YY/T 0618-2017 PDF English
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Test methods for bacterial endotoxins of medical devices - Routine monitoring and alternatives to batch testing
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Bacterial endotoxins. Test methodologies, routine monitoring, and alternatives to batch testing
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YY/T 0618-2017: Test methods for bacterial endotoxins of medical devices - Routine monitoring and alternatives to batch testing
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0618-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.01
C30
Replacing YY/T 0618-2007
Test methods for bacterial endotoxins of medical devices -
Routine monitoring and alternatives to batch testing
Issued on. FEBRUARY 28, 2017
Implemented on. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 Principles of quality management system... 11
5 Non-pyrogenic label... 13
6 Selection of product unit... 14
7 Choice of technique... 15
8 Methodological validation... 15
9 Use of technique... 20
10 Alternatives to batch testing... 24
Appendix A (Informative) Background information on bacterial endotoxin testing.. 28
Appendix B (Informative) Guidelines for test methods, routine monitoring, alternatives
to batch testing... 32
Appendix C (Informative) Out-of-specification (OOS) and failure investigation guide
... 50
References... 53
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0618-2007 "Bacterial endotoxins - Test methodologies
routine monitoring and alternatives to batch testing". The main differences from YY/T
0618-2007 are as follows.
- MODIFY the name of the standard into. Test methods for bacterial endotoxins of
medical devices - Routine monitoring and alternatives to batch testing;
- MODIFY the scope;
- ADD the terms, Control standard endotoxin (see 3.4); geometric mean endpoint
(see 3.11); investigation test (see 3.14); out of specification (see 3.21);
- MODIFY "Appendix B -- Test methods, routine monitoring and guidelines for
alternative to batch testing";
- ADD "Appendix C -- Out of specification (OOS) and failure investigation
guidelines".
Please note that some content of this document may be patented. The issuing authority
of this document assumes no responsibility for identifying these patents.
This standard was proposed by the China Food and Drug Administration.
This standard shall be under the jurisdiction of the National Standardization Technical
Committee for Biological Evaluation of Medical Devices (SAC/TC 248).
Drafting organizations of this standard. Shandong Medical Device Product Quality
Inspection Center, Tianjin Medical Device Quality Supervision and Inspection Center
of the China Food and Drug Administration, Shanghai Songli Biotechnique Co., Ltd.
The main drafters of this standard. Sun Lingxiao, Wang Xin, Zhu Lili, Jiang Hua, He
Hongbing, Wu Xujun.
This standard replaces the standard previously issued as follows.
- YY/T 0618-2007.
1 Scope
This standard specifies basic guidelines for test methods for bacterial endotoxins, which
are applicable to the determination of medical devices, components or raw materials.
Note. Although the scope of this standard is limited to medical devices, the requirements
specified in this standard and the guidelines given may also apply to other medical products.
This standard does not apply to the evaluation of pyrogens, other than bacterial
endotoxin.
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) is
applicable to this standard.
Pharmacopoeia of the People's Republic of China 2015 Edition
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Bacterial endotoxin test; BET
Tests for the determination of active bacterial endotoxins, by mixing a liquid test
sample with Limulus amebocyte lysate, wherein the results of proportional
responses are measured by visual inspection, turbidity, chromogenic or other
validated test methods.
3.2
Batch
A specified quantity of raw material, intermediate or finished product, which is
expected or claimed to be produced in a specified production cycle with uniform
characteristics and quality.
3.3
Chromogenic technique
A BET method, for quantification or detection of endotoxin, based on the principle
that the measured color reaction is proportional to the reaction -- between the limulus
amebocyte lysate and endotoxin.
3.4
Control standard endotoxin; CSE
Endotoxin preparations, which are calibrated on the basis of national standards.
3.5
Depyrogenation
Validated process for removing or inactivating endotoxins.
4 Principles of quality management system
4.1 Document formation
4.1.1 The bacterial endotoxin test procedure shall be described in detail.
4.1.4 Calculations and data transfer shall be properly controlled. If electronic data is
used, the software used shall be validated and a record of validation shall be kept.
4.2 Management responsibilities
4.3 Product realization
The steps for procurement shall be detailed. These steps shall be consistent with the
quality management system requirements.
4.4 Personnel
4.5 Equipment
4.5.1 All equipment which is required for the proper conduct of the specified tests, shall
be available. The planned maintenance and calibration shall be carried out, in
accordance with documented procedures. Maintenance and calibration records shall be
kept.
4.6 Reagents and materials
4.6.1 The material preparation method, which is used in the bacterial endotoxin test,
shall be specified, including the corresponding identification test.
4.6.2 All Limulus amebocyte lysates used in the test shall be licensed.
4.7 Measurement, analysis, improvement
Procedures shall specify the handling requirements for abnormal, unexpected or out-of-
specification results, including corrective and preventive actions.
5 Non-pyrogenic label
5.1 For the products, that come into direct or indirect contact with intravascular,
intralymphatic or intrathecal products, OR products that may come into contact with
similar systemic contact (such as infusion sets, transfer devices, catheters, implants,
infusion components), OR ophthalmic products for intraocular use (e.g., silicone oils,
viscoelastic products, intraocular lenses), it shall evaluate endotoxins.
5.3 Any product, that is labeled as being nominally non-pyrogenic, shall have definitive
proofs, which may include.
5.4 All components of the product claimed to be non-pyrogenic shall be included in the
test procedure. Any item of product within an exempt package shall be documented
(e.g., a handle or strap). Claims of "non-pyrogenic fluid circuits" shall be supported by
appropriate evaluation of the associated components and surfaces of the fluid circuits
used.
5.5 For multi-component kits, the labels and claims shall be consistent with the
documented evaluation of the components, in the package in contact with the
circulatory, lymphatic or cerebrospinal fluid system.
5.6 Product endotoxin limits shall be determined, in accordance with appropriate
regulatory requirements.
6 Selection of product unit
6.1 The sampling criteria for the selection of product units, in the bacterial endotoxin
test, are based on the premise that the production process is controlled and the
requirements of the quality management system are met.
6.4 Test samples should be selected from the finished product, which includes all factors
that may affect or increase endotoxin levels (e.g., packaging).
6.5 Samples may include pre-sterilized and post-sterilized products. The sterilized
sample contains all the factors that could affect the product or endotoxin testing.
6.6 In the inspection of multi-component kits (program packages) or complete sets of
products, depending on the use of the product, sometimes each component can be
evaluated individually, sometimes all the contents can be regarded as a whole for
evaluation.
7 Choice of technique
7.1 Testing laboratories currently have three bacterial endotoxin testing techniques to
choose from. The selection of each technique should be based on adequate evaluation
of laboratory skills, experience, sample size requirements, data handling requirements,
test sample properties.
7.2 The selected method shall be confirmed, in accordance with Chapter 8.If the test
method or technique is changed, validation/verification shall be carried out (see 8.6).
8 Methodological validation
8.1 Identification of test endotoxin limits
8.1.1 The test endotoxin limit is defined as the maximum allowable concentration of
8.2 Maximum validated dilution factor (MVD)
8.2.1 The product may sometimes interfere with bacterial endotoxin tests
(inhibition/enhancement). Interference is usually mitigated by diluting the product
extract, with endotoxin testing water (LRW) or other suitable diluents.
8.2.2 If a product is tested according to MVD, the endotoxin test should be regarded as
a qualitative test. Results are expressed as pass/fail.
8.2.3 When a product is tested, at a dilution lower than the MVD, additional dilutions
may be required, to determine whether a positive result meets the test requirements.
Dilution can be used to obtain a valid test result. Additional dilutions may not require
validation. Diluents other than water may interfere with use AND shall be re-validated.
8.3 Qualification of reagents and analysts
8.3.1 Pre-tests (identification of labelled values/validation of linearity)
8.4 Product identification/validation
8.4.1 General
Each product or product parent (see B.6.3) shall be identified/validated, to fully confirm
that the test sample itself will not inhibit or enhance the bacterial endotoxin test system;
otherwise, it will interfere with the accuracy and lambda of BET. See 8.5, for sample
interference information.
8.4.2 Gel-clot technique
8.4.2.1 Prepare the solution, according to Table 1.The dilution of the sample solution
shall be less than or equal to the MVD, meanwhile the test system shall not contain any
detectable endotoxin. Dilution series and negative controls for each endotoxin dosage
are tested.
8.5 Sample interference
If there is interference in the bacterial endotoxin test, the sample extract can be diluted
and/or treated appropriately, to remove the inhibition or enhancement effect.
8.6 Maintenance of identification/validation
8.6.2 A batch shall be taken for validation, under the following circumstances.
9 Use of technique
9.1 Key test parameters
9.1.1 Temperature
The general incubation temperature for bacterial endotoxin test methods is (37 ± 1) °C.
Refer to the reagent manufacturer's instructions for selection of appropriate parameters.
9.2 Equipment and reagents
9.2.3 The product label of the Limulus amebocyte lysate manufacturer will give storage
requirements for lyophilized and reconstituted reagents. If the storage conditions in the
laboratory are different from those recommended by the manufacturer, the storage
conditions shall be confirmed.
9.3 Sample preparation
9.3.1 General
9.3.2 Medical devices
9.3.2.1 The instruments are usually leached together, for routine endotoxin testing.
When the test determines the endotoxin level per device or the variability between
devices, the device needs to be tested separately. See Appendix B or relevant regulations,
for guidelines on the appropriate sample size.
9.3.2.5 The volume of LRW, which is used for leaching instruments, depends on the
size of the instrument. Calculate the test endotoxin limit, in accordance with 8.1, OR
the maximum amount of extract, that can be used after pooling. To overcome
interference, the sample extract may be further diluted to a level not exceeding the
calculated MVD, as shown in 8.2.
9.3.3 Liquids/biological products
9.4 Routine inspection and monitoring
9.4.3 Color development and turbidity techniques
See 8.4.3 for routine test methods.
9.4.4 Test frequency
Bacterial endotoxin testing shall be performed, in accordance with a documented
sampling plan (see Chapter 6), which has a defined sampling frequency and sample size.
9.5 Interpretation of results
9.5.1 A valid routine test needs to observe the following results.
9.5.2 For the gel limit test, it is acceptable, if the validity of each parameter of the test
product complies with 9.5.1 AND both test tubes of the sample solution are negative.
If a positive result appears in any sample tube, see Appendix C.
9.5.4 In the chromogenic method and the turbidimetric method, if the average endotoxin
concentration of each tube of the sample solution is less than the product endotoxin
limit, after the dilution, AND concentration is corrected, the test preparation meets the
test.
9.6 Change control
See 8.6, for specific requirements for maintaining product identification/validation.
9.7 Out-of-specification values and failure investigation
When a sample exceeds the endotoxin limit of the product, it shall be investigated (see
Appendix C).
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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