The drift can also be extracted from the trend analysis of the verification test. Related Topic: weighing balance Calibration. 5. 6.2 Check that platform and exposed parts of the balance are clean and dry. 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. You have to record ten measurements with the 10 mg weight … 5.4 If Zero error is not eliminated check the reason for zero error for rectification of the zero error. Use the built-in spirit level to check the horizontal positioning of the balance. It is determined from technical data and the external calibration certificate. 4. b. This procedure can be used in your internal calibration laboratory to calibrate most of your digital weighing scale. 6.3 Check the level of the balance with the help of spirit level. 6.4 Record the displayed weight in respective verification formats. Your balance must provide the same result for repeated weighing of the same load under the same measurement conditions. 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. 3. Metric weights and weight sets, avoirdupois weights, ASTM Class 0 through … 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. 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). 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. Reproduction and Distribution of the same without written permission is prohibited. (Proposed criterion: RSD not more than 0.05%, calculated from all weighings at different locations on the pan). 4.2 Ensure that the balance platform/ pen is not touching to any surface. 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. PRECAUTION: Use the trolley balance for material weighing within its verification range only. Record the observations in balance calibration record format. (3) Verify that the mass determination of reference filters before and after a filter weighing session are less than a specified tolerance. Result will be note down the reading in the balance verification record. c. 6.2 Accuracy. 5.6.4 Repeat the above steps using 50gm & 100 gm. • 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. 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. Then, two sub-sets of weights are made and their masses are recorded. 6.2.1 Clean the balance and standard weights with a lint free dry cloth. Verify scale tolerances and display resolution. Perform accuracy check of weigh balances once a year, approximately six months after vendor calibration, using reference weights. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). Switch on the scale, allow it to warm up and then press the button or key for “auto-calibrate” or “calibrate”. 3.2 Head Production/ engineering/ warehouse /Quality Assurance and quality control are responsible to ensure overall compliance with this is SOP. Repeat the procedure for another standard weight. 5.7.2 Note the weight . Press zero adjustment ‘⇒ 0 ⇐ ‘ on terminal before starting weighing process. Using a 3-1 Weighing Design (IR5672) May 2019 Job Aids: SOP 5 Calibration-DWright V18 EXCEL | SOP 5-Control Chart DWright V03 EXCEL. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks. 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. 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. Remove the material, which is touching the balance and check for zero error. Mail us at: info@pharmastate.com. Dust off the balance pan with a clean soft brush. Close the sliding door, press on enter key of the printer. 2. Depyrogenation method and washing of test tubes for BET. 2. 4.4 Use the balance for the material weighing within its operation range only. External Calibration. This process should be used to verify scale accuracy and reinforce quality importance. 4.3 Before operation ensures that balance is clean, dry and labeled properly. (Proposed criterion: linearity error ≤ accuracy of the balances). High precision calibration with quick turnaround. % – percentageg – Gramkg – KilogramLC – Least countNLT – Note Less ThanSOP – Standard Operating procedurewt. Use the balance in the manner recommended by the manufacturer for each step of the verification procedures. 4.7 Use calibrated Standard weight for verification of the balance consider the certified value of the calibrated standard weight for calculation of tolerance. 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. The weight should be placed between halfway to ¾ of the distance from the center of the pan to its. 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. 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). 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. Drift: Normally, a 10mg standard weight is used to carry out a drift check. Ensure that you place the balances in an area with controlled humidity and temperature. 5.1 Ensure that the balance is connected to an electric point With a cord attached to balance. They should not be exposed to direct sunlight since it can cause temperature variations inside the weighing chamber. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. 6.4 Switch on the main power supply of the balance. 4.8 Reject the standard weight when found defective and replace it with the new certified weight. Minimum weight:- The minimum weight value depends on the type of balance. Measurement uncertainty:- The measurement uncertainty can be calculated according to GUM or other relevant documents or can be determined from the external calibration certificate. © PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. Suggested process for verifying analytical balance accuracy and performance 1. DOCX PDF: 6: Weighing By Transposition 1986. (Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. PROCEDURE: 6.1 Check the cleanliness of the area. Applications with mandatory verification of balances and test weights include: - in commercial trade when the price of a commodity is determined by weighing Related: Drift and Its Importance in Analytical Balances 5.7 For precision 5.7.1 Place 5 gm. weights. (a) Scope and frequency. Before you can start the calibration of the weighing instrument, you … 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. check the cleanliness of balance. The correlation coefficient is calculated by comparing the nominal and measured masses of the weights. Keep the balance in a vibration-free environment. Introduction This guide explains the weighing and calibration procedures of the Weighline Track Scale when using the standard Weighline application. Established in 2007 by METTLER TOLEDO, GWP is a standardized methodology for the secure selection, calibration and operation of weighing equipment. 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. Good Weighing Practice (GWP) is a global standard that ensures consistent accuracy, quality and compliance in any weighing process. First, the combined mass of all four weights is weighed and recorded. 1. The external check is done for three factors: 1. Please note this verification procedure does not replace the service, calibration, and planned maintenance performed by Grand Rapids Metrology. 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). Use a mild detergent, DI water and lint free wipe if necessary. 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. The weighing procedure can be separated into three basic steps: planning, checking the balance, and weighing the material. Place the standard weight on the platform, the display should be same or within one least count., as per weight placed. All compilations/publications are for informational purposes only & we do not suggest to take any action/decision on the basis of this information. 1.2.2. 6.0 PROCEDURE. The mean measurement, standard deviation and relative standard deviation can be calculated from the resulting data. 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. Preparations before calibration. Check the balance leveling gauge to make sure bubble is inside the target. 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. Note: For balance having a capacity equal or more than 500 kg verify the balances based on the maximum operating range. Annexure for daily verification of balance: Save my name, email, and website in this browser for the next time I comment. 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. use an external spirit level for balance which is not provided for it. if we require adjust the level using leveling screw which are provided at the base of the balance. For the latest updates pertaining to this compilation visit the relevant website. Check for mechanical and electronic defects. Record the observations in the balance calibration record. 6.2.2 Place the standard weights near the instrument. in the weighing pan. If using an electronic balance, The following soft keys should be showing: 1. 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. 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. Exclusive platform for Professionals working in the pharmaceuticals industry for Jobs, News, Pharmaceutical Guidelines & SOPs, B2B Networking, Professional Profile display space. 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. Retrieve the R&D limits for weighingapplication. 4.9 Ensure that there is no weight on the platform of the balance when it is not in use. 5.2.2 Check the level of the weighing balance; center the position of the air bubble. 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). 5.6.3 Calculate the difference between the weight in certificate and observed weight. Before each use, the lab verifies accuracy of the balance with calibrated standard weights. The same weight should always be used in these verifications. 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. Discover how to achieve the accurate results every time with METTLER TOLEDO's Standard Operating Procedures for routine testing. The same weight should always be used in these verifications. 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. 3.1 The designee concerned department is responsible for Daily verification of balance. Linearity:- The results obtained from a series of accuracy checks can be used to calculate the correlation coefficient and to check for linearity. 5.7 Switch off the balance and main power supply at the end of day. marized procedure for verification of scales compatibility to the process is shown in Figure 1 and outlined below: 1. After placing the weights, verify the use range of the balance. After initialization display terminal displays in 0.0000 g in normal weighing mode. Most internal calibrations will first display a “no weight” measurement, and then require a specified standard check weight to be placed on them. Follow these instructions for two draft, static weighing of a car with a single Weighline scale. 5.3 Check for zero error and correct if any by pressing Zero button. Pharma Industry Guidelines, Production, Quality Assurance. Procedure 10.1 All data are to be recorded on the "Balance or ScaleCalibration" form asshown onfigure 1. 4. How to examine the repeatability of the balance in routine testing? Adjust level, if not leveled. Fill the verification label as per SOP Daily signed with Marker Pen. 1.2 Many laboratory balances have more than one range. 6.1 General. View all posts by PharmaState Blog. (2) Zero and span the balance within 12 h before weighing any filter. Repeat the procedure for five times and record the readings. maximum weight used on the balance), depending on the type of balance. (1) Independent verification of PM balance performance within 370 days before weighing any filter. After that, it may require a specified standard check weight to be placed on them. It is recommended. 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. A simplified procedure is proposed as follows: A weight of approximately 50% of the maximum capacity of the balance (depending on the type of balance) is weighed at least 10 times and the mean measurement, standard deviation and relative standard deviation are calculated. 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. 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. 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. Articles/SOPs/Compilations/Published Content on pharmastate.blog is protected by Indian & International Copyright Laws. d=0.1 mg)). – Weight. Why? 5.2 Check that the spirit level of the balance is in its proper position. 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. 5.6.2 Note the weight. nach ISO 9000ff, TS 16949, VDA 6.1, FDA, GLP, GMP, ...). DAkkS calibration is always necessary when checking equipment (Balance or test weight) is to be used in a QM process (e.g. Balance/scale. edge and be measured at each location in the following sequence: center, front left, back left, back right, front right, and (optional) again center. Touch “Adjust.int” icon on the screen to enable internal adjustment. Check of Weigh Balances a. It is recommended that the weights have approximately 5%, 50% and 100% of the maximum capacity of the balance (or of the. Allow the balance for 30 min for stabilization. Check SOP (or new process requirements) for weighing setpoints and limits. 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. 5.6.5 Record the reading in Annexure-II. 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. Our primary manufacturers of mass and test weights include Rice Lake Weighing Systems, Sartorius, and Troemner. Our lab is using an analytical balance and it is calibrated annually by an external provider. Check for mechanical and electronic defects. 4.1 Avoid impact /mechanical shocks to the balance. Drift test:- A drift test is only performed on 5, 6 or 7 decimal scale balances. 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. The expanded uncertainty (k = 2) must be less than one-third of the applicable This section describes three verifications. 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. The test procedure may specify requirements for the weighing device, such as the capacity, accuracy, sensitivity, and readability. 10.2 Check the balance or scale to ensure that it is 10. 2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in the department at plants. Each range will have a different accuracy, readability, and sensitivity. Calibration Weights and Calibration Mass Sets with Calibration certification and Nist Traceable Calibration of laboratory balances. 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