YY 1277-2023 English PDF (YY1277-2023)

Delivery: 2 working-hours manually (Sales@ChineseStandard.net)
Need delivered in 3-second? USA-Site: YY 1277-2023
Get Quotation: Click YY 1277-2023 (Self-service in 1-minute)
Historical versions (Master-website): YY 1277-2023
Preview True-PDF (Reload/Scroll-down if blank)

YY 1277-2023: Steam sterilizer - Performance requirements for biosafety
YY 1277-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.080.10
CCS C 47
Replacing YY 1277-2016
Steam sterilizer - Performance requirements for biosafety
ISSUED ON: SEPTEMBER 5, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 6
5 Test methods ... 8
Appendix A (Informative) Installation of the biological seal ... 12
Appendix B (Informative) Guide to the drainage safety test method ... 15
Appendix C (Informative) Guide to the exhaust safety test method ... 17
References ... 18
Steam sterilizer - Performance requirements for biosafety
1 Scope
This document specifies the biosafety performance requirements for pressure steam
sterilizers (hereinafter referred to as sterilizers) and describes the corresponding test
methods.
This document applies to the sterilization of materials, instruments, utensils, culture
media, waste and other items for the purpose of biosafety, so as to prevent the
contamination of personnel, animals, plants or the environment by pathogenic factors
transmitted by aerosols and other means.
The sterilizers specified in this document are generally used in laboratories or other
places with biosafety requirements and biosafety level II or above.
This document does not specify safety requirements related to the risk range of use, nor
does it specify requirements for validation and routine control of moist heat sterilization.
This document is not applicable to the sterilization of confined liquids.
2 Normative references
The provisions of the following documents constitute the essential clauses of this
document through normative references in this text. Among them, for referenced
documents with dates, only the versions corresponding to the dates are applicable to
this document; for referenced documents without dates, the latest versions (including
all amendments) are applicable to this document.
GB 18281.3 Sterilization of health care products - Biological indicators - Part 3:
Biological indicators for moist heat sterilization processes
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 biosafety
The hazards or potential risks caused by various biological factors to the country,
society, economy, people's health and ecological environment.
3.2 containment area
Areas with relatively high biological risks, where the airtightness of the enclosure
structure, airflow, personnel entry, and individual protection are controlled.
3.3 non-containment area
Areas with relatively low biological risks, which also refer to areas outside the
containment area.
4 Requirements
4.1 Double door interlock
Double-door sterilizers shall be equipped with double-door interlocking devices. In
normal use, the double doors cannot be unsealed at the same time. After the door on the
containment area side is unsealed, an effective sterilization cycle shall be carried out
before the door on the non-containment area side can be unsealed.
4.2 Instruments and display devices
4.2.1 For sterilizers used in laboratories or other places with a biosafety level of level 3
or 4, the sterilization chamber pressure gauge and pressure sensor shall be of diaphragm
type.
4.2.2 The display device on the non-containment area side of the double-door sterilizer
shall be able to display the cycle operation status.
4.3 Control system
The use authority of the control system shall be managed at level three or above.
4.4 Alarm
4.4.1 Abnormal alarm of exhaust gas filter
For sterilizers used in laboratories or other places with a biosafety level of level 3 or 4,
the manufacturer shall specify the range of pressure difference between the front and
rear ends of the exhaust gas filter; when the pressure difference between the front and
rear ends exceeds or falls below the set value, the sterilizer shall alarm.
4.4.2 Abnormal alarm of external utility facilities
4.4.2.1 The manufacturer shall specify the pressure range of the external steam source;
when the pressure of the external steam source exceeds the specified range, the sterilizer
shall alarm.
4.4.2.2 The manufacturer shall specify the external water source pressure range; when
the external water source pressure exceeds the specified range, the sterilizer shall alarm.
4.4.2.3 The manufacturer shall specify the external compressed air pressure range;
when the external compressed air pressure exceeds the specified range, the sterilizer
shall alarm.
4.5 Data transmission
Sterilizers used in laboratories or other places with a biosafety level of level 3 or 4 shall
have data transmission systems and data transmission interfaces. Data can be
transmitted through wired communication (such as Ethernet, fax, and audio and video
monitoring) or wireless communication.
4.6 Drainage safety
4.6.1 The sterilizer shall be equipped with a sampling interface for condensed water
discharged from the sterilization chamber.
4.6.2 The condensed water discharged from the sterilization chamber shall be sterile.
4.7 Exhaust safety
4.7.1 For sterilizers used in laboratories or other places with a biosafety level of level
2, it shall be determined whether the exhaust gas from the sterilization chamber uses a
sterilization device based on the risk assessment results. If necessary, the exhaust gas
from the sterilization chamber shall pass through at least a one-stage sterilization device,
and the exhaust gas from the sterilization chamber shall be sterile.
4.7.2 For sterilizers used in laboratories or other places with a biosafety level of level
3, the exhaust gas from the sterilization chamber shall pass through at least a one-stage
sterilization device, and the exhaust gas from the sterilization chamber shall be sterile.
4.7.3 For sterilizers used in laboratories or other places with a biosafety level of level
4, the exhaust gas from the sterilization chamber shall pass through at least a two-stage
sterilization device, and the exhaust gas from the sterilization chamber shall be sterile.
4.7.4 If a high-efficiency filter is used as a sterilization device for the exhaust gas, the
filter shall meet the following requirements:
a) The filtration efficiency of particles with a diameter of 0.2 μm shall not be less
than 99.99%;
b) Be able to withstand high-temperature steam not less than 140 ℃;
c) Use hydrophobic filter element;
5.2 Instrument and display device test
5.2.1 For sterilizers used in laboratories or other places with a biosafety level of level 3
or 4, refer to the quality certification documents of the pressure gauge and pressure
sensor provided by the manufacturer to determine whether the diaphragm type is used.
5.2.2 Run the sterilizer program and check whether the display device in the non-
containment area of the double-door sterilizer can display the cycle operation status.
5.3 Control system test
Check whether the use authority of the control system is managed at level three or above.
5.4 Alarm test
5.4.1 Abnormal alarm test of exhaust gas filter
Check whether the manufacturer has specified the range of pressure difference before
and after the exhaust gas filter. Connect a manually adjustable valve in series at the
pressure sensor in front of the exhaust gas filter; when the program runs to the state of
decreasing pressure in the inner chamber, the process of adjusting the valve from open
to closed causes the pressure difference between both ends of the filter to increase.
Connect an adjustable valve in series at the pressure sensor at the rear of the exhaust
gas filter; when the program runs to the state of decreasing pressure in the inner chamber,
the process of adjusting the valve from open to closed causes the pressure difference
between both ends of the filter to decrease. Simulate the pressure difference between
the front and rear ends exceeding or falling below the set value, and check whether the
sterilizer alarms.
5.4.2 Abnormal alarm test of external public facilities
5.4.2.1 Check whether the manufacturer has specified the pressure range of the external
steam source; set the pressure of the external steam source to a value higher or lower
than the specified pressure range and check whether the sterilizer alarms.
5.4.2.2 Check whether the manufacturer has specified the pressure range of the external
water source; set the pressure of the external water source to a value higher or lower
than the specified pressure range and check whether the sterilizer alarms.
5.4.2.3 Check whether the manufacturer has specified the pressure range of the external
compressed air source; set the pressure of the external compressed air source to a value
higher or lower than the specified pressure range, and check whether the sterilizer
alarms.
5.5 Data transmission test
Check the data transmission system and data transmission interface through actual
operation, and check the data transmission method.
5.6 Drainage safety test
5.6.1 Check whether the sterilizer is equipped with a sampling interface for the drainage
from the sterilization chamber.
5.6.2 Perform the sterility test according to the method provided by the manufacturer
or refer to Appendix B for the sterility test.
5.7 Exhaust safety test
5.7.1 Carry out the sterility test according to the method provided by the manufacturer
or refer to Appendix C for the sterility test.
5.7.2 Check the high-efficiency filter as follows:
a) Check the instructions or quality certification documents of the high-
efficiency filter;
b) Perform filter disassembly and assembly operations to check whether a single
person can complete the replacement of filters and components;
c) Place the self-contained biological indicator that complies with GB 18281.3
into the high-efficiency filter through the sterilization effect test interface,
sterilize it in place, then take it out and culture it according to the conditions
specified by the biological indicator manufacturer. The result shall be negative;
d) Check whether the filter has a test interface for sterilization in-place effect;
e) Check whether there is an integrity test interface and use an integrity tester to
check the integrity of the high-efficiency filter.
5.7.3 Check whether the sterilizer is equipped with a sampling port for exhaust gas from
the sterilization chamber.
5.8 Biological sealing structure test
5.8.1 Check the biological sealing structure or device of the double-door sterilizer in
the following manner:
a) Check whether the double-door sterilizer has a biological sealing structure and
whether the biological sealing structure is installed on the side close to the
containment area;
b) Check whether the double-door sterilizer is equipped with a sealing device for
Appendix B
(Informative)
Guide to the drainage safety test method
B.1 Indicator strain
The spore suspension of Geobacillus stearothermophilus (ATCC 7953 or SSIK 31 strain)
with the bacterial content of 5.0×105 CFU/mL~5.0×106 CFU/mL.
B.2 Culture medium
Bromocresol purple glucose peptone water medium.
B.3 Experimental group
B.3.1 Pour a suspension of Geobacillus stearothermophilus at least 1/9 of the volume
of condensed water produced in the sterilization inner chamber when the sterilizer is in
the cold state with no load onto the bottom of the inner chamber of the sterilizer.
B.3.2 Run the sterilization program and when sterilization is completed, exit the
program, taking care to terminate the drainage of the inner chamber to ensure that the
condensed water remains in the inner chamber.
B.3.3 Collect an appropriate amount of condensed water into the sampling device in a
sterile manner.
B.3.4 Perform a sterility test on the collected fluid according to the membrane filtration
method in the sterility test method in Pharmacopoeia of the People's Republic of China
(Volume 4).
B.4 Positive control group
Take an appropriate amount of prepared Geobacillus stearothermophilus spore
suspension as a positive control.
B.5 Negative control group
The test is carried out in reference to the experimental group, using sterile water instead
of the Geobacillus stearothermophilus spore suspension.
B.6 Result determination
The incubation temperature is 56 ℃±1 ℃, and the incubation time is 48 h. There is
Appendix C
(Informative)
Guide to the exhaust safety test method
C.1 Indicator strain
The spore suspension of Geobacillus stearothermophilus (ATCC 7953 or SSIK 31 strain)
with the bacterial content of 5.0×105 CFU/mL~5.0×106 CFU/mL.
C.2 Culture medium
Bromocresol purple glucose peptone water medium.
C.3 Experimental Group
C.3.1 Inject the prepared Geobacillus stearothermophilus suspension into the
sterilization inner chamber by using an aerosol generator.
C.3.2 Maintain the sterilization chamber pressure not less than 30 kPa and collect an
appropriate amount of exhaust gas into the culture medium in a sterile manner.
C.4 Positive control group
Take an appropriate amount of prepared Geobacillus stearothermophilus spore
suspension as a positive control.
C.5 Negative control group
The spore suspension of Geobacillus stearothermophilus is replaced with sterile water
and the test is carried out in reference to the experimental group.
C.6 Result determination
The incubation temperature is 56 ℃±1 ℃, and the incubation time is 48 h. There is
bacterial growth in the positive control group, and no bacterial growth in the negative
control group, otherwise the test is invalid. If there is no bacterial growth in the
experimental group, the test is qualified; otherwise, the test is unqualified.
For inoculation tubes that are difficult to identify visually or suspected of being
contaminated, appropriate microbiological techniques should be used for
microbiological identification.