Our primary manufacturers of mass and test weights include Rice Lake Weighing Systems, Sartorius, and Troemner. 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). It is recommended that the weights have approximately 5%, 50% and 100% of the maximum capacity of the balance (or of the. Record the observations in the balance calibration record. 6.2.2 Place the standard weights near the instrument. Each range will have a different accuracy, readability, and sensitivity. 6.2.1 Clean the balance and standard weights with a lint free dry cloth. Verify scale tolerances and display resolution. marized procedure for verification of scales compatibility to the process is shown in Figure 1 and outlined below: 1. 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). 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. 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. Switch on the scale, allow it to warm up and then press the button or key for “auto-calibrate” or “calibrate”. c. 2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in the department at plants. 3. After placing the weights, verify the use range of the balance. 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. 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. 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. 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. You have to record ten measurements with the 10 mg weight … 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. Suggested process for verifying analytical balance accuracy and performance 1. if we require adjust the level using leveling screw which are provided at the base of the balance. 4.5 check the spirit level of the balance for its proper position. It must be remembered, however, that taring should only be carried out initially when performing either the single point check or repeatability user checks. Close the sliding door, press on enter key of the printer. 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. DOCX PDF: 6: Weighing By Transposition 1986. Check the balance leveling gauge to make sure bubble is inside the target. The mean measurement, standard deviation and relative standard deviation can be calculated from the resulting data. 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. Applications with mandatory verification of balances and test weights include: - in commercial trade when the price of a commodity is determined by weighing 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. use an external spirit level for balance which is not provided for it. 5.2 Check that the spirit level of the balance is in its proper position. Perform accuracy check of weigh balances once a year, approximately six months after vendor calibration, using reference weights. If using an electronic balance, allow to warm up for at least 60 minutes. – Weight. 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. 6.2 Operate the balance as described in step 5.1 To 5.7. Dust off the balance pan with a clean soft brush. (3) Verify that the mass determination of reference filters before and after a filter weighing session are less than a specified tolerance. 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries. Result will be note down the reading in the balance verification record. Articles/SOPs/Compilations/Published Content on pharmastate.blog is protected by Indian & International Copyright Laws. 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. Fill the verification label as per SOP Daily signed with Marker Pen. 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. 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. Mail us at: info@pharmastate.com. 2. 10. © PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. Use a mild detergent, DI water and lint free wipe if necessary. edge and be measured at each location in the following sequence: center, front left, back left, back right, front right, and (optional) again center. Good Weighing Practice (GWP) is a global standard that ensures consistent accuracy, quality and compliance in any weighing process. 3.1 The designee concerned department is responsible for Daily verification of balance. Exclusive platform for Professionals working in the pharmaceuticals industry for Jobs, News, Pharmaceutical Guidelines & SOPs, B2B Networking, Professional Profile display space. (Proposed criterion: linearity error ≤ accuracy of the balances). Established in 2007 by METTLER TOLEDO, GWP is a standardized methodology for the secure selection, calibration and operation of weighing equipment. Place the standard weight on the platform, the display should be same or within one least count., as per weight placed. If using an electronic 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. 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. % – percentageg – Gramkg – KilogramLC – Least countNLT – Note Less ThanSOP – Standard Operating procedurewt. 4.9 Ensure that there is no weight on the platform of the balance when it is not in use. 4.2 Ensure that the balance platform/ pen is not touching to any surface. 1. 5.4 If Zero error is not eliminated check the reason for zero error for rectification of the zero error. Check the balance leveling gauge to make sure bubble is inside the target. 5.2.2 Check the level of the weighing balance; center the position of the air bubble. Allow the balance for 30 min for stabilization. Drift test:- A drift test is only performed on 5, 6 or 7 decimal scale balances. 5.6.3 Calculate the difference between the weight in certificate and observed weight. Balance/scale. Your balance must provide the same result for repeated weighing of the same load under the same measurement conditions. Record the observations in balance calibration record format. Then, two sub-sets of weights are made and their masses are recorded. Please note this verification procedure does not replace the service, calibration, and planned maintenance performed by Grand Rapids Metrology. 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. The same weight should always be used in these verifications. 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. The following soft keys should be showing: 1. check the cleanliness of balance. (Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. The same weight should always be used in these verifications. 6.3 Check the level of the balance with the help of spirit level. (Proposed criterion: RSD not more than 0.05%, calculated from all weighings at different locations on the pan). 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. 1.2 Many laboratory balances have more than one range. Our lab is using an analytical balance and it is calibrated annually by an external provider. Related Topic: weighing balance Calibration. 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. Calibration Weights and Calibration Mass Sets with Calibration certification and Nist Traceable Calibration of laboratory balances. 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. in the weighing pan. Repeat the procedure for five times and record the readings. 10.2 Check the balance or scale to ensure that it is 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. 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). 5.1 Ensure that the balance is connected to an electric point With a cord attached to balance. 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. (a) Scope and frequency. Process validation is a key requirement of all regulations. 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. nach ISO 9000ff, TS 16949, VDA 6.1, FDA, GLP, GMP, ...). The weight should be placed between halfway to ¾ of the distance from the center of the pan to its. For the latest updates pertaining to this compilation visit the relevant website. 6.0 PROCEDURE. 6.1 General. PROCEDURE: 6.1 Check the cleanliness of the area. View all posts by PharmaState Blog. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). Ensure that you place the balances in an area with controlled humidity and temperature. Check for mechanical and electronic defects. Remove the material, which is touching the balance and check for zero error. Pharma Industry Guidelines, Production, Quality Assurance. This section describes three verifications. Check of Weigh Balances a. After initialization display terminal displays in 0.0000 g in normal weighing mode. DAkkS calibration is always necessary when checking equipment (Balance or test weight) is to be used in a QM process (e.g. 5.6.5 Record the reading in Annexure-II. Use the balance in the manner recommended by the manufacturer for each step of the verification procedures. Adjust level, if not leveled. Weighing of liquid and/ or volatile material (which has a low boiling point) shall be done as per procedure defined below. The weighing procedure can be separated into three basic steps: planning, checking the balance, and weighing the material. d=0.1 mg)). 6.4 Record the displayed weight in respective verification formats. How to examine the repeatability of the balance in routine testing? The drift can also be extracted from the trend analysis of the verification test. 4. Most internal calibrations will first display a “no weight” measurement, and then require a specified standard check weight to be placed on them. Reproduction and Distribution of the same without written permission is prohibited. Using a 3-1 Weighing Design (IR5672) May 2019 Job Aids: SOP 5 Calibration-DWright V18 EXCEL | SOP 5-Control Chart DWright V03 EXCEL. After that, it may require a specified standard check weight to be placed on them. The external check is done for three factors: 1. 5.6.4 Repeat the above steps using 50gm & 100 gm. 3.2 Head Production/ engineering/ warehouse /Quality Assurance and quality control are responsible to ensure overall compliance with this is SOP. Keep the balance in a vibration-free environment. Measurement uncertainty:- The measurement uncertainty can be calculated according to GUM or other relevant documents or can be determined from the external calibration certificate. Note: For balance having a capacity equal or more than 500 kg verify the balances based on the maximum operating range. 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. Use the built-in spirit level to check the horizontal positioning of the balance. 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). Check for mechanical and electronic defects. (2) Zero and span the balance within 12 h before weighing any filter. External Calibration. Metric weights and weight sets, avoirdupois weights, ASTM Class 0 through … Related: Drift and Its Importance in Analytical Balances 5.7 For precision 5.7.1 Place 5 gm. 1.2.2. 6.2 Accuracy. 4.3 Before operation ensures that balance is clean, dry and labeled properly. 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. 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. The test procedure may specify requirements for the weighing device, such as the capacity, accuracy, sensitivity, and readability. (1) Independent verification of PM balance performance within 370 days before weighing any filter. Drift: Normally, a 10mg standard weight is used to carry out a drift check. Preparations before calibration. Check SOP (or new process requirements) for weighing setpoints and limits. 5.6.2 Note the weight. 6.4 Switch on the main power supply of the balance. Minimum weight:- The minimum weight value depends on the type of balance. PRECAUTION: Use the trolley balance for material weighing within its verification range only. Why? Depyrogenation method and washing of test tubes for BET. 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. Press zero adjustment ‘⇒ 0 ⇐ ‘ on terminal before starting weighing process. Annexure for daily verification of balance: Save my name, email, and website in this browser for the next time I comment. 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. 3. 2. 4.8 Reject the standard weight when found defective and replace it with the new certified weight. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks. 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. Procedure 10.1 All data are to be recorded on the "Balance or ScaleCalibration" form asshown onfigure 1. 4. 5. The correlation coefficient is calculated by comparing the nominal and measured masses of the weights. 4.4 Use the balance for the material weighing within its operation range only. • 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. This procedure can be used in your internal calibration laboratory to calibrate most of your digital weighing scale. Touch “Adjust.int” icon on the screen to enable internal adjustment. b. 5.3 Check for zero error and correct if any by pressing Zero button. It is recommended. 5.7.2 Note the weight . High precision calibration with quick turnaround. weights. 6.2 Check that platform and exposed parts of the balance are clean and dry. This process should be used to verify scale accuracy and reinforce quality importance. The expanded uncertainty (k = 2) must be less than one-third of the applicable It is determined from technical data and the external calibration certificate. 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. 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.