Microbiology

Entry and exit procedure; Purpose

To detail the Standard Operating Procedure for Entry and Exit in Sterility Testing Area of XX Pharmaceuticals Ltd.

Entry and exit procedure; Scope

This SOP define the Entry & Exit Procedure of personnel who will get entry & exit in sterility testing area in Microbiology Laboratory of General Building at XX Pharmaceuticals Limited.

Definitions/Abbreviations

[] Not Applicable

Responsibilities

• The roles and responsibility are as follows
• Executive/Senior Executive, Microbiology
• Follow the instructions of this procedure correctly.

Assistant Manager, Microbiology QC

• To confirm that this mentioned procedure is kept up to date.
• To confirm appropriate personnel from the section are trained on this procedure.

Head of Quality Assurance

• Take initiative approval of SOP
• To confirm the overall implementation of the SOP

Procedure

Instructions

• Only certified, trained & validated employees can enter into the sterility testing area.
• All employees are responsible to maintain their personnel hygiene & cleaning regularly.
• To follow aseptic technique during change procedure
• Always confirm sterility of the garments to be worn in the proper area.
• Always confirm that sterile garments in the Laminar Air Flow dress cabinet.
• The person infected by flue, cold, open lesions (i.e.: eczema) should not enter into sterility test area.
• Confirm that AHU[Air Handling Unit] of sterile testing area is switched on at least one hour before starting testing in that mentioned area.

Step 01: Entry into Change room- 01 (Room no: GMB012, Grade: C)

• Take away the whole garments (except undergarments), wrist watch, Jewelry, & any kind of ornaments after entering into the change room 01.
• Personal/Street shoe must be put off into shelf of the step over bench. Cross step over bench & put on dedicated shoe kept into shelf of the other site.
• Use 70% IPA from the IPA dispenser to rub Hand.

Step 02 : Entry into Change room 02 (Room Grade: C)

• Put on a pair of sterile hand gloves very carefully.
• Wear sterile primary gown having two parts (Trouser & shirts) & a hood to cover the hairs.
• Rub the hands with 70% sterile IPA.

Step 03: Entry into Change Room 03 (Room Grade: B)

• Take sterile garments from dress cabinet which was formerly kept into the dress cabinet in change room 03 of sterility testing area.
• Put on sterile dress with sterile overall, head gear, face mask, Shoes, Sterile hand gloves & safety goggles and confirm aseptic clothing. The procedure of proper clothing is described below:

Putting on Gloves

1. Open the bag of sterile cleanroom latex free gloves & fold out to expose folded cuff area of the gloves.
2. Put on the glove by put in the fingers into latex free glove & pulling on the folded cuff area to cover the palm, confirming that only inside of the cuff is touched.
3. With gloved fingers, fold gloves over the arms, pulling them up over the wrists & forearms, confirming that gloves endure its sterility.

Putting on Hood

1. Open bag having sterile hood ensuring the contents remain sterile.
2. With care & only touching inside of hood, turn hood inside out & place on the head, confirming that all head is covered & no bouffant cap is unprotected.
3. Clasp hood around the neck by clipping self-possessed buttons under chin.
4. Being cautious not to touch outside surfaces, adjust hood to cover all of head.

Putting on Mask

[] Put on facemask & by touching as minimal area as possible tie on mask & making sure it fits comfortably.

Putting on Safety Eyewear

[] Put on sterile safety eyewear glasses remain on isolated portion of Laminar air Flow of dress cabinet.

Putting on Safety Overalls

1. Open bag having sterile overall, confirming innards remain sterile. Unfold left & right sides of overall.
2. Taking top folded edge of overall unfold it towards you until it is lying flat to reveal full length of zipper.
3. Take hold of upper edge of each leg inaugural & gather a handful of the garment in each hand, to catch up legs of overall.
4. Continue to gather garment in this way so that when overall is held up it does not touch floor.
5. Lifting overall, hold in front of you & step into one leg at a time, gradually releasing gathered fabric to allow each foot to push through.
6. Take care not to allow arms of overall to touch floor.
7. Pull overall up to waist height, taking care not to touch outer side of the overall.
8. Slip hands into sleeves, one at a time & then slip remainder of overall over shoulders.
9. Check that hood skirt is completely inside collar of overall & fasten overall with the zipper.

Step 04 : Entry into Sterility testing room 04 (Room Grade: B)

• Spray gloved hands & wrists with sterile 70% IPA.
• Flashing door with help of elbow, enter into sterility test room.

Step 05: Exit from testing room

• After completion test remove used hand gloves put off into waste bin.
• Rub hands with the help of 70% Iso Propyl Alcohol
• Pull door to enter into change
• Pull door to enter into second Change room then enter into first change room.
• Take clean laboratory dress from cabinet put in the change room 01.
• Send used garments to laundry for washing.
• Enter information regarding entry exit procedures such as entry time, exit time, purpose,
• Analyst name signature in log book, Annexure-I

Download Annexure Here

Annexure I Log book of Entry and Exit Personnel of Sterility Testing Area

Air Borne Particle Counter; Purpose

To describe a standard operation, Cleaning & Calibration procedure of Air Borne Particle Counter.

Air Borne Particle Counter; Scope

Procedure is applicable to Air Borne Particle Counter of at XX Pharmaceuticals Limited.

Definition/Abbreviation:

Particle counter: An analytical device to count non-viable particles of specific sizes.

IPA : Isopropyl Alcohol.

Responsibilities:

The roles and responsibility is as follows:

Microbiologist

[] Follow the instructions of this procedure correctly.

Asst. Manager, Microbiology/QC

[] Ensure that SOP is technically sound & reflects the required working practices.

[] Confirm this procedure is kept up to date

Head of Quality Assurance

[] Take initiative to Approval of SOP.

Procedure

Instructions

[] Never use IPA on the display to wash it.

[] Don’t let the verification filter to be moistened.

[] Use your finger dab directly, don’t uses your nail on touch screen.

Operation

• Turn on power switch.
• Press “CONFIG” for “DATA SETUP”.
• Select particle size with pressing “PARTICLE” option.
• Select the particle size for another date setup then Press” BACK “option
• Press ” SAMPLE” option for delay time, sampling time, sampling volume and no. of cycle setup then pressing “ENTER” for saving input.
• To go to main display, Press ” BACK” option.
• For manual mode or automatic mode, Press “SETTING”
• For counting the particle, Press the “START” option.
• Depending on room size, calculate number of sample.
• Go to main the display
• Press “CONFIG “
• Pressing” LOCATION” option, Select Location.
• Press” EDIT “option, if required to add new location.
• To go to main display, Press the “BACK” option.

Set Location & Recipe

• Go to the main display
• Select the “CONFIG” option
• Select the “RECIPE” option
• Select the location
• Write location name
• Select the particle size
• Select sampling time & sampling volume
• Write down desired volume.
• Select delay & set delay time (Initial one is 05 second by default).
• Enable print average if needed
• Select Auto print (if needed)
• To go to main display Press “BACK” option.
• Top count the particle, Press the “START”.
• Completion of counting cycle is stopped automatically.
• Then press “START” option for another cycle & counting the particle.
• Take Print When Auto print option is disable
• Go to the Main Display.
• Press “DATA” option
• Press” RANGE” option
• Pressing “MAIN” option, Go to main display

Verification Test( Zero Count Test)

• Go to the Main Display
• Click on the Sampling Button
• Select the location (Location should be 5)
• Write Zero count test
• Select time (1minute)
• Select Unit( Ft ³ )
• Select the Zero count test
• Select the Sample

Cleaning

[] Clean Air Borne Particle Counter with & pipe with a piece of clean cloth

[] Use 70% sterile IPA damped cloth to clean it.

[] Clean the Display only with a clean sterile dry cloth.

Calibration Procedure

[] Contact with the supplier to the equipment to calibrate as per schedule.

[] Perform the calibration yearly or as per supplier instructions.

Download Annexure Here

 Annexure I Air borne particle Counter Logbook

Water Bath; Purpose

The tenacity of this SOP is to define the operation, calibration & cleaning of Water Bath

Water Bath; Scope

This procedure is applicable for Water Bath installed in Microbiology section at XX Pharmaceuticals Limited.

Definitions/Abbreviations

LED: Light Emitting Diode

Responsibilities:

The roles and responsibility are as follows

Executive/Senior Executive, Microbiology

• To confirm that the instructions of this procedure are properly followed.
• To maintain the record correctly as per SOP.
• To confirm cleaning of shaking water bath maintaining safety guidelines.

Assistant Manager, Microbiology

• To confirm that this process is kept up to date.
• To ensure that the SOP is technically sound & reflects required working practices.
• To 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.

Procedure

Instructions

• Laboratory coat, hand gloves & safety glasses must be worn while handling instrument.
• Never touch the liquid within the bath as it may be very hot.
• Each time use the display or a thermometer to check the temperature.
• Never block ventilation slots during operation.
• Each time disconnect bath from electricity supply before cleaning.
• Allow the liquid in bath to cool down to 40°C before draining.
• Use only purified water, never operate water bath without water.
• Fill the it prior to connection to power supply.
• It should be covered with a lid or polypropylene spheres to achieve optimum performance.
• Always use the stainless steel flat lid with concentric rings when the instrument is not in use to avoid contaminants landing in the bath liquid.
• Don’t touch any electrical contacts or open any closure panel that may be risk of electrical shock when above 60˚C or below room temperature,

Operating Procedure

• Check the calibration date of the instrument before each time use. If the calibration is out of date, calibrate it and then use.
• Check water level, If require adjust the water bath to an appropriate level with purified water.
• Switch on the power from the main.
• Using the switch “I” ON, “O” OFF button located at the rear side of it, Switch on the Water bath When ON (I) the switch is illuminated & unit performs a self-test where all segments of the 3 digit LED display & indicators illuminated.
• To display “SP1” to set temperature, press & hold down key for more than 1.5 seconds. “SP1” will show blinking.
• To select required temperature, use up or down arrow keys.
• Heater indicator will illuminate. Wait until the display flashes between “SP1” & set temperature and will revert to show actual liquid temperature.
• When the bath temperature is either 4°C above or below set temperature, LED indicator will illuminate.
• Open concentric ring & place beaker or suitable container with sample on sphere of it.
• After completion of work, switch off bath by using “I” ON, “O” OFF switch, located at rear side of back of it.

Calibration Procedure

• Calibrate Water bath once in a year.
• Fill purified water in water bath to an suitable level.
• Switch on the bath using “I” ON, “O” OFF switch, located at the rear side of back of the Water bath.
• Set desired temperature against calibrated standard thermometer at 35⁰C, 45⁰C, 65⁰C.
• Wait 30 minutes to equilibrate.
• Verify temperature using a calibrated standard thermometer & record the temperature in the Calibration information sheet for Water bath (as per Annexure-I).

Cleaning Procedure

• When water becomes dirty, clean instrument otherwise clean once in a week.
• Switch ‘OFF’ the instrument.
• Disconnect main power supply.
• Open stainless steel flat lids with concentric rings of the water bath.
• Use purified water to wash the stainless steel flat lids and concentric rings.
• To reduce potential biological contamination, remove the water from water bath.
• Wash it with soapy water & then purified water.
• Mop with clean dry cotton cloth.
• To remove any deposits, use 10% nitric acid on a cloth (wear suitable gloves).
• Gently heat to 50°C for an hour after adding 1 liter of vinegar to water in the stainless steel tank, empty and brush the lime away for descaling then rinse thoroughly afterwards.
• Fill with purified water up to desired level .
• Close the stainless steel flat lids with concentric rings.

 Download Annexure Here

Annexure I Calibration Information Sheet for Water Bath

Cooled incubator Purpose

To operate, clean and calibrate Cooled Incubator in order to support the growth of Yeast and mould in Microbiological analysis.

Cooled incubator Scope

This SOP applies for operation, cleaning and calibration of Cooled Incubator, Model: ICP600 in Microbiology Section of at XX Pharmaceuticals Limited.

Definitions/Abbreviations

N/A

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Operation, cleaning & calibration

Assistant Manager, Microbiology

Ensure Operation, cleaning, calibration and application of sound information.

Head Quality Assurance

Take initiate to approval of SOP

Procedure:

Instructions

• Do not wipe with damped cloth at on position.
• Use only 70% IPA or ethanol to wipe chamber
• Do not overload chamber with tested items.
• Do not keep items those may produce inflammation with air.
• Keep all tested items to avoid touch inner surface of the chamber.
• Do not move the Cooled Incubator at on position. Severe vibrations may cause serious damage of the temperature probes.

Operating Procedure

• Press push/turn control key to put on main power switch in front of instrument. The Cooled Incubator will start in normal mode with display of timer, chamber temperature, alarm temperature (red color indication).
• Hold down SET key & turn the push/turn control key at the clockwise or anti clockwise for setting date, local time, operating temperature at [23.5± 2.5]⁰C, alarm temperature at 30⁰ After setting, SET key will be released the display briefly flashes the set point. 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.
• Hold down the SET key (approximately 3 seconds) to select the operation mode, if require. The current operating mode will be flashed on the display. There are three operating mode in the Cooled Incubator:
• Normal Operation
• Weekly Programmer
• Ramp time Programme Operation
• Select required programme and set as per operation manual.
• Select fan speed to set air changes. Selected position of fan speed will show in display.
• Turn the push/turn control at clockwise until fan symbol flashing to move the air slider opens and closes the air valve to control the supply and discharge of air.
• Check chamber temperature using by a calibrated digital thermometer, when the setting Temperature reaches.
• Keep the required materials inside the chamber.

Cleaning & Disinfection :

• Switch off Cooled Incubator and disconnect the power plug.
• Remove all test flasks and others items from chamber.
• Clean inside of chamber initially with dry cloth and wipe finally with 70% IPA wetted cloth.
• Clean outside of chamber with dry cloth.
• Disinfect all surfaces with 5% Savlon solution and dry the outer surface.
• Reload all items into chamber when reach to dry the chamber surface.
• At the end of cleaning, connect the power plug and switch on.
• Clean the chamber once in a month.
• Clean the outer surface every day.

 Performance Check

• Check chamber temperature daily once.
• Record chamber temperature in Daily temperature Record
• Temperature range ± 2.5C from the set temperature.

Calibration of Cooled Incubator

• Insert standard thermometer or thermocouples into chamber.
• Place at different location of chamber at least 6 position.
• Press & 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 :
• 1 : 15⁰C
• 2 : 22⁰C
• 3 : 30⁰C
• Select required calibration temperature in SETUP key & set the corresponding calibration correction to 0.0⁰
• Measure deviation from selected calibration temperature under the steady conditions, using a reference instrument.
• Set calibration correction in SETUP key. If the measured reference temperature is too low, the calibration correction setting is negative sign.
• Adjust temperature if require from adjusting value of calibration temperature (CAL). The correction value should not more than ±10C.
• Carry out check measurement using the reference thermometer.
• Carry out others two calibration temperatures in the same manner.
• Calibrate the incubator once in a year ± 15 days.
• Record calibration in Calibration Record, as per Annexure-V of Engineering SOP

 Maintenance

• If Cooled Incubator shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for corrective action.
• After corrective action, recalibrate Cooled Incubator.

Download Annexure Here

Annexure I Cooled Incubator Operation Log Book

Oven Purpose

To dry all properly cleaned glassware which is subject to use in chemical analysis & also to sterilize cleaned glassware which is subject to use in different microbiological analysis.

Oven Scope

This SOP applied for operation of Oven, which model is: UNE600 in QC Section, Microbiology Section & Product Development Section of at XX Pharmaceuticals Limited.

Definition/Abbreviation

N/A

Responsibilities

The roles and responsibility is as follows

Executive, Microbiology/ Executive, QC

Operation, cleaning & disinfection and performance checking of oven.

Assistant Manager, Microbiology

• Ensure Operation, cleaning & disinfection and performance checking.
• Ensure that oven is calibrated.
• Checking that SOP is technically informative.

Head of Quality Assurance

Take initiative to Approval of SOP

Procedure

Instructions

• Never enter open hands in the chamber of oven.
• To keep or remove glassware, wear temperature resistance gloves.
• Avoid to keep glassware into chamber with water or any other solution.
• Do not dry plastic materials using oven.
• Always keep door closed & avoid opening door for long period.

Operating Procedure

Sterilization of Glassware for Microbiological Analysis

• To put on the main power switch, Press push/turn control key in front of the instrument. Oven will start in normal mode with the display of the chamber temperature, timer, alarm temperature.
• Turn the push/turn control key by hold down the SET 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.
• To select the programme, Press & hold down SET key and rotate push/turn control key at clockwise and select “Ramp timer” mode.
• Set the work days group using the push/turn control by holding down the SET key and Press push/turn control to select the ramp segment “t1” If the day is not required, it will be off position.
• Set the time using push/turn control by hold down the set key &
• Use the push/turn control, to Select ramp segment “t2”. Hold down SET key and using the push/turn control set the time.
• Until the temperature display is flashing, Turn push/turn control clockwise. Set the required temperature setpoint using push/turn control
• Select setpoint waiting time by hold down the SET key. Hold down SET key and set on using the push/turn control. After the SET key has been released the function for setpoint waiting time is stored.
• Hold down SET key & set time using the push/turn control then Select hold time “t3”.
• Hold down SET key & set time using push/turn control after selecting cooling time “t4”.
• Select program repeats “loop”. Hold down the SET key and set 2 for repeats using the push/turn control.
• To set the air changes, select the fan speed. Turn the push/turn control clockwise until the fan symbol is flashing. Set fan speed 50% suing the push/turn control holding down the SET key.
• Turn the push/turn control clockwise until monitor temperature display is flashing. Set the alarm temperature using the push/turn control holding down the SET key & select alarm temperature.
• Turn push/turn control at clockwise until the fan symbol flashing to move the air slider opens & closes the air valve to control the supply and discharge of air.
• Turn the push/turn control clockwise until the stop symbol ▀  is flashing. Select start ► using the push/turn control holding down the SET key and On releasing the SET key the program starts to run

Glassware Drying

• To put on main power switch. Press push/turn control key in front of the instrument. The oven will start in normal mode with display of chamber temperature, timer, alarm temperature.
• Select operating mode “Normal operation” holding down SET key (approximately 3 seconds) the current operating is flashing.
• Select temperature set point by hold down the SET key & use the push/turn control to select required temperature set point. After the SET key has been released the oven briefly flashes the temperature setpoint. Heating is indicated by the orange heater symbol.
• Select fan speed. Turn push/turn control clockwise until fan symbol is flashing while the holding down the SET key. To set 50% fan speed use the push/turn control
• Turn the push/turn control clockwise until the monitor temperature display is flashing. Select the alarm temperature. Use the push/turn control to set the alarm temperature by holding down the SET key.
• 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.
• Remove dried glassware from oven at the end of drying,

Cleaning of Oven

• Clean the inner benches of Oven with a cleaned cloth.
• Use 70% IPA or ethanol to disinfect the inner surfaces.
• Clean the outer surfaces with dry cleaned cloth.
• Disinfect the outer surfaces with 5% Dettol /Savlon solution.

Calibration of Oven

• Insert standard thermocouples or thermometer into the chamber.
• At least 6 position to be consider to place different location of chamber.
• Press & hold down SET key until the normal mode light blinking.
• To reach SETUP light, turn push/turn control key clock wise.
• Select Calibration to rotate push/turn control key.
• Use the following temperature for calibration:
• 1 : 150⁰C
• 2 : 200⁰C
• 3 : 250⁰C
• Select required calibration temperature in SETUP key & set the corresponding calibration correction to 0.0⁰
• Under the steady conditions, using a reference instrument, measure the deviation from the selected calibration temperature.
• If the measured reference temperature is too low, the calibration correction setting is negative sign, set the calibration correction in SETUP key.
• The correction value should not more than ±10C.
• Adjust the temperature if require from adjusting value of calibration temperature (CAL), carry out the check measurement using the reference thermometer.
• Carry out others two calibration temperatures in the same manner.
• Calibrate incubator once in a year.
• Record calibration in Oven Calibration Record, Annexure-II.

Maintenance

Inform to supplier or Engineering Department for maintenance, If Oven shows any mechanical, electrical or any others problem, after maintenance, recalibrate the oven.

Download all Annexure here

Annexure I Oven Calibration Record

Annexure II Oven Log Book

 

 

Vortex Mixer; Purpose

To establish the procedure for ideal operation and cleaning of Vortex Mixer, Model: Genius 3 KIA, Fisher Scientific, UK in microbiology test.

Vortex Mixer; Scope

This SOP applies for operation, cleaning of Vortex Mixer, Model: Genius 3 KIA, Fisher Scientific, UK in Microbiology Section at XX Pharmaceuticals Limited.

Definitions/Abbreviations

NA

Responsibilities

The roles and responsibility is as follows:

Executive/ Senior Executive, Microbiology

Operate & clean of Vortex Mixer.

Asst. Manager, Microbiology

• Ensure Operation, cleaning & application of sound technical information.
• Keep the up to date of SOP.
• Review that SOP is technically informative.

Head of Quality Assurance

Take initiative to Approval of SOP

Procedure:

Instructions

• Do not press hardly on platform.
• To avoid movement during vortex, keep Vortex Mixer in a fixed place.
• Do not vortex any materials for long time.
• To avoid overflow during vortex, maintain the level of test solution into test tube/Vial/test flask.

 Operation Procedure

• Switch ON the power button. The red indicator light will be illuminated.
• Press SET switch to select the automatic vortex or manual vortex.
• Set time to press TIMER button as per requirement.
• Adjust vortex speed by turning SPEED button at clockwise for increasing or anti clockwise for decreasing.
• Place test tube/vial/test flask on the platform.
• Attach tube/vial with the machine for more than 1 minute vortex.
• Press START button if set manual vortex.
• Touch test tube/vial on platform to start the vortex automatically.
• Remove test tube at the end of vortex.
• Switch OFF power button.
• Disconnect machine.
• Press MAINS switch off.

Cleaning Procedure

• Switch off Vortex Mixer and disconnect the power plug.
• Clean outer surface with dry cloth.
• Disinfect outer surfaces of Microscope with 5% Dettol/Savlon solution.
• Clean daily once.

Maintenance

Inform to supplier or Engineering Department for repairing, If Colony counter shows any mechanical, electrical or any others problem.

Colony counter; Purpose

To establish the procedure for ideal operation and cleaning of Colony Counter, Model: SC6, Stuart UK, in microbiology test.

Colony counter; Scope

This SOP applies for operation and cleaning of Colony Counter, Model: SC6, Stuart, UK in Microbiology Section of General Building at XX Pharmaceuticals Limited.

Definitions/Abbreviations

N/A

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Perform operation & cleaning.

Manager, Microbiology

Confirm that operation is carried out properly.

Keep the SOP up to date.

Review that SOP is technically informative & application of sound knowledge.

Head of Quality Assurance

Take initiative to Approval of this SOP

Procedure:

Instructions

• Do not press hardly on counting platform.
• Do not use any concentrate cleaning or disinfection solution to outer surface of machine.
• Do not open petridish during colony counting because all micro-organisms are unscrupulous pathogen.
• Cover with a pack of clear discs to protect receiver plate from dust and scratches.

Operation Procedure

• Turn on unit pressing by <ON/OFF> switch located at back of the unit.
• Select plate receiver background as per requirement either dark or white pressing by side panel.
• Select appropriate adaptor for use of less than 90 mm petridish & place it on the receiver plate.
• Adjust sensitivity turning the control knob at clockwise for increasing and at anticlockwise for decreasing.
• Place covered Petridish on receiver plate, using centering adapter if required.
• Press & hold the <correct/reset> key to ensure display is set to zero before counting.
• Mark on each colony with a felt tip pen. Every time a colony is marked, apparatus will register count with a bleep sound and counter advance.
• Press <correct/reset> key once for removal of each count If unwanted counts are made.
• Place first petridish on receiver plate to use averaging facility.
• At end of the count, press the <save> key to store the count in the memory. This will indicated by three dashes on the display. Replace petridish with next and press <save>key to resume the count. Repeat until all dishes have been counted.
• At the end of the run press the <average> key to display the average count. When average facility is active a red LED spot at the top left hand corner of the display will be visible.
• Press & hold the <correct/reset> key until the display returns to zero when count is completed. This will clear the memory of saved counts.
• Switch unit OFF at mains after all the counting is completed.
• Maintain Colony Counter Log Book, Annexure-I for each operation.

Cleaning & Disinfection Procedure     

• Remove plate from instrument for cleaning the receiver plate,
• Make sure that instrument is switch off position.
• Disconnect power plug.
• Remove petridish from platform.
• Clean outside of the equipment initially with dry cloth.
• Disinfect the outer surfaces with 5% Dettol/Savlon solution.
• Finally clean with Purified water.
• Clean after each work.

Maintenance

Inform to supplier or Engineering Department for corrective action, If Colony counter shows any mechanical, electrical or any others problem.

Download Annexure Here

Annexure I: Colony Counter Logbook

Biosafety Cabinet; Purpose

To establish the ideal operation of Bio-safety Cabinet to confirm that the air are free from any microorganisms & any particle in order to favor microbiological test.

Biosafety Cabinet; Scope

This SOP applies for operation of Bio-safety Cabinet, Model: AC2-4E1 in Microbiology Section at XX Pharmaceuticals Limited.

Definitions

• BSC    : Bio-safety Cabinet
• DOP   : Dioctyl Phthalate
• HEPA : High Efficiency Particulate Air.
• IPA     : Iso Propyl Alcohol.
• PAO   : Poly alpha olefin.

Responsibilities

The roles and responsibility is as follows

Executive, Microbiology

Operation, cleaning & disinfection and performance checking of Bio-safety Cabinet

Manager, Microbiology

• Ensure Operation, cleaning & disinfection, performance checking and application of sound technical information.
• Review that SOP is technically informative.

Head of Quality Assurance

Take initiative to Approval of SOP

Procedure:

Instructions

• Do not wipe HEPA filter side of BSC.
• Do not turn on UV light without full cover of slash.
• Move always gently during operation of BSC to minimize air turbulence.
• Care should be taken that water do not enter into HEPA filter through working station of down flow.

Operating Procedure

• Press UV light button to turn on the UV light.
• Wait for 30 minutes.
• Press light button to turn on.
• Pull up front slash at 50% open position. Open position (%) will be indicated on the display.
• If show alarm, adjust position of slash.
• Press FAN button to start up and wait for 3 minutes.
• After 3 minutes, fan will be automatically started and
• Use 70% ethanol/IPA to wipe all the surfaces of workstation, except in front of HEPA filter.
• Use 70% ethanol to wipe all materials (Glassware’s, containers and other articles) before bringing them inside the Bio-safety Cabinet.
• Start the work.
• Use 70% ethanol to wipe again entire platform after finishing work.
• Press light button to turn off.
• Pull down to cover front slash at 0% open position. Open position (%) will be indicated on the display.
• Press UV light button to turn on the UV light
• Wait for 30 minutes to disinfect the whole cabinet.
• After 30 minutes, press UV light button to turn off.
• Disconnect the power plug of the cabinet.

Performance Check

• Check the performance of HEPA filter by monitoring the Particle count and Microbial count once in a year and prepare the report in Annexure-I & Annexure-II
• Check efficiency of HEPA filter by DOP/PAO test once in six months and prepare the report in Annexure-I & Annexure-II

Maintenance

• Inform to the supplier or Engineering Department for maintenance, if Bio-safety Cabinet shows any mechanical, electrical or any others fault.
• After maintenance, check HEPA filter efficiency & monitor Particle Count and microbial count.

Microscope; Purpose

To establish the procedure for ideal operation & cleaning of Microscope for use in microbiological test.

Microscope; Scope

This SOP applies for operation, cleaning and of Microscope, Model: CX21-LED SET1, Olympus, Japan in Microbiology Section at XX Pharmaceuticals Limited.

Definitions/Abbreviations

N/A

Responsibilities

The roles and responsibility is as follows

Executive/ Sr. Executive, Microbiology

Operation, cleaning and performance checking of Microscope

Manager, Microbiology

Ensure Operation, cleaning & disinfection and performance checking.

Head of Quality Assurance

Take initiative to Approval of SOP

Procedure:

Instructions

• Use 2.5% Dettol/Savlon solution for cleaning of objectives lens, eyepieces and condenser.
• Do not use any concentrate alcohol or any others solution.
• Use only immersion oil on slide.
• Wipe properly objective lens to remove immersion oil at the end of use.
• Do not disassemble the microscope without approval of Head of Microbiology Section.

Operation Procedure

• Wipe entire platform with clean cloth.
• Prepare specimen (stain, if necessary) on a glass slide & place it on stage properly under objective lens with aid of adjustment knob.
• Put on switch for light source.
• Rotating light intensity adjustment knob for increase or decrease brightness clockwise or anticlockwise.
• Adjust objective lens (10x, 40x, 100x) according to requirement.
• Use both coarse focus and then Fine focus for better visualization.
• Focus an area on the specimen, which is clearly defined or not over crowded.
• Do not move specimen holder directly by hand this will damage rotator mechanisms of the knob.
• First focus specimen with 10x then with 45x, and then with 100x objective lens (if necessary).
• After work is done wipe again lens & platform with another clean cloth, separately.
• Cover the microscope at end of the work.

Cleaning & Disinfection Procedure        

• Switch off Microscope & disconnect power plug.
• Remove slide from stage.
• Clean outside of chamber with dry cloth.
• Use 2.5% Savlon/Dettol solution to Disinfect outer surfaces of Microscope
• Clean Objective lens smoothly & Ocular lens with clean, soft, fiber free cloth before and after use.
• Clean objective lens with cider wood oil if found any stain on lens.

Maintenance

If Microscope shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for corrective action.

Incubator; Purpose

To operate, clean & calibrate incubator in order to support the bacterial growth in microbiological test.

Incubator; Scope

This SOP applies for operation, cleaning and calibration of Incubator, Model : INE500 & INE600 in Microbiology Section At  XX Pharmaceuticals Ltd.

Definitions/Abbreviation

[] CAL.1: Calibration Temperature 1

[] CAL.2: Calibration Temperature 2

[] CAL.3: Calibration Temperature 3

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

• Follow the instructions of this procedure correctly.

Assistant Manager, Microbiology

• Confirm that this procedure is kept up to date.
• Confirm appropriate personnel from the section are trained on this procedure.
• Confirm that SOP is technically sound and reflects the required working practices.

Head of Quality Assurance

Take initiative to Approval of this SOP

Procedure

Instructions

• Do not wipe with damped cloth at on position.
• Use only 70% IPA or Ethanol to wipe chamber with any disinfectants
• Never overload the chamber with tested items.
• Do not keep the items those may produce inflammation with air.
• Keep all tested items to avoid the touch inner surface of the chamber.
• Do not move the incubator at on position. Severe vibrations may cause serious damage of the temperature probes.

Operation Procedure

• To the front of the instrument, Press push/turn control key to put on the main power switch. The incubator will start in normal mode with display of the timer, chamber temperature, alarm temperature (red color indication).
• Turn the push/turn control key by holding down SET key, at the clockwise or anti clockwise for setting date, local time, operating temperature, and alarm temperature. After setting, SET key will be released the display briefly flashes the set point.
• The display then changes to the actual current temperature & starts to the setting temperature. The temperature will be automatically augmented at setting temperature and display the setting temperature digitally.
• Observe display temperature until its stable position.
• Hold down the SET key (Approximately 3 Seconds) to select the operation mode, if require. The current operating mode will be flashed on the display. There are three operating mode in the incubator.
  1. Normal Operation
  2. Weekly Programmer
  3. Ramp time Programme Operation­­­

• Select required programme & set as per operation manual.
• Select fan speed to set air changes.
• Turn the push/turn control at clockwise until the fan symbol flashing to move air slider opens & closes the air valve to control supply and discharge of air.
• Check chamber temperature using by a calibrated digital thermometer, when setting Temperature reaches.
• Keep required materials inside incubator.
• Incubator will automatically control Temperature.
• Instrument will automatically adjust the temperature. When the temperature exceed the setting temperature, “off” light will illuminate and if the temperature decrease the “on” light will illuminate.

Cleaning & Disinfection Procedure

• Switch off incubator & disconnect power plug.
• Remove all test flasks & others items from chamber of incubator.
• Clean inside of chamber initially with dry cloth & wipe finally with 70% IPA wetted cloth.
• Clean outside of chamber with dry cloth.
• Disinfect all surfaces with 5% Savlon solution & dry outer surface of the incubator.
• Reload all items into chamber when reach to dry chamber surface.
• At the end of cleaning, connect the power plug and switch on the incubator.
• Clean chamber once in a month.
• Clean outer surface of the incubator every day.

Performance Check

• Check chamber temperature daily once.
• Record chamber temperature in Daily temperature Record, Annexure-I.
• Temperature range ± 2.5° C from set temperature.

Calibration Procedure

• Press and hold down SET key until 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

• 1 : Temperature calibration at low temperature
• 2 : Temperature calibration at medium temperature
• 3 : Temperature calibration at high temperature
• Select required calibration temperature in SETUP key & set corresponding calibration correction to 0.0⁰
• Measure the deviation from selected calibration temperature under the steady conditions, using a reference instrument.
• Set calibration correction in SETUP key. If measured reference temperature is too low, calibration correction setting is negative sign.
• Adjust temperature if require from adjusting value of calibration temperature (CAL). Correction value should not more than ±10C.
• Carry out check measurement using reference thermometer.
• Carry out others two calibration temperatures in the same manner.
• Calibrate incubator once in a year ± 15 days.
• Record calibration in Calibration Record, as per Annexure-V of Engineering SOP

Maintenance

• If Incubator shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for corrective action.
• After corrective action, recalibrate incubator.

Download All Annexure Here:

Annexure I Daily Temperature Record of Instrument

Annexure II Incubator Operation Log Book