YY/T 1268-2015 English PDF (YYT1268-2015)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click YY/T 1268-2015
Historical versions: YY/T 1268-2015
Preview True-PDF (Reload/Scroll if blank)

YY/T 1268-2015: Product adoption and process equivalence for ethylene oxide sterilization
YY/T 1268-2015
YY
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 ind...