Prepared by:- Akshay Auti

Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

1) Qualification shall be done half 1) Validation frequency not 1) Validation frequency not
yearly or yearly (Page no.-12). clearly defined. clearly defined.
1 Validation Frequency
2) Qualification of pure steam shall 2) Qualification of pure steam 2) Qualification of pure steam
be done yearly shall be done yearly shall be done yearly
Chamber Leak Test: A test
When the sterilizer is tested as
conducted to evaluate possible
described in Clause 18 the rate
This test should be carried out in air infiltration to the chamber
VLT (Acceptance criteria: - of pressure rise shall be within
2 accordance with BS EN 285 clause under vacuum (Vacuum leak
0.013 bar per 10 min). the specified limits and in any
18. test).
case shall be not greater than
Acceptance criteria not defined
0.13 kPa/min (1.3 mbar/min.)
in PDA
1) The calibration of thermometric
test equipment should be checked
before and after the thermometric
tests. Temperature sensors should 1) Ensure a measurement
be as described in HTM 01-01 Part B. error not exceeding 0.5 K at
Calibration of
2) The recorder should be accurate the used sterilization
Thermocouple sensor
enough to show clearly whether the PDA TR-01 2007 not clearly temperature.
(Acceptance criteria: -
measured temperatures are within defined the calibration details of 2) The measurement error for
3 difference between the
the band or not. For all the types of thermocouple sensor with a pressure difference of any
thermocouple sensor and
equipment covered by this guidance, acceptance criteria. 1.5 kPa (15 mbar) shall not
master sensor shall be
the repeatability of the recorder exceed 0.1 kPa (1mbar) over
±0.3 degree C
should be ± 0.25ºC or better, and the the pressure range that may
limit of error of the complete occur during the test.
measurement system (including
sensors) should be no more than
0.5ºC. (HTM 01-01 Part B)
1) Bowie dick shall be 1) Class 2 indicators are designed for Air Removal Test: A test used to 1) When the sterilizer is tested
tested to check unwanted use in the Bowie-Dick test for steam evaluate air removal and steam as described in clause 17 the
4 gases or non-condensable penetration. Class 2 indicators for penetration in an empty indicator shall show uniform
gases inside autoclave by the standard towel pack are specified sterilizer that is used for color change throughout the
using bowie dick test kit in BS EN ISO 11140-3. Alternative porous/hard goods load indicator in accordance with

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

about 100 to 200mm indicators for use in the Bowie-Dick sterilization (E.q. Bowie-Dick EN ISO 11140-3 : 2009 and the
above the drain point. test are test) instructions for the use of the
2) Color shall be change if specified in BS EN ISO 11140-4 (Page indicator.
there is no unwanted No. 19). 2) According to EN ISO 11140-
gases present in 3 : 2009
autoclave. Color change
from purple to black.
The time control and
indicating equipment shall be
Time Operation
graduated in hours, minute
verification Between HMI
and seconds as applicable and
5 and vendor data logger Not defined in HTM Guideline Clearly not defined in PDA
have a measurement error not
shall not be more than
exceeding 1% of each defined
1%.
time interval of the operating
cycle. (Page no.-29)
1) This test is used to demonstrate
that the operating cycle, without The following may be
extended drying, will not cause an considered to increase drying When the sterilizer is tested as
increase in moisture in a standard efficiency: heating, deep described in 20.1 (Load
Load dryness Test (At
test pack sufficient for there to be vacuum, pulsing or a dryness, small load, textiles)
6 present not include in
uncertainty about the dryness of combination of these processes. the mass of the test pack shall
protocol)
loads routinely processed. Typically, a key parameter for not increase by more than 1%.
2) This test should be carried out in load items with specific drying (Page no.-37).
accordance with BS EN 285 clause needs
20.
Empty chamber heat During an operating cycle, with an Empty chamber heat Empty chamber heat
distribution study. empty chamber, checks should be distribution study not defined in distribution study not defined
1) Temperature made that the following PDA TR-01 2007 but the in EN 285 2015 but the
7 uniformity is acceptable recommendations are met (several acceptance criteria same as acceptance criteria same as
from 121.0°C to 124.0°C cycles may be necessary to complete loaded chamber heat loaded chamber heat
during sterilization hold all the checks): distribution come penetration distribution come penetration
time. 1) the selection of automatic or study study

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

2) The temperature of an manual control is by key code or 1) Variation in the temperature 1) The sterilization
individual sensor does not tool; measured by each probe. temperature band shall have
fluctuate by more than ± 2) the selection of one control mode 2) Variation in the temperature the lower limit defined by the
1°C during sterilization inactivates the other control mode; measured from probe to probe. sterilization temperature and
hold time. 3) water, steam or compressed air 3) Difference in temperature an upper limit of +3 k. (page
3) The temperature cannot be admitted into the between the probes and the set no. 35).
between all sensors does chamber when the equipment is temperature. 2) The equilibrium time shall
not fluctuate by more under automatic control until the 4) Minimum Fo value is 21.2 not exceed 15 s for sterilizer
than ± 2°C during door is closed, locked and sealed; minute should kill the BIs to a chamber up to 800 L unable
sterilization hold time. 4) the operating cycle cannot start PNSU of 1.0 in 100. space and 30 s for large
4) Equilibration time not until the door is closed, locked and 5) Equilibrium time is the period sterilizer chambers. (page no.
more than 15 Sec. sealed; that elapses between 35).
5) Minimum FO value 5) the cycle may be advanced attainment of the minimun 3) Temperature difference
shall not be less than 20 sequentially under manual control – specified sterilizing temperature from one probe not differ
minutes for 20 minutes this function should be protected by in the chamber. from another by more than 2
hold time. password/code entry; 6) Equilibrium time not defined K.
6) Minimum FO value 6) the indicated and recorded values clearly in this guideline. 4) Within probe difference
shall not be less than 30 of 7) Temperature difference not define in EN 285 2015.
minutes for 30 minutes cycle variables are within the limits between probe to probe and 5) Door opening temperature
hold time. specified by the manufacturer within probe not defined clearly not defined in EN 285 2015
7) A visual indication of throughout the cycle; in this guideline.
the cycle completion 7) there are no leaks of water, steam 8) Door opening temperature
should be there. aerosols, air, gas or effluent not defined in PDA TR-01 2007.
throughout
the cycle.
8) there is no evidence of
interference to or from other
equipment connected to the same
services;
9) operation and reading of all
instruments appears to be
satisfactory;

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

10) the temperature of surfaces

routinely handled by the operator
does not exceed 55ºC;
11) the effluent temperature does
not
exceed that recommended in HTM
01-01 Part B.
12) Temperature not differ from one
another by more than 2ºC.
13) the indicated and recorded
chamber
pressures are within 0.05 bar of the
measured pressure.
14) The equilibration time begins
when the
temperature in the reference point
(that is, the
point where the cycle control
temperature
sensor is situated) first attains the
sterilization temperature. It ends
when the holding time begins.
(Equilibrium time not defined clearly
in HTM PART-C 2016).
15) the equilibration time
determined from the measured
temperatures does not exceed 15
seconds for chambers up to 800 I
and 30 seconds for larger chambers
(According to HTM PART-3 2010);
16) Within probe difference not
defined (HTM PART-C 2016).

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

17) Minimum and maximum Fo not

defined in this guideline. (HTM PART-
C 2016).
18) The door opening system cannot
be operated until the chamber has
been vented to atmosphere and the
chamber pressure is within 200 mbar
of atmospheric pressure;
19) A temperature of 80°C is
regarded as a safe maximum at
which the door can be opened. The
door cannot be opened until the
temperature inside all the containers
has fallen below 80°C. Failure to
observe this requirement has led to
serious accidents resulting from the
explosion of glass containers. (HTM
TM-01 2010)
During the holding time- 1) The full-load test is designed to 1) Variation in the temperature 1) In loaded chamber
1) Temperature demonstrate that, at the levels at measured by each probe. temperature sensor and
uniformity is acceptable which cycle variables are set, rapid 2) Variation in the temperature pressure intrument use.
from 121.0°C to 124.0°C and even penetration of steam into measured from probe to probe. 2) Seven temperature probe
during sterilization hold the centre of a load occurs, and the 3) Difference in temperature use for loaded chamber.
time. sterilizing condition is achieved in a between the probes and the set 3) The sterilization
2) The temperature of an test load of specified maximum mass temperature. temperature band shall have
8
individual sensor does not and of sufficient size to fill the usable 4) Minimum Fo value is 21.2 the lower limit defined by the
fluctuate by more than ± chamber space. minute should kill the BIs to a sterilization temperature and
1°C during sterilization 2) This test should be carried out in PNSU of 1.0 in 100. an upper limit of +3 k. (page
hold time. accordance with BS EN 285 clause 5) Equilibrium time is the period no. 35).
3) The temperature 16.2. (According to HTM PART-C that elapses between 4) The equilibrium time shall
between all sensors does 2016) attainment of the minimun not exceed 15 s for sterilizer
not fluctuate by more than 3) Place 12 temperature sensors in specified sterilizing temperature chamber up to 800 L unable

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015
± 2°C during sterilization the following positions: (According to in the chamber. space and 30 s for large
hold time. HTM PART-3 2010). 6) Equilibrium time not defined sterilizer chambers. (page no.
4) Equilibration time not a. one in an active chamber clearly in this guideline. 35).
more than 15 Sec. discharge (see paragraph 6.26); 7) Temperature difference 5) Temperature difference
5) Minimum Fo value (According to HTM PART-3 2010). between probe to probe and from one probe not differ
shall not be less than 20 b. five on each of the two chamber within probe not defined clearly from another by more than 2
minutes for 20 minutes side walls (one at the approximate in this guideline. K.
hold time.
centre and four adjacent to the 8) Door opening temperature 6) Within probe diference not
6) Minimum Fo value
corner positions of the usable not defined in PDA TR-01 2007. defind in EN 285 2015.
shall not be less than 30
minutes for 30 minutes chamber space); (According to HTM 7) Door opening temperature
hold time. PART-3 2010). not defined in EN 285 2015
c. one on the plane of the usable
chamber space (not on the wall) at a
point nearest to the steam inlet port.
(According to HTM PART-3 2010).
4) During the holding time:
(i) the measured temperatures are
within the sterilization temperature
band specified for the operating
cycle;(According to HTM PART-3
2010).
(ii) the indicated and recorded
chamber temperatures are within
2°C of the
temperature measured in the active
chamber discharge; (According to
HTM PART-3 2010).
(iii) the temperature measured in
each load item does not fluctuate
more than ± 1°C, and does not differ
from that in other load items by
more

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

than 2°C;(According to HTM PART-3

2010).
(iv) the indicated and recorded
chamber pressures are within 0.05
bar of the measured pressure;
(According to HTM PART-3 2010).
d. at the end of the cycle:
(i) the temperature sensors have
remained in position;(According to
HTM PART-3 2010).
(ii) the items containing sensors are
intact; (According to HTM PART-3
2010).
(iii) the temperature measured in
any fluid containers is not greater
than 90°C (plastic) or 80°C
(glass).(According to HTM PART-3
2010).
1) In practice, loading conditions 1) Two principal sterilization
specified in the thermometric tests cycle design approaches that
for small and full loads carried out may be used for the
during commissioning are designed development of sterilization
to be representative of the nature of processes are the overkill design
production loads. It depend upon approach and the product Load design/development not
9 Load Design/development
Time of sterilization and size of specific design approach. Both defined by EN 285 2015
autoclave (According to HTM PART-C of these approaches are able to
2016) provide the same level of
2) Guidance on the design of loading sterility assurance to the
conditions to achieve efficient product or material to be
sterilization can be found in Part 4 of sterilized.

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

this SHTM. 2) Describe the load type like

3) Loads consisting of small Porous/hard load e.g.
containers, such as vials and i) Filters (disc membrane,
ampoules, have a large surface-area- cartridge membrane, depth
to-volume ratio and therefore will filter.
cause steam to condense rapidly ii) Stoppers and other polymeric
during the heat-up stage. Where closure material.
steam is admitted to the chamber iii) Tubing and hoses.
through a single inlet, it will first iv) Garments.
condense on the ampoules nearest v) Cleaning equipment.
to the inlet and these will vi) Machine change parts.
consequently heat up faster than (Filters should be sterilized
those further from the inlet. This will according to
produce a large difference in manufacturer’s
temperature across the chamber and recommendations).
an extended equilibration time. This 3) Liquid-filled containers e.g
is acceptable provided that the i) Formulation (solution,
product can withstand the extended suspensions and / or emulsion in
heating experienced by the their final container (e.g., vial,
ampoules bag, bottle, ampoule or syringe.
near the steam inlet and the ii) Post-test or post-process
ampoules slowest to heat up are waste fluids containing
correctly identified for the potentially pathogenic
thermometric PQ test. (According to microorganism.
HTM PART-4 2010).
4) Where the product cannot
withstand this extended heating, the

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Sr. No. Test Parameter HTM TM-01 2016 PDA TR-01 2007 EN 285 2015

size of the load should be reduced so

that it can be placed further from the
steam inlet. A sterilizer with multiple
inlets is the preferred solution
(According to HTM PART-4 2010)

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