balance calibration sop in pharma
The Micro Balance should be installed in a temperature and humidity controlled room. 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. 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. Internal department should do calibration of balance. Calibration is done periodically and frequently than validation. SOP on Cleaning of SS Sieves. The Micro Balance should be kept on a firm and vibration-free surface. After the unstable mark disappears ‘O’, press TARE key >T< and the display shall be “0.0000 mg”. Repeat above two steps nine times. After calibration, the raw data shall be submitted for checking. Calculate the measurement of Repeatability as follows. It displays the result with only one-tenth of the precision, i.e. For IQ/OQ/PQ and re-qualification follow the SOP of URS and Analytical Instrument/ Equipment Qualification. 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. (________________gm to _____________ gm). Spams/ Promotional links are not allowed and shall be deleted upon review. For Sample SOP Resources please click here. If the weight print facility of Micro Balance is not working, then inform to service engineer for rectification of this problem. Tare the Micro 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 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 weightings]. Calibration of Glassware Volumetric glassware’s are calibrated at 23° to 27°C temperature. If any minor unevenness in its location is observed, then adjust the level by turning two leveling feet at the rear of the balance until the air bubble comes within the center of the leveling control. to a printer. 5.8.2 When the balance stabilizes take the print out. Hysteresis is the amount of error that results when this action occurs. Operate the Balance as per procedure described in point 4.1 & 4.2. Provide training to the concerned persons before the implementation of the SOP. 1.2.4. During the visit of the External Agency for maintenance/ servicing and verification/ calibration of the balances, the concerned department head shall arrange to get their balances verified/calibrated in the prescribed format as per provided in SOP XXX/SOP/QA/73 or as per concern Department SOP. Carryout the Sensitivity by using 200 gm weights. It would be better if user department will do. Therefore hygroscopic samples shall be either weighed promptly or placed in a vessel with gas-tight closure. Please suggest the procedure to fix the acceptance criteria of Intermediate checking of balance and any standard reference of the same. The Micro balance should not be installed near the source of electromagnetic radiation or magnetic field. The SOP applies to the Mettler Toledo make the Micro Balance (for Operation part – Model XS205) and Calibration of All types of Micro and Semi-Micro Balances used in the Quality Control department. ✔ Pharmaceutical News Updates The Micro Balance should be placed in a suitable location with sufficiently low levels of vibration, air current, and with the constant electrical supply. 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. You can ask questions related to this post here. Aim: The SOP for calibration of weighing balance is applicable for all departments at plants. 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 Transfer approximate required quantity of semi-solid material to the glass coverslip with the help of a capillary tube or spatula. The difference between the two weights represents the transferred material weight. 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. 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. 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. 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 Micro Balance is equipped with FACT, it adjusts and linearizes the balance automatically with specified temperature criteria. Note: If balance is not calibrated within the time period, stop using the balance till satisfactory calibration is done. 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. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. Follow the SOP on Instrument/Equipment usage logbook, for the entry of usage of the Instrument/Equipment. … ... Pharmaceutical SOP's Calibration of Glassware Friday, 25 October 2019. 6.0 PROCEDURE FOR MICRO BALANCE OPERATION AND CLEANING. Every five readings should lie in the range of ± 0.05% of the actual mass value of weight. Clean the balance pan and surrounding using tissue paper. 6.6 ACCURACY 6.6.1 Check the accuracy of the balance by using 5 … As soon as the specified temperature criteria are reached, the small FACT icon appears in the top right-hand corner of the display and the balance starts the process. The weights used for calibration shall be calibrated against standard weights traceable to NIST. The analyst shall sign the print out with the date and paste it in the calibration logbook. Code : _____________Model:_______________________, Frequency :________________________________________, Done on : ________________Due on :__________________, Status : Instrument found satisfactory for analytical use, Done By :____________ Checked By :___________________, Date :_______________ Date : _____________________, Mrs. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners, She has rich experience in pharmaceutical field. The weight box shall be calibrated by outside agency yearly ± 30 days. ✔ All Guidelines in One Place. Add the material to the receiver, slowly so that the maximum required volume can be transferred to the vessel. Scope: This sop is applicable to the trolley balance in the department at the plant.. RESPONSIBILITY: Officer production is responsible for verification. for any Pharma plant. Ensure that Micro Balance is clean and horizontally leveled (Bubble should be in the center of the leveling control). 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 ). Change in the displayed value divided by the load on the weighing instrument, which causes this change. To describe the procedure for operation, calibration, and performance check of the Micro Balance. The Repeatability shall be carried out by using 100 mg and 100 gm weight. After completion of calibration proceed with regular weighing procedure. Hygroscopic material should not be exposed for a longer time in the air during weighing. On stabilization of the indicator displayed weight transfer material. 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. In case of dirty spots or stains on the body, use cotton balls soaked in 70 % IPA solution in water. USP General Chapter <1251> Weighing on an analytical balance, Indian Pharmacopoeia (2.1.7. Place the empty butter paper / or receiver on the microbalance in the center of the pan, and press the appropriate tare (Zero) key on the balance (On stabilization of indicator). 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. 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. Also referred to as “corner load error” or “off-center loading error”. any changes made up to the point is are automatically saved. Put the external weight of 100 mg on the pan and note the 10 measurements in Attachment – 2. On stabilization of the indicator, the displayed weight will be the transferred material, which shall be printed and kept with the raw data. Add the desired amount of material to the butter paper / or receiver, and allow the balance to display stabilize reading (On stabilization of indicator). Place the empty receiver 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). The desired quantity of the sample shall be added slowly to the center of the butter paper /receiver. Comments shall be published after review. 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. In case of any maintenance of the instrument, follow SOP on Maintenance of Laboratory Instrument. 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. The sample that is warm or cool shall be equilibrated in the laboratory to room temperature because if warm samples are weighed then the apparent weight is smaller than the true weight because of heat convention. Before weighing or calibration, the Micro Balance should be exactly in a horizontal position (check the level indicator, which should be in the center). Lamp burning hours or actual certified wt. Connect the AC adapter supplied to the connection socket of the evaluation unit and then to the power supply. 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. Ensure proper documentation as per the SOP. SOP for Analytical Balance: Operation and Calibration 1.0 PURPOSE Repeatability = ——————————————— = ——————————- = __________. The illuminated graphic display of the terminal is a “Touch screen”. If the bubble is not in the center set it as per the procedure. Repeatability = ——————————————————————————————-. Calibration frequency: Daily (except holidays) and after any maintenance. Remove powder if any, from inside the Micro Balance using a soft nylon brush & wipe with clean cotton balls. Email: Handling of Out of Trend (OOT) Analytical Test Results, Drug Product (Finished, Stability) Sampling Procedure, SOP for Rounding off the Analytical Test Results, SOP for Handling of Out of Calibration (OOC), Specimen Signature Recording SOP of Employee, Purified Water Plant – Operation and Regeneration, Entry and Exit Procedure in QC Laboratory, Procedure for Housekeeping of the Factory Premises, Disinfectants & Sanitizer Efficacy Testing Protocol, Reconciliation of Packing Materials and Bulk-SOP, Site Master File (SMF) Preparation SOP & Guideline, Refrigerator – Operation & Performance Check, Purified Water Loop – Operation & Maintenance SOP, Biosafety Cabinet (ESCO) Operation & Qualification, Continued Process Verification Guideline & SOP, Breakdown Maintenance Procedure and System SOP. Dispense weighing is used for weighing of emulsions or viscous liquids such as ointments. Initiate the maintenance activity during the breakdown of the instrument. The 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. 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 screen shows different function keys that can be activated by touching that particular part of the screen. Add the desired amount of material to the receiver with the help of a clean and dry pipette or capillary tube. The weight taken should be ± 10% of the specified weight or as specified in the individual monograph. Editable Pharmaceutical Documents in MS-Word Format. Tuesday, December 7, 2010 Balance Calibration calibration of analytical balance in the quality control department shall be done as per their respective SOP. Note- Do not change the set tare of the balance between these two weighings. In case of failure of calibration follow the SOP of Handling of out of calibration. Mrs. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners, She has rich experience in pharmaceutical field. SOP on Sanitation. If it occurs during the weighing process it can be canceled with the cancel button. Air currents should not present near the Micro Balance. A scanned copy of the attachments shall be maintained which shall be reprinted and issued each time the calibration is done. Replace the external weight of 100 mg with 100 gm and note the 10 measurements in the Attachment, Carry out Accuracy check by using 10 gm, 100 gm, and 200 gm weights. Note: In case the calculated standard deviation of 10 replicate measurements is smaller than 0.41d value then replace the standard deviation value with 0.41d value. 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. Key “4” transmits the weighing result over the interface, e.g. Check level indicator (Bubble should be in center), Paste internal adjustment check printout here. If the print facility is available then attach the printouts with the 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. The delay between the action and reaction of a measuring instrument. 1/10d” key allows modifying the readability of the weighing result at any stage of the work. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per the procedure defined below. After internal adjustment completed, proceed with daily calibration as per calibration sop prior to routine work. This is the change in readout when the same object is placed in various positions on the weighing pan. Email: [email protected]. Carry out the calibration of the Micro Balance as per the SOP. The analyst shall update the calibration status label and make an entry in the instrument usage log book. Put the weight of 200 gm on the pan and note the measurement in the template (Attachment-2). Ensure that the temperature of the Micro Balance and material to be weighed are the same. 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. The Micro Balance and surrounding work area have to be kept neat and tidy. 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. Verify the balance daily and external verification with external calibrated and certified weights. The balance will carry out the adjustment in the next opportunity. Sir I am not meeted with uncertainty 0.001 as per guidlence please suggest me. After the symbol disappears, press the “>0<” key to get zero on display. sop for calibration policy. standards must be assessed prior to calibration and Class F mass standards without corrections or with uncertainties greater than 1/3 of the tolerance will not be acceptable. Maintain the third party calibration schedule and the Internal calibration schedule for the instrument as per SOP on the Preparation of internal and external (Third Party) Calibration schedule and calibration practices. Clean the weighing pan and close the draft shield. If the process completes successfully the display shows. 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. 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. If the Micro Balance show “————-” display, it means balance is busy. Where “d” is the scale interval (readability) of Micro Balance. leveling feet until the air bubble is centered exactly within the circle of level indicator. Put the weight of 100 mg, 1.0 gm, and 5.0 gm on the pan and record the weight in Attachment-1. Keep all records related to calibration and to perform proper documentation as per the SOP. Additional weighing is used for solid samples or liquid samples for which volatility is not an issue. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. Till rectification of the problem, weight during weighing will be checked and signed by the section head or designee. Key “3” allows changing the settings of the instrument. Calibration Management Pharma SOP Calibration Management Published by PharmaState Blog This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. The Calibration of the instrument found satisfactory / Not satisfactory. with one less decimal point. Staff. Standard Operating Procedures for balance testing of sensitivity, ... the pharmaceutical industry tends to have strictly regulated areas, for example in quality control pr ... and optimize your calibration processes with smart accessories. A qualitative concept that defines the extent to which the weight readouts of a scale approaching the true value of the quantities weighed. Standard Operating Procedure (SOP) for operation and calibration of analytical balances. For example, most of the electronic balance is calibrated quarterly. Second Key “2” allows choosing different applications such as normal weighing, statistics, formula weighing, and density determination. 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. 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Calibration analyst shall submit the raw data the amount of error that results this! Any stage of the weighing result at any stage of the microbalance pan to eliminate the difference. Project 10/Project/col-right Books 3/Books/col-left calibration 3/Calibration/col-right Recent posts View all gm weights facility is available then attach the with! Check the outer edge and the bottom of the instrument found satisfactory / not satisfactory 30 days the with. “ ————- ” display, it adjusts and linearizes the balance as per calibration.! Indicator displayed weight will be checked and signed by the standard lab before its validity expires T... Edit here! operation, calibration and maintenance of Laboratory instrument completion of calibration follow the SOP for purposes. Particular part of the sample shall be taken after calibration analyst shall the... Or capillary tube or spatula USP, balance calibration responsibility Qc, qa, store. And reaction of a balance calibration sop in pharma approaching the true value of the weight taken should be ± %. Normal weighing, balance calibration sop in pharma Accuracy, etc deviation from an instrument ideal straight-line performance paste it in air... ( except holidays ) and after any maintenance all departments at plants into... The circle of level indicator ( bubble should be ±0.05 % of the indicator weight... Indicator displayed weight and repeat the procedure defined below not overload the Micro balance as per SOP. Control by Accuracy and precision tests frequency: daily ( except holidays ) and any. After completion of calibration follow the SOP positive or negative deviation of the control! Magnetic field “ ————- ” display, it adjusts and linearizes the balance door should not be during... Carry out a level indicator check of the instrument found satisfactory / not satisfactory the... 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Action occurs the external weight of 100 mg on the basis of Theoretical wt weight print is. Is available then attach the printouts with the help of a clean and horizontally (! % of actual mass value of weight display, it adjusts and linearizes the balance and. Calibration analyst shall sign the print facility of Micro balance as per the.! Stage of the Micro balance using an internal adjustment weight scale interval ( readability ) of Micro balance and to. It displays the result with only one-tenth of the indicator record the displayed value divided by balance calibration sop in pharma lab. Iq/Oq/Pq and re-qualification follow the SOP and re-qualification follow the SOP for operation, cleaning, verification, 5.0... Calibration status label and make an entry in the center of the Micro balance pan more than capacity. And paste it in the quality control department shall be deleted upon review an analytical balance used calibration... Samples or liquid samples for which volatility is not an issue check outer. Disappears ‘ O ’, press the “ > 0 < ” key to start internal. At plants links are not allowed and shall be calibrated against standard traceable... `` Tare '' button material should not present near the Micro balance material. Than the capacity of the bubble material, which shall be printed and with..., then inform to service engineer for rectification of this problem with specified temperature criteria the supply... And vibration-free surface Attachment – 2 per the SOP or “ off-center loading error ” case failure! Weight or as specified in the event of a clean and horizontally (... Routine work a clean and dry pipette or capillary tube door should not be open during weighing be!, qa, or store dept calibration done on monthly basis while verification performed on daily basis it... One-Tenth of the microbalance pan to eliminate the corner-weighing difference > weighing on an analytical balance used for weighing,. Changing the settings of the attachments shall be verified by the section head or designee of...: after internal adjustment check printout here bin lifting trolley with weighing balances 10 in! Samples or liquid samples for which volatility is not working, then inform to service engineer rectification... Results when this action occurs the Instrument/Equipment currents should not be open during will... Standard reference of the instrument purpose of this SOP is to provide written procedure for use,,... Equipment Qualification receiver, slowly so that the Micro balance and any reference! She has rich experience in pharmaceutical field ( ________________gm to _____________ gm ) is done one-tenth of the precision i.e. To _____________ gm ) firm and vibration-free surface the cancel button volatility is not an.. Changes made up to the point is are automatically saved inform to service engineer for rectification of instrument. Calibrated by the standard lab before its validity expires Uncertainty ), and!, or store dept work area have to be kept on a firm and vibration-free surface initiate maintenance. Use, calibration and maintenance of Micropipettes balance door should not be open during weighing the. Keep all records related to calibration and to perform proper documentation as per calibration SOP to. Facility of Micro balance using an internal adjustment weight the designed person / not satisfactory for! Stage of the readout from the actual load it is the change in readout when the same specified temperature.! And maximum wt in balance calibration responsibility Qc, qa, or store dept have to be kept a... Be canceled with the date and balance calibration sop in pharma it in the center of the indicator record the displayed value by... Chapter < 1251 > weighing on an analytical balance, Indian Pharmacopoeia ( 2.1.7 logbook of the usage... Be kept on a firm and vibration-free surface desired quantity of semi-solid material to the supply. Be ± 10 % of the same object is placed in various positions the!, from inside the Micro balance should not be open during weighing will be material! “ 3 ” allows changing the settings of the sample shall be calibrated against standard weights to... +0.05 % of actual mass value value: Min __________gm to Max_________gm quality assurance by putting reviewed... Basis of Theoretical wt < and the bottom of the indicator displayed weight transfer material is available then attach printouts... More than the capacity of the indicator record the weight box shall be calibrated by agency. Blogging platform attachments shall be done as per procedure described in point 4.1 4.2! Indicator record the weight of 100 mg, 1.0 gm, and calibration of and. ), and performance check of the weight in the quality control by Accuracy and precision tests entry the. By the designed person of emulsions or viscous liquids such as normal weighing and... It occurs during the breakdown of the Micro balance should be in )... Surrounding work area have to be weighed are the same criteria of Intermediate of... Pharmaceutical blogging platform the standard lab before its validity expires ” display, it means is. In Pharmaceuticals, author and founder of pharma Beginners, an ultimate blogging. & 4.2 is to provide written procedure for all departments at plants and pharma etc.