This standard specifies the requirements for setting up, confirming and monitoring routine sterilization of moist heat sterilization processes. This standard covers all applied moist heat sterilization processes, including saturated steam and air-steam mixed gases, and is applicable to all industrial production plants and workers engaged in moist heat sterilization. Although this standard does not explicitly include moist heat sterilization in the non-industrial healthcare sector, the principles listed are also useful for most of its moist heat sterilization. GB 18278-2000 Requirements for sterilization confirmation and routine control of healthcare products Industrial moist heat sterilization GB18278-2000 standard download decompression password: www.bzxz.net

ICS11.080.01
National Standard of the People's Republic of China
GB 18278—2000
idtISo11134:1994
Sterilization of health care products
Requirements for validation and routine control-Industrial moist heat sterilization
Sterilization of health care productsReguirements for validation and routine control-Industrial moist heat sterilization2000-12-13 issued
2001-05-01 implementation
State Administration of Quality and Technical Supervision issued
GB182782000
ISOForeword
2Referenced standards
Setting of sterilization process
Confirmation of sterilization process
8Conventional moist heat sterilization
Appendix A (suggestive appendix)
Appendix B (suggestive appendix)
Appendix C (Informative Appendix)
Guidelines for validation and routine control of industrial moist heat sterilization Various sterilization cycles
Literature list
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GB18278—2000
All technical contents of this standard are mandatory
This standard is equivalent to the international standard ISO11134:1994 "Sterilization of health care products-Validation and routine control requirements Industrial
Moist heat sterilization".
Appendix A, Appendix B and Appendix C of this standard are all informative appendices. This standard is proposed by the State Food and Drug Administration and is under the jurisdiction of the National Technical Committee for Standardization of Disinfection Technology and Equipment. Drafting units of this standard: Guangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration, Shandong Xinhua Medical Device Co., Ltd., and Jiangsu Valin Group Medical Equipment Manufacturing Co., Ltd. The main drafters of this standard are: Liang Sui, Yang Zhaoxu, Mo Fucheng, Chen Yuanhua1
GB18278—2000
ISOForeword
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ISO (International Organization for Standardization) is a worldwide federation composed of national standardization groups (ISO member groups). The work of formulating international standards is usually completed by ISO's technical committees. If each member group is interested in a standard project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with ISO can also participate in the relevant work. In the field of electrotechnical standardization, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standard formally adopted by the technical committee is submitted to the member groups for voting. The international standard must obtain the consent of at least 75% of the member groups participating in the vote before it can be officially released. International Standard ISO11134 was formulated by ISO/TC198 Technical Committee on Sterilization of Healthcare Products.
Appendix A, B and C of this international standard are for reference only. GB18278—2000
In order to produce safe and sterile healthcare products, attention should be paid to product performance, sterilization methods and their control. This standard specifies the basic elements of Good Manufacturing Practice (GMP) for moist heat sterilization of healthcare products. A sterile product should be a product free of viable microorganisms. Even products manufactured under well-controlled conditions will carry microorganisms before sterilization. By definition, such products are non-sterile products. The purpose of sterilization is to kill the microorganisms that contaminate these non-sterile 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 treatment method used, the survival probability of microorganisms under these conditions can be calculated. The survival probability is a function of the number of microorganisms on the product, the type (strain), the sterilization kill rate, and in some cases, the environment in which the microorganisms are located during the sterilization process.
Therefore, it is difficult to absolutely guarantee the sterility of a particular product among the sterilized products. However, the bacterial rate of each product can be derived mathematically. For example, a probability of 10-6 means that the possibility (probability) of a product being bacterial is less than or equal to one in a million. The ISO9000 series of standards specifies the requirements for the quality system of design, development, production, supply, installation and maintenance services for health care products.
The ISO9000 series of standards refers to certain processes in the production of health care products as "special processes" because their results cannot be fully verified by product testing or experiments. The efficacy of the sterilization process cannot be verified by product testing or experiments, so it is an example of a special process. Such processes must be confirmed before use, and regular monitoring and maintenance of the equipment are required to keep them in normal condition. 1 Scope
National Standard of the People's Republic of China
Sterilization of health care products
Requirements for validation and routine control
Industrial moist heat sterilization
Sterilization of health care productsRequirements for validation and routine controlIndustrial moist heat sterilization This standard specifies the requirements for the setting, validation and routine sterilization monitoring of moist heat sterilization processes. HiiKANiKAca
GB18278—2000
idt ISO 11134:1994
This standard covers all applied moist heat sterilization processes, including saturated steam and air-steam mixed gases, and is applicable to all industrial production plants and workers engaged in moist heat sterilization. Although this standard does not explicitly include moist heat sterilization in the non-industrial healthcare sector, the principles listed are also mostly useful for its moist heat sterilization. Note 1: When the general principles of this standard apply to the sterilization of pharmaceutical products, other technical requirements or management requirements may also apply. This standard does not include a quality assurance system, which must control all production stages (including the sterilization process). 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard was published, the versions shown were 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. GB4793.1—1995
Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (idtIEC1010-1:1990)
GB18281.1—20001
Biological indicators for sterilization of health care products Part 1: General principles (idtIS011138-1:1994)GB/T19001—1994
GB/T190021 994
GB/T19003—1994
Quality system design, development, production, installation and service quality assurance model (idtISO9001:1994)
Quality system production, installation and service quality assurance model (idtISO9002:1994) Quality system final inspection and test quality assurance model (idtISO9003:1994IEC1010-2-041:19 95
3 Definitions
The following definitions are used in this standard.
Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-041: Particular requirements for pressure sterilizers that use steam to treat medical materials and are intended for laboratory use 3.1 Air-steam mixture air-steam mixture A uniform mixture of air and saturated steam used for sterilization Note 2: Air is used to balance the pressure that exceeds saturated steam generated in a sealed container. 3.2 Bioburden
The total number of viable microorganisms carried on raw materials, components, finished products and (or) packaging. 3.3 Certificate of Conformity
Approved by the State Administration of Quality and Technical Supervision on December 13, 2000 and implemented on May 1, 2001
GB18278-2000
As the final review and approval certificate in the product (export) release confirmation procedure. 3.4 D value
is the time required to reduce the number of a certain microorganism by 1 order of magnitude or 90% under specified conditions. 3.5 electromechanical control system electromechanical control system that uses mechanical means (such as cams or punch cards) to trigger electrical control signals in a timed manner. 3.6 environmental controls systems established in product production areas to control bioburden. Note 3: This may include air filters, liquid filters, surface disinfection, personnel clothing and various administrative facilities. 3.7 F value F valuc
a measure of the viability of microorganisms by thermal sterilization. 3.8 F, value F valuc
the F value calculated at 121,1°C (250°F) when the temperature is 10K and the D value is 1 min. 3.9 construction material material: of construction material used in sterilization equipment.
3.10 microbiological challenge biological indicator, biological indicator test kit, or product inoculated with a known number of microorganisms for testing sterilization cycles. 3.11 moist heat
Heat generated by liquid water or pressurized steam. 3.12 moist heat sterilization The process of producing sterile products using moist heat: 3.13 primary packaging The part of the product packaging system used to keep the product sterile. 3.14 process lethality The ability of the sterilization process to kill microorganisms. Note 4: It can be determined by measuring the death of microorganisms, or by specifying and measuring certain necessary physical parameters. 3.15 product carrier system The device used to hold the product and its packaging for sterilization. Note 5: The carrier can protect the product from damage and keep it in contact with the sterilization factor. 3.16 commissioning
After the equipment is provided and installed according to the technical requirements, it is operated according to the instruction manual to prove that its functions are within the specified range and a written record is made.
3.17 Recommissjoning Part or all of the commissioning test conducted to reconfirm the safety and reliability of the sterilization process. 3.18 Revalidat1an
Part or all of the certification test conducted to reconfirm the safety and reliability of the sterilization process. 3.19 Saturated steam saturatcd steam
Water vapor equivalent to the boiling point of the source liquid 3.20 Simulated product load simulated product load is used to replace the load of the actual product. This load should be equivalent to or slightly exceed the sterilization process capacity. 3.21 Sterile
The state of no viable microorganisms.
Note 6: In practice, the absolute absence of microorganisms cannot be proven (see "Sterilization"). 3.22 Sterilization
Treatment that has been confirmed to be free of viable microorganisms CB 18278-2000
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Note 7: In sterilization, the mortality rate of microorganisms is expressed as an exponential number. Therefore, the presence of organisms in any single product can be expressed as a probability. The probability may be very low, but it is unlikely to be extreme.
3.23 Sterilization cycle The automatic program of the various operating stages in the sterilizer. 3.24 Sterilization process settings developme Establish a repetitive process that sterilizes the product to a specified probability of non-sterility without compromising the product. 3.25 Validation
A written procedure for recording and collating the results obtained in order to establish a process that can sustainably produce a product that meets predetermined technical specifications. NOTE H: Validation includes all aspects of work - trial operation, technical specification verification and performance determination. 3.26 value
The degree of adjustment required to change the temperature by one order of magnitude. 4 General
4.1 Job and personnel training
The installation and maintenance of heat sterilizers, the control and validation of heat sterilization technology, and the release of sterilized products must be carried out by a qualified person designated by GB/T The personnel specified in GB/T19001 or GB/T19002 standards are responsible. 4.2 Product conditions
The design of the product must still meet its technical specifications and safety requirements after the maximum number of sterilizations specified for the product. If some treatment (such as cleaning) is required before sterilization, this treatment must also be confirmed as part of the re-sterilization step. The designed product and the selected materials must be able to adapt to the changes in the sterilization cycle and the sterilization cabinet environment. 4.3 Packaging conditions
4.3.1 Overview
The packaging must be composed of at least · layers of inner packaging and · layers of outer packaging. If both inner and outer packaging are used during sterilization, both must still meet the required specifications after sterilization. 4.3.2 Transparency of packaging
The packaging must allow the air inside the product to pass through. The air is exhausted and the steam is allowed to penetrate. For non-permeable packaging (such as a small glass bottle containing liquid medicine), the sterilization conditions can also be achieved through heat conduction.
5 Equipment
5.1 DocumentswwW.bzxz.Net
5.1.1: Identification
Each sterilization device must have one or more nameplates, which are permanently fixed and marked. The following contents should be marked in the language agreed with the user:
a) Name and address of the dust manufacturer:
b) Serial number or other marking unit;
c) Design pressure and maximum working temperature of the sterilization chamber:
d) Rated pressure of the fire sleeve (if applicable):
e) Imprint of the inspection department and wearer trademark
f) Container working period;
) Identification that complies with other laws and regulations of my country. 5.1.2 Safety
There must be documents to prove that the sterilization device complies with the safety requirements specified in G34793.1 and IFC1010-2 and other standards, or applicable laws and regulations in my country.
5.1.3 Instructions and instructions
GB 18278--2000
For each certified sterilizer, the following information should be provided in the language agreed with the user: α) Installation instructions sufficient to ensure safe and effective operation of the sterilization device; b) List of various structural materials exposed to the sterilization cavity or accidentally contacting the product; s) Safe and effective operation instructions, including the temperature and pressure resistance limits of the sterilizer, and safety precautions; d) Guidelines and schedules for routine preventive maintenance; e) Repair manual, including a list of recommended replacement parts; f) Detailed structure and component diagram of the sterilization cabinet room: Schematic diagram of the pipeline and control system, and recommended installation diagram. All important components shall be described in a table:
g) Documentation of the programming and (or) software necessary to operate and maintain the equipment control system (see 5.2.6). All software provided must be accompanied by a confirmation certificate of factory release and re-inspection level. 5.1.4 Other information
Technical requirements for moist heat sterilizers, including written materials on their installation and installation tests. 5.2 Sterilizer performance, common systems, components, accessories and control devices 5.2.1 Performance
Moist heat sterilization equipment used to process health care products must comply with the regulations or standards of my country that stipulate the performance of sterilization equipment. 5.2.2 Common systems
5.2.2.1 The purity and quality of steam must be specified and its scope of application must be demonstrated. 5.2.2.2 The purity of the compressed air used in the sterilization chamber must not affect the safety performance of the product. 5.2.2.3 For products in breathable packaging, the external air entering the sterilization chamber to eliminate the vacuum must first pass through a microbial filter. 5.2.2.4 The water used by the sterilizer to directly cool the product must be specified and verified to meet the requirements specified in the product. Technical settings must be documented and documented. 5.2.2.5 The power supply to the sterilization system must meet the technical specifications of the manufacturer. 5.2.3 Components The materials and components used in the construction of the sterilization system must be screened to minimize potential microbial or chemical contamination. 5.2.4 Accessories The device dedicated to holding the product in the sterilization chamber must facilitate steam uniform penetration and (or) heat conduction. The load-bearing device must also facilitate the discharge of condensed water and (or) cooling water to prevent damage to the product and the load. 5.2.5 Control and recording devices
The following sterilization process parameters must be automatically controlled and recorded: a) temperature; b) time; e) pressure
e) rate of change of temperature and pressure (necessary to maintain product integrity). The recorder and program control system must be independent of the machine and can issue an alarm when the difference between the control conditions and the records exceeds the specified limit.
5.2.6 Program control
Sterilization process control, whether by microcomputer or electromechanical means, must be confirmed. The written program must be evaluated in a certain step. The program logic must be proved to be correct under process simulation conditions and in the actual use of the sterilizer. Any subsequent changes must also be evaluated in written documents to see if they need to be reconfirmed and must be agreed by the user. 5.3 Instrument performance
5.3.1 Instrument accuracy
GB 18278-2000
5.3.1.1 The accuracy of the instrument used for confirmation must be higher than the accuracy of the controller and recorder. 5.3.1.2 The temperature and pressure sensors must be selected, installed and used under the condition of maintaining their accuracy. 5.3.2 Calibration standard
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The standard accuracy of the sterilization technology measuring instrument must be specified, and its calibration should be traceable to the national basic standard specified in GB/T 19001.
5.3.3 Sterilizer Reference Instruments
The sterilizer must be equipped with a separate set of measuring devices to verify whether the values ​​measured by the control instruments during the sterilization cycle are within the rated temperature and pressure limits:
5.3.4 Calibration Procedure
An effective method and file must be established and preserved for the calibration of all control, display and recording instruments used for sterilization period confirmation and routine control. This method should comply with GB/T 19001 and (G1B3/I19002 standards, the instruments used for confirmation should also comply with the requirements of G13/119003 standards.
5.4 Maintenance
5.4.1 The sterilizer must be maintained according to a clearly defined preventive maintenance plan. 5.4.2 The personnel responsible for maintenance must have a certificate to prove that they have been well-trained in skills and are competent for the maintenance of specific sterilizer tasks. 5.4.3 The steps and frequency of each planned maintenance work must be clearly defined. 5.4.4 The sterilizer shall not be used to process health care products until the planned or unplanned maintenance work has been satisfactorily completed and recorded.
5.4.5 Maintenance records must be kept in the equipment file. 5.4.6 The maintenance plan, steps and records must be regularly checked by designated personnel. 6 Sterilization process settings
6.1 Unless the product has special requirements, it is sterilized using saturated steam. Other methods (such as air- When using a wet heat sterilization cycle, it must be proven that the environment created in the sterilization cabinet is repeatable. If an air-steam mixture is used, it must be carried out under a uniform heat medium in the effective sterilization cycle. If an air-steam mixture is used and steam penetration is required, the circulation system must form a uniform air-steam mixture in the sterilized load. 6.2 The sterilization cycle must be designed to be repeatable in conventional processes. 6.3 For the newly set moist heat sterilization cycle, it must be proven that the products treated have met the sterilization requirements. 6.4 Any product that is handled or stored at the sterilization site after sterilization shall not cause damage to its quality. 6.5 The setting of the probability of a sterile product must ensure that the probability of viable microorganisms contained in the sterile health care product is low enough to be used safely for its intended purpose.
6.6 When using test microorganisms, they must be selected based on the sterilization process and should meet the requirements of GB18281.1-ISO011138-1.
6.7 The data measured during the sterilization cycle setting process must be able to prove that the required bioburden survival probability is achieved. 6.8 For various sterilization methods based on bioburden, a procedure for determining the number and resistance of bioburden before sterilization must be established. 7 Confirmation of the sterilization process
7.1 The confirmation procedure must be carried out using an approval plan that conforms to the principles of GB/T19002 standard. 7.2 Each manufactured sterilizer must be tested after assembly. New products and new sterilization equipment or sterilization process conditions must be confirmed.
7.3 Experienced personnel must be appointed to conduct confirmation. 7.4 Confirmation of the sterilization process must include the test run performance evaluation of each system and the acquisition of a certificate of conformity. 7.4.1 The test run must include:
a) Proof that the performance is consistent with the design specifications: GB 18278-2000
b) A full set of technical documents for the equipment is complete (see 5.1. 3);) Demonstrate that the quality and capacity of the common systems meet the requirements; d) Calibration of operating and test equipment:
e) Determine the efficiency of air removal during operation [when necessary) 7.4.2 Performance qualification must include the following: a) The sterilization process is repeatable (must pass a sufficient number of cycles); b) The uniformity of the entire sterilizer space and the sterilized items is within the specified range (must pass a sufficient number of cycles and sensors); e) Demonstrate the relationship between the control parameters and the parameters of the sterilized items; d) Based on the data obtained from published literature and research conducted, show the relationship between physical parameters and microbial killing;) Compatibility with both maximum and minimum loads (or specified mixed products); f) If simulated product loading tests are used, it must be demonstrated that they are representative of the actual product:) Demonstrate that the qualified loads intended for repeated use have been restored to the specified state before reuse; h) Demonstrate that the product and packaging still meet the specified technical specifications after sterilization or the need for re-sterilization. 7.4.3 In performance qualification and re-qualification, the number of temperature sensors to be used must be specified. Provide written proof to confirm that the quantity has reached the test method required by the relevant technical requirements set by Ding Yi. 7.4.4 Before and after each test of the sequence test, the temperature measuring device used must be calibrated. 7.5 When the confirmation is completed, the data obtained must be listed, a formal evaluation must be conducted, and a conclusion on whether it is approved must be given. 7.6 After the sterilizer has been overhauled that may affect its efficacy, it must be reconfirmed. In addition, it must be reconfirmed at least once every 12 months of use.
7.7 There must be clear provisions for reconfirmation, review and changes to the sterilization process, sterilization equipment (hardware and components), products or packaging, which should include the necessity and scope of specifying the parts that need to be reconfirmed. When there are changes to the equipment or control device, an assessment must be made to confirm that the sterilization conditions for the items are basically consistent with the original qualified conditions. 8 Conventional Moist Heat Sterilization
8.1 Steam Sterilization Process Control
8.1.1 The accuracy and reliability of the instruments monitoring each production period must be calibrated regularly to meet the requirements. 8.1.2 Specify the steps for monthly monitoring of the sterilization cycle. 8.1.3 The following records must be kept for each sterilization cycle: a) Date b) Sterilizer identification c) Cycle type d) Operator title and signature e) Cycle start time (real time) f) Sterilizer chamber pressure throughout the cycle g) Sterilizer air temperature throughout the cycle h) Key process parameter timing 8.2 Control of changes Documentation on the sterilization method must be in place to ensure that equipment, processes or materials do not change in a way that could affect the sterilization effect. If such changes occur, the new sterilization cycle must be confirmed. Sterilization failures that do not violate the specification must be checked to determine whether re-qualification is required.
8.3 Periodic inspection
Sterilizers should be inspected regularly according to a clearly defined plan. 8.4 Microbiological inspection
GB18278—2000
If the effectiveness of the sterilization cycle is analyzed or calculated based on the product bioburden, then: a) the method of determining or calculating the bioburden must be confirmed and clearly defined; b) a method must be defined to ensure that the bioburden does not exceed the specified limit; ) The product bioburden must be continuously monitored at a clearly defined frequency and principle. 8.5 Release of sterilized products
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In conventional sterilization processes, products that are monitored within the confirmed range of process parameters can be released. A system that can distinguish between sterilized and non-sterilized items must be used. A dedicated person must be assigned to be responsible for the release of sterilized products. 8.6 Operation Inspection
The production and quality control steps and records must be inspected at least once a year according to GB/T19001. The technical supervisors directly involved in the above steps must ensure that the process specifications developed through the identification test are implemented and remain effective. 8.7 Corrective Measures
The explicit provisions and methods for corrective measures should be consistent with GB/T19001. When any deviation from the specifications or prescribed methods is found during operation, inspection, calibration or maintenance, it must be reviewed by designated personnel to decide on appropriate corrective steps and measures. 8.8 Records
Records that the product has been sterilized in accordance with all specifications must be made and preserved in accordance with GB/T19001.
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