GB 18280-2000 Sterilization confirmation and routine control requirements for medical care products Radiation sterilization
Some standard content:
GB18280-2000
All technical contents of this standard are mandatory. For the time being, this standard is equivalent to the international standard IS011137:1995 "Sterilization of medical and health products". The contents of Technical Corrigendum 1 (1997) have been included. Appendix A, Appendix B, Appendix C and Appendix D of this standard are all indicative appendices. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for the Promotion of Sterilization Technology and Equipment Standards. The drafting unit of this standard: Beijing Radiation Application Research Center, West China University of Medical Sciences. The drafters of this standard: Jian Ao Ji, Zhang Chao Wu. 551
Confirmation and routine control requirements - Taoshe
GB18280-2000
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by ISO technical committees. Each member has the right to participate in the work of a technical committee in which it is interested. International organizations (official or non-official) in liaison with ISO may also participate in the work. ISO maintains a close working relationship with the International Electrotechnical Commission (IEC) in all aspects of electrotechnical standardization. Draft international standards formally adopted by the technical committee are submitted to the member bodies for voting. International standards can be formally published only if they are approved by at least 75% of the member bodies voting. International Standard ISO 11137 was prepared by ISO/TC198 Technical Committee on Sterilization of health care products.
Appendices A, B, C and D of this international standard are for reference only. 55
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GB18280—2000
This standard specifies the requirements to ensure that the operations associated with radiation sterilization can be carried out correctly. These include documented work procedures that demonstrate that radiation processing, i.e., operation within specified limits, will consistently produce product treated with a pre-established limit.
Radiation processing is a physical process that exposes a product to ionizing radiation. In an undesigned apparatus, the product is exposed to radiation produced by radionuclides such as cobalt-60 (°Co) or cerium-137 (13Cs), or to electrons or X-rays produced by an electron beam generator. Radiation sterilization is a safe and reliable industrial sterilization method when properly applied. Sterilization is one of the factors that cannot be proven by retrospective testing and product testing. It is important to recognize that a validated and precisely controlled sterilization process is not the only factor related to product sterility and suitability for its intended use. Attention must be paid to the microbiological status of the raw materials and/or components used, the microbial barrier properties of the packaging materials, and the control of the production, assembly, packaging and storage environment. Sterile products are products that are free of viable microorganisms. Microorganisms may be present on products produced under controlled processing conditions before sterilization, although the number of bacteria is usually very small. By definition, these products are sterile. The purpose of the sterilization process is to kill the microorganisms that contaminate these products. The killing of microorganisms by physical and chemical factors follows an exponential law. Therefore, regardless of the size of the sterilization dose or the method of treatment, the probability of microbial survival can be calculated. The probability of survival is the probability of microorganisms on the product. The sterility assurance level (SAL) is a mathematically derived function of the number and type of microorganisms (biological burden), the lethality of the sterilization process, and, in some cases, the environment in which the microorganisms are located during processing. It follows that in a population of sterilized products, the sterility of each individual product cannot be guaranteed in an absolute sense. The Sterility Assurance Level (SAL) is defined as the probability of viable microorganisms on a single-photon product.
The original manufacturer has the sole responsibility to ensure that all sterilization operations and quality assurance tests used for the product are appropriate, sufficient, and correctly performed. However, the operator of the irradiator is responsible for implementing the required dose in accordance with the confirmed processing instructions. 556
1 Scope
National Standard of the People's Republic of China
Sterilization of Health Care Products
Validation and Routine Control Requirements
Radiation Sterilization
Sterilization of health care products-Requirement for validation and routine cuntrolRadiation stcrilization
GB 182802000
idt ISO 11137: 1995
This standard specifies various requirements for validation, process control and routine monitoring of health care products in radiation sterilization. It is applicable to continuous and batch irradiation devices using radionuclides cobalt-60 and cobalt-137, as well as irradiation devices using electron beam or X-ray generators.
Supplementary references are also provided in the appendix to this standard. The design of the device, obtaining a license, operator training and various factors related to radiation safety are not within the scope of this standard. This standard does not include the evaluation of the suitability of the product for its intended use. Biological indicators used for validation or monitoring, or sterility tests used for product release are not included in this standard, because these methods are not recommended for use in radiation sterilization. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. At the time of publication of this standard, the versions shown are valid. All standards are subject to revision, and parties using this standard should investigate the possibility of using the latest versions of the following standards. GB/T 19001—1994
Quality system Quality assurance model for design, development, production, installation and servicing GB/T19002—1994
ISO 11737-1:1995
1ISO 11737-2: 1998
3 Definitions
Quality system Quality assurance model for production, installation and servicing - Microbiological methods - Part 1: Determination of the total number of microorganisms on products Medical devices Sterilization -
Sterilization of medical devices
This standard adopts the following definitions.
3.1 “Health care products” and related terms 3.1.1 Batch
Microbiological methods—Part 2: Sterility during validation of sterilization processes A certain quantity of semi-finished or finished products that are expected to be identical in characteristics and quality and produced during a certain manufacturing cycle. 3.1.2 Health care products hcalth product includes medical devices, pharmaceutical products (drugs and biological products) and in vitro diagnostic products 3.1.3 Priniary manufacturer A company or group responsible for the manufacture, performance and safety of a health care product. 3.1.4 Product category Product category Approved by the State Administration of Quality and Technical Supervision on December 13, 2000 - TKAONIKAca-
Implemented on May 1, 2001
GB 18280--2000
(1) (sterilized by or X-ray radiation) Products of similar bulk density that show similar dose distribution patterns. (2) (irradiated by electron beam) Products with similar maximum surface density showing similar dose distribution patterns. 3.1.5 Product unit
A collection of health care products, various products or components in one inner packaging. 3.2 “Irradiator\ and related terms
3.2.1 Batch [type] irradiator An irradiator from which irradiation containers can be loaded or removed only when the radiation source is in the storage position. 3.2.2 Bulk density
The mass of the product and all packaging materials in the irradiation container divided by the volume determined by the dimensions of the outermost packaging. 3.2.3 Continuous [type] irradiator An irradiation device that can load and unload products when the source is in solitary mode. 3.2.4 Irradiatiun container A carrier, trolley, tray or other container that transports products through the irradiator. 3.2.5 Irradiator
A device that can safely and reliably perform irradiation sterilization processing, including radiation source, transmission device and radiation source mechanical device, safety facilities and shielding system
3.2.6 Irradiator operator Irradiatoroterator is responsible for applying the prescribed (radiation) dose to the company or group of health care products. 3.2.7 Surface density The density of the cylinder of the outermost packaging or irradiation container through which the electron beam passes, expressed as the ratio of the surface area of the cross-section at a point where the ratio is the largest.
Note 1: The unit value of surface area is x/cm* (190 31-3:1992.3.6). 3.2.8 Timer setting The time interval selected for the irradiation container to stay at each irradiation position. It controls the irradiation time. 3.3 "Radiation source" and related terms
3.3.1 Average beam current average beam current The time average value of the beam current produced by the electron beam generator. 3.3.2 Bremsstrahlung
Broad-spectrum electromagnetic radiation emitted when a high-energy electron is subjected to a strong magnetic or electric field, such as electromagnetic radiation near the nucleus of an atom. Note 2: In fact, bremsstrahlung is generated when an electron beam strikes any material (converter). The bremsstrahlung spectrum depends on the energy of the electrons, the material of the converter and its thickness. It includes all energies up to the maximum energy of the incident electrons. 3.3.3 Converter Target for high-energy electron beams, usually a material with a high atomic mass, in which the radiation energy of the incident electrons is lost, producing X-rays (bremsstrahlung). 3.3.4 Electron beam Electron heam Continuous or pulsed high-energy electrons. 3.3.5 Electron energy Electron energy Kinetic energy of the electrons in the electron beam. 3.3.6 Gamma ray Short-wavelength electromagnetic radiation (photons) emitted by radioactive material during nuclear decay. NOTE 3 This is a general term. NOTE 4 For irradiation of health care products, the radiation is usually high-energy penetrating photons emitted by radioactive nuclides such as cobalt-60 or rhodium-137. 3.3.7 Source activitysaureaactivity558
GB18280-2000
The amount of radioactive nuclei cobalt-60 or -137 measured in becquerrl or curie (1Ci=3.7×101'Bg, and 1Bqls-1).
3.3.8 X-raysX-rays
Short-wavelength electromagnetic radiation emitted when high-energy electrons are accelerated, decelerated or redirected by strong electric or magnetic fields. Note 5: This is a general name.
Note 6: The term usually includes the effective radiation produced when high-energy electrons are decelerated in the vicinity of atoms and the characteristic single-energy radiation emitted when the electrons of the atoms are transformed into a more tightly bound state. In this standard, the definition of "primary radiation" is used. 3.4 Terms related to dose measurement
3.4.1 Absorbed doseabsorbeddose
The amount of radiation energy transferred to a unit mass of a substance. The unit of absorbed dose is gray (Gy), 1Gy=】J/kg (=100rads). 3.4.2 Dase
See absorbed dose.
3.4.3 Dosimeter
A device or system that has a repeatable and measurable response to radiation. It can be used to measure the amount of radiation in a given material. 3.4.4 Dose measurement dosimetry system A system used to determine absorbed dose. It consists of a dosimeter, measuring instruments and a program for use with the system. 3.4.6 Primary standard dosimeter A dosimeter of the highest metrological quality, established and maintained by a national or international standards organization as an absorbed dose standard. 3.4.7 Reference dosimeter refcrcncc Standard dosimeter A dosimeter with high metrological quality that can be used as a standard to provide measurements with traceability and consistency with those measured using a base dose meter.
3.4.8 Routine dosimeter A dosimeter that has been calibrated with a master, reference or transfer standard dosimeter and is used for routine dose measurements. 3.4.9 Transfer dosimeter A dosimeter, usually a reference dosimeter, used as a means of comparing absorbed dose measurements at different locations. 3.5 "Confirmation\ and related terms
3.5.1 Calibration
Comparison of a metrological system or instrument of unknown accuracy with a metrological system or instrument of known accuracy (traceable to a national standard) to determine, compare, report or adjust to eliminate any deviation of the uncalibrated metrological system or instrument from the required performance range. 3.5.2 Installation qualification Obtain and record evidence that the equipment has been provided and installed in accordance with the technical requirements. When operated according to the instructions for use, the equipment functions within the predetermined limits.
3.5.3 National Standard National statutory standard, in: country, all other standards related to this value are based on this standard to determine their values. 3.5.4 Process qualification Obtain and record evidence in writing that the sterilization process will produce qualified health care products. 3.5.5 Product qualification Obtain and record evidence in writing that the health care product is qualified for its intended use after radiation treatment. 3.5.6 Validation
Establish written evidence that provides a high degree of assurance that a specific process can continuously produce products that meet predetermined technical specifications and quality characteristics. 3.6 "Sterility\ and related terms
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3.6.1 Sterility
The state of being free of viable microorganisms.
GB18280-2000
Method 7: In practice, it is impossible to prove the absolute statement that there are no microorganisms. 3.6.2 Sterility assurance level leycl,sAl The probability of the presence of viable microorganisms on a unit product after sterilization. Note 8: SAL is usually expressed as 10-*.
3.6.3 Sterilization
The process that has been confirmed to make the product free of viable microorganisms. Note 9: In the sterilization process, the death law of microorganisms is expressed by an exponential function. Therefore, the presence of microorganisms on any single product can be expressed as a probability. The probability can be reduced to a very low number, but it may be reduced to. The probability can be expressed as the sterility assurance level (SAL) 3.6.4 Sterilization agent chapter sterilization dose The minimum absorbed dose required to achieve the specified sterility assurance level 3.7 Terms related to dose setting
3.7.1 Bioburden
The total number of viable microorganisms on a product.
Note 10: In the context of radiation sterilization, the bioburden should be tested immediately before sterilization. 3.7.2 Fraction positive The quotient of the number of positives in the photobacterial test sample (hereinafter referred to as the sample) as the numerator and the number of samples as the denominator. 3.7.3 Increased dose A series of doses used for several unit products or their components, which is used to establish and confirm the sterilization dose in the dose setting method. 3.7.4 Radiation stability The ability of a health care product to remain usable for a predetermined life after being treated with the maximum radiation dose. 3.7.5 Sterilization dose audit Sterilization dose audit Testing activities to determine whether the sterilization dose needs to be changed. 3.8 Related to Appendix B Related terms
3.8.1 Sterility testing A test performed to prove the presence of viable microorganisms. 3.8.2 Positive sterility test A sterility test in which microbial growth is detected after the sample is cultured. 3.8.3 Negative sterility test A sterility test in which no microbial growth is detected after the sample is cultured. 3.8.4 False positive
The turbidity of the test result is interpreted as the growth of bacteria in the test sample, but the growth is caused by contamination with foreign microorganisms or the turbidity is the result of the interaction between the sample and the test medium. 3.8.5 False negative
The result of the test is interpreted as a lack of growth, either because there is growth but it is not detected, or because there are viable microorganisms but they do not grow. 3.8.6 Aerobic organism A microorganism that uses oxygen as the final electron acceptor in its metabolism. 3.8.7 Anaerobic organism (1) An organism that does not use oxygen as the final electron acceptor in its metabolism. (2) A microorganism that can grow only in the presence of oxygen. 3.8.B Facultative anaerobes Microorganisms that can perform both aerobic and anaerobic metabolisms. 560
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3.8.9 Sample item portion, SIP The portion specified for the unit healthcare product being tested 3.8.10 Verification dose (I)*kGy) Veriicatian dose The irradiation dose estimated to reach 10-\SAL for a unit product or component. It is used in the dose setting method to establish and confirm the sterilization dose.
3. B.11 D1T gray (D1ckGy) The radiation dose required to kill 90% of the total number of homologous microorganisms. Here, it is assumed that the death of microorganisms follows the original kinetics.
4 Documentation
In order to ensure reproducibility, the process confirmation, processing steps and all other factors that affect sterilization should be documented. The documentation shall be carried out and maintained in accordance with GB/T 19001 and/or GB/T 19002, as applicable. 5 Personnel
The responsibility for validation and routine control of irradiation sterilization shall be delegated to qualified personnel who shall comply with the requirements of GB/T 19001-1994, 4.1.2.2 and 4.18 and/or GB/T 19002-1994, 4.1.2 and 4.17, as applicable. 6 Validation of the sterilization process
6.1 Overview
The validation of the sterilization process shall include the following components: a) Product validation in an irradiation device that has undergone installation qualification; b) Installation qualification;
c) Process qualification with specified product or simulated product in qualified equipment; d) Review and approval of documented management certification procedures for a), h) and c); e) Activities to support the maintenance of validation.
6.2 Product Identification
6.2.1 Product and Packaging Materials Evaluation
Before radiation sterilization of critical medical products, the effects of radiation on the product (or product components) and the materials used in the packaging should be considered. Procedures should be performed to demonstrate the quality, safety and performance of the product during its shelf life. Such testing should include the characteristics necessary for the intended function of the product.
In particular, the following should be considered when designing the test procedures: the process steps, limits, radiation doses, radiation sources, raw material properties and storage environment variations.
A maximum acceptable dose should be established for each product and package. NOTE: Guidance on the identification of product and packaging materials is provided in Annex A. 6.2.2 Selection of Sterilants
6.2.2.1 The number and radiation resistance of the natural microbial population present on or in the product should be known to determine the sterilization dose that will achieve the pre-selected SAL. When selecting the sterilization dose, one of the following methods (a) and (b) may be selected: a) When selecting the sterilization dose, use
i) biological load information, or
i) information obtained from incremental dose experiments. 12 Examples of these dose setting methods are methods 1 and 2 in the Appendix L. b) After demonstrating its suitability, 25 kGy may be selected as the sterilization dose. 561
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Equipment Documentation
Product and Packaging
Material Evaluation
GB 18280--2000
6.2 Product Qualification
G.3 Installation Qualification
Equipment Testing
Equipment Calibration
6.4 6.5 Certification
Document Summary
Review and Approval
6.6 Maintenance of Certification
Irradiation Equipment
Requalification
Sterilization Dose
Irradiation Equipment
Dose Distribution Diagram
Product Dose Distribution Diagram
Sterilization Dose
Figure 1 Components of a Typical Validation Procedure
GB 18280—2000
6.2.2.2 The various basic technical requirements for obtaining the information required for sterilization dose selection using information on bioburden or fraction number, as well as for justifying the selection of 25 kGy, shall be
a) tested by a qualified microbiological laboratory; b) tested in accordance with IS0 11737-1 and IS0 Complete microbiological testing in accordance with the requirements of 11737-2. α) Have a cobalt-60 or caesium-137 radiation source, or an electron beam or X-ray irradiator with an energy level and dose rate similar to that used in the process. The source or electron beam (or X-ray) irradiator is required to be able to accurately implement a dose of 1 kGy and above. 6.2.3 Sterilization dose conversion When the product is transferred between two irradiators, if the second device uses the same sterilization dose as the dose selected for the first device in accordance with 6.2.1 and 6.2.2, only the following data shall be considered. For the conversion between the electron beam or X-ray device and other irradiators (electron beam → electron beam, X-ray: electron beam → X-ray; electron beam → X-ray; X-ray → X-ray), the data should be able to show that the inactivation of microorganisms using the alternate sterilization dose is not affected by the different characteristics of the radiation sources of the two devices, especially the radiation energy and the dose rate implemented, or the difference in the dose distribution through the product.
For transfers between two irradiation units, data should be available to demonstrate that, using the same sterilization dose, the inactivation of microorganisms is not affected by differences in the dose distribution through the product between the two units. 6.3 Installation Qualification
An installation qualification procedure should be established, documented and completed. 6.3.1 Equipment Documentation
There should be documentation describing the irradiation unit and its operation. This documentation should be kept for the life of the irradiation unit and include: a) Specifications and characteristics of the irradiation unit;
6) A description of the location of the irradiation unit in a building where operators have a means of separating unirradiated from irradiated product; c) A description of the structure and operation associated with the transfer system; e) A description of the size of the irradiation container and a description of the materials and construction; e) A description of the methods of operating the irradiation unit and associated transfer system; f) For the unit, a certificate indicating the date of the source activity and the location of the individual sources in the source rack; g) Any modifications to the irradiation unit.
Other documents shall include instrumentation descriptions used to control, monitor and record critical process parameters. The documentation shall be maintained in accordance with GB/T 19001 and/or GB/T 15002, as applicable. For devices, critical process parameters shall include timer settings, exposure time or transfer speed during the irradiation period, and dose measurement. For electron beam and X-ray devices, critical process parameters shall include electron beam characteristics (average electron beam current, electron energy, scan width), transfer speed, transfer speed feedback circuit and/or control feedback circuit, and dose-based measurement disk. 6.3.2 Equipment testing
Add 1 Equipment including radiation source, transfer machinery, safety features and auxiliary systems shall be tested and demonstrated to operate well according to design specifications. Test method results shall be documented.
6.3.3 Equipment calibration
A documented calibration procedure shall be implemented to ensure that the equipment and dose measurement system are calibrated (traceable to national standards) and maintained within the specified accuracy, in accordance with GB/T 19001 requirements. For irradiators, this includes calibration of the irradiator cycle timer or transfer speed, weighing equipment, and dose measurement systems. For electron beam and γ-ray irradiators, this includes calibration of the electron beam characteristics, speed of the equipment moving the irradiation container, weighing equipment, and dose measurement systems.
Dosimeters of known accuracy should be used in the confirmation and band gauge control of radiation sterilization. Appropriate dose-based measurement procedures should be used, with appropriate TTKAoNTKAca-
systematic comparisons and documentation.
GB18280:2000
Note 13: Changes that can affect dose determination are discussed in Research Note C, 6.3.4 Dose distribution diagram of irradiation device
Dose distribution test shall describe the characteristics of irradiation device according to the value, distribution and reproducibility of dose implementation. For X-ray irradiation device, dose distribution test shall be carried out within the bulk density range that the irradiation device can handle, using materials of the same density to fill the irradiation container to the design limit. The container shall be used to determine the absorbed dose of multiple internal sites. If there are more than 10 product channels in the irradiation device, a dose distribution diagram shall be made for each channel used. For electron beam irradiation device, dose distribution test shall be carried out with materials of the same density. The dose distribution diagram shall show the dose distribution characteristics of the irradiation space of the material transmitted by the irradiation field, and the relationship between dose and dose distribution and the operating parameters of the electron beam system in the product irradiation within the entire operating range shall be established. If the irradiation device does not have 10 product channels, a dose distribution diagram shall be made for each channel used. All records, including records of the operation of the irradiator, the results and conclusions of the dose distribution test, shall be kept and reviewed in accordance with GB/T 19001 and (or) GB/T19002, as appropriate: 6.4 plus T. Determination
6.4.1 Determination of product loading pattern
Establish a product loading pattern for each product type. The technical specifications of the loading pattern shall be documented as follows. 6.4.1.1 and X-ray device
a) Description of the packaged product, including size and density, and acceptable deviations in these parameters, and, where necessary, the orientation of the product in the package:
b) Description of the product loading pattern in the irradiation container: c) Description of the irradiation container and its size. 6.4.1.2 Electron Beam Apparatus
a) Description of the packaged product, including the orientation of the unit count within the package, package dimensions and mass, the orientation of the product within the package, and the acceptable variations in these parameters; b) Description of the product loading pattern within the irradiation container; d) Description of the irradiation container and its dimensions.
6.4.2 Product Dose Distribution Diagrams
Dose distribution studies should identify the minimum and maximum dose areas within the product load for the specified loading pattern and study the repeatability of the process. This information will then be used in routine work to select dose measurement sites. Dose distribution testing should be performed on a sufficient number of representative irradiation containers to determine the variation of the absorbent disk between representative containers, especially in the expected maximum and minimum dose areas and at routine monitoring locations. Dose distribution testing work should be performed at the extremes of the density range for each product type without regard to process dose. The product loading pattern and channels used for processing should be included in this work. Equipment that processes only product loads that present the same dose distribution characteristics as those during the dose distribution test shall comply with the requirements for product dose distribution testing when the process is finalized. If the product load pattern size or stacking density does not fully conform to the existing dose distribution data, additional dose distribution tests shall be conducted.
All records, including records of irradiation parameters, results, and conclusions drawn from the dose distribution test, shall be kept in accordance with the requirements of GB/T 19001 and (or) GB/T 19002 for document applicability. 6.5 Certification
The information collected and provided during product identification, installation identification, and process confirmation shall be documented for review by designated individuals or groups at the time of receipt and kept in accordance with the requirements of GB/T 19001 and (or) GB/T 19002 for document applicability. 6.6 Maintenance of validation
6.6.1 Calibration procedures
Recalibration of the equipment and dose system (see 6.3.3) shall be carried out at specified intervals. Recalibration shall be based on stability, date and use. GB 18280-2000
and shall comply with the requirements of GB/T 19001 and (or) GB/T 19002, as applicable. 6.6.2 Requalification of irradiation equipment
If changes occur in the irradiation equipment that affect the dose distribution, some or all of the installation qualification procedures (see 6.3) shall be repeated. 6.6.3 Sterilization dose audits
The audit shall be carried out at a given and documented frequency. To demonstrate that the sterilization dose continues to be effective, the audit shall be carried out in response to any changes that may significantly affect the biological load or properties. If no changes have been made, the audit shall be conducted at least once every three months, 7
Routine Process Control
Process control includes the control and monitoring of processing equipment, the management of products before, during and after irradiation, tape gauges and preventive maintenance, product dose monitoring, continuity and documentation of irradiation. 7.1 Process Specifications
Process specifications shall be established for each product or product type. The specifications shall include the following: a) the type or types of products covered by the specification; b) the maximum dose and sterilization dose allowed (see 6.2); c) the relationship of the product loading pattern and the dose at the monitoring position to the dose at the maximum and minimum dose positions (see 6.4.1); d) the monitoring position of the conventional dosimeter (see Annex C); c) for (radiation) sterilization, the relationship between product density, dose and source intensity; d) for electron beam and X-ray sterilization, the relationship between beam characteristics, transport speed, product structure and dose. Sometimes, products require multiple exposures to the irradiation field, some of which involve relocation of the product. These requirements should be included in the technical specifications. 7.2 Product Management
Documents describing the management of products before, during and after radiation sterilization should be established and maintained. Products should be managed and stored in a manner that ensures that their efficacy and microbiological condition are not altered. The product counting system should be used throughout the receipt, loading, unloading, post-sterilization management and release of products.
7.2.1 Product Transportation and Receiving
In order to ensure the settlement of product accounts, the processing records of sterilized products should include the total number of products received. Discrepancies between the received quantity and the quantity on the shipping wheel or transfer document should be resolved before processing. 7.2.2 Storage of products before and after irradiation
Products before and after irradiation treatment should be stored in separate areas. If separate areas are not individually marked for non-sterile and sterile product storage, or if product storage areas are located away from the loading and unloading areas of the irradiator, the status of individual trays or products should be identifiable.
7.3 Routine and preventive maintenance
Routine and preventive maintenance procedures (usually recommended by the equipment supplier) should be documented and performed. Preventive maintenance should be recorded and comply with the requirements of GB/T 1900| and/or GB/T 19002, as applicable. 7.4 Product irradiation
7.4.1 Process control
The irradiator should be operated and maintained consistently according to established documented procedures that ensure compliance with established and documented process specifications.
7.4.1.1 Irradiators
1) Controls For a given product or product type, timer settings and/or conveyor speeds should be controlled and adjusted based on the decay of the source. The cycle timer should have an alternative means to monitor any deviation from the current set interval. The source should be controlled to ensure that it is in the correct irradiation position.
b) Monitoring The position of the source, the timer setting and the operation of the irradiation container should be monitored. c) Product loading The product should be loaded into the irradiation container according to the designed product loading pattern.2 Electron beam equipment
a) Description of the packaged product, including the orientation of the unit count within the package, package dimensions and mass, the orientation of the product within the package, and the acceptable variations in these parameters, b) Description of the product loading pattern or patterns within the irradiation container, and b) Description of the irradiation container and its dimensions.
6.4.2 Product Dose Distribution Diagrams
Dose distribution studies should identify the minimum and maximum dose areas within the product load for the specified loading pattern and study the repeatability of the process. This information will then be used in routine work to select dose measurement sites. Dose distribution testing should be performed on a sufficient number of representative irradiation containers to determine the variation of the absorbent disk between representative containers, especially in the expected maximum and minimum dose areas and at routine monitoring locations. Dose distribution testing work should be performed at the extremes of the density range for each type of product regardless of process dose. The product loading pattern and channels used for processing should be included in this work. Equipment that processes only product loads with the same dose distribution characteristics as those used in the dose distribution test should meet the requirements for product dose distribution testing when determined. If the product loading pattern size or stacking density does not fully conform to the existing dose distribution data, the dose distribution should be measured.
All records, including irradiation parameters, results, and conclusions from the dose distribution test, should be kept in accordance with the requirements of GB/T19001 and (or) GB/T19002 for applicability. 6.5 Certification
The information collected and provided during product identification, installation identification, and processing confirmation should be documented for review by designated individuals or groups at the time of receipt, and kept in accordance with the requirements of GB/T 19001 and (or) GB/T19002 for applicability. 6.6 Maintenance of validation
6.6.1 Calibration procedures
Recalibration of the equipment and dose system (see 6.3.3) shall be carried out at specified intervals. Recalibration shall be based on stability, date and use. GB 18280-2000
and shall comply with the requirements of GB/T 19001 and (or) GB/T 19002, as applicable. 6.6.2 Requalification of irradiation equipment
If changes occur in the irradiation equipment that affect the dose distribution, some or all of the installation qualification procedures (see 6.3) shall be repeated. 6.6.3 Sterilization dose audits bZxz.net
The audit shall be carried out at a given and documented frequency. To demonstrate that the sterilization dose continues to be effective, the audit shall be carried out in response to any changes that may significantly affect the biological load or properties. If no changes have been made, the audit shall be conducted at least once every three months, 7
Routine Process Control
Process control includes the control and monitoring of processing equipment, the management of products before, during and after irradiation, tape gauges and preventive maintenance, product dose monitoring, continuity and documentation of irradiation. 7.1 Process Specifications
Process specifications shall be established for each product or product type. The specifications shall include the following: a) the type or types of products covered by the specification; b) the maximum dose and sterilization dose allowed (see 6.2); c) the relationship of the product loading pattern and the dose at the monitoring position to the dose at the maximum and minimum dose positions (see 6.4.1); d) the monitoring position of the conventional dosimeter (see Annex C); c) for (radiation) sterilization, the relationship between product density, dose and source intensity; d) for electron beam and X-ray sterilization, the relationship between beam characteristics, transport speed, product structure and dose. Sometimes, products require multiple exposures to the irradiation field, some of which involve relocation of the product. These requirements should be included in the technical specifications. 7.2 Product Management
Documents describing the management of products before, during and after radiation sterilization should be established and maintained. Products should be managed and stored in a manner that ensures that their efficacy and microbiological condition are not altered. The product counting system should be used throughout the receipt, loading, unloading, post-sterilization management and release of products.
7.2.1 Product Transportation and Receiving
In order to ensure the settlement of product accounts, the processing records of sterilized products should include the total number of products received. Discrepancies between the received quantity and the quantity on the shipping wheel or transfer document should be resolved before processing. 7.2.2 Storage of products before and after irradiation
Products before and after irradiation treatment should be stored in separate areas. If separate areas are not individually marked for non-sterile and sterile product storage, or if product storage areas are located away from the loading and unloading areas of the irradiator, the status of individual trays or products should be identifiable.
7.3 Routine and preventive maintenance
Routine and preventive maintenance procedures (usually recommended by the equipment supplier) should be documented and performed. Preventive maintenance should be recorded and comply with the requirements of GB/T 1900| and/or GB/T 19002, as applicable. 7.4 Product irradiation
7.4.1 Process control
The irradiator should be operated and maintained consistently according to established documented procedures that ensure compliance with established and documented process specifications.
7.4.1.1 Irradiators
1) Controls For a given product or product type, timer settings and/or conveyor speeds should be controlled and adjusted based on the decay of the source. The cycle timer should have an alternative means to monitor any deviation from the current set interval. The source should be controlled to ensure that it is in the correct irradiation position.
b) Monitoring The position of the source, the timer setting and the operation of the irradiation container should be monitored. c) Product loading The product should be loaded into the irradiation container according to the designed product loading pattern.2 Electron beam equipment
a) Description of the packaged product, including the orientation of the unit count within the package, package dimensions and mass, the orientation of the product within the package, and the acceptable variations in these parameters, b) Description of the product loading pattern or patterns within the irradiation container, and b) Description of the irradiation container and its dimensions.
6.4.2 Product Dose Distribution Diagrams
Dose distribution studies should identify the minimum and maximum dose areas within the product load for the specified loading pattern and study the repeatability of the process. This information will then be used in routine work to select dose measurement sites. Dose distribution testing should be performed on a sufficient number of representative irradiation containers to determine the variation of the absorbent disk between representative containers, especially in the expected maximum and minimum dose areas and at routine monitoring locations. Dose distribution testing work should be performed at the extremes of the density range for each type of product regardless of process dose. The product loading pattern and channels used for processing should be included in this work. Equipment that processes only product loads with the same dose distribution characteristics as those used in the dose distribution test should meet the requirements for product dose distribution testing when determined. If the product loading pattern size or stacking density does not fully conform to the existing dose distribution data, the dose distribution should be measured.
All records, including irradiation parameters, results, and conclusions from the dose distribution test, should be kept in accordance with the requirements of GB/T19001 and (or) GB/T19002 for applicability. 6.5 Certification
The information collected and provided during product identification, installation identification, and processing confirmation should be documented for review by designated individuals or groups at the time of receipt, and kept in accordance with the requirements of GB/T 19001 and (or) GB/T19002 for applicability. 6.6 Maintenance of validation
6.6.1 Calibration procedures
Recalibration of the equipment and dose system (see 6.3.3) shall be carried out at specified intervals. Recalibration shall be based on stability, date and use. GB 18280-2000
and shall comply with the requirements of GB/T 19001 and (or) GB/T 19002, as applicable. 6.6.2 Requalification of irradiation equipment
If changes occur in the irradiation equipment that affect the dose distribution, some or all of the installation qualification procedures (see 6.3) shall be repeated. 6.6.3 Sterilization dose audits
The audit shall be carried out at a given and documented frequency. To demonstrate that the sterilization dose continues to be effective, the audit shall be carried out in response to any changes that may significantly affect the biological load or properties. If no changes have been made, the audit shall be conducted at least once every three months, 7
Routine Process Control
Process control includes the control and monitoring of processing equipment, the management of products before, during and after irradiation, tape gauges and preventive maintenance, product dose monitoring, continuity and documentation of irradiation. 7.1 Process Specifications
Process specifications shall be established for each product or product type. The specifications shall include the following: a) the type or types of products covered by the specification; b) the maximum dose and sterilization dose allowed (see 6.2); c) the relationship of the product loading pattern and the dose at the monitoring position to the dose at the maximum and minimum dose positions (see 6.4.1); d) the monitoring position of the conventional dosimeter (see Annex C); c) for (radiation) sterilization, the relationship between product density, dose and source intensity; d) for electron beam and X-ray sterilization, the relationship between beam characteristics, transport speed, product structure and dose. Sometimes, products require multiple exposures to the irradiation field, some of which involve relocation of the product. These requirements should be included in the technical specifications. 7.2 Product Management
Documents describing the management of products before, during and after radiation sterilization should be established and maintained. Products should be managed and stored in a manner that ensures that their efficacy and microbiological condition are not altered. The product counting system should be used throughout the receipt, loading, unloading, post-sterilization management and release of products.
7.2.1 Product Transportation and Receiving
In order to ensure the settlement of product accounts, the processing records of sterilized products should include the total number of products received. Discrepancies between the received quantity and the quantity on the shipping wheel or transfer document should be resolved before processing. 7.2.2 Storage of products before and after irradiation
Products before and after irradiation treatment should be stored in separate areas. If separate areas are not individually marked for non-sterile and sterile product storage, or if product storage areas are located away from the loading and unloading areas of the irradiator, the status of individual trays or products should be identifiable.
7.3 Routine and preventive maintenance
Routine and preventive maintenance procedures (usually recommended by the equipment supplier) should be documented and performed. Preventive maintenance should be recorded and comply with the requirements of GB/T 1900| and/or GB/T 19002, as applicable. 7.4 Product irradiation
7.4.1 Process control
The irradiator should be operated and maintained consistently according to established documented procedures that ensure compliance with established and documented process specifications.
7.4.1.1 Irradiators
1) Controls For a given product or product type, timer settings and/or conveyor speeds should be controlled and adjusted based on the decay of the source. The cycle timer should have an alternative means to monitor any deviation from the current set interval. The source should be controlled to ensure that it is in the correct irradiation position.
b) Monitoring The position of the source, the timer setting and the operation of the irradiation container should be monitored. c) Product loading The product should be loaded into the irradiation container according to the designed product loading pattern.The relationship between product structure and dose. Sometimes, products need to be exposed to the irradiation field multiple times, some of which involve relocation of the product. These requirements should be included in the technical specifications. 7.2 Product Management
Documents describing the management of products before, during and after radiation sterilization should be established and maintained. Products should be managed and stored in a manner that ensures that their efficacy and microbiological status are not altered. The product counting system should be used throughout the receipt, loading, unloading, post-sterilization management and release of products.
7.2.1 Product Transportation and Receiving
In order to ensure the settlement of product accounts, the processing records of sterilized products should include the total number of products received. Discrepancies between the received quantity and the quantity on the shipping wheel or transfer document should be resolved before processing. 7.2.2 Storage of products before and after irradiation
Products before and after irradiation treatment should be stored in separate areas. If separate areas are not individually marked for non-sterile and sterile product storage, or if product storage areas are located away from the loading and unloading areas of the irradiator, the status of individual trays or products should be identifiable.
7.3 Routine and preventive maintenance
Routine and preventive maintenance procedures (usually recommended by the equipment supplier) should be documented and performed. Preventive maintenance should be recorded and comply with the requirements of GB/T 1900| and/or GB/T 19002, as applicable. 7.4 Product irradiation
7.4.1 Process control
The irradiator should be operated and maintained consistently according to established documented procedures that ensure compliance with established and documented process specifications.
7.4.1.1 Irradiators
1) Controls For a given product or product type, timer settings and/or conveyor speeds should be controlled and adjusted based on the decay of the source. The cycle timer should have an alternative means to monitor any deviation from the current set interval. The source should be controlled to ensure that it is in the correct irradiation position.
b) Monitoring The position of the source, the timer setting and the operation of the irradiation container should be monitored. c) Product loading The product should be loaded into the irradiation container according to the designed product loading pattern.The relationship between product structure and dose. Sometimes, products need to be exposed to the irradiation field multiple times, some of which involve relocation of the product. These requirements should be included in the technical specifications. 7.2 Product Management
Documents describing the management of products before, during and after radiation sterilization should be established and maintained. Products should be managed and stored in a manner that ensures that their efficacy and microbiological status are not altered. The product counting system should be used throughout the receipt, loading, unloading, post-sterilization management and release of products.
7.2.1 Product Transportation and Receiving
In order to ensure the settlement of product accounts, the processing records of sterilized products should include the total number of products received. Discrepancies between the received quantity and the quantity on the shipping wheel or transfer document should be resolved before processing. 7.2.2 Storage of products before and after irradiation
Products before and after irradiation treatment should be stored in separate areas. If separate areas are not individually marked for non-sterile and sterile product storage, or if product storage areas are located away from the loading and unloading areas of the irradiator, the status of individual trays or products should be identifiable.
7.3 Routine and preventive maintenance
Routine and preventive maintenance procedures (usually recommended by the equipment supplier) should be documented and performed. Preventive maintenance should be recorded and comply with the requirements of GB/T 1900| and/or GB/T 19002, as applicable. 7.4 Product irradiation
7.4.1 Process control
The irradiator should be operated and maintained consistently according to established documented procedures that ensure compliance with established and documented process specifications.
7.4.1.1 Irradiators
1) Controls For a given product or product type, timer settings and/or conveyor speeds should be controlled and adjusted based on the decay of the source. The cycle timer should have an alternative means to monitor any deviation from the current set interval. The source should be controlled to ensure that it is in the correct irradiation position.
b) Monitoring The position of the source, the timer setting and the operation of the irradiation container should be monitored. c) Product loading The product should be loaded into the irradiation container according to the designed product loading pattern.
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