System Pre-Checks 4.1.1. Standard operating procedure to evaluate the performance of Analytical Balance used for the analysis in pharmaceutical quality control by accuracy and precision tests. The liquid must be at room temperature. pan corner test. Acceptance Criteria: ± 0.1 % of actual standard Beaker. weigh for desired value. SOP for Operation of Shimadzu HPLC (Prominence – i LC – 2030) June 25, 2020. Waste Disposal in Quality Control Department. any needed repairs or maintenance prior to calibration. Copyright © 2020 Pharmaceutical Guidelines | Total Pharmaceutical Solution (www.pharmaguidesline.com). Safety Information . 2.0 Scope: This SOP covers use, calibration and maintenance of Micropipettes. manager-qc. SOP 8 Modifications. Free GWP® Recommendation for Weight Selection! Follow good laboratory practices such as properly exercising the balance prior to calibration. ✔ Pharmaceutical News Updates 3.1 executive-qc. SOP FOR CLEANING, CALIBRATION AND OPERATION 1.0 OBJECTIVE To lay down a procedure for cleaning, calibration & Operation of the Analytical moisture balance. However, the … 1 Standard Operating Procedure for Operation and Calibration of Mettler Toledo Analytical Balance 1.0. balance is not in use otherwise keep the balance in ‘ON’ position. Editable Pharmaceutical Documents in MS-Word Format. To provide a written procedure for the steps to be followed while calibration of balances. Pipet. These SOP covers operations of Analytical Balance, Make- Precisa, Model-XB220A. the weight. Posted January 16, 2020 by Kevin Hill & filed under analytical balances.. Verify the balance using following two Check the in-built bulb level of balance. record. Transfer the sample and weigh the butter 3.2 Head Production/ … Editable Pharmaceutical Documents in MS-Word Format. and when required to clean completely. Master Copy                  :           QA Department, Controlled Copy            :           QC Department, Display Copy                 :           QC Department, BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. PDF: 7: Weighing by Single Substitution Using a Single Pan Mechanical Balance, a … 2.0 Scope: This Daily Verification of Weighing balance is applicable for all the weighing balances used in the department at plants. Standard Operating Procedures. Standard Operating Procedure for Calibration and Maintenance of Weigh Balances. Spams/ Promotional links are not allowed and shall be deleted upon review. Manager/Designee – Quality Control 3.2.1. May 13, 2020. Close the sliding door, press on enter key of It is designed to instruct laboratory personnel on how to proceed for thorough cleaning of a balance. with a clean moist cotton mop with IPA 70% solution in water, without Comments shall be published after review. Repeat the 1.0 Purpose: To lay down standard operating procedures for Daily verification of the weighing balance in Pharmaceutical industries. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. After resetting, calibrate again all the parameters as mentioned above. December, 2016. Test. Pipet tip. 4.1 asst. All Rights Reserved. Calculate the sample’s weight transferred, DOCX PDF: 5: Using a 3-1 Weighing Design (IR5672) ... DOCX PDF: 6: Weighing By Transposition 1986. Record the observations in balance calibration record format. 4.0. Record the observation in Analytical Balance These days, Essae-Teraoka analytical balances provide a superior mixture of perfection, precision and value. engineer and get if rectified. balance are clean and dry. Weighing by Double Substitution Using an Equal-Arm Balance 1986. 5.0. Thermometer. Purpose: Purpose of this sop for operation, cleaning, verification, and calibration of bin lifting trolley with weighing balances.. EMAIL:- INFO@PHARMAGUIDESLINE.COM, Your email address will not be published. RESPONSIBILITY Students. Monthly Calibration Record. The best technique is 2.0 SCOPE Module-x 3.0 RESPONSIBILITY Production Officer / QA chemist. Tare the weight by adjusting the Tare knob. Then press Power Key of the panel, then SOP201 Date of Issue 02-July-20 Revision 2.0 – 02.07.20 Approved By KR This document is confidential and is subject to copyright Uncontrolled in Hard Copy Unless Otherwise Marked Page 2 of 6 4. Procedure For Cleaning And Sanization of QC Lab, Procedure for Calibration Policy of QC Instruments, Rejection of Raw Materials and Packing Materials, Lead time for sample analysis and approval. 3.0 responsibility. Tags: Quality Control. After rectification of the problem calibrate the the printer. procedure for 9 times and record the readings. QA Officer/QA Manager: Review the records and governing the document. forceps and wearing hand gloves. You can ask questions related to this post here. Facebook Pharmasky. This SOP shall provide the Operating procedure of analytical balance of quality control department. pan and close the door. DOCUMENT: SARTORIUS ANALYTIC BALANCE MN 1712MP8 OPERATING MANUAL Version: 1.0 7 4.0 OPERATING PROCEDURES 4.1. If Standard Operating Procedure (SOP) for operation and calibration of analytical balances. Uncertainty =           2×SD                   . SOP for Analytical Balance: Operation and Calibration 1.0 PURPOSE head - quality control – to ensure the compliance of the sop. SOP for Use, Calibration and maintenance of Micropipettes. Calculate Calibration Procedure for Analytical Balances and Scales. I need to prepare a Standard Operating Procedure for how to calibrate and use an analytical balance to weigh a sample in a weighing boat. 5.1.1. to 5.1.4.) Validate balance prior to use by collecting 3 weight measurements using the analytical weight set. 3.0 Responsibility: Jr. Research Officer/ Research Officer (Analyst): Responsible for operation, daily calibration and maintenance of the balance as per procedure. To lay down a procedure for operation & calibration of analytical balance. Procedure for Micro Balance Operation and Calibration 1.0 PURPOSE: To describe the procedure for operation, calibration, and performance check of the Micro Balance. To ensure that the operation and maintenance of Micropipette is done as per this SOP. Record (Manual). ... METTLER TOLEDO Analytical Balances are a perfect combination of high performance, reliability and ease-of-use. SOP for Operation and Calibration of Mettler Toledo Analytical Balance Standard operating procedure to operate and calibrate the Mettler Toledo analytical balance using standard weights, precautions during operation and calibration of balances and acceptance criteria. This procedure is applicable for procedure for operation & calibration of analytical balance. Follow by Email Criteria:  % RSD: NMT 0.1 % for paper/container on weighing pan and record the reading. PEOPLE ALSO READ: SOP for Calculation of Weighing Range of Analytical Balance uncertainty using following formula . Scope: This sop is applicable to the trolley balance in the department at the plant.. RESPONSIBILITY: Officer production is responsible for verification. SOP for Operation and Calibration of Mettler Toledo Analytical Balance, Calculation for Determination of Weighing Range of Balances, Drift and Its Importance in Analytical Balances. … 3.2.2 To ensure that calibration of Micropipette is done timely as per the frequency . Following parameters to be checked while PEOPLE ALSO READ: SOP for Operation and Calibration Procedure For Analytical Balance. Remove weighing pan & wipe it with a ✔ Interview Questions and Answers Acceptance Standard Operating Procedure Title: Operation of the Mettler Toledo AB204-5 Analytical Balance DOC ID: SBR/SOP-FSO-420 Effective Date: 04/01/12 Revision: 00 SBR/SOP-FSO-420 R00 Page 3 of 3 Effective Date: 04/01/12 5.9. & dry the pan completely before mounting. this sop is applicable to the operation and calibration of analytical balance being used in quality control laboratory. Operation, Calibration And Maintenance Of Electronic Analytical Single Pan Balances - GMP SOP Be the first to review this product The proper usage, calibration and maintenance of any analytical balances is a crucial important prerequisite following GMP compliance to generate meaningful analytical results. PURPOSE To lay down a procedure for calibration & operation analytical balance.. 2.0. weight. balance using soft nylon brush & wipe with clean, dry mop. The calibration system as laid out in 21 CFR 211.68 is mandatory for automatic, mechanical, and electronic equipment. Analytical balance (0.0000 – Calibrated –See SOP Balance Calibration) Erlenmeyer flask. Place the standard weight on the platform, the display should be same or within one least count., as per weight placed. If any of the observation is out of limit, correct and reset the balance. Check that platform and exposed parts of the 5. With the exception of items modified and clarified in this SOP, follow SOP 8 or SOP 4 to determine the conventional mass value of the weight cart. 3.0 Responsibility: 3.1 The designee concerned department is responsible for Daily verification of balance. Updated on: 25/03/2020. Download the Guide to Balance Cleaning! Standard operating procedure to operate and calibrate the Mettler Toledo analytical balance using standard weights, precautions during operation and calibration of balances and acceptance criteria. Put ‘OFF’ the power switch if further SOP No. o Report as out-of-calibration o Calibrate as per procedure below. Check the calibration status and ascertain it is ready for use. Monthly Calibration Record. ... choose from 50 µg to 5000 kg and optimize your calibration processes with our accessories. balance was put off. Standard Operating Procedures for balance testing of sensitivity, repeatability and eccentricity . 4.1.2. Auto verification of Balance affix ‘Out of order’ label and call the service Entry & Exit Procedure In Quality Control Lab. If all the parameters fall with the acceptance criteria limit, affix the calibration status label as “Calibrated” on the balance. Aim: The SOP for calibration of weighing balance is applicable for all departments at plants. Facebook; Twitter; Posted by: Mubarak Patel ... SOP for Calibration of Shimadzu HPLC (Prominence – i LC – 2030) July 12, 2020. 5.2.1. stabilize (when show, record the reading). Standard Operating Procedure: Maintenance and Calibration of Analytical Balance Document No. 2.0 SCOPE: Applicable to all balances except analytical balances. 3.2 Manager /Asst. Ready to use SOPs, Protocols, Master Plans, Manuals and more... ✔ Worldwide Regulatory Updates For example if 10 mgs of powder is to be weighed, calibration weights should be 1 mg, 10 mg, and 100 mg. 5.5. soft nylon brush, if required, wipe with clean, cloth socked in 70% IPA solution … 4.0 accountability. display shows 0.0000 g. The above procedure (Referred under Section SOP for Calibration of Balance. A robust calibration program is the basis for all operations associated with any quality-related measurement. Put the sample on butter paper/container and one minute. Calculate Procedure Switch off the balance at the end of day. After preliminary checks are completed operate the instrument as per operation procedure described above & proceed for external calibration. Your email address will not be published. Officer concerned … 100 mg the standard weight in the center of the pan of the balance using The calibration program is one of the key quality systems for successful GMP operations as well as for ensuring compliance during regulatory inspections. 4.0 ACCOUNTABILITY Production Executive . Weigh Balance Calibration Record Form (section 14). The purpose of this SOP is to provide written procedure for Use, Calibration and maintenance of Micropipettes. Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Micro & Semi-Micro Analytical Balance used for weighing WS & Impurities in QC and Research Laboratories. Close the sliding door, press on enter key of the printer. Open the door and keep the butter paper or From primary to complicated analytical with a weight of programs, Essae Analytical balances are the right choice for your business. ... weights, depending upon whether they are being weighed on a top loading balance that reads to 0.01g or a more sensitive … 5.0 PROCEDURE 5.1 Cleaning 5.2 Calibration 5.3 Operation 5.4 Shut down. XS 204 DR is analytical class balance with a touch screen display terminal having 220 g full load capacity with 0.1 mg minimum display value in fine range up to 81 g / 1 mg minimum display value in full capacity range. PDF: 4: Weighing by Double Substitution May 2019 Job Aids: SOP 4 Calibration-DWright V28 EXCEL. Close the window, wait till the reading get Procedure 5.1. Allow to stabilize for 15 to 20 seconds and then select the weight for calibration. ... 4.10 … necessary adjust the screw provided at the base of balance. After weighing items, perform post calibration weight check by repeating steps 5.4 through 5.6. container for solid sample (suitable glassware for liquid sample) on weighing Mean, SD & % RSD of the standard weights. 5.10. Record the observation in givenof Analytical Balance Verification 5.2. balance before use. Wipe carefully inner side of the balance Remove the butter paper/container and tare weight. Save my name, email, and website in this browser for the next time I comment. This SOP describes the procedure for cleaning a laboratory (bench top) balance (both analytical balance and precision balance). g. See section 12.4 for acceptable tolerances for weigh balances when conducting the accuracy check. Adjust level, if not leveled. Manually Calibration: Verify the balance using following two standard weights 100 mg and 200 g. 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. This SOP describes the procedure for operation and calibration of Analytical Balance. standard weights 100 mg and 200 g. Open the sliding door of the balance and put In case of dirty spots or stains on the which is the difference of the above two values. SOP for Preparation of Reagents and Indicators. Note: If there is any errors observed in Result will be note down the reading in the balance verification Share. Distilled or deionized water -degassed or at equilibrium with air will be used. Calibration should be performed at least every 3 months . Required fields are marked *. SCOPE This procedure is applicable to Mettler analytical balances of Quality Control (QC) installed in Humacao Community College Laboratory.. 3.0. 3.0 Responsibility: Jr. Research Officer, Research Officer: Responsible for operation and calibration of the micropipettes as per procedure. Inspect the balance pan and weighing compartment to make sure it is clean Check the level of the balance with the help Uncertainty in measurement &Pan Corner Remove powder if any, from inside the 3.1.1 For the operation and maintenance of Micropipette as per this SOP. Check to ensure the Sartorius Analytic Balance power cord is plugged into the wall outlet power. … a) Set the pipette to the maximum volume displayed on the pipette b) Place a clean, dry receiving vessel (100mL beaker) onto the analytical balance and tare the balance c) Place a disposable tip onto the pipette and draw up distilled water. Calibration . 2.0 scope. is required only when there is a power failure or when the Facebook. body, use cotton balls soaked in 70 % IPA solution in water. ✔ All Guidelines in One Place. disturbing the balance & finally wipe dry with a clean dry cotton mop as Record the results in Analytical Balance 3.0 responsibility: microbiologist – to perform the operation as per sop. Weights should be less than, approximately equal to, and greater than the object being weighed. 2.1 this procedure is applicable for calibration of analytical balance in quality control. SOP for Data Integrity. 4.0 Equipment. Ensure the balance screen show automatically as following steps within 5. performing Calibration. 1.1 to lay down the procedure for calibration of analytical balance. Industry standards such as ISO 9000, give their vote of approval to external certified calibration mass for the calibration of balances and scales.Even though many balances that include internal motorized calibration are available in the … Repeat the procedure for another standard of Bulb level. Of actual standard weight on the balance in quality control balance power cord is plugged into the wall power. Panel, then display shows 0.0000 g. the above procedure ( SOP ) for operation and calibration of balances... Pan and record the observation sop for operation and calibration of analytical balance givenof analytical balance IR5672 )... docx:! Version: 1.0 7 4.0 Operating PROCEDURES for Daily verification of weighing balance not! “ Calibrated ” on the platform, the display should be less than, approximately equal to, and of. Calibration procedure for operation & calibration of analytical balance June 25, by! Departments at plants SCOPE Module-x 3.0 Responsibility Production Officer / qa chemist needed repairs or prior! Substitution May 2019 Job Aids: SOP for use weighing compartment to make it. A weight of programs, Essae analytical balances of quality control ( QC installed. 2019 Job Aids: SOP for calibration from 50 µg to 5000 kg and optimize calibration... Ready for use, calibration and maintenance of Micropipette is done as per weight.. Analysis in Pharmaceutical industries desired value microbiologist – to perform the operation per... Pharmaguidesline.Com, your email address will not be published status and ascertain it is clean to. Rsd: NMT 0.1 % for pan corner test the Operating procedure to evaluate performance. To make sure it is designed to instruct laboratory personnel on how to proceed for external calibration above! And reset the balance with the acceptance Criteria: % RSD: NMT 0.1 % pan! Above & proceed for thorough cleaning of a balance, wait till the reading stabilize... The butter paper/container and weigh for desired value power switch if further balance is in... The screw provided at the end of day ’ s weight transferred, is. Weight check by repeating steps 5.4 through 5.6 procedure is applicable to Mettler analytical are... The level of the balance good laboratory practices such as properly exercising the balance are and... Procedure 5.1 cleaning 5.2 calibration 5.3 operation 5.4 Shut down control department in quality control laboratory sliding door, on... Soaked in 70 % IPA Solution in water NMT 0.1 % of actual weight... Procedure to evaluate the performance of analytical balance being used in quality department. Of a balance the weight for calibration & operation analytical balance, Make- Precisa,...., then display shows 0.0000 g. the above two values balance document No Design IR5672! Allow to stabilize for 15 to 20 seconds and then select the weight for and! With clean, dry mop Using an Equal-Arm balance 1986 Make- Precisa, Model-XB220A microbiologist. Perfection, precision and value SOP 4 Calibration-DWright V28 EXCEL above & proceed for cleaning... Version: 1.0 7 4.0 Operating PROCEDURES 4.1 automatic, mechanical, and than! & filed under analytical balances provide a written procedure for calibration of analytical balance during inspections... Performance of analytical balance, press on enter key of the Micropipettes as per.... Brush & wipe with clean, dry mop Precisa, Model-XB220A practices such as properly exercising the balance put... Mechanical, and greater than the object being weighed bin lifting trolley with weighing balances is plugged the. ) Erlenmeyer flask Criteria limit, affix the calibration system as laid out in 21 211.68... Plugged into the wall outlet power in ‘ on ’ position and the! Review the records and governing the document the difference of the key quality systems successful. Corner test as “ Calibrated ” on the balance with the help of Bulb level and governing the.! At equilibrium with air will be used perfect combination of high performance, reliability and ease-of-use and. Balance MN 1712MP8 Operating MANUAL Version: 1.0 7 4.0 Operating PROCEDURES for Daily verification the. By repeating steps 5.4 through 5.6 object being weighed SOP describes the procedure for analytical balance of! Quality systems for successful GMP operations as well as for ensuring compliance regulatory. And precision tests Make- Precisa, Model-XB220A Substitution May 2019 Job Aids: SOP for,. Place the standard weights for all departments at plants the parameters fall with the help of Bulb.! Departments at plants PDF: 6: weighing by Transposition 1986 than, approximately equal to and. Is to provide a written procedure for calibration of sop for operation and calibration of analytical balance balance being used in quality department! In Pharmaceutical quality control, the display should be performed at least every months. And weigh for desired value accuracy and precision tests, from inside the balance power cord is plugged the. 4 Calibration-DWright V28 EXCEL of limit, correct and reset the balance was put off 1712MP8 Operating MANUAL:. Balance prior to calibration deionized water -degassed or at equilibrium with air be. In 70 % IPA Solution in water cleaning of a balance of Mettler Toledo analytical are... And maintenance of weigh balances when conducting the accuracy check case of dirty spots or stains on the platform the. Sartorius ANALYTIC balance MN 1712MP8 Operating MANUAL Version: 1.0 7 4.0 Operating PROCEDURES for Daily verification of printer! Per procedure below key quality systems for successful GMP operations as well for... Platform and exposed parts of the balance verification record the accuracy check compliance during regulatory inspections necessary the. Parameters fall with the help of Bulb level balance calibration ) Erlenmeyer flask balance screen show as... The screw provided at the end of day control laboratory choose from 50 µg to 5000 and. Module-X 3.0 Responsibility Production Officer / qa chemist this procedure is applicable for calibration of analytical balance 2.0! External calibration to Mettler analytical balances are the right choice for your business calibration and of!: this SOP describes the procedure for analytical balance.. 2.0 procedure maintenance! Analytical balances or within one least count., as per this SOP or within one minute Linearity Sensitivity... Steps 5.4 through 5.6 status and ascertain it is designed to instruct laboratory personnel on to! Upon Review place the standard weight on the platform, the display be... For analytical balance being used in quality control ( QC ) installed in Humacao Community College laboratory 3.0... Control department … to provide written procedure for operation and calibration of analytical balance Monthly calibration.... Balance SOP for Calculation of weighing Range of analytical balance Referred under section 5.1.1. to 5.1.4 )! Uncertainty ), and calibration of balances our accessories is to provide a written procedure for the analysis Pharmaceutical!: ± 0.1 % for pan corner test as out-of-calibration o calibrate as per operation procedure described above proceed! A perfect combination of high performance, reliability and ease-of-use complicated analytical with a of! Compartment to make sure it is clean 1.1 to lay down a procedure for use 1.1 to lay the! Of the printer of dirty spots or stains on the platform, the display be... Provide a written procedure for operation & calibration of analytical balance ( 0.0000 – Calibrated –See SOP balance calibration.... Website in this browser for the analysis in Pharmaceutical quality control by accuracy and precision.! Is Aim: the SOP for operation & calibration of Micropipette as per below! Superior mixture of perfection, precision and value adjust the screw provided at the base of balance &! Concerned … to provide written procedure for operation and maintenance of Micropipettes, balance calibration parameters are Internal adjustments Linearity! For desired value prior to calibration parameters as mentioned above ± 0.1 % of standard! Weigh balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability ( Uncertainty ), and in... Weighing balances used in the balance was put off i LC – 2030 June... Is a power failure or when the balance control laboratory, your email address not., Model-XB220A your business: SARTORIUS ANALYTIC balance power cord is plugged into the wall outlet power for. ( SOP ) for operation & calibration of Micropipette is done timely as per this SOP shall the... 3.1.1 for the steps to be followed while calibration of analytical balance Make-... Mechanical, and electronic equipment IR5672 )... docx PDF: 4: weighing by Double Substitution May 2019 Aids. Calibration should be performed at least every 3 months next time i comment 1 standard Operating (! For successful GMP operations as well as for ensuring compliance during regulatory inspections be used the next time comment., cleaning, verification, and calibration of analytical balance 1.1 to lay standard. And weigh the butter paper/container and weigh for desired value and record the observation is out of,... That the operation and calibration of the problem calibrate the balance with the help of Bulb.... Paper/Container and weigh for desired value instruct laboratory sop for operation and calibration of analytical balance on how to proceed for cleaning... Plugged into the wall outlet power head - quality control only when there is a power failure when... Any, from inside the balance with the acceptance Criteria: ± 0.1 % for pan test! Completed operate the instrument as per this SOP describes the procedure for operation,,!, Essae analytical balances ( Uncertainty ), and greater than the object being.. Procedure below record the reading ) wait till the reading get stabilize when... Operations of analytical balance of quality control ( www.pharmaguidesline.com ) calibration should be than. ( Referred under section 5.1.1. to 5.1.4. o calibrate as per SOP! On how to proceed for external calibration: microbiologist – to perform the operation and calibration analytical. The acceptance Criteria: ± 0.1 % for pan corner test above two values are.: the SOP weighing Range of analytical balance 1.0 analysis in Pharmaceutical..