SOP Title: Operation, Cleaning and Calibration of Moisture Analyzer
- Objective:
To lay down the procedure for Operation, Cleaning and Calibration of Moisture Analyzer.
- Scope:
This SOP is applicable for Operation, Cleaning and Calibration of Moisture Analyzer located in Quality Control Laboratory.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Moisture Analyzer as per this SOP.
- Engineering Department: To carry out preventive maintenance as per schedule and procedure defined.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department.
- Procedure:
| 5.1 | Safety Precautions/Instructions: | |||
| 5.1.1 | Ensure all the electrical connections are properly earthed. Ensure the power plug of the Moisture Analyzer is fixed in the socket properly. | |||
| 5.1.2 | Ensure that the ON/OFF switch is working properly by switching “ON” the Moisture Analyzer. | |||
| 5.1.3 | Analysts must be familiar with precautions described in respective Material Safety Data Sheet of the materials before weighing it. | |||
| 5.1.4 | Moisture Analyzer Maximum range is 60 gm and Minimum range is 0.001 gm, do not exceeds the maximum weight limit. Weighing range is 0.5 gm to 40 gm. | |||
| 5.1.5 | Do not place flammable materials near the moisture Prohibitions analyzer. | |||
| 5.1.6 | Check the cleanliness of the Balance and its surrounding area. | |||
| 5.1.7 | The moisture analyzer includes a heater that heats samples to dry them off during measurement. The heater becomes hotter than the preset heating temperature. Incorrect handling may cause fire, explosion, burn injury. | |||
| 5.1.8 | Level the balance using levelling feet so that level indicator bubble is centered within the circle of levelling indicator | |||
| 5.2 | Front Panel-Keyboard: | |||
| 5.2.1 | Introduction to the Keys of Moisture Analyzer : | |||
| 5.2.2 | The front panel of the instrument keys are functional keys as follows: | |||
| 5.2.3 | ||||
To enter the main menu. |
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| “►“ To select the items. | ||||
| “▼” To move to the lower level. | ||||
| “▲” To move to the upper level. | ||||
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| 5.3 | Operational Procedure: | |||
| 5.3.1 | Check the validity of calibration before starting any operations. | |||
| 5.3.2 | Connect the power supply cord to the switch board and switch “ON” the balance and allow the balance to warm up for about 30 minutes. | |||
| 5.3.3 | When the power switch is turned on, the version number “*1” is displayed and the internal system is checked automatically. Then, “oFF” appears on the display panel.
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| 5.3.4 |
The device enters the standby state i.e. it shows Main Measurement Display.
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| Setting Measuring Condition | ||||
| 5.3.5 | There are five types of drying modes (Standard drying automatic ending mode, Standard drying timed ending mode, rapid drying mode, slow drying mode, and stepped drying mode) for measurement conditions. | |||
| A) Setting the temperature and the amount of change in moisture content (▲M) as measurement condition(AUTO: Standard drying automatic ending mode): | ||||
| 5.3.6 | In this mode, it dries a sample at the set temperature. When the amount of change in the moisture content take place below the set value, It terminates the measurement automatically. | |||
| 5.3.7 | The instrument can create 9 different program, before starting an run check the program number. Program parameter can be checked by selecting required program no. | |||
| 5.3.8 | Press “Menu” key, the display will show “program”. Press “►” to enter the program No., further Press “▲” or “▼” to create or edit the program number For example PNO.1 | |||
| 5.3.9 | After enter the program No. Press “▲” or “▼” to select “AUTO” mode for measuring condition and Press “Enter” key. | |||
| 5.3.10 | After selection of “AUTO” mode, Press “▲” or “▼” to select the temperature within the range from 50 °C to 200 °C in 1-degree increments. | |||
| 5.3.11 | After selection of temperature, Press “▲” or “▼” to select the moisture change rate per 30 seconds within the range from 0.01 % to 0.1 % in 0.01-percent increments. | |||
| 5.3.12 | To return the previous step Press “◄” key. | |||
| 5.3.13 | Press “Enter” key to save the programme and Press “ESC” key to return to the standby state. | |||
| B) Setting Temperature and Time as Measuring Conditions (TIME: Standard drying timed
ending mode): |
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| 5.3.14 | In this mode, it dries a sample at the set temperature. When the time set as the ending condition is reached, it terminates the measurement automatically. | |||
| 5.3.15 | This mode is suitable for measurements to be completed within a limited time. | |||
| 5.3.16 | Press “Menu” key, the display will show “program”. Press “►” to enter the program No. | |||
| 5.3.17 | After enter the program No. Press “▲” or “▼” to select “TIME” mode for measuring condition and Press “Enter” key. | |||
| 5.3.18 | After selection of “TIME” mode, Press “▲” or “▼” to select the temperature within the range from 50 °C to 200 °C in 1-degree increments and followed by selection of drying time. | |||
| 5.3.19 | Press “▲” or “▼” to select the drying time within the range from 1 minutes to 4 hours in one minute increment or 4 hours to 12 hours in one hour increments. | |||
| 5.3.20 | To return the previous step Press “◄” key. | |||
| 5.3.21 | Press “Enter” key to save the programme and Press “ESC” key to return to the standby state. | |||
| C) Measuring Samples by Raising Temperature Rapidly (RAPID: Rapid drying mode): | ||||
| 5.3.22 | In this mode, it raises the temperature rapidly until the amount of change in moisture content per 30 seconds drops below the set value. It dries a sample at the set temperature. | |||
| 5.3.22 | As the ending condition, select either the amount of change in moisture content per 30 seconds or the time. | |||
| 5.3.23 | When the amount of change in moisture content per 30 seconds drops below the set value, or the time reaches the set value, the measurement terminates automatically. | |||
| 5.3.24 | This mode is suitable for measuring liquid or other samples that take time to be dry. | |||
| 5.3.25 | Press “Menu” key, the display will show “program”. Press “►” to enter the program No. | |||
| 5.3.26 | After enter the program No. Press “▲“ or “▼” to select “RAPID DRYING” mode for measuring condition and Press “Enter” key. | |||
| 5.3.27 | After selection of “RAPID DRYING” mode, Press “▲“ or “▼” to select the moisture change rate per 30 seconds within the range from 0.1 % to 9.9 % in 0.01-percent increments. | |||
| 5.3.28 | For selection of temperature Press “▲“ or “▼” to select the temperature within the range from 50 °C to 200 °C in 1-degree increments and followed by selection of drying time. | |||
| 5.3.29 | As the ending condition, select either the amount of change in moisture content per 30 seconds or the time. | |||
| 5.3.30 | If moisture change rate is selected, specify the value within the range from 0.01% to 0.1% in 0.01% increment and if Time is selected, specify the time within the range from 1 minutes to 4 hours in one minute increment or 4 hours to 12 hours in one hour increments. | |||
| 5.3.31 | To return the previous step Press “◄” key. | |||
| 5.3.32 | Press “Enter” key to save the programme and Press “ESC” key to return to the standby state. | |||
| D) Measuring Samples by Raising Temperature Gradually (SLOW: Slow drying mode): | ||||
| 5.3.33 | In this mode, it raises the temperature more gradually than measurements in normal conditions, taking about five minutes from the time the measurement begins until the temperature reaches the preset level. | |||
| 5.3.34 | As the ending condition, select either the amount of change in moisture content per 30 seconds or the time. | |||
| 5.3.35 | When the amount of change in moisture content per 30 seconds drops below the set value, or the time reaches the set value, the measurement terminates automatically. | |||
| 5.3.36 | Sample that change in composition take place when exposed in rapid temperature and it burn dry. Slow drying mode is suitable for such sample to measure their moisture content. | |||
| 5.3.37 | This mode is suitable for measuring samples such as protein and high molecular compound that change when heated in a high temperature. | |||
| 5.3.38 | Press “Menu” key, the display will show “program”. Press “►” to enter the program No. | |||
| 5.3.39 | After enter the program No. Press “▲“ or “▼” to select “Slow drying mode” mode for measuring condition and Press “Enter” key. | |||
| 5.3.40 | After selection of “Slow drying mode ” mode, Press “▲“ or “▼” to select the temperature within the range from 50 °C to 200 °C in 1-degree increments . | |||
| 5.3.41 | As the ending condition, select either the amount of change in moisture content per 30 seconds or the time. | |||
| 5.3.42 | If moisture change rate is selected, specify the value within the range from 0.01% to 0.1% in 0.01% increment and if Time is selected, specify the time within the range from 1 minutes to 4 hours in one minute increment or 4 hours to 12 hours in one hour increments. | |||
| 5.3.43 | To return the previous step Press “◄” key. | |||
| 5.3.44 | Press “Enter” key to save the programme and Press “ESC” key to return to the standby state. | |||
| e)Measuring Samples by Setting Temperature Step by Step (STEP: Stepped drying mode): | ||||
| 5.3.45 | If the crystal of hydrate is dried off, heat changes its composition. As a result moisture content measured differently depending on the drying temperature. | |||
| 5.3.46 | In Stepped drying mode, the drying temperature of sample in maximum three steps, which is suitable for measuring moisture content at different temperatures. | |||
| 5.3.47 | In the Stepped drying mode, the drying temperature and time in one to three steps for measurement purpose. | |||
| 5.3.48 | As the ending condition, select either the amount of change in moisture content per 30 seconds or the time. | |||
| 5.3.49 | After measuring a sample by changing drying temperature in two or three steps, when the amount of change in moisture content per 30 seconds drops below the set value, or the time reaches the set value, the measurement terminate automatically. | |||
| 5.3.50 | Set the temperature and time of the first step, second step and the third step. | |||
| 5.3.51 | Press “Menu” key, the display will show “program”. Press “►” to enter the program No. | |||
| 5.3.52 | After enter the program No. Press “▲” or “▼” to select “Stepped drying mode” for measuring condition and Press “Enter” key. Followed by the selection of temperature of the first step. | |||
| 5.3.53 | Press “▲” or “▼” to select the temperature of the first step within the range from 50 °C to 200 °C in 1-degree increments. | |||
| 5.3.54 | After select the temperature, Press “▲” or “▼” to select the time of the first step within the range from 1 minutes to 240 minutes in 1 minutes increments. | |||
| 5.3.55 | Press “▲” or “▼” to select the temperature of the second step within the range from 50 °C to 200 °C in 1-degree increments. | |||
| 5.3.56 | After select the temperature, Press “▲” or “▼” to select the time of the second step within the range from 1 minutes to 240 minutes in 1 minutes increments. | |||
| 5.3.57 | If the Measurement ends at the second step, then select the rate of moisture value within the range from 0.01 % to 0.1 % in 0.01-percent increments. | |||
| 5.3.58 | Press “Enter” key to save the programme and Press “ESC” key to return to the standby state. | |||
| 5.3.59 | If the measurement proceeds to the third step, select the time and specify the value within the range from 1 minutes to 240 minutes in 1 minute increment. | |||
| 5.3.60 | As the ending condition, select either the amount of change in moisture content per 30 seconds or the time. If moisture change rate (∆M) is selected, specify the value within the range from 0.01 % to 0.1 % in 0.01-percent increments. | |||
| 5.3.61 | If TIME is selected, set a time between 1 and 240 minutes, in one minutes increment. | |||
| 5.3.62 | To return the previous step Press “◄” key. | |||
| 5.3.63 | Press “Enter” key to save the programme and Press “ESC” key to return to the standby state. | |||
| Moisture Analyzer Setting: | ||||
| Measurement Standard: | ||||
| 5.3.64 | Change in the moisture analyzer setting can be done by setting a sample code or by setting a moisture analyser ID. | |||
| 5.3.65 | Press “Menu” key, the display will show “program”. Further Press “▲” or “▼” to Select “UNIT” from the menu. | |||
| 5.3.66 | Select the type of unit as per requirement.
[M/W] – Moisture content (Wet Base) [D/W] – Dry content (Wet Base) [M/D] – Moisture content (Dry Base) [GRAM] – Mass |
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| 5.3.67 | Press “▲” or “▼” and select the type of unit. | |||
| Method to Start Measurement: | ||||
| 5.3.68 | After setting measuring condition for different types of drying mode mentioned at no. 5.3.5, “Easy” and “Normal” option shall be used to perform moisture content. | |||
| 5.3.69 | Generally “Easy” option shall be used for routine testing. | |||
| 5.3.70 | Ensure that Select the method to start measurement before placing a sample. | |||
| 5.3.71 | Press “Menu” key, the display will show “program”. Further Press “▲” or “▼” to Select “START” from the menu and “Enter” to select the method to start measurement. | |||
| 5.3.72 | Select the method to start measurement from the following two types: | |||
| 5.3.73 | Easy: Place a sample and close the heater cover, and the measurement will start automatically without pressing “START” key. | |||
| 5.3.74 | Normal: Press “START” key to start the measurement. Start the measurement even by keeping open heater cover. This is useful when the weight of a volatile sample is measure before it is dried. | |||
| 5.3.75 | If the stability mark ( ) is shown while “Easy” method appears, it indicate “Easy” method is set. | |||
| 5.3.76 | If only “Easy” method appears on screen without stability mark then it shall be considered as “Normal” method is set. | |||
| 5.3.77 | Press “Enter” key to move towards other parameters. | |||
| Setting Sample Codes: | ||||
| 5.3.78 | Set sample codes to identify the sample (object) from measurement results. | |||
| 5.3.79 | The sample code consists of four digits. The first and second digits allow “0 to 9”, “- (hyphen)”,”A to Z”, or “_ (underscore)” to be entered, and the third and fourth digits only allow “0 to 9”. For example for an Paracetamol API set the code as PA01. | |||
| 5.3.80 | Program no. and sample code are correlated. For example for program no.1 sample code is PA01. Then same code will be applied for Program no. 1 for all future testing. | |||
| 5.3.81 | Press “Menu” key, the display will show “program”. | |||
| 5.3.82 | Further Press “▲“ or “▼” to Select “Code” and press “Enter”. | |||
| 5.3.83 | In “Code” option a 4-digit number appears and the first digit flashes. | |||
| 5.3.84 | Press “▲“ or “▼” to enter a sample code. | |||
| 5.3.85 | Press “Enter” key to return to the standby state. | |||
| Setting the Date and Time: | ||||
| 5.3.86 | Press “Menu” key, the display will show “program”. | |||
| 5.3.87 | Further Press “▲“ or “▼” to Select date setting “Date” and press “Enter”. | |||
| 5.3.88 | Select the date format by pressing “▲“ or “▼” keys and Press”►“move to the next step. | |||
| 5.3.89 | Enter the year, month and day by pressing “▲“ or “▼” keys. Press “Enter” key to save the settings and Press”►“move to the next step. | |||
| 5.3.90 | Enter the hour and minute by pressing “▲“ or “▼” keys. Press “Enter” key to save the settings and Press”►“move to the next step. | |||
| 5.3.91 | Press “ESC” key to return to the standby state. | |||
| Restricting the Menu Display: | ||||
| 5.3.92 | Restrict the menu display so that the moisture analyser setting cannot be changed without authorization. | |||
| 5.3.93 | Press “Menu” key, the display will show “program”. | |||
| 5.3.94 | Further Press “▲” or “▼” to Select “Lock” and press “Enter”. | |||
| 5.3.95 | Enter the password by using “▲” or “▼” keys. When “Lock” is displayed, Press “ESC” key to return to the standby state. | |||
| Setting the Password: | ||||
| 5.3.96 | Restrict the menu display by setting the password. The password consists of four digits, and each digit allows “0 to 9” to be entered. | |||
| 5.3.97 | Press “Menu” key, the display will show “program”. | |||
| 5.3.98 | Further Press “▲” or “▼” to Select “PASS” and press “Enter”. | |||
| 5.3.99 | Enter the password by using Pressing “►” keys. | |||
| 5.3.100 | Press “ESC” key to return to the standby state. | |||
| 5.3.101 | Setting the Moisture Analyzer ID: | |||
| 5.3.102 | Set the moisture analyzer IDs, to identify which unit is responsible for measured data when the data check. | |||
| 5.3.103 | The ID consists of four digits, and each digit allows “0 to 9”, “- (hyphen)”, “A to Z”, or “_ (underscore)” to be entered. | |||
| 5.3.104 | Press “Menu” key, the display will show “program”. | |||
| 5.3.105 | Further Press “▲“ or “▼” to Select “ID” and press “Enter”. | |||
| 5.3.106 | Enter the ID by using Pressing “►” keys. | |||
| 5.3.107 | Press “ESC” key to return to the standby state. | |||
| Actual Procedure to Measure Moisture Content: | ||||
| 5.3.108 | Confirm that the device is in the standby mode. If it is not, Press “ESC” key to return to the standby state refer point no. 5.3.4 | |||
| 5.3.109 | Enter the Program Number which already exist or create Programme as per sample requirement refer point no. 5.3.8 | |||
| 5.3.110 | Press “Menu” key, the display will show “program” and press “Enter”. Press “▲“or”▼” to Select the drying modes as per sample requirement refer point no. 5.3.5 to 5.3.63. | |||
| 5.3.111 | Press “ESC” key to return to the standby state. | |||
| 5.3.112 | Press “▲“or”▼” to select measurement standards refer point no. 5.3.64 to 5.3.67 | |||
| 5.3.113 | Further Press “▲“or”▼” to select the method to start the measurement refer point no. 5.3.68 to 5.3.77 | |||
| 5.3.114 | Further Press “▲“or”▼” to set sample code refer point no. 5.3.78 to 5.3.85 | |||
| 5.3.115 | Further Press “▲“or”▼” to set date and time refer point no. 5.3.86 to 5.3.91 | |||
| 5.3.116 | Hold the handle of heater cover and carefully open the cover. | |||
| 5.3.117 | Place a sample pan on the pan supporter. | |||
| 5.3.118 | Placing a sample on the warmed sample pan may cause evaporation of moisture from the sample before starting measurement. | |||
| 5.3.119 | Before using sample pan ensure that it is in room temperature when measuring another sample. | |||
| 5.3.120 | Be sure that the Stability mark ( ) is displayed, it indicates that instrument is ready for analysis. | |||
| 5.3.121 | If the Stability mark is not displayed then press “O/T” to adjust the zero point. | |||
| 5.3.122 | Place a sample (object) on the sample pan and sample weight will appear on display. | |||
| 5.3.123 | Ensure that the sample placed should be as flat as possible and spread uniformly on the pan so that heat is applied evenly to the sample during measurement. | |||
| 5.3.124 | Place a sample with at least 0.5 grams on the sample pan. | |||
| 5.3.125 | After placing the sample, immediately close the sample pan with the heater cover. | |||
| 5.3.126 | If the instrument is in “Easy” method then RUN process will start Automatically. | |||
| 5.3.127 | For manual start, press “START” key to RUN process and the display will show “ΔM value“. | |||
| 5.3.128 | The heater fan will get start. | |||
| 5.3.129 | If the printer is connected, after Press “START” immediately Printer will print initial information such as Make, Model, Serial No., ID No., Code, Date, Time, Program No., Unit, Mode, Temperature and time or Moisture change rate, sample initial weight etc. | |||
| 5.3.130 | Press”▼” key to return to the previous display. | |||
| 5.3.131 | After completion of process a short beep sounds is heard, it indicate that the measurement is completed. | |||
| 5.3.132 | The display panel shows the measurement result and the measurement completed indicator ” “. | |||
| 5.3.133 | If the printer is connected to the instrument, Printer will print final information such as Moisture content in %, Time taken to complete the run and Dry sample weight. It will print the data automatically. | |||
| 5.3.134 | After completion of run the heater fan will stop automatically. | |||
| 5.3.135 | Press “ESC” key to return to the standby state. | |||
| 5.3.136 | After the measurement of a sample is completed, sample pan and the sample are hot after measurement. | |||
| 5.3.137 | Open the heater cover with the help of side holder. Take precaution, the heater cover is hot during and immediately after measurement. | |||
| 5.3.138 | Wait until heater cover and sample pan are cooled to room temperature. Remove sample pan with the help of sample holder and dispose the sample as laboratory waste. Ensure that heater cover and sample pan has attain room temperature, before performing next measurement. | |||
| 5.3.139 | Hold an edge of the sample pan with the handler to dispose a sample. | |||
| 5.3.140 | After the disposal, return the sample pan onto the pan supporter. | |||
| 5.3.141 | Update the “Instrument/Equipment Usage Log Book” as per SOP “Calibration of Instruments and Equipments in Quality Control”. | |||
| Aborting Measurement: | ||||
| 5.3.142 | To abort the measurement while process is run mode, Press “STOP” key, a long beep sound is heard and Instrument will display “ABORT”. | |||
| 5.3.143 | Press “ESC” key to return to the standby state without Printing the measurement result or Press “STOP” key again, the measurement completed indicator ” ” is displayed, the measurement results will print and the device enters the standby state. | |||
| 5.3.144 | Press “Menu” key, the display will show “program”. Press “▲“or”▼” to Select “Print”. Further press “►” keys to select “Memory”. By selecting “Memory” option it will print all moisture data report starting from installation till upto the date. | |||
| 5.4 | Calibration Procedure: | |||
| 1) Day of use Calibration
2) Quarterly Calibration |
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| A)Day of use Calibration: | ||||
| 5.4.1 | Frequency: Before starting an analysis on moisture Analyser, calibrate the instrument with Standard Weight as specified in the “Annexure ”. | |||
| B)Quarterly Calibration | ||||
| 5.4.2 | Frequency: Quarterly or after carrying out any major maintenance work. | |||
| 5.4.3 | Generate the A. R. No. on the “Instrument/Equipment Calibration Register” as per SOP and give requisition to QA Department for calibration formats of instruments on the due date of calibration. | |||
| 5.4.4 | For issuance of calibration report refer SOP “Control of documents, Preparation, Approval, Issuance and Maintenance. | |||
| 5.4.5 | Perform the calibration of instrument as per Annexure and procedure mentioned below. | |||
| 1. Sensitivity check: | ||||
| 5.4.6 | Place the standard weights on the weighing pan one by one as specified in the “Annexure”. | |||
| 5.4.7 | Enter the details in calibration report. Ensure that the results obtained, comply with the acceptance criteria. | |||
| 2. Moisture Content | ||||
| 5.4.8 | Take a 5 gm of primary standard Sodium Tartarate Dihydrate in the sample pan and set the temperature at 120° C to perform moisture content test for the calibration of moisture analyser. | |||
| 5.4.9 | After use of primary standard Sodium Tartarate Dihydrate, enter its usage in Primary Standard Receipt and Usage Record. | |||
| 5.4.10 | Repeat the same operation procedure from point no. 5.3.108 to 5.3.141 | |||
| 5.4.11 | After completion of moisture content, Enter “Print” key to take print of result or if printer is connected Automatically printer will print the result. | |||
| 5.4.12 | Enter the details in calibration report, Ensure that the results obtained, comply with the acceptance criteria. | |||
| 5.4.13 | Update the “Instrument/Equipment Usage Log Book” as per SOP “Calibration of Instruments and Equipments in Quality Control” .Update the “Annual Calibration Schedule” as per SOP “Equipment’s/Instruments Calibration“ | |||
| 5.4.14 | Affix the “Calibration Status” on the Instrument as per SOP “Calibration of Instruments and Equipment’s in Quality Control”. | |||
| 5.4.15 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |||
| 5.5 | Cleaning Procedure: | |||
| 5.5. 1 | Cleaning of the Moisture Analyzer should be done before and after use. | |||
| 5.5. 2 | Remove dust and powder with the help of tissue paper or soft nylon brush. | |||
| 5.5. 3 | Do not leave anything on the weighing pan after use. | |||
| 5.5. 4 | Clean the inside, outside and shutter of the balance with tissue paper or soft cloth soaked to remove any oily substances or spots from the balance. | |||
| 5.5. 5 | Clean the Moisture Analyzer with dry tissue paper. | |||
| 5.5. 6 | If any breakdown occurs, follow procedure as per SOP “Calibration of Instruments and Equipments”. | |||
- Definitions/Abbreviations:
- Definitions:
- Breakdown: Any activity leading to operation of instrument/equipment other than the set parameters or unusual sound or vibration observed in the instrument/equipment.
- Calibration: Tests performed to ensure that the instrument/equipment is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
- Preventive Maintenance: Maintenance activity performed to ensure that the instrument/equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.
- Moisture Analyzer: Itcovers a variety of methods for measuring moisture content in both high level and trace amounts in solid. Moisture in percentage amounts is monitored as a specification in Drugs.
- Abbreviations:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| CAL | Calibration |
| °C | Degree celecius |
| g | gram |
| A. R. No. | Analytical Reference Number |
Day of Use Calibration Record (Daily)
Note: Carry out the calibration of the instrument as per SOP for the following parameters:
| Standard Weights | Certified value | Sensitivity Range |
| 0.1000 g | ||
| 0.5000 g | ||
| 5.0000 g | ||
| 10.0000 g |
Performance Check: Acceptance Criteria: + 0.1%
|
Date |
Zero Error |
Standard Weights |
Remark |
Sign |
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| 0.1000 g | 0.5000 g | 5.0000 g | 10.0000 g | ||||
Calibration Report (Quarterly)
- Sensitivity Check: Acceptance Criteria: + 0.1%
| Sr. No. | Standard
weight |
Certified value | Sensitivity Range | Observation in gm |
| 1. | 0.1 g | |||
| 2. | 1 g | |||
| 3. | 5 g | |||
| 4. | 10 g |
- Moisture Content
| Sr. No. | Test | Specification Limit | Sample Weight
(gm) |
Temperature | Observation | Remarks |
| 1. | Sodium Tartarate Dihydrate. |
Standard Equipments used:
| Sr. No. | Name of standard | Batch No. | Valid upto |
| 1. | Sodium Tartarate dihydrate |
The results Complies / Does not complies as per acceptance criteria.
Performed By: ________________ Date:________________ Checked By: ______________ Date: ______________
*Note – Ready to use SOP available in “DOWNLOAD” Section.