1.0 OBJECTIVE:
1.1 To describe the procedure for the operation of the Shimadzu Moisture Analyzer for determination of moisture content/loss on drying of pharmaceutical raw materials, in-process materials, finished products, and packaging materials.
2.0 SCOPE:
2.1 This SOP applies to all personnel of the Quality Control Department responsible for moisture analysis using the Shimadzu Moisture Analyzer.
3.0 RESPONSIBILITIES:
3.1 Designee Production / Quality Assurance (QA) / Quality Assurance (QC): Operation, cleaning and documentation.
3.2 Department Head: Overall compliance.
3.3 QA Department: Periodic verification and SOP compliance.
4.0 DEFINATIONS:
4.1 Loss on Drying (LOD): The percentage reduction in the weight of a sample after drying under specified conditions, as defined in the approved analytical method or pharmacopoeia.
4.2 Moisture Content: The amount of water present in a sample, expressed as a percentage of the sample weight, determined using the approved analytical method.
5.0 PROCEDURE:
5.1 Before Operation:
5.1.1 The designee shall ensure that the instrument is clean and free from any residue before use.
5.1.2 The designee shall verify that the calibration status of the instrument is valid prior to analysis.
5.1.3 The designee shall ensure that the instrument is connected to the power supply and is in proper working condition.
5.1.4 The instrument shall be switched ON and allowed to stabilize as per the manufacturer’s recommendation.
5.1.5 Clean and dry aluminum sample pans shall be used for moisture determination.
5.1.6 The designee shall ensure that the approved analytical method and specification are available before commencing the analysis.
5.2 Sample Analysis:
5.2.1 The empty sample pan shall be placed on the sample holder and the balance shall be tared.
5.2.2 The specified quantity of the sample shall be placed uniformly on the sample pan to ensure even drying.
5.2.3 The heating chamber shall be closed carefully.
5.2.4 The approved drying program shall be selected, or the drying parameters shall be entered as specified in the approved analytical method.
5.2.5 The analysis shall be initiated by pressing the Start key.
5.2.6 The analysis shall be allowed to continue until the predetermined end-point is reached.
5.2.7 The moisture content or Loss on Drying (LOD) result displayed by the instrument shall be recorded in the approved analytical worksheet.
5.2.8 Where duplicate or replicate analyses are specified in the approved test method, the analysis shall be repeated accordingly.
5.3 After Completion of Analysis:
5.3.1 The heating chamber shall be opened only after adequate cooling to avoid burns.
5.3.2 The used sample pan shall be removed carefully using suitable forceps, where applicable.
5.3.3 The sample chamber, pan holder, and surrounding area shall be cleaned using a soft brush or lint-free cloth.
5.3.4 The instrument shall be switched OFF after completion of analysis, unless otherwise required for continuous operation.
5.3.5 The instrument usage shall be recorded in the instrument logbook.
5.4 Handling of Abnormal Conditions:
5.4.1 If any abnormal condition, instrument malfunction, unstable balance, heating failure, or error message is observed during analysis, the analysis shall be discontinued immediately.
5.4.2 The Designee QA shall be informed without delay.
5.4.3 The instrument shall not be used until the cause of the abnormal condition has been investigated and resolved.
5.4.4 Any abnormal condition affecting the analysis shall be handled in accordance with the applicable Deviation / Investigation SOP.
6.0 REFERENCE:
6.1 Instrument User Manual
7.0 RECORDS:
Sr No. Title Nature of Document Document No.
NA NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01