View all posts by PharmaState Blog. Allow the balance for 30 min for stabilization. Repeat the procedure for five times and record the readings. This procedure can be used in your internal calibration laboratory to calibrate most of your digital weighing scale. 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. 5.2 Check that the spirit level of the balance is in its proper position. If using an electronic balance, 5.2.2 Check the level of the weighing balance; center the position of the air bubble. 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. 4.3 Before operation ensures that balance is clean, dry and labeled properly. 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. Related: Drift and Its Importance in Analytical Balances 5.7 For precision 5.7.1 Place 5 gm. Before you can start the calibration of the weighing instrument, you … Note: For balance having a capacity equal or more than 500 kg verify the balances based on the maximum operating range. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. 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. 5.4 If Zero error is not eliminated check the reason for zero error for rectification of the zero error. It must be remembered, however, that taring should only be carried out initially when performing either the single point check or repeatability user checks. 1.2 Many laboratory balances have more than one range. 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. 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). Articles/SOPs/Compilations/Published Content on pharmastate.blog is protected by Indian & International Copyright Laws. (3) Verify that the mass determination of reference filters before and after a filter weighing session are less than a specified tolerance. Fill the verification label as per SOP Daily signed with Marker Pen. PROCEDURE: 6.1 Check the cleanliness of the area. Press zero adjustment ‘⇒ 0 ⇐ ‘ on terminal before starting weighing process. in the weighing pan. High precision calibration with quick turnaround. 4.2 Ensure that the balance platform/ pen is not touching to any surface. If using an electronic balance, allow to warm up for at least 60 minutes. 4.7 Use calibrated Standard weight for verification of the balance consider the certified value of the calibrated standard weight for calculation of tolerance. (2) Zero and span the balance within 12 h before weighing any filter. It is recommended that the weights have approximately 5%, 50% and 100% of the maximum capacity of the balance (or of the. 3.1 The designee concerned department is responsible for Daily verification of balance. The same weight should always be used in these verifications. 1. 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. d=0.1 mg)). All compilations/publications are for informational purposes only & we do not suggest to take any action/decision on the basis of this information. The weight should be placed between halfway to ¾ of the distance from the center of the pan to its. First, the combined mass of all four weights is weighed and recorded. 5.3 Check for zero error and correct if any by pressing Zero button. 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. 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. edge and be measured at each location in the following sequence: center, front left, back left, back right, front right, and (optional) again center. 4.9 Ensure that there is no weight on the platform of the balance when it is not in use. Our primary manufacturers of mass and test weights include Rice Lake Weighing Systems, Sartorius, and Troemner. Annexure for daily verification of balance: Save my name, email, and website in this browser for the next time I comment. (1) Independent verification of PM balance performance within 370 days before weighing any filter. For the latest updates pertaining to this compilation visit the relevant website. 6.2.2 Place the standard weights near the instrument. The weighing procedure can be separated into three basic steps: planning, checking the balance, and weighing the material. Switch on the scale, allow it to warm up and then press the button or key for “auto-calibrate” or “calibrate”. After initialization display terminal displays in 0.0000 g in normal weighing mode. After placing the weights, verify the use range of the balance. Preparations before calibration. • 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. Use the balance in the manner recommended by the manufacturer for each step of the verification procedures. check the cleanliness of balance. Keep the balance in a vibration-free environment. marized procedure for verification of scales compatibility to the process is shown in Figure 1 and outlined below: 1. 4.8 Reject the standard weight when found defective and replace it with the new certified weight. Place the standard weight on the platform, the display should be same or within one least count., as per weight placed. 6.2 Accuracy. Most internal calibrations will first display a “no weight” measurement, and then require a specified standard check weight to be placed on them. Drift: Normally, a 10mg standard weight is used to carry out a drift check. Our lab is using an analytical balance and it is calibrated annually by an external provider. 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. 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. Applications with mandatory verification of balances and test weights include: - in commercial trade when the price of a commodity is determined by weighing 6.3 Check the level of the balance with the help of spirit level. 2. 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. 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. Why? 6.4 Record the displayed weight in respective verification formats. 6.2 Operate the balance as described in step 5.1 To 5.7. 2. 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. It is determined from technical data and the external calibration certificate. Ensure that you place the balances in an area with controlled humidity and temperature. 3.2 Head Production/ engineering/ warehouse /Quality Assurance and quality control are responsible to ensure overall compliance with this is SOP. The mean measurement, standard deviation and relative standard deviation can be calculated from the resulting data. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). PRECAUTION: Use the trolley balance for material weighing within its verification range only. Follow these instructions for two draft, static weighing of a car with a single Weighline scale. 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. Depyrogenation method and washing of test tubes for BET. 5.6.5 Record the reading in Annexure-II. Related Topic: weighing balance Calibration. 6.4 Switch on the main power supply of the balance. Check for mechanical and electronic defects. % – percentageg – Gramkg – KilogramLC – Least countNLT – Note Less ThanSOP – Standard Operating procedurewt. Use a mild detergent, DI water and lint free wipe if necessary. 4. Check the balance leveling gauge to make sure bubble is inside the target. use an external spirit level for balance which is not provided for it. 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). DAkkS calibration is always necessary when checking equipment (Balance or test weight) is to be used in a QM process (e.g. Linearity:- The results obtained from a series of accuracy checks can be used to calculate the correlation coefficient and to check for linearity. 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. 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 expanded uncertainty (k = 2) must be less than one-third of the applicable c. 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. 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. 3. Measurement uncertainty:- The measurement uncertainty can be calculated according to GUM or other relevant documents or can be determined from the external calibration certificate. Please note this verification procedure does not replace the service, calibration, and planned maintenance performed by Grand Rapids Metrology. 1.2.2. Perform accuracy check of weigh balances once a year, approximately six months after vendor calibration, using reference weights. Remove the material, which is touching the balance and check for zero error. 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries. Metric weights and weight sets, avoirdupois weights, ASTM Class 0 through … Repeat the procedure for another standard weight. 4.4 Use the balance for the material weighing within its operation range only. nach ISO 9000ff, TS 16949, VDA 6.1, FDA, GLP, GMP, ...). Result will be note down the reading in the balance verification record. 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. Each range will have a different accuracy, readability, and sensitivity. Before each use, the lab verifies accuracy of the balance with calibrated standard weights. Minimum weight:- The minimum weight value depends on the type of balance. Calibration Weights and Calibration Mass Sets with Calibration certification and Nist Traceable Calibration of laboratory balances. Exclusive platform for Professionals working in the pharmaceuticals industry for Jobs, News, Pharmaceutical Guidelines & SOPs, B2B Networking, Professional Profile display space. 5.6.3 Calculate the difference between the weight in certificate and observed weight. 4.1 Avoid impact /mechanical shocks to the balance. 6.2.1 Clean the balance and standard weights with a lint free dry cloth. 5.7 Switch off the balance and main power supply at the end of day. Touch “Adjust.int” icon on the screen to enable internal adjustment. Use the built-in spirit level to check the horizontal positioning of the balance. 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. How to examine the repeatability of the balance in routine testing? 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. 5.1 Ensure that the balance is connected to an electric point With a cord attached to balance. The drift can also be extracted from the trend analysis of the verification test. Retrieve the R&D limits for weighingapplication. Process validation is a key requirement of all regulations. Procedure 10.1 All data are to be recorded on the "Balance or ScaleCalibration" form asshown onfigure 1. 10. (Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. Good Weighing Practice (GWP) is a global standard that ensures consistent accuracy, quality and compliance in any weighing process. 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. The following soft keys should be showing: 1. Your balance must provide the same result for repeated weighing of the same load under the same measurement conditions. The correlation coefficient is calculated by comparing the nominal and measured masses of the weights. It is recommended. Established in 2007 by METTLER TOLEDO, GWP is a standardized methodology for the secure selection, calibration and operation of weighing equipment. 6.0 PROCEDURE. 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 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. Reproduction and Distribution of the same without written permission is prohibited. 2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in the department at plants. Dust off the balance pan with a clean soft brush. After that, it may require a specified standard check weight to be placed on them. The external check is done for three factors: 1. Balance/scale. They should not be exposed to direct sunlight since it can cause temperature variations inside the weighing chamber. The same weight should always be used in these verifications. Then, two sub-sets of weights are made and their masses are recorded. Check for mechanical and electronic defects. maximum weight used on the balance), depending on the type of balance. – Weight. 6.1 General. 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). Record the observations in balance calibration record format. This process should be used to verify scale accuracy and reinforce quality importance. 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. © PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. 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. Check the balance leveling gauge to make sure bubble is inside the target. weights. The test procedure may specify requirements for the weighing device, such as the capacity, accuracy, sensitivity, and readability. Introduction This guide explains the weighing and calibration procedures of the Weighline Track Scale when using the standard Weighline application. (Proposed criterion: RSD not more than 0.05%, calculated from all weighings at different locations on the pan). 10.2 Check the balance or scale to ensure that it is Check SOP (or new process requirements) for weighing setpoints and limits. Drift test:- A drift test is only performed on 5, 6 or 7 decimal scale balances. Record the observations in the balance calibration record. 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. Verify scale tolerances and display resolution. Using a 3-1 Weighing Design (IR5672) May 2019 Job Aids: SOP 5 Calibration-DWright V18 EXCEL | SOP 5-Control Chart DWright V03 EXCEL. Mail us at: info@pharmastate.com. DOCX PDF: 6: Weighing By Transposition 1986. 4.5 check the spirit level of the balance for its proper position. 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. 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. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks. 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. Adjust level, if not leveled. 5.6.2 Note the weight. Pharma Industry Guidelines, Production, Quality Assurance. b. 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. 3. You have to record ten measurements with the 10 mg weight … (Proposed criterion: linearity error ≤ accuracy of the balances). 6.2 Check that platform and exposed parts of the balance are clean and dry. 5. Close the sliding door, press on enter key of the printer. Check of Weigh Balances a. External Calibration. 5.7.2 Note the weight . (a) Scope and frequency. Suggested process for verifying analytical balance accuracy and performance 1. This section describes three verifications. 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