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. 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. Check level indicator (Bubble should be in center), Paste internal adjustment check printout here. Operate the Balance as per procedure described in point 4.1 & 4.2. Always use a calibrated weight box for calibration purposes. Calibration of Glassware Volumetric glassware’s are calibrated at 23° to 27°C temperature. Note: Hysteresis in the Micro Balance is caused by excessive stretching of the springs, and it is primarily due to overloading or to the accidental dropping of an object onto the pan. When the display has stabilized, document the weight. 5 kg standard weight but in certificate it shows 4.997 kg or 4.999 kg, in this condition we changed every year log book & sop balance calibration & verification format due to change in wt ( In certificate by different Party ). If the calibration is not successful, the display will show an appropriate message indicating that the calibration process is aborted as a result of an error. Be sure the balance is warmed up, leveled and calibrated before starting. Position the test weight on the center of the weigh pan. Calibrate the Micro Balance as per the given calibration procedure. Clean the balance pan and surrounding using tissue paper. Clean the weighing pan and close the draft shield. Note- Do not change the set tare of the balance between these two weighings. Repeatability = ——————————————— = ——————————- = __________. Dispense weighing is used for weighing of emulsions or viscous liquids such as ointments. The Micro balance should not be installed near the source of electromagnetic radiation or magnetic field. Standard operating procedure to evaluate the performance of Analytical Balance used for the analysis in pharmaceutical quality control by accuracy and precision tests. Key “4” transmits the weighing result over the interface, e.g. 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. Calculate the measurement of Repeatability as follows. The Micro Balance should be installed in a temperature and humidity controlled room. Verify that the operator is experienced in precision weighing techniques and has had specific training in SOP 8, SOP 4, SOP … The illuminated graphic display of the terminal is a “Touch screen”. Tuesday, December 7, 2010 Balance Calibration Note: If balance is not calibrated within the time period, stop using the balance till satisfactory calibration is done. Add the desired amount of material to the receiver with the help of a clean and dry pipette or capillary tube. SOP on Password Policy For Computers and Softwares in Pharmaceutical Plant; SOP on Recruitment of Employees; SOP on Preventive maintenance of Vibro Sifter; Handling of Break Down Maintenance; Calibration of UV-VIS Spectrophotometer; SOP on Guideline for Preparation of Site Master File; Recording System for U.V. SOP for Analytical Balance: Operation and Calibration 1.0 PURPOSE Press the “Adjust.int” key to start the internal calibration. Remove powder if any, from inside the Micro Balance using a soft nylon brush & wipe with clean cotton balls. Key “1” returns the screen from any menu level back to the active application. 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. 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. If the bubble is not in the center set it as per the procedure. Add the desired amount of material to the butter paper / or receiver, and allow the balance to display stabilize reading (On stabilization of indicator). The ability of a weighing instrument to display corresponding results under constant testing conditions, when the same load is repeatedly placed onto the weighing pan in the same manner. 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. Carry out the calibration of the Micro Balance as per the SOP. calibration of analytical balance in the quality control department shall be done as per their respective SOP. Airflow within the hood potentially can cause Micro Balance instability, so after a Micro Balance has been installed under the hood, perform a rigorous qualification study with suitable weight in order to determine the acceptability of the Microbalance performance in this environment. The analyst shall update the calibration status label and make an entry in the instrument usage log book. 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. Every five readings should lie in the range of ± 0.05% of the actual mass value of weight. Editable Pharmaceutical Documents in MS-Word Format. Follow the SOP on Instrument/Equipment usage logbook, for the entry of usage of the Instrument/Equipment. Check the outer edge and the bottom of the receiver. Calibration frequency: Daily (except holidays) and after any maintenance. First, carry out a level indicator check of the bubble. The calibration templates i.e Attachments -1 and Attachment -2 shall be filled for the details like minimum and maximum weight limits (as calculated above) against their actual weight for the weights mentioned in the template. ... Pharmaceutical Technology Excipients for Tablets with examples 4 weeks ago; Standard Operating Procedure (SOP) for operation and calibration of analytical balances. In the event of a spill re-qualification of Micro Balance may be required, depending on the nature of the spill. In case of any maintenance of the instrument, follow SOP on Maintenance of Laboratory Instrument. Put the external weight of 100 mg on the pan and note the 10 measurements in Attachment – 2. … The analyst shall sign the print out with the date and paste it in the calibration logbook. 5.8.2 When the balance stabilizes take the print out. After the unstable mark disappears ‘O’, press TARE key >T< and the display shall be “0.0000 mg”. The analyst shall update the calibration status label and make an entry in the instrument usage logbook of the Micro Balance. After internal adjustment completed, proceed with daily calibration as per calibration sop prior to routine work. Latest Jobs recent/hot-colored SOP's 10/SOP's/col-left Project 10/Project/col-right Books 3/Books/col-left Calibration 3/Calibration/col-right Recent posts View all. ... Pharmaceutical SOP's Calibration of Glassware Friday, 25 October 2019. Many chemicals, such as salts are corrosive, and material of this nature should not be spilled on the Micro Balance pan or inside the balance housing. Editable Pharmaceutical Documents in MS-Word Format, can say for minimum weight selection for calculation of measurement of uncertanity, i m satisfied from the sops. PHARMA NOTES Navigation-Menus (Do Not Edit Here!) Push the glass draft gently backward and place the butter paper / weighing bottle on to the balance … Also referred to as “corner load error” or “off-center loading error”. Initiate the maintenance activity during the breakdown of the instrument. If the print facility is available then attach the printouts with the template. 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. 6.0 PROCEDURE FOR MICRO BALANCE OPERATION AND CLEANING. Sir I am not meeted with uncertainty 0.001 as per guidlence please suggest me. If it occurs during the weighing process it can be canceled with the cancel button. Ensure the implementation of the system as per the SOP. Many chemicals, such as salts are corrosive, and material of this nature should not be spilled on the balance pan or inside the Micro Balance housing. Sir tell about minimum and maximum wt in balance calibration. Hygroscopic material should not be exposed for a longer time in the air during weighing. The weight box shall be calibrated by outside agency yearly ± 30 days. 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 Use this function after switching on the Micro Balance and allow the balance to equilibrate for an hour and then use the balance for weighing. Weights and balances), Preparation of internal and external (Third Party) calibration schedule and, URS and Analytical Instrument/ Equipment Qualification –. To describe the procedure for operation, calibration, and performance check of the Micro Balance. “Adjust.int” key allows adjustment of the Micro Balance using an internal adjustment weight. Keep all records related to calibration and to perform proper documentation as per the SOP. 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. Ensure proper documentation as per the SOP. Place the clean and dry glass coverslip on the Micro Balance in the center of the pan and press the appropriate tare (Zero) key on the balance (On stabilization of indicator). The desired quantity of the sample shall be added slowly to the center of the butter paper /receiver. Email: [email protected]. The weighing of the sterile or bio-hazardous samples shall be done within the confines of a clean bench, bio-safety cabinet, isolator, or similar containment device. 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. Hygroscopic material readily absorbs moisture from the atmosphere and steadily gains weight. Transfer 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.