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. This process should be used to verify scale accuracy and reinforce quality importance. Reproduction and Distribution of the same without written permission is prohibited. c. 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. DOCX PDF: 6: Weighing By Transposition 1986. 4.2 Ensure that the balance platform/ pen is not touching to any surface. 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. Place the standard weight on the platform, the display should be same or within one least count., as per weight placed. 4. Process validation is a key requirement of all regulations. 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). High precision calibration with quick turnaround. (a) Scope and frequency. The expanded uncertainty (k = 2) must be less than one-third of the applicable 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. Check the balance leveling gauge to make sure bubble is inside the target. Check SOP (or new process requirements) for weighing setpoints and limits. The drift can also be extracted from the trend analysis of the verification test. Note: For balance having a capacity equal or more than 500 kg verify the balances based on the maximum operating range. Procedure 10.1 All data are to be recorded on the "Balance or ScaleCalibration" form asshown onfigure 1. 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. Verify scale tolerances and display resolution. maximum weight used on the balance), depending on the type of balance. © PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. 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. First, the combined mass of all four weights is weighed and recorded. 4.3 Before operation ensures that balance is clean, dry and labeled properly. 5.1 Ensure that the balance is connected to an electric point With a cord attached to balance. PRECAUTION: Use the trolley balance for material weighing within its verification range only. 6.2 Operate the balance as described in step 5.1 To 5.7. 3. Use a mild detergent, DI water and lint free wipe if necessary. This procedure can be used in your internal calibration laboratory to calibrate most of your digital weighing scale. 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. use an external spirit level for balance which is not provided for it. 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. Calibration Weights and Calibration Mass Sets with Calibration certification and Nist Traceable Calibration of laboratory balances. (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. 1.2.2. Annexure for daily verification of balance: Save my name, email, and website in this browser for the next time I comment. It is recommended. 6.2.2 Place the standard weights near the instrument. Related Topic: weighing balance Calibration. 5.6.5 Record the reading in Annexure-II. Check for mechanical and electronic defects. Press zero adjustment ‘⇒ 0 ⇐ ‘ on terminal before starting weighing process. 6.4 Record the displayed weight in respective verification formats. 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. Then, two sub-sets of weights are made and their masses are recorded. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks. It must be remembered, however, that taring should only be carried out initially when performing either the single point check or repeatability user checks. The mean measurement, standard deviation and relative standard deviation can be calculated from the resulting data. 4.1 Avoid impact /mechanical shocks to the balance. The correlation coefficient is calculated by comparing the nominal and measured masses of the weights. 2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in the department at plants. 6.1 General. You have to record ten measurements with the 10 mg weight … After that, it may require a specified standard check weight to be placed on them. Before you can start the calibration of the weighing instrument, you … Adjust level, if not leveled. 3.2 Head Production/ engineering/ warehouse /Quality Assurance and quality control are responsible to ensure overall compliance with this is SOP. 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. Why? Perform accuracy check of weigh balances once a year, approximately six months after vendor calibration, using reference weights. Established in 2007 by METTLER TOLEDO, GWP is a standardized methodology for the secure selection, calibration and operation of weighing equipment. 4.8 Reject the standard weight when found defective and replace it with the new certified weight. Fill the verification label as per SOP Daily signed with Marker Pen. 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). 4.7 Use calibrated Standard weight for verification of the balance consider the certified value of the calibrated standard weight for calculation of tolerance. Close the sliding door, press on enter key of the printer. 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. View all posts by PharmaState Blog. Ensure that you place the balances in an area with controlled humidity and temperature. b. Result will be note down the reading in the balance verification record. 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. Suggested process for verifying analytical balance accuracy and performance 1. Introduction This guide explains the weighing and calibration procedures of the Weighline Track Scale when using the standard Weighline application. PROCEDURE: 6.1 Check the cleanliness of the area. 4.9 Ensure that there is no weight on the platform of the balance when it is not in use. The same weight should always be used in these verifications. 6.4 Switch on the main power supply of the balance. They should not be exposed to direct sunlight since it can cause temperature variations inside the weighing chamber. 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. (Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances). 1.2 Many laboratory balances have more than one range. This section describes three verifications. % – percentageg – Gramkg – KilogramLC – Least countNLT – Note Less ThanSOP – Standard Operating procedurewt. Please note this verification procedure does not replace the service, calibration, and planned maintenance performed by Grand Rapids Metrology. Related: Drift and Its Importance in Analytical Balances 5.7 For precision 5.7.1 Place 5 gm. Discover how to achieve the accurate results every time with METTLER TOLEDO's Standard Operating Procedures for routine testing. d=0.1 mg)). 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). The external check is done for three factors: 1. Each range will have a different accuracy, readability, and sensitivity. 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. Record the observations in balance calibration record format. 10. weights. The weight should be placed between halfway to ¾ of the distance from the center of the pan to its. Linearity:- The results obtained from a series of accuracy checks can be used to calculate the correlation coefficient and to check for linearity. All compilations/publications are for informational purposes only & we do not suggest to take any action/decision on the basis of this information. Depyrogenation method and washing of test tubes for BET. – Weight. 2. Balance/scale. Our primary manufacturers of mass and test weights include Rice Lake Weighing Systems, Sartorius, and Troemner. Before each use, the lab verifies accuracy of the balance with calibrated standard weights. 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. 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