Jiangxi Yikang Medical Instrument Group Co., LTD.
1.0 Conclusion
The process validation (IQ, OQ and PQ) for the sterilization systems shown as below has been
completed as protocol (Document#:YKEOSVP1801), and has met the requirements specified in protocol.
•Preconditioning chamber: #4
•Sterilizer: YKS-04
•Aeration room: YKA-01
2.0 Nonconformance and Deviations from the Protocol
There were no nonconformance and deviations from the Protocol.
3.0 IQ Result
3.1 Equipment technical files
The equipment have complete technical files requested by regulations and its operation and
maintenance.
Equipment Technical File Review Form
Equipment description:
•Preconditioning chamber: #4
•Sterilizer: YKS-04
•Aeration room: YKA-01
Acceptance criteria: all the technical files are in place and comply with
related standards and/or regulation if applicable.
Technical file to be verified: Review result
• Business license Pass Fail
• Medical device registration certificate Pass Fail
• Medical device manufacturing permit Pass Fail
• Medical device sanitation permit Pass Fail
• Operation manual Pass Fail
• Sterilization systems diagram Pass Fail
• Installation instruction Pass Fail
• Maintenance procedure Pass Fail
• Safety operation guidance Pass Fail
• Spare parts list Pass Fail
• Product qualification certificate Pass Fail
• Fault conditions Pass Fail
• Instructions for health and safety of personnel Pass Fail
• Conditions for the safe storage of EO Pass Fail
• Purchasing agreement Pass Fail
3.2 Calibration of instruments
Instruments work well and were calibrated within defined interval.
Monitoring and Measuring Instrument Calibration Review Form
Equipment description:
•Preconditioning chamber: #4
•Sterilizer: YKS-04
•Aeration room: YKA-01
Acceptance criteria: All the monitoring & measuring instruments are
calibrated as schedule and valid.
Instrument to be verified: Review result
• Water tank temperature sensor Pass Fail
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Jiangxi Yikang Medical Instrument Group Co., LTD.
• Preconditioning chamber temperature sensor Pass Fail
• Preconditioning chamber humidity sensor Pass Fail
• Sterilizer chamber temperature sensor Pass Fail
• Sterilizer chamber humidity sensor Pass Fail
• Sterilizer chamber pressure sensor Pass Fail
• Sterilizer chamber pressure meter Pass Fail
• EO vaporizer temperature sensor Pass Fail
• EO temperature sensor Pass Fail
• Steam vaporizer pressure meter Pass Fail
• Incubator temperature meter Pass Fail
• Balance Pass Fail
• Aeration room temperature meter Pass Fail
3.3 The main components of equipment were provided as predetermined specification and
installed properly.
Main Components Installation Review Form
Equipment description:
•Preconditioning chamber: #4
•Sterilizer: YKS-04
Acceptance criteria: All the components are provided as specified specification and installed
properly.
Equipment components to be verified: Review result
• Chamber and door construction Pass Fail
• Seals and connections on chamber and piping construction Pass Fail
• Supply systems for gases and liquids (air, steam, EO and water) Pass Fail
• Filters Pass Fail
• Gas circulation systems Pass Fail
• Gas injection systems Pass Fail
• Vacuum systems including pumps, pump cooling systems and piping Pass Fail
• Equipment that detects atmospheric levels of EO Pass Fail
3.4 Electric supply system
Electric supply system were provided as specified specification and installed properly so as to
adequately and consistently supply the power needed for proper equipment and
instrumentation operation.
Electric Supply System Installation Review Form
Item name Specification Proper Safety Correct
compliance installation identification
label
Switches Pass Fail Pass Fail \ Pass Fail
Keystokes Pass Fail Pass Fail \ Pass Fail
Links Pass Fail Pass Fail \ Pass Fail
Sensors Pass Fail Pass Fail \ Pass Fail
Ampere and volt meters Pass Fail Pass Fail \ Pass Fail
Fuse boxes Pass Fail Pass Fail \ Pass Fail
Electric wires Pass Fail Pass Fai \ Pass Fail
Power instruments Pass Fail Pass Fail \ Pass Fail
Heating elements Pass Fail Pass Fail \ Pass Fail
Humidification elements Pass Fail Pass Fail \ Pass Fail
Safe earth-connection Pass Fail Pass Fail Pass Fail Pass Fail
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Jiangxi Yikang Medical Instrument Group Co., LTD.
3.5 Computer system
Computer system were provided as specified specification and installed properly.
Computer system installation review form
Equipment description:
•Preconditioning chamber: #4
•Sterilizer: YKS-04
Acceptance criteria: Computer system shall be
provided as specified specification and installed
properly.
Element to be verified: Review result
• Host computer Pass Fail
• Display Pass Fail
• Printer and connection Pass Fail
3.6 Software
The software used for computer control systems is able to consistently control the entire process in
accordance with the parameters preset.
Equipment description:
•Preconditioning chamber: #4
•Sterilizer: YKS-04
Item Acceptance criteria Check Result
Parameters input and All parameters can be set and adjusted Pass Fail
adjustment properly
Functional keys Functional keys work properly Pass Fail
Temperature alarms Alarms work properly Pass Fail
Pressure alarms Alarms work properly Pass Fail
Preconditioning Time Set at 6h to verify if actual run time is 6h
Preconditioning Set at 52℃ to verify if actual temperature Pass Fail
Temperature
controlled at (52±2)℃
Recording interval Set recording interval at 2min to verify if Pass Fail
parameters are recorded every 2min
Air removal temperature Set air removal temperature at 52℃ to Pass Fail
verify if air removal will not be conducted
until temperature reach up to 52℃.
Depth of vacuum Set vacuum depth at -50 kPa to verify if Pass Fail
the vacuum will be stabilized at (-50±1)
kPa
Vacuum dwell time Set vacuum hold time at 6min to verify if Pass Fail
the dwell time is 6min
Steam admission Check if steam shall be injected properly. Pass Fail
EO injection Check if EO shall be injected properly. Pass Fail
Exposure time Set exposure time at 8h to verify if actual
exposure time is 8h.
Depth of vacuum for Set flushing vacuum depth at -20 kPa to Pass Fail
flushing verify if the vacuum will be stabilized at (-
20±1) kPa
Number of flushing Set number of flushing at 5 to verify if Pass Fail
actual flushing number is 5.
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Jiangxi Yikang Medical Instrument Group Co., LTD.
Water tank temperature Set water tank temperature at 56 to verify Pass Fail
if water tank temperature controlled at
(56±3)℃
3.7 Safety
Equipment description:
•Preconditioning chamber: #4
•Sterilizer: YKS-04
•Aeration room: YKA-01
Acceptance criteria: installation environment complies with the following requirements.
Element to be verified: Review result
• Ventilation device should be equipped with the sterilization area Pass Fail
• Fire source shall be away from the sterilization area at least 30meters Pass Fail
• Sterilization area shall be away from office and dormitory Pass Fail
• EO bottle shall be stored in a temperature controlled individual room Pass Fail
• Use of personal protection devices Pass Fail
• Proper location of installation Pass Fail
3.8 Acceptance Approval of Installation Qualification
The sterilization systems were provided and installed properly.
4.0 OQ Result
4.1 Preconditioning chamber
Result
Process variable Acceptance criteria
Run#1 Run #2
± 3 ℃ of the average (50.1-54.6) ℃ (50.2-54.7) ℃
Preconditioning temperature
recorded temperature
Preconditioning humidity 30%-80% 45.1%-63.9% 46.7%-70.5%
Preconditioning time 6h 6h 6h
4.2 Sterilizer chamber
Result
Process Phase Process variable Acceptance criteria
Run#1 Run #2
Depth of vacuum (-50±1)kPa -50.4 kPa -49.7 kPa
Vacuum time 30min 30 min 30 min
Air removal
Rate of attainment of 1.7 1.7
(1.5-1.8)kPa/min
vacuum kPa/min kPa/min
Vacuum dwell time 10min 10min 10min
Chamber leak test
Pressure change ≤1kPa 0.1Kpa 0.1kPa
Pressure on admission of 12.0kPa 12.3kPa
(10-14)kPa
EO
Pressure rise on 62.3kPa 62.2kPa
(60-64)kPa
admission of EO
EO injection time 30min 30min 30min
EO injection Rate of attainment of 2.1 2.1
specified pressure on ≤2.1kPa/min kPa/min kPa/min
admission of EO
Weight of EO injected 20kg 20kg 20kg
(24.3- (21.5-
EO temperature (15-39) ℃
30.4)℃ 34.2)℃
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±3℃of the (50.2- (49.9-
Exposure temperature average recorded 54.6) ℃ 55.1) ℃
temperature
47.9%- 49.5%-
Sterilization Exposure humidity 30%-80%
70.2% 72.4%
(8.5-12.7) (9.3-12.4)
Exposure pressure (0-14)kPa
kPa kPa
Exposure time 8h 8h 8h
Depth of vacuum to -20.1 kPa -20.3 kPa
(-20±1)kPa
remove EO
Vacuum time 5min 5min 5min
Flushing Rate of attainment of 4 kPa/min 4.1
(3-8)kPa/min
vacuum to remove EO kPa/min
Number of times of 5 5
5
repetition
4.3 Aeration room
Process Phase Process variable Acceptance criteria Result
Aeration Ventilation fans Always working Ventilation fans work properly.
4.4 Acceptance Approval of Operational Qualification
The sterilization systems are capable of delivering the specified process parameters within defined
tolerances, the OQ is successful.
5.0 MPQ result
5.1 BI (internal and external PCDs), product sterility and bioburden incubation result
Cycle Exposure Incubation Result
time PCD Product Sterility Product
3M(self- FUTURE Fungi Aerobic, bioburden
contained) anaerobic
bacteria
1st half 4 hours PCD#1(45) Negative Negative n/a n/a n/a
cycle PCD#2(45) Negative Negative n/a n/a n/a
A(45) n/a n/a Negative Negative Complies
Fractional 3 hours PCD#1(45) 13positive/ 15positive/ n/a n/a n/a
cycle 32negative 30negative
PCD#2(45) 24positive/ 25positive/ n/a n/a n/a
21negative 20negative
A(45) n/a n/a Negative Negative n/a
2nd half 4 hours PCD#1(45) Negative Negative n/a n/a n/a
cycle PCD#2(45) Negative Negative n/a n/a n/a
A(45) n/a n/a Negative Negative n/a
3rd half 4 hours PCD#1(45) Negative Negative n/a n/a n/a
cycle PCD#2(45) Negative Negative n/a n/a n/a
A(45) n/a n/a Negative Negative n/a
Note:
a. Positive controls for all four cycles all have growth.
b. PCD#1(internal PCD), PCD#2(external PCD).
c. “A” stands for Nasal cuffed endotracheal tube, I.D 10.0 (ET-110E1).
5.2 Sterilization validation parameters results
5.2.1 Preconditioning temperature and humidity
Cycle Temperature ,℃ Humidity
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Jiangxi Yikang Medical Instrument Group Co., LTD.
1st half cycle T1: 47.2-50.8 (45.1-72.7)%
T2: 22.2-34.3
Fractional cycle T1: 50.2-53.7 (45.9-69.3)%
T2: 24.2-36.9
2nd half cycle T1: 47.0-50.7 (44.2-68.6)%
T2: 23.3-35.6
3rd half cycle T1：47.3-50.9 (46.5-71.1)%
T2：21.8-32.9
Note:
T1: Preconditioning temperature
T2: Sterilization load temperature at the end of preconditioning
Humidity refers to the relative humidity of the sterilization load at the end of
preconditioning
5.2.2 Sterilization temperature and humidity
Cycle Exposure time Temperature, ℃ Humidity
1st half cycle 4hours T1: 47.2-50.8 (41.4-67.4)%
T2: 23.8-41.6
Fractional cycle 3hours T1: 50.5-54.0 (42.0-65.5)%
T2: 25.9-42.7
2nd half cycle 4hours T1: 47.1-50.9 (44.1-67.9)%
T2: 24.5-41.5
3rd half cycle 4 hours T1：47.3-50.9 (43.9-66.8)%
T2：22.4.4-40.9
Note:
T1: Chamber temperature
T2: Sterilization load temperature during exposure
Humidity refers to the relative humidity of the sterilization load during
exposure
5.2.3 Remaining parameters for half cycles
Acceptance 1st half 2nd half 3rd half
Process Phase Process variable
criteria cycle cycle cycle
Temperature of loads ≤10℃ ≤10℃ ≤10℃ ≤10℃
before preconditioning
Preconditioning
Preconditioning time 6h 6h 6h 6h
Transfer time 30min 30min 30min 30min
Depth of vacuum (-50±1)kPa -49.8kPa -50.2kPa -50.0kPa
Vacuum time 30min 30min 30min 30min
Air removal
Rate of attainment of (1.5- 1.7kPa/min 1.7kPa/min 1.7kPa/min
vacuum 1.8)kPa/min
Chamber leak Vacuum dwell time 10min 10min 10min 10min
test Pressure change ≤1kPa 0.1kPa 0.1kPa 0.1kPa
Pressure on admission of (6-11)kPa 10.2kPa 10.5kPa 10.7kPa
EO injection EO
Pressure rise on admission (56-61)kPa 59.9kPa 60.6kPa 60.6kPa
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of EO
EO injection time 30min 30min 30min 30min
Rate of attainment of ≤2.1kPa/min 2kPa/min 2kPa/min 2kPa/min
specified pressure on
admission of EO
Weight of EO injected 19kg 19kg 19kg 19kg
EO temperature (15-39) ℃ (23-34) ℃ (25-36) ℃ (24-35) ℃
(-4-11) kPa (3.9- (4.3-10.2) (4.6-10.4)
Exposure pressure
10.6)kPa kPa kPa
Sterilization Exposure time 4h 4h 4h 4h
Depth of vacuum to remove (-20±1)kPa -20.3kPa -19.7kPa -20.3kPa
EO
Vacuum time (3-5)min 5min 5min 5min
Flushing Rate of attainment of (3- 4.1kPa/min 3.9kPa/min 4.1kPa/min
vacuum to remove EO 8)kPa/min
Number of times of 5 5 5 5
repetition
5.2.4 Remaining parameters for fractional cycle
Acceptance Fractional
Process Phase Process variable
criteria cycle
Temperature of loads before ≥10℃ ≥10℃
preconditioning
Preconditioning
Preconditioning time 6h 6h
Transfer time 30min 30min
Depth of vacuum (-50±1)kPa -50.3kPa
Vacuum time 30min 30min
Air removal
(1.5- 1.7kPa/min
Rate of attainment of vacuum
1.8)kPa/min
Vacuum dwell time 10min 10min
Chamber leak test
Pressure change ≤1kPa 0.1kPa
Pressure on admission of EO (10-14)kPa 13.7kPa
Pressure rise on admission of (60-64)kPa 63.9kPa
EO
EO injection time 30min 30min
EO injection
Rate of attainment of specified ≤2.1Kpa/min 2.1kPa/min
pressure on admission of EO
Weight of EO injected 20kg 20kg
EO temperature (15-39) ℃ (25-36) ℃
(0-14) kPa (6.6-13.4)
Sterilization Exposure pressure
kPa
Exposure time 3h 3h
Depth of vacuum to remove EO (-20±1)kPa -20.2kPa
Vacuum time (3-5)min 5min
Flushing Rate of attainment of vacuum to (3-8)kPa/min 4kPa/min
remove EO
Number of times of repetition 5 5
6.0 PPQ result
6.1 BI (External PCDs) incubation result
Cycle Exposure External PCD incubation result
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time 3M(self-contained) FUTURE
1st full cycle 8 hours PCD#2(45) Negative Negative
2nd full cycle 8 hours PCD#2(45) Negative Negative
3rd full cycle 8 hours PCD#2(45) Negative Negative
Note: Positive controls for all three cycles all have growth.
6.2 Process parameters result
6.2.1 Preconditioning temperature and humidity
Cycle Temperature ,℃ Humidity
1st full cycle T1: 50.2-53.9 (44.5-69.3)%
T2: 23.9-36.4
2nd full cycle T1: 50.3-53.8 (44.3-67.8)%
T2: 24.3-35.7
3rd full cycle T1: 50.2-53.8 (43.6-66.9)%
T2: 23.5-34.9
Note:
T1: Preconditioning temperature
T2: Sterilization load temperature at the end of preconditioning
Humidity refers to the relative humidity of the sterilization load at the end of
preconditioning
6.2.2 Sterilization temperature and humidity
Cycle Exposure time Temperature, ℃ Humidity
1st full cycle 8hours T1: 50.1-54.0 (43.1-67.5)%
T2: 27.2-49.5
(cold point: 9H)
2nd full cycle 8hours T1: 50.2-53.9 (44.6-66.6)%
T2: 26.4-48.9
(cold point:9H)
3rd full cycle 8hours T1: 50.4-53.7 (42.9-68.2)%
T2: 25.7-49.6
(cold point: 11E)
Note:
T1: Chamber temperature
T2: Sterilization load temperature during exposure
Humidity refers to the relative humidity of the sterilization load during
exposure
Cold point: during routine sterilization PCD shall be placed at a clod point.
6.2.3 Remaining parameters
Acceptance 1st full cycle 2nd full 3rd full cycle
Process Phase Process variable
criteria cycle
Temperature of ≥10℃ ≥10℃ ≥10℃ ≥10℃
loads before
preconditioning
Preconditioning
Preconditioning 6h 6h 6h 6h
time
Transfer time 30min 30min 30min 30min
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Jiangxi Yikang Medical Instrument Group Co., LTD.
Depth of vacuum (-50±1)kPa -50.0kPa -50.2kPa -49.8kPa
Vacuum time 30min 30min 30min 30min
Air removal
Rate of attainment (1.5- 1.7kPa/min 1.7kPa/min 1.7kPa/min
of vacuum 1.8)kPa/min
Chamber leak Vacuum dwell time 10min 10min 10min 10min
test Pressure change ≤1kPa 0.1kPa 0.1kPa 0.1kPa
Pressure on (10-14)kPa 13.5kPa 13.1kPa 13.4kPa
admission of EO
Pressure rise on (60-64)kPa 63.4kPa 63.2kPa 63.1kPa
admission of EO
EO injection time 30min 30min 30min 30min
Rate of attainment ≤2.1Kpa/min 2.1kPa/min 2.1kPa/min 2.1kPa/min
EO injection
of specified
pressure on
admission of EO
Weight of EO 20kg 20kg 20kg 20kg
injected
EO temperature (15-39) ℃ (23-35) ℃ (24-36) ℃ (22-35) ℃
(0-14) kPa (3.6-13.3) (4.0-13.4) (4.1-13.6)
Sterilization Exposure pressure
kPa kPa kPa
Exposure time 8h 8h 8h 8h
Depth of vacuum to (-20±1)kPa -20.3kPa -20.4kPa -20.3kPa
remove EO
Vacuum time (3-5)min 5min 5min 5min
Rate of attainment (3-8)kPa/min 4.1kPa/min 4.1kPa/min 4.1kPa/min
Flushing
of vacuum to
remove EO
Number of times of 5 5 5 5
repetition
Aeration Ambient Ambient Ambient Ambient
temperature temperature temperature temperature temperature
Aeration time 7days 7days 7days 7days
Aeration
Ventilation Ventilation Ventilation Ventilation
Air change rate fans always fans always fans always fans always
working working working working
7.0 Acceptance Approval of Performance Qualification
The sterilization systems are able to consistently operate in accordance with predetermined
specification and the process produces product that is sterile and the SAL is 10-6, the PQ is successful.
8.0 Summary
We perform the validation according to the validation protocol, and the validation results comply with the
predetermined acceptance criteria. The validation is successful. Detailed result is shown as follows:
a. The sterilization systems installation comply with the specified requirements, IQ is successful.
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b. The sterilization systems are capable of delivering the specified process within defined tolerances，
and Ancillary systems & software used for computer control systems is able to consistently control
the entire process in accordance with the parameters preset, OQ is successful.
c. PQ-Microbiological
The sterilization process, under anticipated conditions including process parameters, loading pattern
and packaging, can consistently produce a product which meets the requirements for sterility, PQ-
Microbiological is successful. Result as follows:
For half cycles, internal and external PCDs and products have no growth; for fractional cycle with 3-
hour exposure, PCDs has growth, products have no growth, and the resistance of product bioburden,
internal PCD and external PCD is product bioburden<internal PCD<external PCD.
d. PQ-Physical
The sterilization systems can consistently operate in accordance with predetermined criteria and
produces products that are stile, PQ-physical is successful. Results as follows：
For 3 full cycles, process parameters fall into predetermined criteria, and external PCDs have no growth.
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