YY/T 1268-2015 (YY/T 1268-2023 Newer Version) PDF English
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YY/T 1268-2015: PDF in English (YYT 1268-2015) YY/T 1268-2015
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
Product adoption and process equivalence
for ethylene oxide sterilization
ISSUED ON. MARCH 02, 2015
IMPLEMENTED ON. JANUARY 01, 2016
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Product adoption ... 7
5 Process equivalence ... 13
Appendix A (Informative) Evaluation guide for adoption of products to ethylene
oxide product family or ethylene oxide processing group ... 19
Product adoption and process equivalence
for ethylene oxide sterilization
1 Scope
This standard specifies the equivalence of the sterilization process when using
new equipment in the process of adopting new product or changed product into
the originally validated ethylene oxide sterilization process.
This standard applies to medical devices that have been treated by ethylene
oxide (EO) sterilization and that use conventional release or parametric release.
The ethylene oxide sterilization conditions applicable to this standard include.
a) Adding new products to the already validated ethylene oxide sterilization
process;
b) Evaluating the changes to validated products;
c) Transferring the validated process to a different site or equipment;
d) Evaluating the equivalence of the sterilization process.
Although this standard is intended for use in medical devices, its content also
applies to other related products or materials.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene
oxide sterilization residuals
ISO 11135-1.2007 Sterilization of health care products - Ethylene oxide -
Part 1. Requirements for development, validation and routine control of a
sterilization process of formal devices)
components (e.g., drug-containing kits), manufacturers shall, in addition to
considering the impact of the sterilization process on the shelf life of the
contained product, also consider the regulatory requirements for the safety and
efficacy of the product components.
The ethylene oxide process used for product testing shall include
representative challenges to the product and its packaging system (using the
most challenging process parameters). This requirement is detailed in 7.2.1 of
ISO 11135-1.2007. The documentation shall state the difference between the
challenge process and the routine process. For product acceptance, product
qualification shall demonstrate that these parameters are acceptable.
Note. It should evaluate the ethylene oxide residue of the candidate product
and its packaging, as well as the effect of any changes in the two on product
release. GB/T 16886.7 can be used as a guide for this evaluation.
4.3.3 Determination of product design impact
The design of the candidate product shall be reviewed for difficulty change or
difference in the penetration of ethylene oxide, heat or moisture as compared
to existing product or process challenge devices. Examples of possible
changes include longer lumens, increased closure or more binding surfaces.
Review of product design and initial product’s functional testing are to ensure
that these changes do not adversely affect the functionality of the product.
Note. This evaluation usually does not include the surface of the instrument that
is sealed and not exposed during the intended use, such as. sealed, hollow,
molded or closed cavity components.
4.3.4 Determination of the impact of product materials and characteristics
It shall check any differences in the characteristics of the candidate product that
potentially affect the bioburden of the product, such as manufacturing methods,
equipment, locations, and types and sources of raw materials. It shall review
the composition of the material, to ensure that the product does not maintain a
higher residue level or a residual level that exceeds the specified limits.
4.3.5 Determination of the impact of sterile barrier system
It shall check any factors that create a barrier to ethylene oxide, heat or moisture
permeation in the sterile barrier system of the candidate product. These factors
can be a reduction in the porosity of the permeable material, a smaller
permeable surface area, a closure of the venting surface, or any other feature
that makes the candidate product more challenging to the sterilization process
than existing product or process challenge devices. In addition, it shall evaluate
the effects of changes in the sterile barrier system on the bioburden of the
accordance with the requirements of Appendix A or Appendix B of ISO 11135-
1.2007, it shall use the sample of the candidate product as well as the existing
product or process challenge device to run at least one short-term period, to
perform this study. If the microbial resistance of the candidate product proves
to be less than or equal to the resistance of the qualified product or process
challenge device, the candidate product may be adopted to the existing
ethylene oxide product family or the ethylene oxide processing group. If the
candidate product fails to demonstrate that the resistance is less than or equal
to the qualified product, at least the microbiological performance qualification is
required to be performed, which does not meet the requirements for being
adopted to the existing ethylene oxide product family or ethylene oxide
processing group.
Note. Comparative resistance studies related to the candidate product and the
process challenge device can be performed in the sterilization chamber for
testing purposes. It shall evaluate the candidate product which affects the load
mode of the sterilization process, to determine the effectiveness of the
sterilization chamber for production and the sterilization chamber for testing
purposes.
4.4.3 Study of temperature and humidity distribution
If the technical review indicates that the candidate product may affect the
loading thermodynamic response of the sterilization process, it can perform a
study of temperature and humidity distribution, to evaluate the candidate
product. Distribute the temperature and humidity sensors to the entire
sterilization load based on its initial performance qualification methods, run at
least one cycle to implement this study. If the temperature and humidity
response of the candidate product is comparable to the temperature and
humidity of the existing product or proves to have no adverse effect on the
existing load, the candidate product may be adopted to the existing ethylene
oxide product family or ethylene oxide processing group. If the above results
are not available during loading, at least microbial performance qualification is
required.
The results of the distribution studies may indicate that products that have
limitations on temperature or humidity require further product qualification or
changes to the sterilization process to meet these limits. Although it does not
affect the sterility of the product, it may require performance qualification in this
case.
4.4.4 Study of residue
If the technical review indicates that the candidate product is more challenging
in removing the biocide residue, it may perform a residue study, to evaluate the
candidate product. The study is conducted by performing a complete
a) In accordance with the requirements of ISO 11135-1.2007, implement a
complete sterilization process validation in at least one existing system;
b) Prove and document that all equipment has been installed in accordance
with the equipment specification and run the study on installation
qualification and operational qualification performance in accordance with
the corresponding requirements;
c) Include the allowed tolerances and the process definition of documents at
various stages of the process;
d) Process data analysis related to the tolerances validated for the candidate
equipment and the initial equipment (see 5.3.2).
5.3 Determination of process equivalence
5.3.1 Overview
Compare the data obtained by running the same validated process on each
equipment, to establish the sterilization process equivalence that is delivered
between different equipment. This comparison shall include an evaluation of
the reproducibility ability of the equipment to deliver the expected process
parameters, during loading sterilization in routine production, it may also use
the process data obtained using performance qualification. The parameters and
tolerances delivered shall be the data obtained from the performance
qualification of the initial equipment for the sterilization process.
Equivalence evaluation includes implementation of process analysis and
evaluation, as well as microbiological evaluation.
5.3.2 Process analysis and evaluation
5.3.2.1 Overview
Perform data analysis related to the validated process of the candidate
equipment and initial equipment. Process data shall be collected from the
candidate equipment. These data shall be compared to the range of parameters
for a particular sterilization process as well as the data obtained during the initial
equipment performance qualification process. Establish a range of parameters
for the sterilization process (including all process requirements identified by ISO
11135-1.2007) during initial validation in existing equipment. These
specifications, acceptance criteria, trays or load configurations shall be identical
to the requirements as specified by the initial performance qualification.
Generally, in the equivalent confirmation, the actual parameters to be evaluated
are a subset of the entire process specification. The parameters and the
principles selected shall be documented. Statistical methods for evaluating the
concentration trend of test data and data dispersion can be used for this
2) The temperature inside the cabinet at the selected time point in the
sterilization cycle (for example, the end of the processing or the start of
gas residence);
3) Ethylene oxide concentration (if measured) in the sterilizer at the
selected time point during the gas residence phase of the sterilization
cycle, or gas pressure increase or gas weight.
Other parameters that can be considered include.
1) The depth and rate of evacuation at selected points during the process
of sterilization cycle;
2) The number of times of moisture injection and the rate of moisture
injection;
3) The gas injection temperature and rate as well as the gas usage (mass,
concentration or pressure);
4) The injection rate of air or nitrogen.
Process data analysis is used to indicate that these processes are equivalent
or not equivalent within their capabilities, to meet the existing process
parameter ranges and any additional acceptance criteria. It shall use a format
analysis and assembly of the resulting data for the determination of future
process equivalence.
5.3.3 Microbiological evaluation
During the microbiological evaluation process, run a short cycle or half cycle to
demonstrate that in all evaluated equipment, the sterilization process is capable
of delivering the specified minimum sterility assurance level.
Note. In the process analysis, if the running period is a short cycle or half cycle
and includes microbiological monitoring, these data can also be used for this
evaluation.
In addition to evaluating the delivery of the minimum sterility assurance level,
other factors including the change of sterilization location or manufacturing sites
which affect the bioburden level of the terminally sterilized product shall also be
evaluated. Increased distances between production facilities and sterilization
sites may result in higher bioburden levels, especially for products that support
microbial growth. Even though for products that do not support microbial growth,
the difference of the production environment of products may also result in a
bioburden of more or stronger resistance of the manufactured products as
compared with the qualified products. Another problem to be evaluated is the
different transport conditions for transporting products between different
can be claimed to be equivalent to the existing sterilization process equipment
shall be documented. The document shall at least include.
a) Complete specifications of the candidate equipment. detailed description
of the equipment, operating specifications, tolerances and reference
documents or a list of applicable operating procedures, calibration
procedures and maintenance plans. According to the requirements of ISO
11135-1.2007, the specification shall include or refer to the current
installation qualification;
b) The equipment provides proof of capability or evaluation of the expected
process. According to the requirements of ISO 11135-1.2007, the proof or
evaluation shall include or refer to the current operational qualification;
c) Results of comparison of the candidate process equipment and the
existing validated process equipment. This comparison shall clearly
demonstrate that all major systems and key parameters have been
evaluated, including statistical analysis (if used);
d) The proof or evaluation of product conditions during the sterilization of the
candidate equipment, to demonstrate equivalence with existing processes;
e) The evaluation results of other factors which may affect the mortality rate
of the sterilization process (if applicable);
f) The candidate equipment is equivalent to the specific equipment
referenced in the current validation study, the conclusion that the specified
sterility assurance level is achieved shall be documented and shall include
or refer to additional test results to supplement the existing validation study,
as well as the validation of the routine release of the product which is
sterilized by the use of existing validated cycle or the further test for the
implementation of qualification (e.g., residue testing, functional testing for
first three batches, etc.);
g) Approval by the sterilization specialist and other personnel as specified
within the organization’s regular change control requirements or process
document control measures;
h) A list of applicable sterilizer operating procedures as well as a list of
approved specifications that have been published or changed for
candidate equipment for routine processing of the product.
...... Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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