User Requirement For P H Meter.Sample Copy Only.
- 1. Company Name User Requirements Specification for pH meter Model BVCFTR Edition: 1.00 Page 1 of 6 User Requirement Specification for pH Meter pH Meter Model BVCFTR Equipment Number : 01234 Applies to Supersedes : Matrix : Section : Copy no. : References : User Manual for pH Meter Model BVCFTR. Operation Instruction for pH Meter Model BVCFTR Document number: 12345. USP References - General Chapters <791> pH. European pharmacopeia,2,2.3: Potentiometric determination of pH. Prepared by department no.: XXX Validation Improvement Specialist (date) Fatima Grangeiro Landim (FGL) Reviewed and Approved by: Quality Control Labs Manager (date) QC Manager Quality Assurance (date) Quality Assurance Officer (Initial) (date)
- 2. Company Name User Requirements Specification for pH meter Model BVCFTR Edition: 1.00 Page 2 of 6 Table of Contents 1 Purpose and Scope ............................................................................. 3 2 Responsibilities .................................................................................... 3 3 Definitions and Abbreviations ............................................................... 3 4 Process and Equipment Description .................................................... 3 5 User Requirements .............................................................................. 4 5.1 Design Requirements ................................................................... 4 5.2 Functional Requirements .............................................................. 5 6 Documentation and Regulation ............................................................ 5 7 Support ................................................................................................ 5
- 3. Company Name User Requirements Specification for pH meter Model BVCFTR Edition: 1.00 Page 3 of 6 1 Purpose and Scope This URS details the requirements of the pH Meter (Model BVCFTR) which will be used for the determination of the pH of solutions over the approximate range of pH 2 to pH 12. The pH meter will be used routinely within the QC labs at room 14, building 20 at the Company LLLL. The further qualification activities for the pH meter will be documented in IQ/OQ and PQ protocols. The qualification of the pH meter will include qualification of the temperature accuracy, voltage accuracy, pH accuracy, sign/noise ration and further testing. This is a controlled document. Additional copies are obtained through the issuing company authority. In the event of copying locally, mark each document with a stamp “Uncontrolled copy”. 2 Responsibilities Initials Department Responsibility Title FGL QC Microbiology dept. Author Validation Number XXX Specialist XXX QC Microbiology dept. Approval QC Manager Number XXX XXX QA dept. Number XXX QA Approval QA Officer 3 Definitions and Abbreviations Abbreviation Full text/ Explanation URS User Requirement Specification VMP Validation Master Plan SOP Standard Operating Procedure USP U.S. Pharmacopoeia 4 Process and Equipment Description The degree of acidity or alkalinity of a substance is determined by pH measurement. The QC labs routinely measure the acidity or alkalinity of samples and substances, and accurate pH measurement are essential in a number of different routine situations within the QC Labs.
- 4. Company Name User Requirements Specification for pH meter Model BVCFTR Edition: 1.00 Page 4 of 6 Some of the equipment features are described below: 1. High-contrast display with large characters for easy readability 2. RS232 interface as standard; 3. Choice of print formats (Short / Standard / GLP); 4. Sample ID; 5. Sensor ID; 6. User ID; 7. Data storage (1000 measurements / 400 calibrations / 40 methods); 8. Multilingual (English / German / French / Spanish); 9. Function that enables the time and date to be included on the printout; 10. Electrode holder; 5 User Requirements The pH meter must meet the following User requirements. References Requirements URS1 Must store at least 4 calibration points. Must calculate and display asymmetry and slope values of the calibration URS2 curve. URS3 Alert Alarm, if occur a power failure and /or calibration data is lost. URS4 Large, backlit display showing clearly all relevant information. URS5 Date/time and sensor and sample ID fully recorded for each measurement. To be able to document user ID and sensor serial number for each URS6 measurement. The user interface displays menu and system settings as well as all error URS7 messages and warnings. URS8 The electrode (s) must be suitable for use in a pH range between 0 and 12. 5.1 Design Requirements The pH meter must meet the following Design requirements. References Requirements URS9 Must display pH to 0.001 pH units. URS10 Must have a footprint of no more than 0.6m². URS11 Must display a temperature to 0.1°C. URS12 The electrode must include a temperature sensor. URS13 All electrodes must have serials numbers permanently attached. URS14 Must operate using a 220-240V, 50-60 Hz power supply. URS15 Must have an interface data output to an external printer or software system.
- 5. Company Name User Requirements Specification for pH meter Model BVCFTR Edition: 1.00 Page 5 of 6 References Requirements All the electrodes used in the PH meter must have serial number and the URS16 name of the manufacturer on them. Measurement of the zero point of the electrode shall appear on the body of URS17 the electrode. 5.2 Functional Requirements The pH meter must meet the following Functional Requirements: References Requirements Accurate temperature measurement must be within ± 0.02 pH units at 25°C URS18 for the calibration curve. URS19 Reproducibility of pH measurement must be within ± 0.02 pH units at 25°C. URS20 Accurate temperature measurement to ± 0.5 °C between 20°C and 25°C. 6 Documentation and Regulation The pH meter requires the following documentation. References Requirements URS21 * Manufacturer Manuals (operation & Maintenance). URS22 Manufacturer Quality Documentation. URS23 Declaration of conformity. URS24 All calibration certificates. URS25 Manufacturer is an approved QA company supplier. URS26 Technical Specifications. All documentation supplied by supplier/manufacturer must also contain URS27 information about the electrodes and buffer solutions. URS28 List of recommended spare parts. * The content of the equipment manuals must meet the acceptance criteria of this User Requirement and further Qualification activities shall be included/executed/ and documented in order to verify whether the equipment manufacturer supply the user with Appropriate information, and if there is consistency between documentation. 7 Support References Requirements URS29 Minimum 12 months warranty.
- 6. Company Name User Requirements Specification for pH meter Model BVCFTR Edition: 1.00 Page 6 of 6 References Requirements Spares and accessories (pH electrode, buffer sachets, field case, probe, URS30 etc). Supplier must provide service and repair for the pH meter (training in how to URS31 use the pH meter should be supplied by manufacturer/vendor).
- 7. Company name User Requirement Specification for pH meter Model BVCFTR Edition: 1.00 Page 1 of 1 Change History Edition Effective date Description of change Revised without changes Date / Sign. 1.0 January 2011 Initial version