Vacuum Drying Oven Calibration, Purpose :

Vacuum Drying Oven Calibration, The purpose of this SOP is to describe the operation, calibration and cleaning of Vacuum Drying Oven (Model: VO 200S) used for drying of the raw materials in the quality control laboratory at XX Pharmaceuticals Ltd.

Scope :

Vacuum Drying Oven Calibration, This procedure is applicable for the Vacuum Drying Oven, installed in the quality control laboratory for general block at XX Pharmaceuticals Limited.

Definitions/Abbreviation:

[][]QC: Quality Control

Responsibilities:

The roles and responsibility is as follows:

Officer/Executive/Sr. Executive, Quality Control

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]Arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.

Head of Quality Assurance

[][]Approval of the SOP.
[][]To ensure overall implementation of the SOP.

Annexure:

[][]Annexure-I : Log Book for Vacuum Drying Oven
[][]Annexure-II: Calibration Record of Vacuum Drying Oven

Procedure:

Precaution(s):

[][]Wear the temperature resistance gloves to keep or remove materials from Vacuum Drying Oven.

Operation:

[][]Operation in normal mode
[][]Switch on the main switch of the Vacuum Drying Oven.
[][]Open the door and place the samples into the Vacuum Drying Oven.
[][]Press push/turn control key to put on the main power switch in front of the Vacuum Drying Oven. The Vacuum drying oven will start in normal mode with the display of timer, the chamber temperature, alarm temperature (red color indication).
[][]Select operating mode “Normal operation”. Press and hold on the SET key (approx. 3 sec) until the current operating option is flashing.
[][]Select temperature set point. Hold down the SET key and use the push/turn control key clockwise or anticlockwise to select the required temperature set point.
[][]After the SET key has been released the Vacuum drying oven briefly flashes the temperature set point. Set the temperature as per requirement. Heating is indicated by the orange heater symbol.
[][]Select the fan speed. Turn the push/turn control clockwise until the fan symbol is flashing. While the holding down the SET key. Use the push/turn control to set 50% fan speed.
[][]Select the alarm temperature. Turn the push/turn control clockwise until the monitor temperature display is flashing. Hold down the SET key and use the push/turn control to set the alarm temperature.
[][][][]The display then changes to the actual current temperature and starts to the setting temperature. The temperature will be automatically increased at setting temperature and display the setting temperature digitally.
[][]Observe the display temperature until stable position.
[][]At the end of drying, remove dried materials from Vacuum drying oven.

Operation in cyclic mode :

[][]Press push/turn control key to put on the main power switch in front of the instrument. The Vacuum drying oven will start in normal mode with the display of timer, the chamber temperature and alarm temperature (red color indication).
[][]Hold down SET key and turn the push/turn control key at the clockwise or anti clockwise for setting date, local time, operating temperature, alarm temperature. After setting, SET key will be released the display briefly flashes the set point.
[][]Press and hold down SET key to select the program and rotate push/turn control key at clockwise and select “Ramp timer” mode.
[][]Hold down the SET key and set the work day’s group using the push/turn control. Press push/turn control to select the ramp segment “t1” If the day is not required, it will be off position.
[][]Hold down the SET key and set the time using push/turn control.
[][]Select the ramp segment “t2” using the push/turn control. Hold down the SET key and using the push/turn control set the time.
[][]Turn push/turn control clockwise until the temperature display is flashing. Hold down the SET key and set the required temperature set point using push/turn control.
[][]Select the set point waiting time. Hold down the SET key and set on using the push/turn control. After the SET key has been released the function for set point waiting time is stored.
[][]Select hold time “t3”. Hold down the SET key and set the time using the push/turn control.
[][]Select the cooling time “t4”. Hold down the SET key and set time using push/turn control.
[][]Select program repeats “loop”. Hold down the SET key and set 2 for repeats using the push/turn control.
[][]Select the fan speed to set the air changes. Turn the push/turn control clockwise until the fan
[][]symbol is flashing. Hold down the SET key and set fan speed 50% suing the push/turn control.
[][]Select the alarm temperature. Turn the push/turn control clockwise until the monitor temperature display is flashing. Hold down the SET key and set the alarm temperature using the push/turn control.
[][]Turn the push/turn control at clockwise until the fan symbol flashing to move the air slider opens and closes the air valve to control the supply and discharge of air.
[][]Start the program. Turn the push/turn control clockwise until the stop symbol ▀ is flashing. Hold down the SET key and select start ► using the push/turn control. On releasing the SET key the program
starts to run.

Vacuum pump operation:

[][]After setting the drying temperature, switch on the vacuum pump.
[][]After completion of vacuum drying, turn the push/turn control knob until the Open door option is displayed. Press SET key to release the vacuum. Switch off the vacuum pump. Then the door of Vacuum drying oven can be opened.

Calibration:

[][]Frequency: Perform calibration of the instrument once in a year or if the system has been moved, serviced or a malfunction is suspected.

Temperature Calibration

[][]Insert the standard thermometer or thermocouples into the chamber.
[][]Press and hold down SET key until the normal mode light blinking.
[][]Turn push/turn control key clock wise to reach SETUP light.
[][]Select Calibration to rotate push/turn control key.
[][]Use three calibration temperatures as below :
CAL.1 : 30°C
CAL.2 : 100°C
CAL.3 : 200°C
[][]Select the required calibration temperature in SETUP key and set the corresponding calibration correction to 0.0°C.
[][]Measure the deviation from the selected calibration temperature under the steady conditions, using a reference instrument.
[][]Set the calibration correction in SETUP key. If the measured reference temperature is too low, the calibration correction setting is negative sign.
[][]Adjust the temperature if require from adjusting value of calibration temperature (CAL). The correction value should not more than ±0.50C.
[][]Carry out the check measurement using the reference thermometer.
[][]Carry out others two calibration temperatures in the same manner.
[][]Measure the vacuum pressure and input the data on calibration record.
[][]In case of internal calibration, record calibration data in Vacuum drying Oven Calibration Record, as per Annexure-II.

Calibration of pressure for vacuum chamber

[][]Calibrate pressure of vacuum chamber by calibrated multi-functional calibrator using five calibration pressures as below :
CAL.1 : 10 mbar
CAL.2 : 50 mbar
CAL.3 : 100 mbar
CAL.4 : 500 mbar
CAL.5 : 900 mbar
[][]Record calibration data in Vacuum drying Oven Calibration Record, as per Annexure-II.
[][]Cleaning of Vacuum Drying Oven :
[][]Clean the inner part of Vacuum drying oven with a cleaned cloth.
[][]Disinfect the inner surfaces with 70% IPA or ethanol when required.
[][]Clean the outer surfaces with dry cleaned cloth.

Maintenance :

[][]If Vacuum drying oven shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for maintenance.
[][]After maintenance, recalibrate the Vacuum drying oven.

Muffle furnace, Purpose :

Muffle furnace, The purpose of this SOP (Standard Operating procedure) is to describe the operation and maintenance of Muffle furnace for the determination of Ash, Sulphated ash/residue on ignition and Loss on ignition and other tests (which required higher temperatures and furnace) of the materials under specified condition.

Muffle furnace, Scope :

This procedure is applicable for Muffle furnace (Model: Carbolite, CWF1200), installed in the quality control laboratory for general block of  XX  Pharmaceuticals Limited.

Definitions:

SOP: Standard Operating Procedure.
QC: Quality Control.

Responsibilities:

The roles and responsibility is as follows:

Executive, QC

[][]To ensure that the instructions of this procedure are correctly followed.
[][]To ensure cleaning of Muffle Furnace safety rules.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.

Head of Quality Assurance

[][]To ensure the overall implementation of the SOP.
[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Do not open the door during operation of Muffle Furnace.
[][]Always wear vinyl/heat resistance gloves to put and to remove the crucible from the furnace using the long tongs.
[][]Ensure that heating elements are isolated from the door and the inner surface of the chamber.

Operation:

[][]Connect the instrument to the main power supply.
[][]Switch ‘ON’ the mains.
[][]Press “■” key button.
[][]Display will show SPºC.
[][]Use “▲” up or “▼” down arrow key button to set the required temperature.
[][]Press “■” key button.
[][]Then display will show SPrr.
[][]Use “▲” up or “▼” down arrow key button to set ram temperature.
[][]Press “■” key button.
[][]Display will show t S.
[][]Use “▲” up or “▼” down arrow key button to set the time (Hr:Min) by a single press.
[][]Machine will automatically increase the temperature according to ramp temperature.
[][]After reach the set temperature, machine will hold that temperature according to set time.
[][]Then display will show ‘End’.
[][]Switch OFF the instrument and mains.

Cleaning procedure:

[][]Insure that main power switch of the equipment is “OFF” position and at room temperature.
[][]Clean the outer surface of the furnace with a damp cloth.
[][]Clean the inner surfaces with dry cleaned cloth or soft nylon brush.

Maintenance:

[][]If Muffle furnace shows any mechanical, electrical or any others problem, inform to supplier or
[][]Engineering Department for maintenance.

Calibration of Digital Hygrometer, Purpose :

Calibration of Digital Hygrometer, This purpose of this SOP is to describe to operate of Hygrometer for the determination of temperature and humidity of Quality Control Laboratory, Microbiology Laboratory, and Product Development.

Calibration of Digital Hygrometer, Scope :

This procedure is applicable for the determination of room temperature and humidity by digital hygrometer used in Quality Control Laboratory, Microbiology Laboratory, and Product Development of  XXP Pharmaceuticals Ltd.

Definitions/Abbreviation:

N/A

Responsibilities:

The roles and responsibility is as follows

Officer/Executive/Sr. Executive, Quality Control

To ensure that the instructions of this procedure are correctly followed

Manager, Quality Control

[][]To ensure that SOP is kept up to date.
[][]To ensure appropriate personnel from the section are trained on this procedure.
[][]To confirm that the SOP is technically sound and reflects the required working practices.

Head of Quality Assurance

[][]To ensure the overall implementation of the SOP.
[][]Approval of SOP

Procedure:

Precaution(s):

[][]Keep the sensor’s protective cap closed to extend the sensor’s life when the meter is not in use.
[][]Do not use for cleaning abrasive or solvents on these instruments.
[][]Do not store or use the meter outside the operating/storage environment.
[][]Allow time to stabilize the meter, when moving from one temperature/humidity extreme to other.

Operation:

[][]Check the calibration sticker to ensure that the instrument is within due date of calibration.
[][]Remove the RH sensor protective cap before use.
[][]Press Power button to turn the meter on.
[][]Setting Time-of-Day:
[][]Slid the CLOCK SET switch, located on the back of the unit to the CLOCK SET position
[][]Press HR and MIN button to set the hours and minutes respectively;
[][]Press and hold the button to rapidly advance the display.
[][]Setting 12/24 Hour Display:

[][]Slide the 12HR/24HR switch, located on the back of the unit to the desired position. In 12 hour format, “AM/PM” will appear on the display.
Selecting °C or °F:
[][]To display the temperature reading in Celsius or Fahrenheit, slide the °C/°F switch, located on the back of the unit, to the desired position.

Viewing the Humidity Memory:

[][]To view the humidity memory, press the HUMIDITY MEMORY button. The maximum humidity reading achieved will be displayed (“MAX” will appear on the display)
[][]Press the HUMIDITY MEMORY button a second time, within 10 seconds, to view the minimum humidity achieved (“MIN” will appear on the display)
[][]Press the HUMIDITY MEMORY button a third time, within 10 seconds, to return the current reading.

Clearing the humidity memory:

The maximum and minimum humidity memory may be cleared individually. To clear the desired humidity memory (MIN or MAX), press the CLEAR button while the memory value is being displayed (follow 7.1.7 to view the Humidity Memory)

Viewing the Temperature Memory:

[][]To view the temperature memory, press the TEM MEMORY button. The maximum temperature reading achieved will be displayed in the middle display (“MAX” will appear to the right of the value);
[][]The minimum temperature reading achieved will be displayed in the top display (“MIN” will appear to the right of the value);
[][]Press the TEM MEMORY button a second time, within 5 seconds, to return the current temperature and time-of-day display.

Clearing the humidity memory:

[][]To clear the temperature memory (MIN and MAX), press the CLEAR button while the memory value is being displayed (follow 7.1.9 to view the temperature Memory)
[][]Use annexure-I for recording of temperature and relative humidity, and use annexure-II for recording of temperature only as per requirements.

Calibration Procedure:

[][]Check the temperature and humidity using a digital thermo hygrometer and record the temperature and humidity in the calibration certificate. as per Annexure-V of Engineering.

[][]Calibrate the digital hygrometer once in a year ± 15 days.

Maintenance:

[][]If Humidity meter shows any mechanical, electrical or any others problem, inform to the supplier or
Engineering Department for maintenance.

Annexure

Annexure-I : Temperature and Humidity Record Sheet
Annexure-II : Temperature Record Sheet

Calibration of Potentiometric Titrator, Purpose :

Calibration of Potentiometric Titrator, The purpose of this SOP is to define the current procedure for the operation, calibration and cleaning of Potentiometric Titrate (Mettler-Toledo, Model: T50) within Analytical laboratory at XX  Pharmaceuticals Ltd.

Calibration of Potentiometric Titrator, Scope :

This procedure is applicable to the determination of the potency and/or purity of raw materials (Active & Excipients), intermediates and drug product etc. in the quality control laboratory of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A

Responsibilities:

The roles and responsibility is as follows:

Executive, QC

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Manager, Quality Control

[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]Arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
[][]Maintaining calibration schedule of the instrument at the defined intervals.

Head Quality Assurance

[][]Approval of the SOP.
[][]To ensure overall implementation of the SOP.

Procedure:

Precaution(s):

[][]Laboratory coat, safety glasses and must be worn while handling the instrument.
[][]Ensure that the main switch and power supply connector are accessible during use.
[][]There is a chance of liquid spillage at high speed. Always gradually increase the speed to the desired level.
[][]Remove the plug from the main socket during cleaning.

General procedure:

[][]Titration is a technique for determining the potency and/or purity of synthetic raw materials, intermediates, drug substances, excipients and drug products, and for standardizing volumetric solutions. Although less specific than chromatographic techniques it is useful for quality control purposes where more details impurity quantization is not requested. Titration for assay of active substances is frequently used in pharmacopoeia monographs for drug substance and drug product.

[][]Samples are quantified by reaction in solution with a volumetric solution of known strength. A graduated glass tube fifed with a stopcock and fine tip is used to deliver deliver variable amounts of titrant, accurately measured, until the point at which the stoichiometric analytical reaction is complete. The endpoint may be determined use of color indicators or electrochemically. Where electrochemically endpoint detection is employed, automated burettes and endpoint detection may be used.

Automatic Burettes:

[][]This type of burette is found on automatic titration and dilution equipment. These devices are capable of very high precision volumetric measurements.

Automatic Titrates:

[][]Two types of automatic titrates are recorded the electrode potential differences during the course of titration as the expected sigmoid curve. This type is recommended for purchase and use since it offers greater accuracy and precision. In the second type, titrant addition is performed automatically until a pressed potential or pH, representing the endpoint, is reached, at which point the titrant addition ceases.

Indicator electrode:

[][]Choice of indicator electrode depends on the substance being examined and be a glass or metal electrode. The reference electrode is generally a calomel or silver-silver chloride electrode. Ensure that electrodes are in good condition. Electrode for non-aqueous titration must be dedicated and not utilized for any aqueous titration techniques.

Overview of titration chemistries:

[][]Titrimetric analyses utilize one of four basic chemistries, Reduction-oxidation, Complex metric, Precipitation and Acid-base, which may also be subdivided into non-aqueous and aqueous titrations.

Operations:

Manual Operation:

Enter the following parameters
[][]Stirrer
[][]Sensor
Temperature sensor
Potentiometric sensor
Polarized sensor
Conductivity sensor
[][]Burette
Rinse burette
Rinsing several burette at the same time
Dispense
Manual titration
[][]Pump
[][]Auxiliary instrument
[][]Sample Changer

You can determine the following parameters:

[][]Press ‘Manual’ to select Parameters.
[][]To ’Set’ parameters and input data. You would like to use and adjust the parameters.
[][]Press “Start’ to start the parameters procedure.
[][]You can select ‘Stop’ to terminate the procedure at any time.
[][]Press ‘Exit’ to end the manual operation.
[][]Press ‘Home’ and retune to main menu.

Methods:

Loops:

[][]There are the following loop types.
[][]A sample loop is for analyzing a sample.
[][]A calibration loop is for calibrating a sensor.
[][]A titer is for determining the titer of a titrate.

Types of Methods

[][]GT: Method for general titration (contains only sample loops or mixed loops).
[][]Calibration: Method for sensor calibration (contains only calibration loops).
[][]Titer: Method for titer determination(contains only titer loops)
Create a new method for general Titrant:
[][]Press ‘Method’
[][]Choose ‘New’ to create a new method on the basis of a template.
[][]From the available templates, choose method template EP by pressing ( ).Then press ok and exit.
You can modify this method in line with your requirements by inserting removing method functions or modify its parameters.
[][]Press ‘Title’ method function, enter a new method ID. After wards, a new method will be stored under this Method ID. Press ok and exit.
[][]Assign a ‘title’ to your new method.
[][]Press Sample button and input Sample ID, Entry Type, Density, Correction factor, Temperature and Entry in line with your requirements. Press ok and exit.
[][]Press Titrant Stand button and select manual stand. Press ok and exit.
[][]Press stirrer button and select stirrer speed and duration. Press ok and exit.
[][]Press Titration [EQP] [1].Press ok and exit.
[][]Input titrant and concentration by pressing titrant button.Press ok and exit.
[][]Press Sensor key and then input type, sensor and unit. Press ok and exit.
[][]Input stirrer speed by pressing stirrer. Press ok and exit.
[][]Input mode and wait time after pressing pre-dispensing key. Press ok and exit.
[][]Input Control and Mode after pressing control. Press ok and exit.
[][]Input molecular weight of the materials after pressing calculation. Press ok and exit.
[][]After inserting all required method function, you can store the new method in the titrator by choosing ‘Save’.

Annexure:

Annexure-I: Calibration Information of Potentiometric Titrator.
Annexure-II: Log Book for Potentiometric Titrator.

Calibration of Fume Hood, Purpose :

Calibration of Fume Hood, The purpose of this SOP is to describe the operation, calibration and cleaning of Fume Hood (Model: ESCO – EFD-4B1).

Calibration of Fume Hood, Scope :

This procedure is applicable for Fume Hood (Model: ESCO – EFD-4B1), installed in the quality control laboratory of  XX Pharmaceuticals Limited.

Definitions/Abbreviation:

[][]SOP: Standard Operating Procedure
[][]QC: Quality Control
[][]Face velocity: Face velocity is the average air flow speed at the sash opening of the fume hood into the work chamber. The measurement is expressed in m/sec or fpm.

Responsibilities:

The roles and responsibility is as follows:

Officer/Executive/Sr. Executive, Quality Control

[][]To ensure that the instructions of this procedure are correctly followed.
[][]To ensure the equipment is left clean and tidy after use.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.

Head of Quality Assurance

[][]To ensure the overall implementation of the SOP.
[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Relevant safety data sheet and safety guidelines must be followed when handling chemicals and reagents.
[][]Hazardous and fuming materials must be handled in fume hood.
[][]Wear appropriate personal protective equipment (PPE) while performing laboratory tasks in a fume hood.
[][]Keep head outside of the hood.
[][]Leave the front sash at the safe working height, when not in use.
[][]Follow laboratory procedure on the use of fume hood.
[][]Ensure the exhaust is operating before commencing work.
[][]Do not use the hood as storage area. Items can block airflow and interfere with containment.
[][]Do not leave uncapped bottles of chemicals in the hood.

Operation:

[][]Switch ‘ON’ the fluorescent lamp of the fume cupboard.
[][]Switch ‘ON’ the external exhaust blower/ fan.
[][]Lift the front sash to access in work area but not beyond the working height marked with yellow tape (30 cm).
[][]Work with the sash as fully lowered as possible, utilizing the sash as natural barrier to accidents which may occur in the hood.
[][]Plug in any electrical equipment used within the cabinet with electrical socket.
[][]Work as far into the hood as possible and with slow, deliberate movements, to minimize the external airflow disturbances.
[][]If performance is suspected, or an airflow alarm is triggered, terminate usage, close the sash completely and cease work.
[][]Report any fault regarding operation, maintenance or cleanliness of the cupboard to the supervisor.
[][]Leave the fume cupboard clean & dry after use.
[][]Turn the external exhaust blower/fan switch ‘OFF’.
[][]Turn the fluorescent lamp switch ‘OFF’.

Calibration:

[][]Calibrate the air flow (face velocity) of the fume cupboard six monthly.
[][]Switch ‘ON’ the fan.
[][]Open the window sash by sliding upward, 30 cm from the bottom.
[][]Take the reading by flow meter at left, right & middle of the fuming hood & record it in the calibration information sheet for Fume Hood (as per Annexure-I) for calculation.
[][]When instrument do not complies with the specified limits, label “Out of calibration” and get serviced.

Cleaning procedure:

[][]Clean the instrument once in a month or when required.
[][]Clean the work surface and walls with appropriate disinfectant agent and soap water.
[][]Clean the sash window using an appropriate agent disinfectant and glass cleaner.
[][]Use clean water to finish the cleaning and wash away any residue of disinfectant agent, soapy water and glass cleaner.
[][]Use a damp cloth to clean the exterior surface of the fume hood, particularly on the front and top in order to remove dust.
[][]Use Methyl-Ethyl-Ketone to remove stain or spot on the stainless steel surface as soon as possible.

Annexure:

Annexure-I: Calibration Information Sheet for Fume Hood.

Calibration of Hot plate ,Purpose :

Calibration of Hot plate, The purpose of this SOP is to describe the operation, calibration and cleaning of Hotplate with Magnetic Stirrer (Model: Fisherbrand – FB65312).

Calibration of Hot plate, Scope :

This procedure is applicable for Hotplate with Magnetic Stirrer (Model: Fisherbrand – FB65312), installed in the quality control laboratory for general block of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]QC: Quality Control.
[][]RPM: Rotations per minute.

Responsibilities:

The roles and responsibility is as follows:

Executive, QC

[][]To ensure that the instructions of this procedure are correctly followed.
[][]To ensure cleaning of hotplate maintaining safety rules.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.

Head of Quality Assurance

[][]To ensure the overall implementation of the SOP.
[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Laboratory coat and thick rubber gloves must be worn while handling the instrument.
[][]Ensure that the main switch and power supply connector are accessible during use.
[][]Remove the plug from the main socket during cleaning.
[][]Never use sharp objects or harsh or abrasive cleaning agents when cleaning.
[][]Spillage must be cleaned up immediately after use.
[][]Do not heat beakers with any type of liquid adhering to backside.
[][]Never touch the top of the plate when the instrument is on.
[][]Never keep the heater in ‘on’ condition, when not in use.
[][]Do not use hotplate until reported faults are repaired.

Operation:

[][]Ensure the equipment is clean, calibrated and free from any dust particle.
[][]Connect the instrument to the main power supply.
[][]Switch ‘ON’ the mains.
[][]Place the beaker containing the solution in the center of the plate.
[][]For stirring option, immerse the Teflon stirring bar into the solution to be stirred.
[][]Switch ‘ON’ the instrument.
[][]Set the required stirring speed (RPM) of stirring bar by means of speed regulator knob. Turn the speed regulator knob clockwise or counter-clockwise to increase or decrease speed respectively.
[][]After stirring is over, slowly decrease the speed to zero by turn knob counter-clockwise.
[][]For heater, set the temperature by rotating the temperature setting knob to the required. It will take 5 to 10 minutes to stabilize. Turn the knob clock wise to increase the temperature or counter clock wise to decrease the temperature.
[][]After heating is over, decrease the set temperature to zero by turn knob counter-clock wise.
[][]Bright red light will flash until surface cools.
[][]After completion of work, switch ‘OFF’ the instrument.
[][]Switch ‘OFF’ the mains when not required.

Calibration:

[][]Calibrate the hotplate once in a year.
[][]Switch ‘ON’ the mains.
[][]Switch ‘ON’ the instrument.
[][]Set the desired temperature using temperature setting knob.
[][]Check the temperature using a duly calibrated thermometer and record the temperature in the calibration information sheet for hotplate with magnetic stirrer (as per Annexure-I).
[][]When instrument do not complies with the specified limits, label “Out of calibration” and get serviced.

Cleaning procedure:

[][]Switch ‘OFF’ the instrument.
[][]Switch ‘OFF’ the mains.
[][]Ensure that the surface of the plate is in room temperature.
[][]De-dust the instrument with a clean dry cloth every day.
[][]Once in a week wet mop the instrument.
[][]Wet mop using a cloth moistened in mild detergent solution and then wipe with a cloth wetted with water.
[][]Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
[][]Allow to dry the instrument before using it again.

Annexure

Calibration Information Sheet for Hotplate with Magnetic Stirrer

Vortex Mixer , Purpose :

Vortex Mixer , The purpose of this SOP is to describe the operation and cleaning of Vortex mixer (Model: Fisherbrand- ZX Classic), for better or error free use.

Vortex Mixer , Scope :

This procedure is applicable for Vortex mixer (Model: Fisherbrand- ZX Classic) used for mixing the solution or dissolving the various substances into solvent, installed in the quality control laboratory of XX  Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]QC: Cephalosporin Quality Control.

Responsibilities

Executive, QC

[][]To ensure that the instructions of this procedure are correctly followed.
[][]To ensure cleaning of vortex mixer maintaining safety rules.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.

Head of Quality Assurance

[][]To ensure the overall implementation of the SOP.
[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Do not press the test tube hardly on the mixing head.
[][]Do not vortex any materials for long time.
[][]Maintain the level of test solution into test tube/Vial/test flask to avoid overflow during vortex.
[][]Set the speed control to the minimum, before turning on the mixer.
[][]Disconnect vortex mixer from power source before attempting any cleaning or maintenance procedures.
[][]Never operate without a shaking head securely attached.
[][]Always wear eye protector during use of vortex mixer.
[][]Always have lids on the tubes when solvents and flammables are used on the mixer.
[][]Shake hazardous samples in appropriate containment vessels.
[][]Replace rubber attachments with new ones when these show progressive signs of wear out.
[][]Do not immerse the unit or pour liquids over it as electrical shock may occur.

Operation:

[][]Switch ‘ON’ the mains.
[][]The yellow light will be illuminated.
[][]Use the ‘continuous’ key to select the automatic vortex or manual vortex.
[][]Set the desired speed with the help of the ‘control’ knob.
[][]In case of automatic vortex option, touch test tube/vial on the mixing head to start the vortex automatically.
[][]For manual vortex, place the test tube on the mixing head and then press ‘continuous’ button.
[][]Adjust the vortex speed by turning ‘control’ knob clockwise to increase speed or anti-clockwise to decrease speed.
[][]Vary the speed and/or the angle of contact and pressure against the mixing attachment to achieve the desired mix.
[][]On completion, turn the ‘control’ knob anticlockwise to the minimum.
[][]Remove the test tube at the end of vortex.
[][]Stop the vortex by press ‘continuous’ button.
[][]Switch ‘OFF’ the mains.

Cleaning procedure:

[][]Switch ‘OFF’ the mains and disconnect the power plug.
[][]After each use, wipe down the mixer with a soft, dry cloth.
[][]Keep the unit clean by immediately blotting any spills. Remove the shaking head, if required. Clean the head with mild detergent. Dry thoroughly, before replacing the head on the unit.
[][]Clean the outer surface of the instrument properly with a non-abrasive cloth or sponge, moistened in mild detergent water, once in a week or when required.
[][]Never use harsh or abrasive cleaning agents.
[][]Allow to dry before use it again.

Calibration of orbital shaker, Purpose :

Calibration of orbital shaker, The purpose of this SOP is to describe the operation, calibration and cleaning of Orbital Shaker (Model: Stuart SSL1), used for shaking flask, bottle and beaker to dissolve solids in liquid.

Calibration of orbital shaker, Scope :

This procedure is applicable for Orbital Shaker (Model: Stuart SSL1), installed in the quality control laboratory XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]QC: Cephalosporin Quality Control.
[][]RPM: Rotations per minute.

Responsibilities:

Executive, QC

[][]To ensure that the instructions of this procedure are correctly followed.
[][]To maintain the records properly as per SOP.
[][]To ensure cleaning of orbital shaker maintaining safety rules.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.

Procedure:

Precaution(s):

[][]Laboratory coat and safety glasses must be worn while handling the instrument.
[][]Ensure that the main switch and power supply connector are accessible during use.
[][]There is a chance of liquid spillage and splashing if containers are over filled and shaken at high speed. Always gradually increase the speed to the desired level. Never set the speed beyond the maximum limit.
[][]Remove the plug from the main socket during cleaning.
[][]The shaker should not be operated at the maximum RPM without a load.
[][]Do not leave the shaker unattended when starting the unit. Be sure all flasks are firmly seated in the platform and securely clutch between screwing bars.
[][]Ensure the speed controller knob are turned off before switch on the instrument.

Operation:

[][]Check the calibration sticker to ensure that the instrument is within due date of calibration.
[][]Place the apparatus on a firm level surface ensuring the platform is free from vibration.
[][]Fit the flasks or bottles or beakers to be shaken between two rubber cushioned horizontal screwing bars and adjust to hold them tightly.
[][]Switch ‘ON’ by pressing the ‘control’ knob.
[][]Red dot in the display shows RPM is selected; this can be adjusted by turn the ‘control’ knob to the right up to desired shaking speed (in rpm). Once the correct speed is displayed press the ‘start/stop’ button to begin motion.
[][]In order to use the timer and RPM press the ‘mode’ button. The red dot on the display moves over to time. The display will show the last stored time in minutes.
[][]Select the desired count down time using the control knob. When the display shows the correct time in minutes.
[][]Rotation can be paused at any time by pressing the ‘start/stop’ button.
[][]Rotation will start again by pressing ‘start/stop’ button and the timer will continue to count down.
[][]The timer can be adjusted without halting the unit. When the timer reaches zero, the unit will be automatically halted and alert will sound.
[][]Press ‘start/stop’ button to revert back to the last time and speed values set or select new value.
[][]The shaking will stop automatically after the desired period and sounds an alert.
[][]Switch OFF completely by pressing the ‘control’ knob. The display will show OFF

Calibration:

[][]Calibrate the orbital shaker once in a year.
[][]Switch ‘ON’ the mains.
[][]Switch ‘ON’ the instrument by pressing ‘control’ knob.
[][]Set the desired time (most commonly used time range) using time setting button.
[][]Check the time using a calibrated stop watch and record the time in the calibration information sheet for Orbital shaker as per Annexure-I.

Cleaning procedure:

[][]Clean the instrument once in a week or when required.
[][]Switch ‘OFF’ the instrument and switch ‘OFF’ the mains.
[][]Clean the instrument properly with a non-abrasive cloth moistened in detergent water.
[][]Never use harsh or abrasive cleaning agents.
[][]Allow to dry before use it again.

Annexure:

Annexure-I: Calibration Information Sheet for Orbital Shaker.