.
Qualification
of High Pressure High Vaccum (HPHV) Steam Sterilizer in Pharmaceuticals is done
by following procedure.
Test
pack size
Justification
for the temperature sensor location of choice
TEMPERATURE
SENSOR PLACEMENT IN THE GARMENTS LOAD (MAXIMUM)
TEMPERATURE
SENSOR PLACEMENT IN THE GARMENTS LOAD (MINIMUM)
TEMPERATURE
SENSOR PLACEMENT IN THE CRITICAL AREA FILTERS LOAD
TEMPERATURE
SENSOR PLACEMENT IN OTHER ACCESSORIES
TEMPERATURE
SENSOR PLACEMENT IN THE CLEANING AIDS
Objective
Procedure
Acceptance
Criteria
1.0 CALIBRATION OF TEMPERATURE SENSORS
1.1 PRE & POST CALIBRATION OF TEMPERATURE SENSORS
Prepare
the container with crushed ice and add enough purified water to ensure the
proper slush solution allow the temperature to stabilize ensure to add
sufficient crushed ice to maintain the equilibrium state of ice & water.
1.2 PROCEDURE
Temperature
sensors which are used for qualification study shall be calibrate in ice bath
at approximately 0°C and in high temperature reference block at 50,100,121,150°C
prior to its usage in qualification.
Record
the temperature of all the sensors while putting them in ice bath after one
minute of temperature stabilization put the individual sensor to the slot of
high temperature reference block which is stabilized at required temperature.
Record the reading at least one minute after stabilization of temperature. Record
the temperature for five minute by data logger and attach the report with print
outs with reports.
1.3 ACCEPTANCE CRITERIA
No
temperature sensors vary by 1°C in ice bath from the mean of temperatures shown
by the calibrated thermometer during the data logging period.
No
temperature sensors vary by 1°C in high temperature reference block from the mean
of temperatures Shown by the calibrated thermometer during the data logging
period.
2.0 QUALIFICATION TESTS
The
High Pressure High Vacuum Steam Sterilizer will be qualified after validating
(As per the methods outlined in this Protocol) the equipment for desired
performance and its ability to sterilize different components and/or loads at
the set parameters & set loading patterns, repeatably & consistently.
The
High Pressure High Vacuum Steam Sterilizer will be considered qualified for
consistent and reliable performance (Validated) on successful completion of the
following tests.
· Vacuum Leak
test (3
Trials without probe &
3 Trials with probe)
· Bowie –Dick
Test for Steam penetration (3 trials on 3 different days)
· Steam
qualification tests (3 trials on 3 different days)
· Empty Chamber
Heat Distribution studies (3 trials) with temperature mapping probes at
different locations of the sterilizer chamber.
· Loaded
Chamber heat penetration studies (3 trials) for each sterilization load of
fixed loading pattern, with temperature mapping probes inside the innermost
possible layer of the load subjected for sterilization.
· Bio-Challenge
studies using Bacillus stearothemophilus spore strips (containing 106 or
more spores per strip) during the heat distribution & heat penetration
studies.
· Estimation of
the F0 value
achieved during the sterilization hold period at each temperature-mapping
probe.
· Quality of
the steam condensate collected from the sampling point provided in the
sterilizer chamber condensate drain line for all loads.
· Vacuum break
filter integrity testing.
To
qualify these tests the equipment should fulfill the acceptance criteria
described in the individual test procedures. After completion of the
qualification tests all the data generated will be compiled together to
evaluate ability of the High Pressure High Vacuum Steam Sterilizer to sterilize
different components at the set parameters and set-loading pattern.
2.1 VACUUM LEAK RATE TEST
Objective
Objective
of this test is to ensure that the rate of vacuum drop is within the acceptable
limits when the High Pressure High Vacuum Steam Sterilizer chamber is subjected
to the vacuum of more than /equal to –0.93 Kg/cm2 on
gauge (equivalent to 100 m bar absolute pressure). 3 Trials should be
done for this qualification test.
Procedure
Record
the set parameters for the vacuum leak test in the Annexure-1 of Attachment
–1.
Operate
the empty Steam Sterilizer as per the SOP. Allow
the sterilization chamber temperature to stabilize.
When
the chamber temperature is stabilized, the vacuum pump starts.
Achieve
chamber pressure (on gauge) equivalent to <- 100 mbar absolute pressure.
Observe channel No.6 of the multi point recorder for vacuum).
When
desire level of pressure is achieved in the sterilizer chamber (Pressure P1)
record the observation in Annexure-2 of
Attachment-1.
Wait
for 5 minutes to stabilize the chamber pressure (This time allowance is
provided to allow evaporation of condensate in the chamber).
After
5 minutes record the observation (Pressure P2) wait for 10 minutes, after 10
minutes record the observations (Pressure P3)
Calculate
rate of Vacuum drop in the sterilizer chamber by using the equation given below
and record the results in Annexure-2 Attachment-1.
The
printout taken during the vacuum leak test should be preserved as per the
Annexure-3 of attachment-1
Compile
the data generated during the qualification test for complete evaluation of the
system.
Prepare
summary and conclusion of the performance qualification studies, which will be
finally approved by the Head – Manufacturing & Head – Quality Assurance.
Remark – The vacuum leak test should be performed only when
the sterilization chamber is empty, dry and at room temperature.
Basis of Calculation
The
actual observations obtained during the vacuum leak test should be compiled in
the Annexure-2 of
Attachment – 1 and
the rate of Vacuum drop should be calculated by using the following formula.
Rate
of vacuum of drop per minute = (P3-P2) / 10
Where,
P2
= Pressure (vacuum) observed after 5 minutes of achieving the desired level of
pressure.
P3
= Pressure (vacuum) observed after 10 minutes of achieving pressure
P2
Acceptance Criteria
When
the Chamber pressure (on gauge) equivalent to <- 100 mBar absolute pressure
is applied, the rate of vacuum drop at the end of 10 minutes holding time
should not be more than 13 mBar i.e., equivalent to NMT 1.3 mBar per minute.
Observation & Results
Record
the observations and results in formats enclosed as Attachment-1
2.2 STEAM QUALITY TESTS
A
continuous supply of saturated steam is required for steam sterilization. Too
high a level of non-condensable gases will prevent the attainment of sterilizing
conditions; too little moisture carried in suspension may allow the steam to
become superheated during expansion into the chamber, while excess moisture may
cause damp loads.
For
all these tests, the steam should be sampled from the steam service pipe. The
measurements are taken during a period of maximum steam demand, when steam is
first admitted to the sterilizer chamber.
Presence
of non-condensable gases more than the desired level might get accumulated
within the sterilization chamber in the form of air pockets, which might affect
steam penetration this leading to probable non-sterile unit.
NOTE:
Silicone rubber tubing is porous to steam and should not be used to carry steam
in these tests.
2.2.1 Non-Condensable Gas Test
Objective
Objective
of this test is to ensure that, The pure steam supply of the High Pressure
High Vacuum Steam Sterilizer does not contain non-condensable gases more than
the desire level (NMT 3.5%) when measured on-line during the standard
sterilization cycle.
Procedure
This
test is used to demonstrate that the level of non-condensable gases in the
steam will not prevent the attainment of sterilization conditions in any part
of the load. The method described should be regarded not as measuring the exact
level of non-condensable gas, but a method by which the provision of acceptable
steam quality can be demonstrated.
The
apparatus is shown and described in Figure No.1 (all sizes are nominal).
Connect the needle valve to the steam service pipe as shown in Figure No.1.
Assemble
the apparatus so that condensate will drain freely from the long rubber tube
into the sampling pipe. If the tube is too short, copper or stainless steel
tubing may also be used.
Fill
the container with cold water until it overflows. Fill the burette and funnel
with cold water, invert them and place them in the container. Draw out any air
that has collected in the burette. With the steam sampling pipe out of the
container, open the needle valve and allow steam to purge the air form the
pipe. Place the pipe in the container, locate the end within the funnel, and
add more cold water until it flows through the overflow pipe. Place the empty
measuring cylinder under the container overflow.
Adjust
the needle valve to allow a continuous sample of steam into the funnel
sufficient to cause a small amount of “Steam Hammer” to be heard. Ensure that
all the steam is discharged into the funnel and does not bubble out into the
container. Note the setting of the needle valve. Close the valve.
Ensure
that the container is topped up with cold water and that the measuring cylinder
is empty. Draw out any air present in the burette.
Ensure
that the sterilizer chamber is empty except for the usual chamber furniture.
Select and start the operating cycle.
When
the steam supply to the chamber first opens, open the needle valve to the
previously noted setting, allowing a continuous sample of steam into the funnel
sufficient to cause a small amount of steam hammer to be heard.
Allow
the steam sample to condense in the funnel. Any non-condensable gases will rise
to the top of the burette. Overspill formed by the condensate and the water displaced
by the gases will collect in the measuring cylinder.
When
the temperature of the water in the container reaches 70-75 °C close the needle
valve. Note the volume of gas collected in the burette (Vb) and the volume of
water collected in the measuring cylinder (Vc).
Calculate
the fraction of non-condensable gases as a percentage as follows.
When
the temperature of the water in the container reaches 70-75 °C close the needle
valve. Note the volume of gas collected in the burette (Vb) and the volume of
water collected in the measuring cylinder (Vc).
Calculate
the fraction of non-condensable gases as a percentage as follows.
Fraction
of non-condensable gases = 100 x (Vb/Vc).
The
test should be considered satisfactory if the fraction of non-condensable gases
does not exceed 3.5 %.
The
test should be done two more times to check consistency. If the results of the
three tests differ significantly, then the cause should be investigated before
proceeding further.
Figure
No.1
Acceptance
Criteria:
The
measured non-condensable gases in the pure steam should not cross 3.5%
Observations
& Results
Record
the observations and results in formats enclosed as Attachment-2, Annexure-1
2.2.2 Superheat
Objective
This
test is used to demonstrate that the amount of moisture in suspension with
steam from the service supply is sufficient to prevent the steam from becoming
superheated during expansion into the chamber.
The
method described here uses a low-volume sample, continuously taken from the
center of the steam service pipe. The level of superheat determined by this
method cannot be regarded as indicative of the true dryness of the steam in the
pipe since condensate flowing along the inner surface is not collected.
However, devices designed to separate free condensate are incorporated into the
steam delivery system to the chamber and therefore the level determined by this
method is representative of steam conditions likely to prevail within the
chamber during the plateau period.
Procedure
This
test should normally follow a satisfactory test for non-condensable gases.
This
test, and the subsequent dryness value test, requires a pitot tube as shown in
figure No.2. The rest of the apparatus is shown and described in figure No.3.
All sizes are nominal.
Fit
the Pitot tube concentrically within the steam service pipe as shown in figure
No.3.
Fit
the sensor entry gland to the steam service pipe. Insert one of the sensors
through the gland and position the axis of the pipe.
Insert
the second sensor through the gland in the expansion tube and position it on
the axis of the pipe. Wrap lagging around the expansion tube. Push the tube onto the pitot.
Figure
No.2.
Ensure
that the sterilizer chamber is empty except for the usual chamber furniture.
Select and start the operating cycle.
From
the measured temperatures, note the temperature in the steam service pipe (for
use in the dryness test) and in the expansion tube (Te) when the steam supply
to the chamber first opens. Calculate the superheat in oC from the following
equation:
Superheat
= Te - To
Where:
To
is the boiling point of water at local atmospheric pressure.
The
test should be considered satisfactory if the superheat measured in the
expansion tube does not exceed 25°C.
Record
the observations and results in formats enclosed as Attachment-2, Annexure-2
Figure
No. 3
2.2.3 DRYNESS TEST
The
accurate measurement of the percentage of moisture content in the steam is
difficult, and the traditional methods where constant steam flow is required
are not suitable for sterilizers. This test should be regarded not as measuring
the true content of moisture in the steam, but as a method by which the
provision of acceptable steam quality can be demonstrated.
Objective
a) This test is used to demonstrate that the
dryness value is not less than 0.90 (if metal loads are to be processed, the
dryness value should not be less than 0.95);
b) Throughout the operating cycle, the
temperature measured in the steam service pipe is within 3°C of that measured
during the superheat test.
Procedure
The
test is conveniently carried out immediately after the superheat test.
This
test requires a pitot tube as shown in Figure No.2. The apparatus is shown and
described in figure No.4. All sizes are nominal. A laboratory balance is also
required, capable of weighing a load up to 2 kg with an accuracy of 0.1g or
better.
If
it is not already fitted, fit the Pitot tube concentrically within the steam
service pipe as shown in figure No.3.
If
it is not already fitted, fit the sensor entry gland to the steam service pipe.
Insert a temperature sensor through the gland and position it on the axis of
the pipe.
Connect
the rubber tube to the longer of the pipes in the stopper, place the stopper in
the neck of the vacuum flask, weigh the whole assembly and note the mass (M1).
Remove
the stopper and tube assembly and pour 650 + 50 ml of cold water (below
27°C) in to the flask. Replace the stopper and tube assembly, weigh the flask
and record the mass (M2).
Support
the flask close to the pitot, and ensure that the rubber tube and flask are
protected from excess heat and draughts, do not connect it to the pitot tube
yet.
Introduce
the second temperature sensor through the shorter of the two pipes in the
stopper and into the water in the flask. Note the temperature of the water in
the flask (To).
Ensure
that the sterilizer chamber is empty except for the usual chamber furniture.
Select and start the operating cycle.
When
the steam supply to the chamber first opens, connect the rubber tube to the
pitot discharge and wrap lagging around it. Arrange the rubber tube to permit
condensate to drain freely into the flask. Not the temperature in the steam
service pipe (TS).
When
the temperature of the water in the flask is approximately 80°C, disconnect the
rubber tube from the pitot, agitate the flask so that the contents are
thoroughly mixed, and note the temperature of the water (T1).
Weigh
the flask and stopper assembly and note the mass (M3).
The
initial mass of water in the flask is given by Mw = M2 – M1
The
mass of condensate collected is given by MC = M3 - M2.
Calculate
the dryness value of the steam from the following equation:
D= (T1-T0) (4.18MW + 0.24) / LMC - 4.18 (TS-T1) / L
Where:
T0
= Initial temperature of the water in the flask (°C);
T1
= Final temperature of the water and condensate in the flask (°C);
TS
= Average temperature of the steam delivered to the sterilizer (°C);
MW
= Initial mass of water in the flask (Kg);
MC=
Mass of condensate collected (Kg);
L=
latent heat of dry saturated steam at temperature TS (kJ Kg-1).
Acceptance
Criteria
The
test should be considered satisfactory if the following requirements are met.
A)
The dryness value is not less than 0.90 (if metal loads are to be processed,
the dryness value should not be less than 0.95);
B)
Throughout the operating cycle, the temperature measured in the steam service
pipe is within 3°C of that measured during the superheat test.
Observation
and results
Record
the observations and results in formats enclosed as Attachment-2, Annexure-3.
2.3 BOWIE – DICK TEST FOR STEAM PENETRATION
Objective
Objective
of this test is to ensure that the vacuum pulses applied before the
sterilization hold period are sufficient to remove the entrapped air or noncondensable gases so as to facilitate rapid and even steam penetration into all parts of
the load and maintaining these conditions for the specified temperature holding
time {8 minutes
(500 seconds Approx) at 121 °C }.
If
air is present in the chamber, it will collect within the Bowie-Dick test pack
as a bubble. The indicator in the region of the bubble will be of different
color as compared to the color on the remaining part of the test paper, because
of lower temperature, lower moisture level or both. In this condition the cycle
parameters to be reviewed and the normal sterilization cycles to be modified
accordingly
Procedure
Record
the set parameters for the Bowie-Dick test cycle in the Annexure-1 of
Attachment-3
Place
one Bowie-dick Test Pack in the center of the sterilization chamber supported
approximately 100 to 200 mm above the sterilization chamber base.
Select
cycle no. 4 on the Control panel & operate the High Pressure High Vacuum Steam
Sterilizer as per the SOP.
The
printout taken during the Bowie-Dick test cycle & the Bowie-Dick test
indicator should be preserved as per the Annexure-3 Attachment-3.
Test
pack size
Remarks
– Bowie-Dick cycle should be normally preceded by a warm-up cycle as the
effectiveness of air removal may depend on all the parts of the sterilizer
being at working temperature.
Acceptance Criteria
The
Bowie-Dick Test indicator should show a uniform color change. No change,
non-uniform change and/ or air entrapment (bubble) spot on the pattern
indicates inadequate air removal from the sterilization chamber.
Observations & Results
Record
the observations and results in formats enclosed as Attachment-3
2.4 HEAT DISTRIBUTION EMPTY CHAMBER
Objective:
Objective
of this test is to ensure that,
· The High Pressure High
Vacuum Steam Sterilizer is capable of attaining a temperature of 121ºC during
the sterilization hold period with steam pressure of 1.2 kg/Cm2.
· Temperature spread within
the range of 121.1°C to 124°C during sterilization cycle will demonstrate the uniform heat
distribution within the chamber.
· Any Location(s) where the
temperature sensor is placed, not achieving minimum sterilization temperature
of 121.1°C throughout the
sterilization temperature hold will be considered as cold spot.
· team condensate collected
during the sterilization cycle from the sample collection port should meet the
requirements for Water for Injection USP.
Procedure
Record
the set parameters for the sterilization cycle to be operated during the test
for empty chamber heat distribution study, in the Annexure-1 of Attachment-4
Pass
minimum 16 no. Temperature mapping probes into chamber through the port of the
sterilizer. Seal the port with silicone sealant so that steam leakage does not
take place.
Suspend
the probes in the chamber in different position so that probes do not touch any
metallic surface, also place biological indicators along with locations of
temperature mapping probes in the sterilizer chamber.
Record
the position of the probes and the biological indicators in a representative
schematic form in the Annexure-2 of Attachment-4
TEMPERATURE
SENSOR PLACEMENT IN THE EMPTY CHAMBER
(NOTE:
The temperature sensors shall be placed in the pre determined locations with
predetermined sensor numbers corresponding to the data logger channels).
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
1
|
Chamber
Drain
|
9
|
Near RTD
two
|
2
|
Steam inlet
right
|
10
|
Near RTD
three
|
3
|
Steam inlet
left
|
11
|
Near RTD
four
|
4
|
Sterile
side door top back side
|
12
|
Near RTD
five
|
5
|
Sterile
side door bottom back
|
13
|
Non-aseptic
door top Left corner
|
6
|
Non-aseptic
door top front side
|
14
|
Non-aseptic
door bottom Right corner
|
7
|
Non-aseptic
door bottom front side
|
15
|
Aseptic
door top left corner
|
8
|
Near RTD
one
|
16
|
Aseptic
door bottom Right corner
|
Justification
for the temperature sensor location of choice
Sensor
no.1-Control sensor of the equipment is located in the condensate
drain. This is very important to know the temperature of the drain point to
evaluate the cycle set parameters.
Sensor
no. 2&3-To verify the probability of excess temperature at
the steam inlet.
Sensor
no.4, 5, 6 &7- Any conduction of heat from the door which may cause
temperature drop at that particular point.
Sensor
nos.8, 9, 10, 11, &12- As these are temperature recording probes at
different points- it is necessary to verify/compare the temperatures obtained
with strip chart of the equipment.
Sensor
nos.13, 14, 15, 16- Any conduction of heat from the door which may cause
temperature drop at that particular point.
Connect
the probes to a suitable data logger, which can scan and print the actual
temperature observed at different locations with respect to time.
Select
cycle No.2 on control panel.
Operate
the High Pressure High Vacuum Steam Sterilizer as per SOP, and also start the data logger to record actual
temperatures within the sterilization chamber with respect to time
Collect
sufficient sample of steam condensate as per the SOP, for analysis in a clean and sterile sample bottle
from the sampling point provided in the steam condensate drain line.
When
the sterilization cycle completes;
1. Collect Strip chart from the Strip chart
Recorder of the sterilizer and preserve as Annexure-3 of Attachment-4
2. Download the data from data logger into the
computer for data-analysis and printing. Enclose the data printouts as per the
Attachment-4
3. Aseptically collect the exposed biological
indicators and send the indicators after wrapping in a sterile enclosure to
microbiology lab. With necessary identification and the observation sheet as
per Annexure-6 of Attachment-4
If
the empty chamber heat distribution studies are acceptable, perform three
consecutive replicate runs to demonstrate cycle and sterilizer reproducibility.
Compile
the data generated during the qualification test for complete evaluations of
the system.
Acceptance
Criteria
There
should be uniform distribution of heat in the sterilizer chamber during the
sterilization hold period and the temperature at each temperature mapping probe
should be within the range of 121.1°C to 124°C during the sterilization hold
period.
Observations
and Results
Record
the observations and results in formats enclosed as Attachment-4.
2.5 HEAT PENETRATION STUDY – GARMENTS (MAXIMUM LOAD)
Objective
Objective
of this test is to ensure that,
· The steam is sufficiently
penetrating into the innermost portions of the Garments with maximum load
subjected for sterilization to achieve desired temperature 121.1°C during the complete Sterilization hold period with steam pressure
of 1.2 Kg/cm2.
· If sterilization
temperature (121.1°C) is not achieved throughout
the cycle, load configuration or size of the load has to be reviewed and cycles
to be repeated.
· Temperature spread within
the range of 121.1°C to 124°C during sterilization hold period indicate that, uniform heating
process which is achieved in the Loaded chamber heat penetration study is not
affected by load. There could be the possibility of lag period for attaining
121.1°C during heat penetration trials as
the probes are placed deep into the load any location(s) where the temperature indicator is placed, not achieving
minimum sterilization temperature of 121.1°C during sterilization temperature
hold period will be considered as cold spot.
· Steam condensate collected
during the sterilization cycle from the sample collection port should meet the
requirements for Water for Injection USP.
Load details
· Boiler Suit – 12 pairs
· Booties – 12 pairs
· Gloves (14 inch) in perforated box – 15 pairs
· Gloves (7 inch) in perforated box – 15 pairs
· Moping dusters – 15 Nos
Procedure
Record
the set parameters for the sterilization cycle to be operated during the test
for the loaded chamber heat penetration study in the Annexure-1 of Attachment-5.
Pass
minimum 16 no. Temperature mapping probe into chamber through the port
provided. Seal the port with silicone sealant so that steam leakage does not
take place. Place the probes inside the load components, which are supposed to
most difficult points for steam penetration, also place biological indicator
strip along with each temperature mapping probe. Record the position of the
probes and the biological indicators in a representative schematic form the
Annexure-2 of Attachment-5.
Connect
the probes to calibrated data logger, which can scan and print the actual
temperature with respect to time.
Operate
the High Pressure High Vacuum Steam Sterilizer as per SOP, and also start the data logger to record actual
temperatures within the sterilization chamber with respect to time.
TEMPERATURE
SENSOR PLACEMENT IN THE GARMENTS LOAD (MAXIMUM)
(NOTE:
The temperature sensors shall be placed in the pre determined locations with
predetermined sensor numbers corresponding to the data logger channels).
SENSOR
NUMBER
|
LOCATION IN THE CHAMBER
|
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
1
|
Chamber
drain
|
9
|
Approx.
center garment bag -1
|
2
|
Glove Pack
(7”) - 1
|
10
|
Approx.
center garment bag –3
|
3
|
Glove Pack
(7”) - 2
|
11
|
Approx.
center garment bag –6
|
4
|
Near RTD-1
|
12
|
Approx.
center garment bag -10
|
5
|
Near RTD-2
|
13
|
Between
2&3 mopping duster
|
6
|
Near RTD-3
|
14
|
Between
5&6 mopping duster
|
7
|
Near RTD-4
|
15
|
Glove Pack
(14”) - 1
|
8
|
Near RTD-5
|
16
|
Glove Pack
(14”) - 2
|
Justification for the temperature sensor location of choice
Sensor
no.1-Control sensor of the equipment is located in the condensate
drain. This is very important to know the temperature of the drain point to
evaluate the cycle set parameters.
Sensor
no. 2, &3 –
To verify the heat penetration of the innermost portion of the small size
gloves.
Sensor
no.4, 5, 6, 7 & 8- As these are temperature-recording probes at
different points- it is necessary to verify/compare the temperatures obtained
with strip chart of the equipment.
Sensor
no.9, 10, 11& 12- To
verify the heat penetration into the innermost portion of the garment load in
the garment pack at different position.
Sensor
no.13 & 14- – To verify the heat penetration of the innermost
portion of the mopping duster load in the box.
Sensor
no. 15 & 16 –
To verify the heat penetration of the innermost portion of the small size
Gloves.
When
the sterilization cycle completes;
1. Collect thermograph from
the multipoint temperature recorder of the sterilizer and preserve as
Annexure-3 of Attachment-5
2. Download the data from
data logger into the computer for data-analysis and printing. Record the
temperature observed at different locations in the Annexure-4 of Attachment-5
3. Aseptically collect the
exposed biological indicators and send the indicators after wrapping in a
sterile enclosure to microbiology lab with necessary identification and the
observation sheet as per Annexure-6 of Attachment-5
If
the heat penetration study is acceptable perform three consecutive replicate
runs to demonstrate cycle and sterilizer reproducibility.
Compile
the data generated during the qualification test for complete evaluation of the
system.
Acceptance Criteria
There
should be uniform penetration of heat in the load subjected for sterilization
during the sterilization hold period and the temperature at each temperature
mapping probe should be within the range of 121.1°C to 124°C during the
complete sterilization hold period.
Observations and Results
Record
the observations and results in formats enclosed as Attachment-5.
2.6 HEAT PENETRATION STUDY – GARMENTS (MINIMUM LOAD)
Objective
Objective
of this test is to ensure that,
· The steam is sufficiently
penetrating into the innermost portions of the garments with minimum load
subjected for sterilization to achieve desired temperature 121.1°C during the complete Sterilization hold period with steam pressure
of 1.2 Kg/cm2.
· If sterilization
temperature (121.1°C) is not achieved throughout
the cycle, load configuration or size of the load has to be reviewed and cycles
to be repeated.
· Temperature spread within
the range of 121.1°C to 124°C during sterilization hold period indicate that, uniform heating
process which is achieved in the Loaded chamber heat penetration study is not
affected by load. There could be the possibility of lag period for attaining
121.1°C during heat penetration trials as
the probes are placed deep into the load
· Any Location(s) where the
temperature indicator is placed, not achieving minimum sterilization
temperature of 121.1°C
during sterilization temperature hold period will be considered as cold spot.
· Steam condensate collected
during the sterilization cycle from the sample collection port should meet the
requirements for Water for Injection USP.
Load details
·
Boiler
Suit – 3 pairs
· Booties – 3 pairs
· Gloves (14 inch) in perforated box – 5 pairs
· Gloves (7 inch) in perforated box – 5 pairs
· Moping dusters – 15 Nos
Procedure
Record
the set parameters for the sterilization cycle to be operated during the test
for the loaded chamber heat penetration study in the Annexure-1 of Attachment-6.
Pass
minimum 16 no. Temperature mapping probe into chamber through the port
provided. Seal the port with silicone sealant so that steam leakage does not
take place. Place the probes inside the load components, which are supposed to
most difficult points for steam penetration, also place biological indicator
strip along with each temperature mapping probe. Record the position of the
probes and the biological indicators in a representative schematic form the
Annexure-2 of Attachment-6.
Connect
the probes to calibrated data logger, which can scan and print the actual
temperature with respect to time.
Operate
the High Pressure High Vacuum Steam Sterilizer as per SOP and also start the data logger to record actual
temperatures within the sterilization chamber with respect to time.
TEMPERATURE
SENSOR PLACEMENT IN THE GARMENTS LOAD (MINIMUM)
(NOTE:
The temperature sensors shall be placed in the pre determined locations with
predetermined sensor numbers corresponding to the data logger channels).
SENSOR
NUMBER
|
LOCATION IN THE CHAMBER
|
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
1
|
Chamber
drain
|
9
|
Approx.
center garment bag -1
|
2
|
Glove Pack
(7”) - 1
|
10
|
Approx.
center garment bag –2
|
3
|
Glove Pack
(7”) - 2
|
11
|
Approx.
center garment bag –3
|
4
|
Near RTD-1
|
12
|
Between
1&2 mopping duster
|
5
|
Near RTD-2
|
13
|
Between
2&3 mopping duster
|
6
|
Near RTD-3
|
14
|
Between
4&5 mopping duster
|
7
|
Near RTD-4
|
15
|
Glove Pack
(14”) - 1
|
8
|
Near RTD-5
|
16
|
Glove Pack
(14”) - 2
|
Justification for the temperature sensor location of choice
Sensor
no.1-Control sensor of the equipment is located in the condensate
drain. This is very important to know the temperature of the drain point to
evaluate the cycle set parameters.
Sensor
nos. 2, &3 –
To verify the heat penetration of the innermost portion of the small size
Gloves.
Sensor
no.4, 5,6 ,7 & 8- As
these are temperature-recording probes at different points- it is necessary to
verify/compare the temperatures obtained with strip chart of the equipment.
Sensor
nos.9, 10 & 11- To
verify the heat penetration into the innermost portion of the garment load in
the garment pack at different position.
Sensor
no. 12, 13 & 14- To verify the heat penetration of the innermost
portion of the mopping duster load in the box.
Sensor
no. 15 & 16 –
To verify the heat penetration of the innermost portion of the small size
Gloves.
When
the sterilization cycle completes;
1. Collect
thermograph from the multipoint temperature recorder of the sterilizer and
preserve as Annexure-3 of Attachment-6
2. Download
the data from data logger into the computer for data-analysis and printing.
Record the temperature observed at different locations in the Annexure-4 of
Attachment-6
3. Aseptically
collect the exposed biological indicators and send the indicators after
wrapping in a sterile enclosure to microbiology lab with necessary
identification and the observation sheet as per Annexure-6 of Attachment-6
If
the heat penetration study is acceptable perform three consecutive replicate
runs to demonstrate cycle and sterilizer reproducibility.
Compile
the data generated during the qualification test for complete evaluation of the
system.
Acceptance Criteria
There
should be uniform penetration of heat in the load subjected for sterilization
during the sterilization hold period and the temperature at each temperature
mapping probe should be within the range of 121ºC to 124ºC during the complete
sterilization hold period.
Observations and Results
Record
the observations and results in formats enclosed as Attachement-6.
2.7 HEAT PENETRATION STUDY- CRITICAL AREA FILTERS
Objective
Objective
of this test is to ensure that,
· The steam is sufficiently
penetrating into the innermost portions of the Filtration accessories load (to
be used in Critical area) subjected for sterilization to achieve desired
temperature 121.1°C during the complete
Sterilization hold period with steam pressure of 1.2 Kg/cm2.
· If sterilization
temperature (121.1°C) is not achieved throughout
the cycle, load configuration or size of the load has to be reviewed and cycles
to be repeated.
· Temperature spread within
the range of 121.1°C to 124°C during sterilization hold period indicate that, uniform heating
process which is achieved in the Loaded chamber heat penetration study is not
affected by load. There could be the possibility of lag period for attaining
121.1°C during heat penetration trials as
the probes are placed deep into the load
· Any Location (S) where the
temperature indicator is placed, not achieving minimum sterilization
temperature of 121.1°C
during sterilization temperature hold period will be considered as cold spot.
· Steam condensate collected
during the sterilization cycle from the sample collection port should meet the
requirements for Water for Injection USP.
Load details
· 0.2m ,
10” Housings – 1 Nos. for Disinfectant filtration
· 4” Air vent Filters – 5 Nos
· Membrane Filter Holder – 1 No.
Procedure
Record
the set parameters for the sterilization cycle to be operated during the test
for the loaded chamber heat penetration study in the Annexure-1 of Attachment-7.
Pass
minimum 16 no. Temperature mapping probe into chamber through the port
provided. Seal the port with silicone sealant so that steam leakage does not
take place. Place the probes inside the load components, which are supposed to
most difficult points for steam penetration, also place biological indicator
strip along with each temperature mapping probe. Record the position of the
probes and the biological indicators in a representative schematic form the
Annexure-2 of Attachment-7.
Connect
the probes to suitable data logger, which can scan and print the actual
temperature with respect to time.
Operate
the High Pressure High Vacuum Steam Sterilizer as per SOP, and also start the data logger to record actual
temperatures within the sterilization chamber with respect to time.
TEMPERATURE
SENSOR PLACEMENT IN THE CRITICAL AREA FILTERS LOAD
(NOTE:
The temperature sensors shall be placed in the pre determined locations with
predetermined sensor numbers corresponding to the data logger channels).
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
1
|
Chamber
drain
|
9
|
Inside Air
Vent Filter -5
|
2
|
Aseptic
door side middle
|
10
|
In Membrane
filter holder
|
3
|
Non-aseptic
door side middle
|
11
|
Near RTD-1
|
4
|
Inside 10”
inch housing
|
12
|
Near RTD-2
|
5
|
Inside Air
Vent Filter -1
|
13
|
Near RTD-3
|
6
|
Inside Air
Vent Filter -2
|
14
|
Near RTD-4
|
7
|
Inside Air
Vent Filter -3
|
15
|
Near RTD-5
|
8
|
Inside Air
Vent Filter -4
|
16
|
Chamber
middle top side
|
Justification for the temperature sensor location of choice
Sensor
no.1-Control sensor of the equipment is located in the condensate
drain. This is very important to know the temperature of the drain point to
evaluate the cycle set parameters.
Sensor
nos. 2, &3 -
Any conduction of heat from the doors that may cause temperature drop at that
particular point.
Sensor
no.4, 5, 6, 7, 8, 9 &10- to
verify the heat penetration at inner most portion of Filtration assembly.
Sensor
nos.11, 12, 13, 14, & 15- As
these are temperature-recording probes at different points- it is necessary to
verify/compare the temperatures obtained with strip chart of the equipment.
Sensor
no.16- to verify the possible excessive heat during the cycle as the
top portion of the chamber.
When
the sterilization cycle completes;
1. Collect
thermograph from the multipoint temperature recorder of the sterilizer and
preserve as Annexure-3 of Attachment-7
2. Download
the data from data logger into the computer for data-analysis and printing.
Record the temperature observed at different locations in the Annexure-4 of
Attachment-7
3. Aseptically
collect the exposed biological indicators and send the indicators after
wrapping in a sterile enclosure to microbiology lab with necessary
identification and the observation sheet as per Annexure-6 of Attachment-7
If
the heat penetration study is acceptable perform three consecutive replicate
runs to demonstrate cycle and sterilizer reproducibility.
Compile
the data generated during the qualification test for complete evaluation of the
system.
Acceptance Criteria
There
should be uniform penetration of heat in the load subjected for sterilization
during the sterilization hold period and the temperature at each temperature
mapping probe should be within the range of 121.1°C to 124°C during the
complete sterilization hold period.
Observations and Results
Record
the observations and results in formats enclosed as Attachement-7.
2.8 HEAT PENETRATION STUDY – OTHER ACCESSORIES
Objective
Objective of this test is to ensure that,
· The steam is sufficiently
penetrating into the innermost portions of accessories load having
gaskets , valves, clamps & sampling aids when subjected for sterilization
to achieve desired temperature 121.1°C during the complete sterilization hold period with steam pressure
of 1.2 Kg/cm2.
· If sterilization
temperature (121.1°C) is not achieved throughout
the cycle, load configuration or size of the load has to be reviewed and cycles
to be repeated.
· Temperature spread within
the range of 121.1°C to 124°C during sterilization hold period indicate that, uniform heating
process which is achieved in the loaded chamber heat penetration study is not
affected by load. There could be the possibility of lag period for attaining
121.1°C during heat penetration trials as
the probes are placed deep into the load
· Any Location(s) where the
temperature indicator is placed, not achieving minimum sterilization
temperature of 121.1°C
during sterilization temperature hold period will be considered as cold spot.
· Steam condensate collected
during the sterilization cycle from the sample collection port should meet the
requirements for Water for Injection USP.
Load details
· For Filtered Disinfectant Solution Storage –
3 Nos
· 1” Teflon Gaskets – 100 Nos.
· 2” Teflon Gasket – 40 Nos
· 1” T.C. Valves – 20 Nos
· 2” T.C. Valves - 5 Nos
· 1” Clamp
· 2” Clamp
Procedure
Record
the set parameters for the sterilization cycle to be operated drying the test
for the loaded chamber heat penetration study in the Annexure-1 of
Attachement-10.
Pass
minimum 16 no. Temperature mapping probe into chamber through the port
provided. Seal the port with silicone sealant so that steam leakage does not
take place. Place the probes inside the load components, which are supposed to
most difficult points for steam penetration, also place biological indicator
strip along with each temperature mapping probe. Record the position of the
probes and the biological indicators in a representative schematic form the
Annexure-2 of Attachment-10.
Connect
the probes to suitable data logger, which can scan and print the actual
temperature with respect to time.
Operate
the High Pressure High Vacuum Steam Sterilizer as per SOP, and also start the data logger to record actual
temperatures within the sterilization chamber with respect to time.
TEMPERATURE
SENSOR PLACEMENT IN OTHER ACCESSORIES
(NOTE:
The temperature sensors shall be placed in the pre determined locations with
predetermined sensor numbers corresponding to the data logger channels).
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
1
|
Chamber
drain
|
9
|
In bet.
T.C. clamp 1 & 2
|
2
|
Aseptic
door side middle
|
10
|
Inside the
Disinfectant storage vessel
|
3
|
Non-aseptic
door side middle
|
11
|
Near RTD-1
|
4
|
In between
20 mm Rubber stoppers pack
|
12
|
Near RTD-2
|
5
|
Inner side
of Teflon coated flexible pipe
|
13
|
Near RTD-3
|
6
|
Between
Teflon Gasket 1 & 2
|
14
|
Near RTD-4
|
7
|
In Between
T.C. valves 1 & 2
|
15
|
Near RTD-5
|
8
|
In between
P. vessel & stand
|
16
|
Chamber
middle top side
|
Justification for the temperature sensor location of choice
Sensor
no.1-Control sensor of the equipment is located in the condensate
drain. This is very important to know the temperature of the drain point to
evaluate the cycle set parameters.
Sensor
nos. 2, &3 -
Any conduction of heat from the doors that may cause temperature drop at that
particular point.
Sensor
no.4, 5, 6, 7, 8, 9 & 10- to
verify the heat distribution & penetration at inner most portions of the
Accessories.
Sensor
nos.11, 12, 13, 14, & 15- As
these are temperature-recording probes at different points- it is necessary to
verify/compare the temperatures obtained with strip chart of the equipment.
Sensor
no.16- to verify the possible excessive heat during the cycle as the
top portion of the chamber.
When
the sterilization cycle completes;
1. Collect
thermograph from the multipoint temperature recorder of the sterilizer and
preserve as Annexure-3 of Attachment-10
2. Download
the data from data logger into the computer for data-analysis and printing.
Record the temperature observed at different locations in the Annexure-4 of
Attachment-10.
3. Aseptically
collect the exposed biological indicators and send the indicators after
wrapping in a sterile enclosure to microbiology lab with necessary
identification and the observation sheet as per Annexure-6 of Attachment-10.
If
the heat penetration study is acceptable perform three consecutive replicate
runs to demonstrate cycle and sterilizer reproducibility.
Compile
the data generated during the qualification test for complete evaluation of the
system.
Related: Computer System Validation
Related: Computer System Validation
Acceptance Criteria
There
should be uniform penetration of heat in the load subjected for sterilization
during the sterilization hold period and the temperature at each temperature
mapping probe should be within the range of 121.1°C to 124°C during the
complete sterilization hold period.
Observations and Results
Record
the observations and results in formats enclosed as Attachement-10.
2.9 HEAT PENETRATION STUDY – CLEANING AIDS
Objective
Objective
of this test is to ensure that,
· The steam is sufficiently
penetrating into the innermost portions of the Cleaning Aids load when
subjected for sterilization to achieve desired temperature 121.1°C during the complete Sterilization hold period with steam pressure
of 1.2 Kg/cm2.
· If sterilization
temperature (121.1°C) is not achieved throughout
the cycle, load configuration or size of the load has to be reviewed and cycles
to be repeated.
· Temperature spread within
the range of 121.1°C to 124°C during sterilization hold period indicate that, uniform heating
process which is achieved in the Loaded chamber heat penetration study is not
affected by load. There could be the possibility of lag period for attaining
121.1°C during heat penetration trials as
the probes are placed deep into the load
· Any Location (S) where the
temperature indicator is placed, not achieving minimum sterilization
temperature of 121.1°C
during sterilization temperature hold period will be considered as cold spot.
· Steam condensate collected
during the sterilization cycle from the sample collection port should meet the
requirements for Water for Injection USP.
Load details
*SS Buckets for Disinfectant Solution – 9 Nos.
Procedure
Record
the set parameters for the sterilization cycle to be operated during the test
for the loaded chamber heat penetration study in the Annexure-1 of
Attachement-11.
Pass
minimum 16 no. Temperature mapping probe into chamber through the port
provided. Seal the port with silicone sealant so that steam leakage does not
take place. Place the probes inside the load components, which are supposed to
most difficult points for steam penetration, also place biological indicator
strip along with each temperature mapping probe. Record the position of the
probes and the biological indicators in a representative schematic form the
Annexure-2 of Attachment-11.
Connect
the probes to suitable data logger, which can scan and print the actual
temperature with respect to time.
Operate
the High Pressure High Vacuum Steam Sterilizer as per SOP, and also start the data logger to record actual
temperatures within the sterilization chamber with respect to time.
TEMPERATURE
SENSOR PLACEMENT IN THE CLEANING AIDS
(NOTE:
The temperature sensors shall be placed in the pre determined locations with
predetermined sensor numbers corresponding to the data logger channels).
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
SENSOR
NUMBER
|
LOCATION IN
THE CHAMBER
|
1
|
Chamber
drain
|
9
|
In between
SS bucket 5&6
|
2
|
Aseptic
door side middle
|
10
|
In between
SS bucket 8&9
|
3
|
Non-aseptic
door side middle
|
11
|
Near RTD-1
|
4
|
Inside SS
bucket - 1
|
12
|
Near RTD-2
|
5
|
Inside SS
bucket - 3
|
13
|
Near RTD-3
|
6
|
Inside SS
bucket - 5
|
14
|
Near RTD-4
|
7
|
Inside SS
bucket - 7
|
15
|
Near RTD-5
|
8
|
In between
SS bucket 2&3
|
16
|
Chamber
middle top side
|
Justification for the temperature sensor location of choice
Sensor
no.1-Control sensor of the equipment is located in the condensate
drain. This is very important to know the temperature of the drain point to
evaluate the cycle set parameters.
Sensor
nos. 2, &3 -
Any conduction of heat from the doors that may cause temperature drop at that
particular point.
Sensor
no.4, 5, 6, & 7- to
verify the heat distribution & penetration at innermost portion of stainless steel baskets.
Sensor
no 8, 9 & 10- to verify
the heat distribution & penetration at outside the baskets.
Sensor
nos.11, 12, 13, 14, & 15- As
these are temperature-recording probes at different points- it is necessary to
verify/compare the temperatures obtained with strip chart of the equipment.
Sensor
no.16- to verify the possible excessive heat during the cycle as the
top portion of the chamber.
When
the sterilization cycle completes;
1. Collect
thermograph from the multipoint temperature recorder of the sterilizer and
preserve as Annexure-3 of Attachment-11
2. Download
the data from data logger into the computer for data-analysis and printing.
Record the temperature observed at different locations in the Annexure-4 of
Attachment-11.
3. Aseptically
collect the exposed biological indicators and send the indicators after
wrapping in a sterile enclosure to microbiology lab with necessary
identification and the observation sheet as per Annexure-6 of Attachment-11.
If
the heat penetration study is acceptable perform three consecutive replicate
runs to demonstrate cycle and sterilizer reproducibility.
Compile
the data generated during the qualification test for complete evaluation of the
system.
3.0 F0 CALCULATION
(a) Numerical F0 VALUE
The
actual observation obtained during the heat penetration studies at different
temperature sensing location are compiled in the table and the observed
temperature shall be subjected to fo calculation at that particular location
the lethality factor calculation is done by using the formula
F0 =
dt ∑10(T-121)/z
F0 =
dt ∑(sum of lethality factor)
Where,
dt = time interval between successive temperature
measurements.
T =observed temperature at that particular time (as
actual temperature recorded).
Z = change in the heat resistance of Geobacillus
stearothermophilus
Spores as temperature is changed (10°C or mentioned in
COA).
(b) F0 value for biological indicators
The
biological F0 value for biological
indicator strip exposed during the sterilization can be calculated as follows.
F0 = D121 (log
A – log B)
Where,
D121 = D Value
of the biological indicator at 121°C
A =experimental biological indicator concentration or spore population
B =desired level of sterility (SAL - 106)
(c) Desired spore log reduction:
Calculate the desired reduction in spore log
population by using the formula
SLR Desired =
log A – log SAL desired
Where,
A = experimental population of biological indicator
SAL desired =
desired level level of sterility (10-6)
(d) Actual spore log reduction :
Calculate the actual reduction in spore population by
using the formula
SLR actual =
Fo/D121.
Where,
Fo = Minimum
calculated Fo value
D121 =
D value of Biological indicator
Acceptance Criteria
There
should be uniform penetration of heat in the load subjected for sterilization
during the sterilization hold period and the temperature at each temperature
mapping probe should be within the range of 121°C to 124°C during the complete
sterilization hold period.
Observations and Results
Record
the observations and results in formats enclosed as Attachement-11.
3.1 ANALYSIS OF THE STEAM CONDENSATE
Objective
Objective
of this test is to ensure that,
The
pure steam used for sterilization process should be of the desired quality and
the condensate collected at the sterilization chamber drain point should meet
the specification of water for injection as per USP.
Procedure
The
steam condensate collected during the sterilization cycles performed during
Empty Chamber Heat Distribution Study and heat penetration study of different
loads should be tested as per water for injection specifications USP.
Record
the observations in the Annexure-12 of relevant Attachments.
Compile
the data generated during the qualification test for complete evaluation of the
system.
Acceptance
Criteria
The
steam condensate sample collected at the drain point of the sterilization
chamber should comply with water
for injection specifications as mentioned in USP.
Observations and Results
Record
the observations and results in formats enclosed as Annexure-12 of relevant
Attachments.
3.2 VACUUM BREAK FILTER INTEGRITY TEST
Objective:
The
objective of the test procedure is to ensure that.
· The 0.2-micron filter being
used as vacuum break filter after completion of sterilization and vacuum cycle
to provide sterile air to protect the sterilized load from possibility of
contamination which may compromise the sterility of the load.
· This test confirms the
consistent integrity of the 0.2 micron filter which provides sterile air into
the sterilizer by determining the Bubble point of the of the filter using Integritest Exacta instrument.
Procedure:
· Wet the filter to be
tested by wetting fluid based on the type of the filter used
(hydrophilic/ hydrophobic). In this case wet the filter with 60% Iso Propyl
Alcohol Solution
· Connect a regulated supply
of dry clean air or nitrogen at 35-120 psi (2.4-8.5 bar) to the inlet tubing
assembly of the instrument with ¼” NPTF side of the filter.
· Connections to the filter
housing are made with the outlet tubing assembly. Two connections are made to
instrument.
· Plug the power cord and
switch on to go to editor screen of the instrument (Integritest Exacta)
· Enter the filter catalog
number, appropriate wetting fluid i.e. 60% IPA solution, filter description and
the type of the filter.
· Following the important
steps for the bubble point testing.
a) System check
b) Clearing the
housing from excess fluid.
c) Determination
of the upstream volume.
d) Pressurizing
the system to the diffusion test pressure (80% of the bubble point
specification if the diffusion test pressure was not entered into the filter
editor)
e) Allow the
pressure to stabilize.
f) Increment
pressure until bubble point is determined.
g) Increase the
pressure to 1 psi below the bubble point specification (Bubble point for the
filter Optiseal filter code no- **** is NLT 18 psig).
h) Increase
pressure in various increments above the bubble point values, until the test is
complete.
· Calculate pressure
decay
· The machine determines the
changes in flow by interception of the tangents method. The intersection
between the diffusion curve and a linear fit of the flow rates above the bubble point is defined as the bubble point.
Acceptance criteria
The
bubble point determined by the above method should be not less than-18 psig.
Observation and results
Record
the observation and results as print out in annexure-1 of attachment-12.
REVALIDATION
SCHEDULE
3.2 SCHEDULED REVALIDATION
Study
|
Frequency
|
|
Validation
|
Routine
|
|
Calibration of all instruments e.g.
Pressure Gauge, Compound Gauges, Timer, DTI, Data logger, Probes.
|
Every Six Month
|
Not required
|
Vacuum Hold Test
|
Every six month three trials
|
Every day one cycle
|
Test for the presence of non-condensable gases in
pure steam used for steam sterilization
|
Every Six month three trials
|
Once in a Month one trial
|
Every six month three trials
|
Once in a week one trial.
|
|
Empty-chamber heat distribution studies (3 cycles)
|
Every six month three trials
|
Not required
|
Loaded chamber heat distribution and heat
penetration studies. (3 cycle each with specific loading pattern).
|
Every six month three trials for each load
|
Not required
|
3.3 UN-SCHEDULED REVALIDATION
Revalidation
shall be carried out in case of
· Major maintenance of critical parts
· Change of cycle program
·
Inclusion of new load
For
unscheduled revalidation Empty chamber and loaded chamber revalidation shall be
carried out. The pattern of the study shall be based on case to case basis and
properly documented.
thanks for the explanation.
ReplyDeleteshall I know is there any guideline or requirement for the acceptance criteria mentioned here?