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and guarantee the accuracy of inspection.
shuttlebus2. Applicable Scope: The procedure is applicable to calibration of 10ml, 25ml, 50ml, 100ml,
500ml and 1,000ml volumetric flask.
3. Responsibilities: QC lab technician shall be responsible for implementation of the procedure,
and lab director shall be responsible for supervising and inspecting the effective implementation of the
procedure.
championship4. Contents:tomorrow night
4.1 Inspection basis: Drug Inspection Instrument Calibration Procedure , and Guide to Drug
Production Validation .
4.2 Principle: Adopt measurement method, namely, u the balance to weigh the mass of pure
water in volumetric flask, and according to the density of the
pure water at such temperature, calculate the volume of volumetric flask. 4.3 Calibration items and technical requirements
数百4.3.1 The glass of volumetric flask shall be clear and transparent.
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4.3.2 The graduation line and division value shall be clear, intact, and durable, the graduation
line shall be straight, and the width of graduation line and the division value shall meet the requirements.
4.3.3 The volumetric flask shall be marked with: 4.3.3.1 Standard temperature (20℃) 4.3.3.2 Total volume and unit xx ml 4.3.3.3 Accuracy class: A or B
4.3.3.4 The non-standard opening and plug, piston core and outer cover must be of the same
matching number.
aflDocument Name: Standard Operation Procedure for Inspection of Volumetric Flask
Document No.: SOP-CH-02-096-00 Page: 2/ 2
4.4.1 One over ten-thousand balance
大学英语综合教程3答案4.4.2 Thermometer with temperature range of 0~50℃and division value of 0.1℃.
4.4.3 Measuring glass
modesty4.4.4 The room temperature of calibration workshop shall be stable and not exceed 20+5℃.
4.4.5 Purified water
4.4.6 V olumetric flask
4.5 Calibration of volumetric flask
4.5.1 V olume calibration: Weigh the cleaned and dried volumetric flask to be calibrated, and get
the mass of empty volumetric flask; add purified water till the graticule of volumetric flask to be calibrated, and weigh the mass of purified water, repeat the calibration again, and take the average value as the final result.
4.5.2 Fit calibration: Fill water till the highest graticule, dry the plug, with no grea, and after
covering it tightly, press the plug with fingers, and rever it for ten times, and every time when it is r
everd, keep it in still state for 10s at least, and there shall be no water leakage.
4.6 Handling of calibration result and calibration interval: According to the calibration data of
above calibration items, look up the table, and judge whether it conforms to corresponding standard grade, the calibration interval is three years, and the calibration interval of ba volumetric flask is one year.
4.7 Notes
4.7.1 The purified water ud in calibration shall be placed indoors at least for more than 1h;
4.7.2 The volumetric flask to be calibrated shall be carefully cleaned until there is no water on
inner wall;
4.7.3 If the room temperature changes, it’s required to record the temperature of water every time
when the purified water is put down.
5. Keeping and Management of Relevant Records: This document shall be prerved in QC
room and managed by QC room director.
6. Supplementary Provisions:aisi
7.
Department head.