CLEANING, OPERATION, MONITORING & PRECAUTIONS OF HPHV STEAM STERILIZER

CLEANING, OPERATION, MONITORING & PRECAUTIONS OF HPHV STEAM STERILIZER

PURPOSE : To lay down the procedure for cleaning, operation, monitoring & precautions of HPHV steam sterilizer.

SCOPE : This SOP is applicable for HPHV steam Sterilizer of SVP Section

HPHV steam sterilizer -Machine Fabric -Unit Preparation Room

REFERENCE(S)

WHO-GMP guide lines & Operating Manual of garment autoclave

Attachment/Annexure/Format

Attachment-I   : HPHV steam sterilizer cycle record

Attachment-II  : Bowie Dick Cycle Record

Attachment-III : Load Pattern I (Minimum Garment Load)

Attachment-IV : Load Pattern II (Maximum Garment Load)

Attachment-V  : Garments Sterilization cycle log sheet

DEFINITION & ABBREVIATION(S)

Bowie Dick test :  The bowie dick test to show whether or not steam penetration of the test pack is even and rapid and thus by implication that air or other non-condensable gases are not present. It does not confirm that sterilization condition in the load have been achieved. It verify that air and other non –condensable gases will become concentrated as bubble in the load and inhibit steam penetration.

The test is based on the use of chemical indicator in the form of adhesive tape stuck to a piece of suitable paper to form a st. and rews cross. It is placed in the center of test pack  of folded huckback towels and then subjected to operation cycle. The indicator tape shows a change in colour in response to combination of time, temperature & moisture.

ABBREVIATION(S)

WFI : Water For Injection

HPHV : High pressure  High vacuum

HMI : Human machine interface

PLC :Programmable Logic Control

SIP : Sterilization In Place

FRL : Filter, regulator, lubricator

cGMP : Current Good manufacturing practice

RESPONSIBILITY

Production department shall be responsible:

Initiating, preparation, review and revision of SOPs.

To provide final draft copy to QA department.

To get SOP approval from all signatories.

To impart the training of the SOP to concerned personal before  effective date of SOPs.

To verify that employees are trained to perform the task.

To maintain the updated list of sops issued to the department by QA.

Production Head shall be responsible for:

Checking of the SOP for procedural, technical content, accuracy & cGMP compliance.

To get the SOP approval from Head Quality Assurance or designee.

To impart the training on SOP to the concerned personnel in between issue date & effective date.

Quality Assurance department shall be responsible for:

To check the draft sops for regulatory and cGMP compliance.

To maintain the approved master copy of the SOP of all department for document control.

To issue the required number of controlled copies to the departments and document the same.

Issuance of change control form required for SOP revision.

Head QA Shall be responsible for:

Review of draft SOP regulatory and cGMP compliance.

Final approval of new & revised SOP by signing off as approved by.

To ensure the implementation of the defined system.

Plant head shall be responsible for:

To approve new or revised SOP.

To ensure the implementation of defined system.

PROCEDURE:

SAFETY/PRECAUTIONS

To ensure the health & safety of personnel using autoclave, it is important to trained the person for their proper use & operation.

The responsible operating person who runs the autoclave, should be there near the autoclave room during operation.

It is responsibility of production designee/person to verify that operator is trained for operation & handling of troubleshooting.

During loading & unloading of articles in autoclave the person should wear heat insulating gloves.

A basic visual inspection should be performed by operator along with engineering person on monthly basis.

Inspection, service, repair records should be available on “ Inter office Memo or request form.

Never open the door of autoclave if clogged steam line, equipment malfunction, clogged drain, it may cause of buildup of scalding water.

After completion of sterilization cycle never open the door while the chamber pressure become zero.

After opening the door wait for 10 minutes to escape steam from chamber & allowed to cool the chamber up to45- 50 degree before unloading the sterilized articles.

Don’t autoclave toxic or flammable, hazardous chemicals.

Never perform the maintenance work during operation of autoclave.

In every three months  verify the chamber & jacket safety valve of autoclave for proper Working.

To check the safety valve trained operator & engineering person both will work together.

To check it close the loading & unloading side door.

Switch ON the chamber steam valve, let the pressure increase above pressure set on safety valve. Steam should come out from the safety valve outlet.

If the safety valve does not operate at set pressure then re-set it at required pressure & check the safety valve as per new setting.

If the safety valve does not operate , then replace it with new one.

Follow the same procedure to check the jacket safety valve verification.

CLEANING

Every week operator before operation clean the chamber strainer.

Remove the guide, shelves & loose plates & clean the chamber internally.

Weekly or whenever necessary clean the autoclave chamber with purified water & remove the trays from autoclave & clean with 0.1% solution of teepol.

Remove both side door gasket & clean the both gasket with IPA 70%v/v solution and lubricate it with the food grade grease & fix again.

Check the door gasket for any damage, if gasket is damaged replace it with new one. check all other gaskets and clamps for any leakage.

Daily clean all the SS lines, valves, outer body of sterilizer  with the IPA 70% v/v solution.

Weekly replace the vacuum pump cooling circulation water from tank & fill with fresh water.

In every three months check the recording instruments for proper print. replace the ink cartridge if necessary.

Every month check the oil level in FRL unit.

UTILITY CHCK

Ensure proper & continuous availability  of WFI or purified water for in-built steam generator with pressure of 2.0-2.5 kg/cm2, if not availability inform to engineering department to provide the same.

Ensure that all the heaters of steam generators are working properly to generate the steam pressure 1.5 – 2.0 kg/cm². If the required pressure not achieved the inform to engineering person to check the heater for proper working.

Ensure that soft water pressure for vacuum pump is 1.5 – 2.0 kg/cm².

Ensure that continuous oil & moisture free compressed air pressure for operation  should be 6 – 8 bar.

Ensure electricity supply should be 3 phase, 415 volt, 50 Hz AC supply for motor & 18 KW Heater with neutral & earthing wire to connect  to control panel.

Ensure all the hot pipes are insulated.

If any of the utility will be discontinue, the operation will stop and cycle will be aborted, before operation inform engineering person to verify all utilities for continuous operation.

All the pressure gauges, temperature sensors, pressure transmitter should be calibrated properly.

Before operation, operator will verify the sensors wire should not be damage or broken, if any of sensors perform malfunctioning, then it should be replace immediately and calibrated again.

Operation:

Switch “ON” the “MAINS” electrical supply of autoclave, Then switch on the “CONTROL ON” switch of panel &  IX HMI will start.

Keep emergency switch in release position.

Check all required utility pressure on the pressure gauges mounted on utility lines.

Press the door close button. Door precondition indication “ON” & start the process through HMI.

Home Page will open on the “IX HMI”. Press the “LOGIN” on HMI and enter the user name & password.

Three level password protection system (operator, supervisor & administrator) is in built in the HPHV sterilizer

Go on “MENU”, press the “START UP”.

 “START UP SCREEN”  will open & Press the “SELECT CYCLE” button again & again for  required cycle from  the following cycles which is show on pressing the “SELECT
CYCLE” button.

• Vacuum Leak Test cycle
• Bowie Dick cycle
• Warm up cycle
• HPHV cycle
• Standard cycle

Process start from “PROCESS START” button.

To take printout, Go to “BATCH REPORT” button & select required data sheet & take print out.

Every day before start the sterilization cycle, daily run vacuum leak test cycle to check any leakage in the chamber or gasket.

Press green colour “DOOR OPEN” button of loading side & unloading side close with the red colour “DOOR CLOSE” button on the main panel & door will attain pressure approx.
3kg/cm² & it will show on the pressure gauge mounted on the autoclave.

Vacuum leak test cycle:

Press the “SELECT CYCLE” on “startup screen” & “VACUUM LEAK TEST CYCLE” will open &  press “PROCESS START” to run the cycle.

Vacuum pump will start & cycle will run in auto mode with following parameters.

Cycle will run for 10 minutes & select the time internal for printing 60 second &  printer will show the parameter of every minutes.

After completion of cycle vacuum pressure will release automatically & get the print out of the cycle and check the leakage it should not be more than 0.013 bar.

After completion of cycle “RED ALARM” will blink “ON” the panel.

Press the “PROCESS END ACK” on the HMI and cycle will over.

Then  Press the green colour “DOOR OPEN” button on the panel of loading side & door Pressure will release and loading side door will open.

Maintain the record in HPHV sterilization log  book

If any abnormality found or leak test pressure reading show more than 0.013 bar, check the door gasket, for any damage or also check all connected valves, clamps to be tighten.

Production & IPQA person will check & verify  the print out of vacuum leak test cycle & verify the leak test pass or fail. duly signed print out will be attached in file.

If leak test pass then go for further process & if leak test will be fail operator will check & rectify the problem.

Bowie Dick cycle:

Bowie dick test  perform with bowie dick test kit to verify the air removal/leakage in autoclave.

In this process steam is introduced in to the jacket, this preheat the chamber, after that vacuum is created & then steam introduced in the chamber up to set value.

These pulses are repeated 3 -4 times to remove air pockets.

In heat up exhaust and steam pulses repeated for uniform temperature distribution & protection.

After completion of fixed no. of pulses the chamber temperature reaches to set sterilization temperature & bowie dick cycle run up to set time.

After completion of sterilization cycle, positive pressure in chamber brought to atmospheric pressure by opening chamber exhaust valve.

To start the cycle open the loading side door by pressing green colour “DOOR OPEN” button on the panel & keep the  “Bowie Dick Kit” on the rack near the drain of empty autoclave.

Close the loading & unloading side door by pressing red colour “DOOR CLOSE” button on the panel, Door will attain the pressure of 3 kg/cm² on the pressure gauge.

Open the WFI loop valve & WFI will fill up in “steam generator” through feed pump.

Switch on the heater by Pressing “HEATER ON” button on the panel to generate steam.

Press the “SELECT CYCLE” in startup screen & open “BOWIE DICK CYCLE” &  press “PROCESS START” to run the cycle.

Cycle will run on “AUTO mode”, with following parameters.

In this process initially 3 vacuum pulse will run to remove the almost 95% air from the chamber and simultaneously steam enter in the jacket, to maintain the required pressure of 1.0-1.2 kg/cm² in the jacket and  to pre heat (90-100ºC)  the chamber.

After 3 pulse cycle sterilization phase achieve at 121.4ºC temperature, with 1.1-1.4 kg/cm² Pressure for 10 minutes.

After 10 minutes hold time “Exhaust phase” start to bring down the chamber pressure up To or below 0.040 bar.

As the chamber pressure get up to or below 0.040 bar process will end.

Press the “PROCESS END ACK” on the panel & press “ DOOR OPEN” button of Loading side & remove out the Bowie dick test kit.

Class-II indicator to be change in colour homogeneously to qualify the autoclave.

Production & IPQA person will check & verify  the Bowie dick test kit & print out of Cycle & duly signed print out will be attached in file,

After satisfactory result, maintain the Bowie dick cycle record.

Warm up cycle:

Warm up cycle run for identification of any leakage & penetration of steam.

In this process steam is introduced in the jacket, this preheat the chamber. After that vacuum is created & then steam is introduced in the chamber up to set value.

After completion of vacuum pulse the chamber temperature reach to the set warm temperature. The control system then control the chamber temperature till the end of warm hold time.

After the warm hold chamber vacuum valve open to create vacuum & vacuum hold start.

After completion of vacuum hold time, the negative pressure of chamber is brought to atmospheric pressure by injecting air through the filter.

To start warm up cycle close the loading & unloading side door by pressing red colour “DOOR CLOSE” button on the panel, door will attain the pressure of approx. 3 kg/cm² on the pressure gauge.

Open the WFI loop valve & WFI will fill up in “steam generator” through feed pump.

Press the “SELECT CYCLE” in startup screen & open “WARM UP CYCLE” &  press “PROCESS START” to run the cycle.

Switch on the heater by Pressing “HEATER ON” button on the panel to generate Steam.

Cycle will run  on “AUTO mode”, with following parameters.

In this cycle steam enter in the jacket & preheat the chamber up to (90-100ºC). then vacuum pulse cycle start up to -0.700 bar.

After vacuum pulse cycle, warm-up  temperature reach at 121.4ºC temperature, with 1.1kg/cm2 pressure for 5 minutes.

Then chamber exhaust and post vacuum hold at -0.500 bar.

After 2 minutes hold time, vacuum breaks phase run and as the vacuum break pressure reach up to -0.050 bar, warm cycle complete.

Press the “PROCESS END ACK” on the panel & press “ DOOR OPEN” button  to open the loading side door.

HPHV cycle :

HPHV cycle run for the sterilization & dry of clean area porous load (garments & latex gloves) etc. In this cycle washed garments are fold under LAF & each gowning set is prepared & packed in sterilized bag. Each set contain one dangri, one head gear, two booties with one pair of gloves.

The cycle run in 5 steps.

Vacuum steam pulse

Heat up

Sterilization hold

Vacuum drying

Sterile air in (vacuum break)

In this process steam is introduced in to the jacket, this preheat the chamber, after that vacuum is created with water ring type vacuum pump & then steam introduced in the chamber up to set value.

These pulses are repeated 3 -4 times to remove air pockets & almost 95% removal of air ensured from chamber.

The vacuum pulse not only remove air pockets but also ensure uniform distribution & penetration of temperature.

After vacuum pules cycle chamber temperature reaches to set sterilization temperature till the end of sterilization time.

The vacuum run at predetermined level & as vacuum level reached at specified time, it dry the specified load. After vacuum completion, the negative pressure in chamber is brought to atmospheric pressure by injecting sterile air.

Then sterilized load is unload from the chamber by opening unloading side door.

To sterilize the garments, gloves& to run the process open the loading side door by pressing green colour “DOOR OPEN” button on the control panel & load the S.S bin of washed and clean garments/linen bag and gloves as per load pattern.

Close the loading side door by pressing red colour “DOOR CLOSE” button on the panel, Door will attain the pressure of approx. 3.0 kg/cm² on the pressure gauge.

Open the WFI loop valve & WFI will fill in the “steam generator” through feed pump.

Switch on the heater by Pressing “HEATER ON” button on the panel & steam generation will start.

Press the “SELECT CYCLE” in startup screen & open “HPHV CYCLE” &  press “PROCESS START” button to run the cycle.

Cycle will run on “AUTO mode”, with following parameters.

Initially 3 vacuum pulse will run to remove the almost 95% air from the chamber and parallel the steam enter in the jacket, to maintain the required pressure of 1.0-1.2 kg/cm² in the jacket and  to pre heat (90-100ºC)  the chamber.

Steam will enter in the chamber to maintain the temperature up to 121.4-124 ºC and Pressure of  1.1 to 1.4 kg/cm2. As the required temperature and pressure will maintained, Sterilization hold will start.

Sterilization hold up to 30 minutes on 121.1ºC-124 ºC and pressure 1.1 kg/cm2 to 1.4 kg/cm2.

After 30 minutes of sterilization hold, chamber will exhaust the steam and “post vacuum” Phase up to pre-determined level approx.(-0.800 bar) for 05 minutes will run to remove
the condensate & drying of the load items.

After post vacuum phase, vacuum break phase run by displacing negative pressure in chamber  to atmospheric pressure by injecting sterile air in the chamber for 20-30 second
Over.

As the chamber pressure become less than approx. 0.00 bar, the HPHV cycle complete.

Press the “PROCESS END ACK” on the panel & press “ DOOR OPEN” button of unloading side & unloading side door will open.

Unload the sterilized load &  and close the door by pressing “ DOOR CLOSE” button on unloading side panel.

Collect the printout of HPHV cycle & chemical indicator strip.

Production person & IPQA person will duly check & verify the  temperature, pressure, F0 value of cycle from graph.

Check the class IV chemical indicator strip/steam indicator kept in the between the garments to be sterilize. It should change the colour from yellow to black.

Attach the duly signed graph from production & IPQA in file & maintain the HPHV steam sterilizer log  book by pasting indicator & attached the print out in file.

Standard cycle:

Standard cycle run to sterilize the S.S filling accessories, S.S spoons, scoops, Silicon tubing, glass wares etc.

The standard cycle made up of three phases.

Heat up

Sterilization hold

Exhaust(cooling) 

When the pressure inside the jacket reached up to a set pressure, steam introduce into the chamber & chamber air pockets are removed through the condensate line.

This will ensure the uniform steam distribution & penetration in the chamber. It is provided with steam traps & air vent system in chamber condensate line ensure maximum removal of air pockets and steam condensate along with some wet steam vapors

As the temperature reach to set sterilization temperature the control system control’s the chamber temperature till the end of cycle.

After hold time completion steam of chamber exhaust to down the chamber pressure up to set atmospheric pressure.

To run the cycle open the loading side door by pressing green colour “DOOR OPEN” button on the panel & load the clean accessories by wrapping with aluminum foil in the chamber of  autoclave.

Close the loading side door by Pressing red colour “DOOR CLOSE” button on the panel, Door will attain the pressure of approx..3 kg/cm² on the pressure gauge.

Open the WFI loop valve & WFI fill up in “steam generator” through feed pump.

Press the “SELECT CYCLE” in startup screen & open “STANDARD CYCLE” &  press “PROCESS START” to run the cycle.

Switch on the heater by Pressing “HEATER ON” button on the panel to generate the  steam.

Cycle will run on “AUTO mode”, with following parameters.

As the pure steam pressure maintain in the steam generator, “heat up” phase start & steam First enter in the jacket, as the required pressure of 1.0-1.2 kg/cm² will attain in the jacket And the temperature of 90-100ºC in the chamber.

Then steam introduce in the chamber & as the temperature of all sensors in the chamber and sump  reach up to 121.4 °C & pressure reach  1.1 to1.2 bar, “sterilization hold” will Start for 30 minutes.

After 30 minutes hold time, “Exhaust phase” start to bring down the chamber pressure up To or below 0.040 bar.

As the set pressure attain process will end.

Press the “PROCESS END ACK” on the panel & press “ DOOR OPEN” button of unloading side & unloading side door will open.

Unload the sterilized accessories & close the door of same.

Collect the printout of HPHV cycle & chemical indicator strip.

Production person & IPQA person will duly check & verify the  temperature, pressure, F0 value of cycle from graph.

Check the class IV chemical indicator strip/steam indicator kept in the between the garments to be sterilize. It should change the colour from yellow to black.

Attach the duly signed graph from production & IPQA in file & maintain the HPHV steam sterilizer log  book by pasting indicator & attached the print out in file.

REVISION HISTORY

Attachment – I

HPHV Steam Sterilizer Log Book

Vacuum Leak – (Test Cycle (Date/Cycle No./Vacuum Pressure (bar)/Hold Time/Actual Leakage/Operated by )

HPHV Cycle ( Load Cycle /Load article /Article Qty. & nos./Cycle start /Hold Time /Temp. (ºC) /Press. (kg/cm2) /Cycle End /F0 value /Operated by /Checked by/ Verified by)

Cleaning (Time /Type/Done By/Checked by )

Maintenance (Time /Type/Done by/Checked by /Remark)

Indicator strip

Attachment – II

Bowie Dick cycle record

Date / Cycle No./Cycle start /Bowie Dick Cycle (Start /End /Temp.(ºC)/ Press. (kg/cm²) )/Cycle End /Result/Operated by /Checked by

Result:  Put (√) or ok for correct observation & (x) for in-correct observations.

Attachment – III

Load Pattern I(Minimum Garment Load)

LOAD PATTERN: I

(MINIMUM LOAD WITH 5 SET OF DRESSES IN ONE CONTAINER)

(Each Set Contain:  One dangri, 1 head gear, 2 booties & 2 hand gloves include in one pair)

Attachment – IV

Load Pattern II (Maximum Garment Load)

LOAD PATTERN: II

(MAXIMUM LOAD WITH 20 SET OF DRESSES IN TWO CONTAINERS)

(Each Set Contain:  One dangri, 1 head gear, 2 booties & 2 hand gloves include in one pair)

Attachment – V

Garments Sterilization Cycle Log Sheet

Date /garments No. /SIP Cycle No. /garments No./SIP Cycle No. /Discard/reject No. /Performed by (Prod.) / Checked by (QA)

Limit : Not be more than 100 sterilization cycle