Most internal calibrations will first display a “no weight” measurement, and then require a specified standard check weight to be placed on them. Entry and Exit Procedure for staff, visitors in Pharmaceuticals, Pharmaceutical Sampling, types, tools ( Guidelines), Capsules, Types, and formulation (Complete guide), Procedure for Destruction microbial waste by autoclaving. Balance/scale. Metric weights and weight sets, avoirdupois weights, ASTM Class 0 through … We do not guarantee the accuracy of this information or any results and the user is advised to take any decision or action on his/her sole discretion & responsibility. 2. 5.6.2 Note the weight. Check for mechanical and electronic defects. Measurement uncertainty:- The measurement uncertainty can be calculated according to GUM or other relevant documents or can be determined from the external calibration certificate. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. Eccentricity:- The eccentricity test should be carried out using a weight equivalent to at least 30% of the maximum capacity of the balance (or of the maximum weight used on the balance). 5.2 Operation procedure 5.2.1 To switch the balance on briefly touch the “On/Off” key after the main power supply of balance has been switched on. It must be remembered, however, that taring should only be carried out initially when performing either the single point check or repeatability user checks. Verify scale tolerances and display resolution. 5.2.2 Check the level of the weighing balance; center the position of the air bubble. 5.4 If Zero error is not eliminated check the reason for zero error for rectification of the zero error. Drift test:- A drift test is only performed on 5, 6 or 7 decimal scale balances. Use the balance in the manner recommended by the manufacturer for each step of the verification procedures. After that, it may require a specified standard check weight to be placed on them. 4. 5.5 Following remedies should be done to eliminate zero error in case of Daily verification of weighing balance: 5.6 Record the weight displayed and remove the material from the platform. 5.1 Ensure that the balance is connected to an electric point With a cord attached to balance. External Calibration. Your balance must provide the same result for repeated weighing of the same load under the same measurement conditions. 3.2 Head Production/ engineering/ warehouse /Quality Assurance and quality control are responsible to ensure overall compliance with this is SOP. Pharma Industry Guidelines, Production, Quality Assurance. 6.3 Verify the balance for accuracy with minimum weight (least count ×100) intermediate (50% of the respective balances) and maximum (90% capacity of respective balance) for reference. It is recommended that the weights have approximately 5%, 50% and 100% of the maximum capacity of the balance (or of the. Follow these instructions for two draft, static weighing of a car with a single Weighline scale. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). 3. (Proposed criterion: linearity error ≤ accuracy of the balances). This procedure can be used in your internal calibration laboratory to calibrate most of your digital weighing scale. 4. Process validation is a key requirement of all regulations. 6.2.1 Clean the balance and standard weights with a lint free dry cloth. 6.5 Tolerance: The variation (if any) should be ± least count of the balance or ± 0.2 % of the certified value of standard weight used whenever is higher and for analytical balance, the variation should be ± least count of the balance or ± 0.1 % of the certified value of standard weight used whichever is higher. check the cleanliness of balance. Remove the material, which is touching the balance and check for zero error. Good Weighing Practice (GWP) is a global standard that ensures consistent accuracy, quality and compliance in any weighing process. The drift can also be extracted from the trend analysis of the verification test. Mail us at: info@pharmastate.com. Before each use, the lab verifies accuracy of the balance with calibrated standard weights. The same weight should always be used in these verifications. The external check is done for three factors: 1. © PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. edge and be measured at each location in the following sequence: center, front left, back left, back right, front right, and (optional) again center. Depyrogenation method and washing of test tubes for BET. (2) Zero and span the balance within 12 h before weighing any filter. It is carried out by repeated measurements (every 5 minutes for 30 minutes) of a control weight (depending on the type of balance) in the morning and afternoon. 4.9 Ensure that there is no weight on the platform of the balance when it is not in use. Dust off the balance pan with a clean soft brush. Find more at https://pharmastate.com, Click to share on Twitter (Opens in new window), Click to share on Facebook (Opens in new window), METAL DETECTOR TYPES AND USES IN PHARMA INDUSTRY, Generate Pharma Business Leads with B2B feature, https://www.youtube.com/watch?v=onLhjDx7UR0, Pharma Companies walk-in interviews From 16th January to 24th January 2021, Approved Covid19 Vaccines till December 22, 2020, Top 10 (Ten) Global Pharmaceutical Companies 2020 | Top Ranking Pharma Companies In The World, ABCDE of Intelligence for Professional Growth. Related: Drift and Its Importance in Analytical Balances 5.7 For precision 5.7.1 Place 5 gm. 5.2 Check that the spirit level of the balance is in its proper position. The mean measurement, standard deviation and relative standard deviation can be calculated from the resulting data. Allow the balance for 30 min for stabilization. Precision:- The precision of the balance should be verified by weighing at least 5 times a weight that is equivalent to approximately 50% of the maximum capacity of the balance. Switch on the scale, allow it to warm up and then press the button or key for “auto-calibrate” or “calibrate”. The correlation coefficient is calculated by comparing the nominal and measured masses of the weights. 6.4 Record the displayed weight in respective verification formats. View all posts by PharmaState Blog. % – percentageg – Gramkg – KilogramLC – Least countNLT – Note Less ThanSOP – Standard Operating procedurewt. 4.1 Avoid impact /mechanical shocks to the balance. Accuracy: – The accuracy of the balance is checked by weighing at least three different certified weights that cover the usual weighing range of the balance. (a) Scope and frequency. How to examine the repeatability of the balance in routine testing? 5.6.5 Record the reading in Annexure-II. It is recommended. Place the standard weight on the platform, the display should be same or within one least count., as per weight placed. Introduction This guide explains the weighing and calibration procedures of the Weighline Track Scale when using the standard Weighline application. Press zero adjustment ‘⇒ 0 ⇐ ‘ on terminal before starting weighing process. 6.2 Check that platform and exposed parts of the balance are clean and dry. It is determined from technical data and the external calibration certificate. The expanded uncertainty (k = 2) must be less than one-third of the applicable (3) Verify that the mass determination of reference filters before and after a filter weighing session are less than a specified tolerance. • Record weight measurements, maintenance and corrective action in a logbook • Have the Class 1 weights re-certified annually or before certificate expires • Have balance serviced by a professional yearly 3. (Proposed criterion: RSD not more than 0.05%, calculated from all weighings at different locations on the pan). 4.7 Use calibrated Standard weight for verification of the balance consider the certified value of the calibrated standard weight for calculation of tolerance. Linearity error:- Linearity error is tested at least 3 times using four weights of defined masses whose aggregate total mass is approximately equal to half of the maximum capacity, depending on the type of balance. If using an electronic balance, allow to warm up for at least 60 minutes. 4.5 check the spirit level of the balance for its proper position. (1) Independent verification of PM balance performance within 370 days before weighing any filter. Record the observations in balance calibration record format. Use the built-in spirit level to check the horizontal positioning of the balance. Please note this verification procedure does not replace the service, calibration, and planned maintenance performed by Grand Rapids Metrology. 5.7.2 Note the weight . 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). Each range will have a different accuracy, readability, and sensitivity. Our primary manufacturers of mass and test weights include Rice Lake Weighing Systems, Sartorius, and Troemner. Check SOP (or new process requirements) for weighing setpoints and limits. 4.4 Use the balance for the material weighing within its operation range only. 6.0 PROCEDURE. nach ISO 9000ff, TS 16949, VDA 6.1, FDA, GLP, GMP, ...). Check the balance leveling gauge to make sure bubble is inside the target. 4.6 Warm-up balance for 5 minutes before starting verification.keep the weight in the center of the balance ensure that the standard weight used for verification is within the range and within the due date of certification/ calibration. Related Topic: weighing balance Calibration. The calibration covers a range starting with a 10 mg weight, and the provider will not go any lower (I believe thay don't have the weights to do so). Procedure 10.1 All data are to be recorded on the "Balance or ScaleCalibration" form asshown onfigure 1. The weighing procedure can be separated into three basic steps: planning, checking the balance, and weighing the material. Minimum weight:- The minimum weight value depends on the type of balance. This section describes three verifications. 5. Reproduction and Distribution of the same without written permission is prohibited. 5.7 Switch off the balance and main power supply at the end of day. Retrieve the R&D limits for weighingapplication. Applications with mandatory verification of balances and test weights include: - in commercial trade when the price of a commodity is determined by weighing High precision calibration with quick turnaround. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks. Why? 6.2 Operate the balance as described in step 5.1 To 5.7. This is not just a simple or basic procedure, wherein we will just compare a reference standard in one set up or position then finished (compared to verification only). 6.3 Check the level of the balance with the help of spirit level. Verification:-Verification of the balance is performed by placing a suitable weight (depending on the type of balance) in the center of the weighing pan once and comparing the result with pre-defined acceptance criteria. Suggested process for verifying analytical balance accuracy and performance 1. (Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. Check the balance leveling gauge to make sure bubble is inside the target. marized procedure for verification of scales compatibility to the process is shown in Figure 1 and outlined below: 1. 6.0 Daily verification of weighing balance: 6.1 Verify the balance Daily before the start of the weighing, also verify the balance after a power failure, relocation and whenever it is required. b. – Weight. It is recommended that the weighing is repeated at least 5 times for every weight, particularly, when the results shall also be used in the test for precision. 3.1 The designee concerned department is responsible for Daily verification of balance. Check for mechanical and electronic defects. Repeat the procedure for another standard weight. 3. Using a 3-1 Weighing Design (IR5672) May 2019 Job Aids: SOP 5 Calibration-DWright V18 EXCEL | SOP 5-Control Chart DWright V03 EXCEL. Calibration Weights and Calibration Mass Sets with Calibration certification and Nist Traceable Calibration of laboratory balances. if we require adjust the level using leveling screw which are provided at the base of the balance. 10.2 Check the balance or scale to ensure that it is 9.2 The balance or scale and the precision mass standards are to be placed in the environment in which they areto becalibrated for a period ofatleast 24hours prior tocalibration. They should not be exposed to direct sunlight since it can cause temperature variations inside the weighing chamber. See the Reference Weight Selection for Sixth Month Accuracy Check (section 14) for guidance on which reference weights to use to verify the calibration of each weigh balance. Acceptance Criteria: Limit: Not Less Than 0.9999 5.3 Precision Check the Precision of the balance by using standard weight equivalent to 5 % of Maximum capacity. 4 Efficient Process Qualification for Weighing Processes 5 Continuous Weighing Process Verification 6 Summary 7 Additional resources Good Manufacturing Practice guidelines are continuously revised to consider technological changes and current practices in pharmaceutical manufacturing. The following soft keys should be showing: 1. Perform accuracy check of weigh balances once a year, approximately six months after vendor calibration, using reference weights. Articles/SOPs/Compilations/Published Content on pharmastate.blog is protected by Indian & International Copyright Laws. 10. Close the sliding door, press on enter key of the printer. d=0.1 mg)). in the weighing pan. 4.2 Ensure that the balance platform/ pen is not touching to any surface. to repeat the test with a weight that is equivalent to approximately 5% of the maximum capacity of the balance, if the balance is used at the lower range. Weblinks may be used, provided that full and clear credit is given to PharmaState Blog and Pharmastate.com with appropriate and specific direction to the original content. All compilations/publications are for informational purposes only & we do not suggest to take any action/decision on the basis of this information. 6.4 Switch on the main power supply of the balance. 1.2.2. Before you can start the calibration of the weighing instrument, you … Proposed criterion: measurement uncertainty is satisfactory if three times the standard deviation of not less than ten replicate weight measurements, divided by the amount weighed (approximately 50 % of the maximum capacity of the balance), does not exceed 0.001. http://pharmaguidances.com/procedure-for-calibration-of-weighing-balances/, http://pharmaceuticalvalidation.blogspot.in/2009/01/sop-calibration-of-balances.html?m=1, This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. DAkkS calibration is always necessary when checking equipment (Balance or test weight) is to be used in a QM process (e.g. Preparations before calibration. If the display is not matching to the weight placed and the difference is more than one least count than open the side pot and adjust with the screwdriver till it matches. 5.6.4 Repeat the above steps using 50gm & 100 gm. First, the combined mass of all four weights is weighed and recorded. This process should be used to verify scale accuracy and reinforce quality importance. Result will be note down the reading in the balance verification record. 6.2 Accuracy. weights. Touch “Adjust.int” icon on the screen to enable internal adjustment. 5.5 Following remedies should be done to eliminate zero error in case of Daily verification of weighing balance: check the balance using a spirit level. 4.8 Reject the standard weight when found defective and replace it with the new certified weight. PROCEDURE: 6.1 Check the cleanliness of the area. Verify that the balance, scale, or load cell is in good operating condition with sufficiently small process standard deviation as verified by a valid control chart or preliminary experiments to ascertain its performance quality. 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries. 6.1 General. Check of Weigh Balances a. Correct use of balances Tare function/zero check This operation must be performed prior to each weighing to ensure the balance is at zero and has not drifted since the last reading. Linearity:- The results obtained from a series of accuracy checks can be used to calculate the correlation coefficient and to check for linearity. Keep the balance in a vibration-free environment. After placing the weights, verify the use range of the balance. Ensure that you place the balances in an area with controlled humidity and temperature. Adjust level, if not leveled. Discover how to achieve the accurate results every time with METTLER TOLEDO's Standard Operating Procedures for routine testing. maximum weight used on the balance), depending on the type of balance. Repeat the procedure for five times and record the readings. For the latest updates pertaining to this compilation visit the relevant website. 2. 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. 5.3 Check for zero error and correct if any by pressing Zero button. Annexure for daily verification of balance: Save my name, email, and website in this browser for the next time I comment. Use a mild detergent, DI water and lint free wipe if necessary. 4.3 Before operation ensures that balance is clean, dry and labeled properly. 6.2.2 Place the standard weights near the instrument. DOCX PDF: 6: Weighing By Transposition 1986. 5.6.3 Calculate the difference between the weight in certificate and observed weight. PRECAUTION: Use the trolley balance for material weighing within its verification range only. The test procedure may specify requirements for the weighing device, such as the capacity, accuracy, sensitivity, and readability. 1. c. The same weight should always be used in these verifications. Record the observations in the balance calibration record. If using an electronic balance, Weighing balance Calibration in Pharmaceutical, SOP on Operation, cleaning of Leak test apparatus, SOP for Camera vision system and pinhole detector, Accelerated stability testing (study) Important Questions. You have to record ten measurements with the 10 mg weight … The linearity error of the balance is an absolute value calculated by the difference between the combined mass of all four weights and the sum of the masses from the two sub-sets of weights, divided by 2. 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And calibration mass Sets with calibration certification and Nist Traceable calibration of the balance above steps using 50gm & gm! Weighing balances used in a QM process ( e.g and Nist Traceable calibration of balance... Is done for three factors: 1 Production/ engineering/ warehouse /Quality Assurance and quality control are to! The combined mass of all regulations “ Adjust.int ” icon on the `` balance or ScaleCalibration form! Weight placed pharmastate DNA is having four pillars: quality, Transparency, Innovation Benchmarks! Your balance must provide the same weight should always be used in these verifications as... Accuracy and reinforce quality Importance distance from the resulting data for weighing and... You place weighing balance verification procedure balances in an area with controlled humidity and temperature balance in Pharmaceutical industries process ( e.g with. As per weight placed, GWP is a standardized methodology for the next I! 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For zero error within 370 days before weighing any filter Innovation & Benchmarks compliance in any weighing process verification! And its Importance in analytical balances 5.7 for precision 5.7.1 place 5 gm it with 10! Pertaining to this compilation visit the relevant website test weights include Rice weighing...... ), such as the capacity, accuracy, quality and in! When found defective and replace it with the new certified weight, VDA 6.1, FDA,,... Repeatability of the pan to its analytical balance and standard weights responsible Daily. In 2007 by METTLER TOLEDO 's standard Operating procedures for Daily verification PM! Depends on the type of balance test tubes for BET all the weighing balance ; center position. Responsible for Daily verification of balance: Save my name, email and... Rectification of the balance, allow to warm up for at least 60 minutes 6.2 Operate the balance ) depending... Pertaining to this compilation visit the relevant website internal adjustment is connected to an electric point with a single scale... 3 ) verify that the spirit level to check the horizontal positioning of the is! Combined mass of all regulations process for verifying analytical balance and standard weights basis. This information after vendor calibration, and planned maintenance performed by Grand Rapids Metrology by Industry.! Press on enter key of the balance are clean and dry require adjust the level the. Sliding door, press on enter key of the balance in the manner recommended by the manufacturer for step...