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YY/T 0618-2017

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Detail Information of YY/T 0618-2017; YY/T0618-2017
Description (Translated English): Test methods for bacterial endotoxins of medical devices--Routine monitoring and alternatives to batch testing
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.01
Word Count Estimation: 34,390
Date of Issue: 2017-02-28
Date of Implementation: 2018-01-01
Older Standard (superseded by this standard): YY/T 0618-2007
Drafting Organization: Shandong Province Medical Device Product Quality Inspection Center, the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Songli Biological Technology Co., Ltd.
Administrative Organization: National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC 248)
Proposing organization: China Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration

YY/T 0618-2017
Test methods for bacterial endotoxins of medical devices-Routine monitoring and alternatives to batch testing
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0618-2007
Medical device bacterial endotoxin test method
Routine monitoring and skipping batch inspection
Testmethodsforbacterialendotoxinsofmedicaldevices-
Routinemonitoringandalternativestobatchtesting
Published on.2017-02-28
2018-01-01 implementation
State Food and Drug Administration issued
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 endotoxin test method routine monitoring and jump batch test", and YY/T 0618-
The main differences in.2007 are as follows.
--- The standard name was changed to. routine monitoring and jumping test of bacterial endotoxin test method for medical devices;
--- Modified the scope;
--- Added terminology, endotoxin working standards (see 3.4); geometric mean endpoint (see 3.11); survey test (see 3.14);
(see 3.21);
--- Revised "Appendix B Test Methods, General Surveillance and Jump Test Guidelines";
--- Added "Appendix C Excess Limit (OOS) and Failure Investigation Guide".
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC248).
This standard was drafted. Shandong Medical Device Product Quality Inspection Center, State Food and Drug Administration Tianjin Medical Device Quality
Supervision and Inspection Center, Shanghai Songli Biotechnology Co., Ltd.
The main drafters of this standard. Sun Lingqi, Wang Wei, Zhu Lili, Jiang Hua, He Hongbing, Wu Xujun.
The previous versions of the standards replaced by this standard are.
---YY/T 0618-2007.
introduction
A pyrogen is any substance that can cause fever. The release of many medical products requires a pyrogen test. Pyrogens can be divided into two categories. micro
Biopyrogens (eg, bacteria, fungi, viruses) and non-microbial pyrogens (eg, drugs, device materials, steroids, plasma products). Heat found
Most of the original endotoxin is a Gram-negative bacterium. Although Gram-positive bacteria, fungi and viruses may be pyrogens, they are pyrogenic
The mechanism is different (systemic action) and the degree of action is lower than that of Gram-negative bacteria. This standard only includes Gram-negative bacterial endotoxin test.
Endotoxin is a high molecular weight lipopolysaccharide (LPS) component of the outer wall of Gram-negative bacteria, such as contaminating human blood or tissue, endotoxin
It can cause fever, meningitis and rapid decrease in blood pressure. When Gram-negative bacteria decompose or cleave, they are mainly composed of proteins, phospholipids and LPS.
The outer wall components of the cells are continuously released into the environment. Endotoxin contamination is difficult to prevent because it is widely found in nature and is stable in nature.
The smaller volume can be passed through a conventional sterilizing filter.
Medical products can be made pyrogenic without the following measures.
1) Production techniques that prevent or control endotoxin aggregation;
2) Depyrogenation by endotoxin inactivation (such as dry heat) or physical removal (such as washing, distillation, ultrafiltration).
This standard focuses on products that are produced without the need to remove the pyrogen step as part of the production process.
The purpose of this standard is to present requirements and guidelines for bacterial endotoxin testing. Includes selection of test product units, selection of test techniques
Selection and confirmation, use of routine test techniques and interpretation of test results. This standard also includes production to support the selection of jump test.
Run confirmation requirements.
Appendix A, Appendix B, and Appendix C contain the following information, respectively.
--- Background and history of endotoxin testing (see Appendix A);
--- Guide to endotoxin test methods (see Appendix B);
--- Jump test and production process confirmation guide (see Appendix B);
--- Test results and survey guidelines for excess results (see Appendix C).
Medical device bacterial endotoxin test method
Routine monitoring and skipping batch inspection
1 Scope
This standard specifies the basic guidelines for bacterial endotoxin test methods for the determination of medical devices, components or raw materials.
Note. Although the scope of this standard is limited to medical devices, the requirements and guidelines given in this standard 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 indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
People's Republic of China Pharmacopoeia.2015 Edition
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Bacterial endotoxin test bacterialendotoxinstest; BET
Determination of active bacterial endotoxin by mixing a liquid test sample with a sputum reagent, by visual inspection, turbidity, color development or other
The accepted test method measures the result of a proportional reaction.
3.2
Batch batch
The quantity of raw materials, intermediates or finished products specified is expected or claimed to be uniform in the characteristics and quality of the production in the specified production cycle.
3.3
Color development technology chromagenictechnique
The BET method for quantifying or detecting endotoxin based on the principle that the measured color reaction is proportional to the reaction between the guanidine reagent and the endotoxin.
3.4
Endotoxin working standard controlstandardendotoxin; CSE
Endotoxin preparations based on national standards.
3.5
Pyrogen depyrogenation
Confirmed process of removing or inactivating endotoxin.
3.6
Endotoxin or bacterial endotoxin endotoxinorbacterial endotoxin
A high molecular weight complex associated with the cell wall of Gram-negative bacteria that is human-heated and specifically reacts with sputum reagents.
3.7
Endotoxin unit endotoxinunit
EU
Standard unit of measurement for endotoxin activity.
3.8
End point (gel) endpoint (gelclot)
The last one of a bacterial endotoxin-positive reaction was observed in a serial dilution or serial concentration of a test solution or in a control solution.
a little bit.
3.9
Enhanced enhancement
Abnormalities in bacterial endotoxin test caused by non-endotoxin-related factors (usually caused by the characteristics of the test sample), resulting in high test response
The total amount of endotoxin actually present.
3.10
Gel technology gel-clottechnique
The BET method for quantifying or detecting endotoxin is based on the principle that the gel reaction produced is a proportional reaction between the guanidine reagent and the endotoxin.
3.11
Geometric mean end point geometricmeanendpoint
The average of the logarithmic values of the endpoints that have been converted from the repeated serial dilutions to the base 10 for determination from a test solution
Concentration trend or mean.
3.12
Inhibition inhibition
Abnormalities in bacterial endotoxin test caused by non-endotoxin-related factors (usually caused by the characteristics of the test sample), resulting in low test response
The total amount of endotoxin actually present.
3.13
Inhibition/enhancement test inhibition/enhancementtest
Used to determine whether a particular bacterial endotoxin test sample contains factors that reduce the accuracy of the test, ie whether it is produced on the test system
Test for inhibition or enhancement.
3.14
Investigation test investigationtest
Re-analyze a sample extract or preparation to verify the original test results.
3.15
鲎 reagent reaction material LALreactivematerial; LAL-RM
Any non-endotoxin component that activates the sputum reagent and causes augmentation.
3.16
Endotoxin test water LALreagentwater; LRW
Purified water or other identified solvents, diluents and/or extracts that can be used in BET, should be unreacted and absent in the process used
interference.
3.17
Sensitivity lambda
The nominal sensitivity of the sputum reagent gel reagent, expressed in EU/mL. Or, for the chromogenic method and the turbidity method, the lowest reference standard curve
Point (endotoxin concentration).
3.18
鲎 reagent limulusamebocytelysate; LAL
Circulation from the horseshoecrab [Limulus polyphemus or Tachypleustridentatus]
The reagent extracted from the blood-deformed cells reacts with endotoxin to produce a gel for bacterial endotoxin test to determine bacterial endotoxin levels.
3.19
Lipopolysaccharide lipopolysaccharide; LPS
Gram-negative bacterial cell wall components, typically composed of lipid A, core polysaccharide, and O-side chain.
3.20
Maximum effective dilution factor maximumvaliddilution; MVD
The maximum dilution of the sample that is capable of detecting the specified test endotoxin limit in relation to the sensitivity of BET.
3.21
Exceeding limit outofspecification; OOS
The sample valid BET test results exceed the specifications for the endotoxin limit of the product.
Note. The term OOS applies only to this document and is different from other regulatory guidelines covering OOS results, such as the US Food and Drug Administration (FDA).
"Research on the results of OOS test for pharmaceutical production".
3.22
Non-pyrogenic
Medical products do not cause an exothermic reaction.
Note. It can also be used to describe and indicate that the endotoxin level of a medical product is below the specified limit.
3.23
Product endotoxin limit productendotoxinlimit
The maximum acceptable level of endotoxin in a given product.
3.24
Product realization productrealization
Development, production and finished product delivery meet the requirements of the quality management system.
3.25
Pyrogen pyrogen
Any substance that produces heat.
3.26
Pyrogenic pyrogen
Medical products can cause fever reactions.
Note. Can be used to describe the endotoxin level of medical products beyond the specified limits.
3.27
Endotoxin national standard referencestandardendotoxin; RSE
An endotoxin preparation extracted from Escherichia coli prescribed in the Pharmacopoeia of the People's Republic of China.
3.28
Test retest
Additional samples of previous test lots were tested.
3.29
Standard control series standardcontrolseries
RSE or CSE serial dilutions used to validate effective endotoxin sensitivity.
3.30
Test endotoxin limit testendotoxinlimit
The maximum endotoxin concentration allowed in the extract. The determined limit is used to calculate the maximum amount of sample leaching (mixing or one unit)
Dilution factor.
Note. This limit is determined by dividing the product endotoxin limit by the volume of LRW used per unit of sample extract.
3.31
Turbidity technology turbidimetrictechnique
The BET method for quantifying or measuring endotoxin, based on the measured color reaction, is the principle that the guanidine reagent is proportional to endotoxin.
3.32
Confirmation of validation
Establish a documented procedure for obtaining, recording, and interpreting the results to ensure that the product meets the results of the predetermined specifications.
4 Principles of quality management system
4.1 Document formation
4.1.1 The bacterial endotoxin test procedure should be specified.
4.1.2 The documents and records required in this standard shall be reviewed and approved by the designated personnel (see 4.2.1) and shall be subject to the specified quality management.
Under the control of the system requirements.
4.1.3 The requirements of the quality management system shall specify the retention of raw data, calculated and derived data, and final data records. Should include in the record
Information about the people involved in sample preparation and testing.
The inspection technique steps and instructions used are approved and should be available for all equipment used and operated.
4.1.4 Calculations and data transfers should be properly controlled. If electronic data is used, the software used should be confirmed and the confirmation record kept.
4.2 Management responsibilities
4.2.1 The responsibilities and rights to complete and perform the steps described in this document should be detailed. Responsibility should be accorded to a quality management system
The required crowd.
4.2.2 If an organization with a separate quality management system assumes the requirements of this standard, the responsibilities and rights of each individual should be specified.
4.3 Product realization
The steps for purchasing should be detailed. These steps should be consistent with the quality management system requirements.
4.4 Personnel
4.4.1 The requirements for assigning bacterial endotoxin testers should be specified in the quality management system requirements.
4.4.2 Training should be conducted in accordance with documented procedures, and records of relevant identification, training and experience of technicians should be retained.
4.4.3 The analyst should identify the bacterial endotoxin test before performing the bacterial endotoxin test (see 8.3.2).
4.5 Equipment
4.5.1 All equipment required for the proper performance of the test shall be in place and planned maintenance and calibration shall be carried out in accordance with documented procedures. should
Keep maintenance and calibration records.
4.5.2 All equipment shall be operated in accordance with the documents of the specified guidelines.
4.6 Reagents and materials
4.6.1 The method of preparation of the materials used in the bacterial endotoxin test shall be specified, including the corresponding identification test.
Note. The corresponding identification test includes the identification of the sensitivity of the sputum reagent.
4.6.2 All bismuth reagents used in the test shall be approved.
4.6.3 Pyrogen removal methods The pyrogen removal methods used for glassware and other equipment should be established, validated and documented.
4.6.4 Materials used in bacterial endotoxin testing should be confirmed to be free of endotoxin if not treated with pyrogen. Proven method, for example,
Check the purchased material samples or confirm the pyrogens by checking the seller's certificate of conformity.
Note. Containers for sample preparation, storage or dilution should be free from interference.
4.7 Measurement, analysis and improvement
Disposal requirements for abnormal, unexpected or over-limit results, including corrective and preventive actions, should be specified in the procedure. These procedures should conform to the quality
Volume management system requirements. See Appendix C for guidelines on exceeding limits and failure investigations.
5 no pyrogen label
5.1 Products that are in direct or indirect contact with intravascular, intralymphatic or intrathecal, or products that may be in contact with similar systems (eg infusion sets, transfer)
Ovoscopes, catheters, implants and infusion sets), or ophthalmic products used in the eye (such as silicone oil, viscoelastic products, intraocular lenses) should be evaluated
toxin.
5.2 Products that meet the endotoxin limit requirements may give a label that claims to be pyrogen free.
Note. Products are usually not labeled as pyrogen-free, as no pyrogen means absolutely no bacterial endotoxin. And the inherent detection limits of all BET methods cannot be tested.
The verification does not contain bacterial endotoxin.
5.3 Any product that uses the logo nominally pyrogen-free shall have exact evidence, which may include.
--- Directly inspect the product by a certified person using a confirmed bacterial endotoxin test;
--- Confirmation of the documentation of the production of pyrogen-free products during the production process; or
--- Other evidence that meets certain applicable standards and/or requirements.
5.4 All components of the product claiming pyrogen-free products shall be included in the test. Any product part of the exempted package should be documented (such as a certain
Handle or drawstring). Claims that “pyrogenic fluid paths” should be supported by appropriate evaluation of the relevant components and surfaces of the fluid circuits used.
5.5 For multi-component kits, the labeling and claims should be in the form of a contact with the circulating, lymphatic or cerebrospinal fluid system.
The evaluation of the pieces is consistent. This label should be consistent with the intended clinical application of the package and its components.
5.6 The endotoxin limit of the product shall be determined in accordance with appropriate regulatory requirements.
Note. The endotoxin limits for medical infusion (blood) and syringes are recommended in GB/T 14233.2-2005.
6 product unit selection
6.1 The sampling criteria for product unit selection in the bacterial endotoxin test are controlled by the production process and meet the requirements of the quality management system.
premise.
6.2 The selection of the test product unit shall be based on the criteria specified in the sampling plan, which may be based on regulatory requirements, published statistics
Program or guide, or confirmation of production operations.
6.3 The sampling group is generally specified as a production batch. If there is data to support different selection bases or use jump test, sample selection
It can be based on the sampling parent not a production batch. If you choose to skip the batch test, see Chapter 10, B.6~B.8 and B.10.
Note. The sampling specification for the sampling parent is not a production batch and should include a risk assessment to evaluate the suitability of the criteria for establishing the sampling parent (see Appendix B).
6.4 The test sample should be selected in the finished product, which includes all factors that may affect or increase endotoxin levels (eg, packaging).
Note. Samples for endotoxin testing can be selected from products rejected by other production quality items, provided that the rejected sample represents a non-rejected product.
6.5 Samples may include pre-sterilized and post-sterilized products. The sterilized sample contains all factors that may affect the product or endotoxin test.
If a sample test prior to sterilization is selected, the sample represents the acceptability of endotoxin levels in the final product should be documented. Inspection procedure
Samples before or after sterilization should be continuously reflected. See B.6.5 for a guide to equality verification.
Note. For products that promote microbial growth, it may not be appropriate to select samples prior to sterilization.
6.6 In the multi-component package product (package) or package inspection, depending on the use of the product, sometimes each
The components are evaluated separately, and sometimes all contents are considered as an overall device evaluation. Standard test procedures should be applied to each component
condition. When using a kit or kit as a stand-alone unit, consider sample preparation and applicable products without changing the method.
Toxin limit. See B.6.6 for more guidelines.
7 Technical choices
7.1 Inspection Laboratories There are currently three bacterial endotoxin testing techniques available. The choice of each technology should be based on laboratory skills,
Adequate assessment of the test, sample size requirements, data handling requirements and the nature of the test sample. Current technologies and methods include.
a) Gel technology. limit test and method of determination;
b) color development techniques. kinetics and endpoint methods;
c) Turbidity technology. kinetics and endpoint methods.
See Appendix B for information on the three methods.
7.2 The method selected should be confirmed in accordance with Chapter 8. If the test method or technique is changed, it should be confirmed/verified (see 8.6).
8 Methodological confirmation
8.1 Identification of endotoxin limits
8.1.1 The test endotoxin limit is defined as the maximum allowable concentration of endotoxin that may be present in a product extract, which is related to the endotoxin limit of the product.
Value related. See Appendix B to determine the endotoxin limit for the product.
8.1.2 Once the endotoxin limit of the product has been determined, the test endotoxin limit can be calculated according to formula (1).
Endotoxin limit for medical device testing (EU/mL)=
KN
(1)
In the formula.
K --- the allowable amount of endotoxin per device (product endotoxin limit);
N --- number of test equipment;
V --- Total amount of extract in the sample combination in milliliters (mL).
8.2 Maximum effective dilution factor (MVD)
8.2.1 Products may sometimes interfere with bacterial endotoxin testing (inhibition/enhancement). Endotoxin test water (LRW) or other suitable
Diluent dilution of the product extract reduces interference. Because dilution will also dilute the endotoxin that may be present, so there is a permission
Dilution limit. The maximum effective dilution factor is calculated according to formula (2).
MVD=
Test endotoxin limit
(2)
In the formula.
Test endotoxin limit, see formula (1);
λ---the identified sputum reagent indicates sensitivity (gel method) or the lowest endotoxin used to draw the reference standard curve (color development and turbidity)
concentration.
This MVD value represents the dilution factor that can be performed to overcome the inhibition/enhancement effect based on the sensitivity of the guanidine reagent. If the MVD is 4,
That is, diluting the sample extract at a ratio of no more than 4 times does not affect the ability to detect endotoxin limits of the product.
If practicable, the product should be confirmed at a dilution below the maximum effective dilution.
8.2.2 If a product is tested in accordance with MVD, the endotoxin test should be considered a qualitative test. The result is expressed as pass/fail.
A positive result indicates that the endotoxin content of the product exceeds the specified endotoxin limit. A negative result indicates the passage of the test.
8.2.3 When a product is tested below the dilution of MVD, additional dilution may be required to determine if the positive result is met.
Test requirements. Dilution can be used to obtain a valid test result. Additional dilution may not require confirmation. Thinner other than water
Interference can occur during use and should be reconfirmed.
8.3 Reagent and analyst qualification
8.3.1 Pre-test (identification of identification values / confirmation of linearity)
8.3.1.1 Pre-test for gel technology
The labeling sensitivity (λ) of each batch of hydrazine reagent should be verified by inspection. The test should be in 4 2-fold dilution series (eg 2λ, λ,
0.5λ, 0.25λ dilution) was performed in a negative control. The geometric mean end point of the dilution series should be in the range of 0.5λ~2λ.
Once identified, the sensitivity is used for all calculations. The geometric mean of the indicated sensitivity is calculated according to equation (3).
Geometric mean = antilg (∑e/F) (3)
In the formula.
∑e---the sum of the logarithmic values of the endotoxin reaction endpoint concentrations for each dilution;
F --- repeat number.
8.3.1.2 Pre-test for color development/turbidity technology
Verification requires confirmation that the linear standard curve spans the endotoxin dilution range used in routine analysis. Should use at least 3 different internal poisons
The concentration of the hormone establishes a standard curve. If the standard curve range is greater than 2 lg, it is advisable to add one lg for each additional lg in the curve range. each
Endotoxin concentrations should be tested in 3 parallels. In the initial quality control test, it is not advisable to take the mean of each point to calculate the linearity, linearity requirements and
The absolute value of the correlation coefficient of the endotoxin concentration range indicated by the sputum reagent production mark |r| ≥ 0.980.
If the standard curve range is less than 2 lg, it is recommended to establish a standard curve with a 2-fold dilution. If the standard curve is greater than 2 lg, it should be 10 times thinner.
The standard curve is established, and a standard is inserted for each additional lg in the range of the standard curve. The standard curve should not exceed 4 lg, because
A curve greater than 5 lg or more is not suitable and produces a false negative result.
The range of this standard curve determined in the reagent identification will be used for routine testing.
8.3.2 Identification of qualifications of analysts
Each analyst engaged in the bacterial endotoxin test should perform a capability confirmation, the analyst's ability confirmation procedure and the 8.3.1 pre-test.
The procedures specified are the same.
8.4 Product Identification/Confirmation
8.4.1 General
Each product or product precursor (see B.6.3) should be identified/confirmed to fully demonstrate the test sample itself for bacterial endotoxin testing.
The system will not produce inhibition or enhancement, otherwise it will interfere with the accuracy and sensitivity of BET. See 8.5 for sample interference information.
At least three batches should be used for initial identification/validation studies for each product or class of products.
Methods for product identification are given in 8.4.2 and 8.4.3.
8.4.2 Gel technology
8.4.2.1 Prepare the solution according to Table 1. The sample solution dilution should be less than or equal to MVD, and the test system should not contain any detectable
Endotoxin. A dilution series and a negative control for each endotoxin addition amount were tested. Geometric mean endpoint concentration of each endotoxin added dilution series
[Formula (3)] shall be determined according to the formula listed in the pre-test of 8.3.1.
Table 1 Preparation of solution for inhibition/enhancement test (gel technique)
Solution diluent endotoxin addition amount endotoxin concentration parallel number
Product Positive Control (PPC)
series
Sample solution
Prepare 2λ solution, then
2 times the initial 2λ preparation
Serial dilution

0.5λ
0.25λ
Product negative control sample solution without NA 2
Standard Control Series LRW
Prepare 2λ solution, then
2 times the initial 2λ preparation
Serial dilution

0.5λ
0.25λ
Negative control LRW without NA 2
8.4.2.2 The sample does not contain interference factors if.
a) The sensitivity of the sputum reagent of the product positive control series is between 0.5λ~2λ;
b) the negative control showed no response;
c) The results of the standard control series are consistent with the sensitivity of the sputum reagent labeling.
8.4.3 Color development technology and turbidity technology
8.4.3.1 Select the endotoxin concentration near the median on the endotoxin standard curve. Prepare the solution as listed in Table 2, the dilution of the sample solution
Should be less than or equal to MVD.
Table 2 Solution preparation for inhibition/enhancement test (color development technique and turbidity technique)
Solution diluent endotoxin addition amount of parallel tubes
Product positive control (PPC) sample solution standard curve median concentration 2
Sample solution sample solution without 2
Standard Control Series LRW Minimum 3 different concentrations per concentration 2
Negative control LRW no 2
8.4.3.2 Subtract the average endotoxin concentration of the sample solution from the positive control of the product and calculate the average recovery of endotoxin added.
8.4.3.3 If the concentration of the product positive control (after subtracting the endotoxin concentration from the sample solution) is known to be added to the endotoxin concentration
Within 50% to.200%, the sample or sample diluent is considered to have no interference factor.
8.5 Sample interference
If there is interference in the bacterial endotoxin test, the sample extract may be diluted and/or treated to remove inhibition or enhancement.
effect.
8.6 Maintenance of identification/confirmation
8.6.1 The purpose of using three batches of confirmation is to determine the presence or variation of the interference factor introduced by the product. Three batches should be taken in the following cases
Reconfirm.
a) changes in the product that may affect the test, including the introduction of new materials, processing procedures or changes in product structure;
b) changes in the extraction method or beyond the specified extraction parameters (such as increased treatment, use of other temperatures, use of other solvents, etc.);
c) changes in test techniques (eg gel technology changed to color development technology); and
d) 鲎Reagent manufacturer or reagent formulation changes.
Note. For the sake of simplicity, it is acceptable to use a batch for verification if there are scientific supporting reasons.
8.6.2 A batch should be confirmed in the following cases.
a) BET test laboratory changes;
b) changes in BET materials, equipment that may affect the test; and
c) The sensitivity of the sputum reagent changes.
Note. In some cases, the available product positive control (PPC) is verified. PPC may fully detect that a change has occurred.
9 Use of technology
9.1 Key test parameters
9.1.1 Temperature
The bacterial endotoxin test method has a universal incubation temperature of (37 ± 1) °C. See the reagent manufacturer's instructions for selecting the appropriate parameters.
9.1.2 Time
The reagent manufacturer's product instruction manual gives the reagent addition and incubation time, and the gel bacterial endotoxin test method is common.
The incubation time was (60 ± 2) min.
9.1.3 pH
The manufacturer's instructions for the sputum reagent give the optimal pH range for the endotoxin reaction. If the pH exceeds this range during the test, it may
Causes interference. If the pH of the product positive control is acceptable during the validation test, no further pH measurements may be required in the future. but,
If the pH must be adjusted during the confirmation, the pH should be measured in a subsequent routine test.
9.2 Equipment and reagents
9.2.1 Since the bacterial endotoxin test requires a defined temperature range, the heating chamber or water bath used for the gel test incubation should record the incubation temperature.
degree. Mechanical pipettes (including fixed, adjustable, and reusable units) should be calibrated periodically. If the laboratory uses color development or turbidity
Technology, hardware and software should be certified according to the manufacturer's instructions for use and validation requirements. Not.
Related standard:   YY/T 0616.1-2016  YY/T 0287-2017
   
 
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