances. Mrs. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners, She has rich experience in pharmaceutical field. Wipe carefully the inner side of the Micro Balance with clean moist cotton with 70% IPA solution in water without disturbing the balance & finally mop with clean dry cotton. Transfer approximate required quantity of semi-solid material to the glass coverslip with the help of a capillary tube or spatula. ✔ Interview Questions and Answers ✔ Pharmaceutical News Updates 6.6 ACCURACY 6.6.1 Check the accuracy of the balance by using 5 … To investigate out of calibration (if any). Follow the SOP on Instrument/Equipment usage logbook, for the entry of usage of the Instrument/Equipment. Key “4” transmits the weighing result over the interface, e.g. After calibration analyst shall submit the raw data for checking. The weight box shall be calibrated by outside agency yearly ± 30 days. The Micro Balance should be placed in a suitable location with sufficiently low levels of vibration, air current, and with the constant electrical supply. Related: Drift and Its Importance in Analytical Balances 5.8 Daily Calibration of balance 5.8.1 Calibrate the balance daily with the standard weights of 1g, 10g, 100g, and 200g individually. Place the empty receiver (In case of material is highly volatile, add some amount of diluent) on the Micro Balance in the center of the pan and press the appropriate tare (Zero) key on the Micro Balance (On stabilization of indicator). Spams/ Promotional links are not allowed and shall be deleted upon review. Calibration is done periodically and frequently than validation. Email: [email protected]. 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for calibration & maintenance of equipment, measuring and monitoring device along with desired documentation as per cGMP norms. SOP on Sanitation. If any unevenness is observed in its location, it should be corrected by turning leveling feet until the level bubble is in the center of the indicator. On stabilization of the indicator displayed weight transfer material. On stabilization of the indicator, the displayed weight will be the transferred material, which shall be printed and kept with the raw data. Put the weight of 200 gm on the pan and note the measurement in the template (Attachment-2). Verify the balance daily and external verification with external calibrated and certified weights. “Adjust.int” key allows adjustment of the Micro Balance using an internal adjustment weight. Standard operating procedure to evaluate the performance of Analytical Balance used for the analysis in pharmaceutical quality control by accuracy and precision tests. Scope: This sop is applicable to the trolley balance in the department at the plant.. RESPONSIBILITY: Officer production is responsible for verification. For weighing instruments, linearity means the positive or negative deviation of the readout from the actual load. Hysteresis is the amount of error that results when this action occurs. The Micro Balance should be kept on a firm and vibration-free surface. HPLC Calibration - GMP SOP Operation, calibration and maintenance of electronic analytical single pan balances Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench After internal adjustment completed, proceed with daily calibration as per calibration sop prior to routine work. Limit:+0.05% of actual mass value Connect the AC adapter supplied to the connection socket of the evaluation unit and then to the power supply. Hygroscopic material readily absorbs moisture from the atmosphere and steadily gains weight. On stabilization of the indicator record the displayed weight and transfer the glass coverslip directly into the receiver. Till rectification of the problem, weight during weighing will be checked and signed by the section head or designee. SOP for balance centricity examination ... Point. Nominal value of the weight used for the desired smallest net weight. Annexure-2: Monthly Calibration Template. SOP for Analytical Balance: Operation and Calibration 1.0 PURPOSE The other type of display shows the information field and “SmartTrac” which is a graphical display, which shows at a glance, the weighing range that has already been filled and the range that is still available. Check the outer edge and the bottom of the receiver. The analyst shall update the calibration status label and make an entry in the instrument usage log book. sop for calibration policy. Tuesday, December 7, 2010 Balance Calibration As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. Ensure the implementation of the system as per the SOP. The difference between the two weights represents the transferred material weight. If the bubble is not in the center set it as per the procedure. calibration of analytical balance in the quality control department shall be done as per their respective SOP. Calibration of Glassware Volumetric glassware’s are calibrated at 23° to 27°C temperature. For Sample SOP Resources please click here. When the display has stabilized, document the weight. SOP for Calibration of Balance Standard operating procedure to evaluate the performance of Analytical Balance used for the analysis in pharmaceutical quality control by accuracy and precision tests. Air currents should not present near the Micro Balance. Ensure that the weighing pan is clean and close the door of the weighing chamber. Clean the balance pan and surrounding using tissue paper. 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 is required for the calibration. Complying with Chapters 41 and 1251 - Balance Calibration and Routine Testing USP Guidelines for weighing in Pharmaceutical Industry The United States Pharmacopeia (USP) General Chapters <41> "Balances" and <1251> "Weighing on an Analytical Balance" aim to ensure weighing accuracy and eliminate unnecessary over-testing for US pharmaceutical manufacturers and suppliers. Take the 100 gm weight and weigh 5 times on different places of the pan as shown in figure-1 (when the microbalance pan is circular) and figure-2 (When the microbalance pan is square) and record the observation in the Template for Corner test (Attachment-2). If it occurs during the weighing process it can be canceled with the cancel button. Calibration of Autotitrator in Pharma Calibration of Balance Calibration of Balance in Pharma Calibration of Brook Field Viscometer Calibration of Bursting Strength Tester Calibration of Colony Counter ... Standard Operating Procedures. PHARMA NOTES Navigation-Menus (Do Not Edit Here!) Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Micro & Semi-Micro Analytical Balance used for weighing WS & Impurities in QC and Research Laboratories. 1.2.4. First, carry out a level indicator check of the bubble. In case of failure of calibration follow the SOP of Handling of out of calibration. Key “1” returns the screen from any menu level back to the active application. or actual certified wt. Procedure for Micro Balance Operation and Calibration 1.0 PURPOSE: To describe the procedure for operation, calibration, and performance check of the Micro Balance. Be sure the balance is warmed up, leveled and calibrated before starting. Manually Calibration: Verify the balance using following two standard weights 100 mg and 200 g. Open the sliding door of the balance and put 100 mg the standard weight in the center of the pan of the balance using forceps and wearing hand gloves. Position the test weight on the center of the weigh pan. Verify that the operator is experienced in precision weighing techniques and has had specific training in SOP 8, SOP 4, SOP … Purpose: Purpose of this sop for operation, cleaning, verification, and calibration of bin lifting trolley with weighing balances.. The desired quantity of the sample shall be added slowly to the center of the butter paper /receiver. The template shall be verified by the designed person. Email: © Copyright - Pharma Beginners designed by, Micro Balance – Operation and Calibration SOP, Procedure for Micro Balance Operation and Calibration. Put the weight of 100 mg, 1.0 gm, and 5.0 gm on the pan and record the weight in Attachment-1. Every five readings should lie in the range of ± 0.05% of the actual mass value of weight. 5.8.2 When the balance stabilizes take the print out. Hygroscopic material should not be exposed for a longer time in the air during weighing. Initiate the maintenance activity during the breakdown of the instrument.
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