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Guideline Qualification of Equipment Annex 9 PH-meter October 2015
Таковой подход можно, к примеру, использовать для жестких фармацевтических форм Gc qualification edqm тесту растворения, на остаточные растворители и микробиологическое тестирование. Qualificatiin отметить, что в нерабочее время воздухообмен в помещении понижается до минимума. Указанное выше действует и в том случае, ежели RP не был зарегистрирован в MS, в Gc qualification edqm подана заявка на получение торговой лицензии - MA. Может кто поделится опытом Переход неймара в баварию компьютеризированных систем как части аналитического оборудования, с что начать, каким испытаниям подвергать?
Откройте для себя все, что может предложить Scribd, включая книги и аудиокниги от крупных издательств. This document is the 9th Annex to the core document Qualification of Equipment, which taken together should be used when planning, performing and documenting the qualification process of pH meters.
The core document contains the introduction and general forms for Level I and II of qualification, which are common to all types of instruments. Annex 9 contains instrument-related recommendations on parameters to be checked at Level III and IV of qualification and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.
This guideline describes the requirements for pH meters used for determination of pH in aqueous solutions. If measurements are made of test solutions of a non-aqueous or partially non-aqueous character, suspensions or emulsions, on a system calibrated as described above, the pH reading can only be considered to be an approximation of the true value apparent pH. Appropriate electrodes should be used for such types of measurement. The general principles of pH measurement together with apparatus and methods are provided in Ph.
Chapter 2. Potentiometric determination of pH. At level I of the qualification of a pH meter selection of instruments and suppliers it is recommended to select a manufacturer of pH meters that can satisfy the needs of the laboratory and works under ISO certification. At level II of the qualification of a pH meter installation and release for use it is recommended to check all requirements set during the selection of the instrument, and calibration should be performed before putting into service by an accredited external service supplier, or internally by appropriately qualified personnel, using certified reference buffers according to an approved procedure.
Before measurement, the electrode s is are checked visually. The electrodes should be appropriately stored according to recommendations of the manufacturer e. Refillable electrodes should be checked to ensure that the level of the inner electrolyte is satisfactory and no bubbles are present in the glass bulb.
The diaphragm of the reference electrode should also be checked. Before first use, or if it has been stored out of electrolyte, it is usually necessary to condition the electrode according to the recommendation of the manufacturer. If the stabilisation of pH is too slow long response time or if there are difficulties in calibration,.
Cleaning procedure depends on the type of sample used as prescribed in the manual. Regular cleaning is recommended. The calibration consists of the determination of the slope and the offset of the measuring system.
Unless otherwise prescribed in the method, all measurements are performed at the same temperature 2. The variation of pH with respect to temperature of a number of reference buffer solutions used for calibration is given in Ph. For the temperature correction, when necessary, follow the manufacturers instructions.
The apparatus is usually calibrated with two buffer solutions which should be chosen so that the expected pH value of the test sample lies in between the pH values of the buffer solutions. The range should be at least 2 pH units. The pH of a third buffer solution of intermediate pH read off on the scale must not differ by more than 0. Alternatively, a multi-point calibration may be performed to cover a wider pH-range.
Certificates of Suitability (from the EDQM)