Criterion on quality control of laboratories - Microbiological testing of food
Some standard content:
ICS03.120.10
National Standard of the People's Republic of China
GB/T27405—2008
Criterion on quality control of laboratories-Microbiological testingof food2008-05-04Promulgated
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of China
2008-10-01Implementation
GB/T27405—2008
Normative reference documents
Terms and definitions
Management requirements
Management system
Document control
Quality and technical records
Customer service
Complaint handling
Non-conforming work control
Corrective measures……
Preventive measures
Internal audit·
Management review·.
Continuous improvement
Technical requirements
Facilities and environmental conditions
Reagents and culture media
Standard materials and standard cultures
Process control requirements,
Contract review…
Confirmation and validation of test methods…
Measurement uncertainty
Sample disposal and confirmation·
Handling of contaminated waste.
Test report·
Internal quality control and external quality assessment Assessment.
7.1 Internal quality control
7.2 External quality assessment
Appendix A (Normative Appendix)
Appendix B (Informative Appendix)
Appendix C (Informative Appendix)
Appendix D (Informative Appendix)
General use of standard cultures
Basic requirements and management of microbiological sterile rooms
Calibration, maintenance and performance verification of equipment
Disinfection treatment methods for microbiological laboratories
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This standard is a series of laboratory quality control specifications Standards include the following standards: GB/T27401 "Laboratory Quality Control Specifications" GB/T27402 "Laboratory Quality Control Specifications - GB/T27403 "Laboratory Quality Control Specifications Animal Quarantine";
Plant Quarantine";
Food Molecular Biology Testing";
-GB/T27404 "Laboratory Quality Control Specifications Food Physical and Chemical Testing"; -GB/T27405 "Laboratory Quality Control Specifications Food Microbiological Testing";
GB/T27406 "Laboratory Quality Control Specifications Food Toxicology Testing". GB/T27405—2008
Please note that some contents of this standard may involve patents. The issuing agency of this standard shall not bear the responsibility for identifying these patents. Appendix A of this standard is a normative appendix, and Appendix B, Appendix C and Appendix D are informative appendices. This standard is proposed and managed by the National Technical Committee for Certification and Accreditation of Standardization (SAC/TC261). This standard is drafted by the China National Accreditation Service for Conformity Assessment. This standard was drafted by: China National Accreditation Service for Conformity Assessment, Shandong Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China. The main drafters of this standard are: Lei Zhiwen, Liu Xuehui, Yuan Xiangjun, Zhang Mingxia, Jiang Yinghui, Jia Juntao, Liu Yunguo, Zhou Lie, Zhao Liqing, Fang Baohai, Wang Dong, Lin Xiuguang, Wu Xinghai, Ma Weixing. The preparation of this standard is mainly based on GB/T27025 "General Requirements for the Competence of Testing and Calibration Laboratories", and at the same time absorbs the content of GB/T19001-2000 "Quality Management System Requirements", refers to the documents of relevant international professional organizations, domestic and foreign industry standards and professional literature, and fully integrates the management experience of relevant domestic laboratories. This standard aims to standardize, guide and help relevant laboratories to meet the specific requirements of GB/T27025 and quality control in this professional field.
Food microbiological testing refers to determining the number or existence of a certain type of microorganism in a unit sample according to certain testing procedures and quality control measures. This standard applies to the quality control of laboratories engaged in microbiological testing of food, food additives, animal feed, food processing machinery, food packaging and food processing environment samples. The bodies that accredit food microbiological testing laboratories can use this standard as a reference.
It is recommended that relevant laboratories should be familiar with and master the relevant contents of GB/T27025 before using this standard. On the product partner network http
1Scope
Laboratory quality control specification
Food microbiological testing
GB/T27405-2008
This standard specifies the management requirements, technical requirements, process control requirements, internal quality control and external quality assessment requirements of food microbiological testing laboratories.
This standard applies to the quality control of laboratories engaged in microbiological testing of food, food additives, animal feed, food processing machinery, food packaging materials and food processing environment samples. Laboratory accreditation bodies can use it as a reference. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all referenced documents with dates, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all referenced documents without dates, the latest versions are applicable to this standard. GB14925 Laboratory animal environment and facilities
GB15981 Evaluation methods and standards for disinfection and sterilization effectsGB/T18202 Hygienic standards for oxygen in indoor airGB19489 General requirements for laboratory biosafetyGB50346 Technical specifications for biosafety laboratory buildingsSN/T1538.1 Guide to culture medium preparation Part 1: General rules for quality assurance of laboratory culture medium preparation (ISO/TS11133-1:2000,MOD)
SN/T1538.2 Guide to culture medium preparation Part 2: Practical guide for culture medium performance testing (ISO/TS11133-2:2003,MOD)
ISO7218 Microbiology of food and animal feeding stuffs-General rules for microbiological examinationsISO16140 Microbiology of food and animal feeding stuffs-Protocol for validation of alternative methods for the validation of alternative methods)ISO 18593 Microbiology of food and animal feeding stuffs-Horizontal methods for sampling techniques from surfaces using contact plates and swabs)EA-04/10 Accreditation in microbiological laboratories3 Terms and definitions
The following terms and definitions apply to this standard. 3.1
Top management of laboratoryA person or group of people who directs and controls the laboratory at the highest level. 3.2
Management personnel of laboratoryA person who is responsible for managing laboratory activities under the leadership of the top manager of the laboratory. http
GB/T 27405—2008
Laboratory capabilityLaboratory capabilityThe materials, environment, information resources, personnel, technology and expertise required for the laboratory to carry out corresponding tests. 3.4
Sample
One or more parts of a whole are taken to provide relevant information about the whole, usually as a basis for judging the whole. 3.5
referencemethod
A method that is published, rigorously validated, and recognized internationally, regionally, nationally, or by the industry. 3.6
alternativemethod
A method that is equivalent to the relevant standard method and is used to detect a target microorganism in a specific product. 3.7
negativedeviation
When the standard method gives a positive result, while the alternative method gives an unconfirmed negative result, if the latter is proven to be positive, this deviation is a false negative.
positivedeviation
When the standard method gives a negative result, while the alternative method gives an unconfirmed positive result, if the latter is proven to be negative, this deviation is a false positive.
referencecultures
A general term for standard strains, standard reserve strains, and working strains. 3.10
referencestrain
Strains defined at least to the genus or species level. Classified and described according to their characteristics, with clear sources. 3.11
reference stocks
The same strain obtained after the standard strain is transferred for one generation. 3.12
working cultures
The same strain obtained after the standard stock strain is transferred. 3.13
limit of determination
When conducting quantitative microbiological testing, the minimum amount of microorganisms that can cause a specific change under the experimental conditions specified in the specific evaluation method. 3.14
limit of detection
When conducting qualitative microbiological testing, the minimum amount of microorganisms that can be detected but cannot give an accurate value. 3.15
specificity
The ratio of the number of negative strains or the number of confirmed colonies to the number of suspected detected objects. 4 Management requirements
4.1 Organization
4.1.1 The food microbiological testing laboratory or its organization shall have a clear legal status. Laboratories are generally independent legal entities, and laboratories that are not independent legal entities must be authorized by the superior legal entity. 4.1.2 Laboratory testing services should be able to meet the work needs of customers GB/T27405—2008
4.1.3 When laboratories carry out work in other places inside or outside their fixed locations, they should comply with the relevant provisions of this standard. 4.1.4 The top management of the laboratory shall be responsible for the design, establishment, maintenance and improvement of the management system, which shall include at least the following aspects: adequately staffing the laboratory and providing all personnel with the authority and resources necessary to perform their duties; a)
Develop policies and procedures to prevent the laboratory and its personnel from being involved in any activities that may reduce their judgment, skills, honesty and impartiality; b)
Develop policies and procedures to ensure that customer confidential information is protected: clarify the laboratory's organizational and management structure, as well as the laboratory's relationship with other relevant organizations; d)
Specify the responsibilities, authority and relationships of all personnel; establish a technical management team and assign corresponding responsibilities and authority to be responsible for technical operations and resource supply (the head of the technical management team is also called the technical person in charge); appoint a quality manager who shall be fully responsible for the operation of the management system; g)
Other laboratory personnel shall be trained and supervised by personnel who are familiar with the purpose, procedures, operations and result evaluation of the inspection according to their experience, capabilities and responsibilities. The top management shall directly appoint and manage quality supervisors; h) Appoint agents for key personnel. In some small laboratories, one person may assume multiple responsibilities. 4.1.5 The laboratory's top manager, technical director, and quality manager should have appointment documents. 4.2 Management system
4.2.1 Policies, plans, procedures, instructions, and operating procedures should be documented and communicated to all relevant personnel, and ensure that relevant personnel are familiar with, understand, and implement them.
4.2.2 The management system should include internal quality control and external quality assessment. 4.2.3 The top manager should preside over the formulation and authorization of the quality policy, objectives, and commitments, and document them and write them into the quality manual (regardless of the name). The top manager or the quality manager should publicize the quality policy and objectives to all employees. The quality policy, objectives, and commitments should be concise and clear, so that relevant personnel can obtain them immediately, and at least include the following: a) The scope of services provided by the laboratory;
b) Commitment to service standards;
Clarify the laboratory's quality management level and technical objectives; c
d) Relevant personnel are familiar with, understand, and implement the requirements of the management system; The laboratory's commitment to professional behavior, inspection quality, and compliance with the management system and relevant laws and regulations. e)
4.2.4 The quality manual should describe the management system and document structure; the quality manual should also specify the responsibilities of personnel in each important position. 4.3 Document control
4.3.1 The laboratory should develop and implement special procedure documents to meet the requirements of document control, and the documents should be backed up and archived. These controlled documents can use paper or paperless media and should comply with national, regional and local regulations. 4.3.2 The document control procedure implemented should ensure that: management system related documents issued to laboratory personnel are approved by authorized personnel before release; a)
Records of the names, validity status and issuance of documents in use are established, which are also called document control records; b)
Only current and confirmed document versions are used in corresponding places; documents should be reviewed regularly, revised when necessary, and approved by authorized personnel: d)
Invalid or obsolete documents should be immediately removed from all places of use or appropriately marked to prevent misuse; e)
If the laboratory allows handwritten modifications to documents before they are reprinted, the modification procedures and authorities should be determined, and the modifications should be clearly marked, signed and dated, and the revised documents should be officially released as soon as possible; g) A procedure should be established to describe how to change and control files running or stored in computer systems. 4.3.3 All documents related to the management system shall be uniquely identified, including: a) title, document number and date of issue;
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GB/T27405-2008
Revision date or revision number, version identification; b)
Page number and number of pages (if applicable);
d) Issuing agency;
e) Source identification;
f) Document distribution number (if applicable).
4.4 Quality and technical records
4.4.1 The laboratory shall establish and implement a set of procedures for the identification, collection, indexing, retrieval, storage, maintenance and safe handling of quality and technical records.
4.4.2 All quality and technical records shall be clear and easy to retrieve, and shall comply with relevant regulations. A suitable storage environment shall be provided and stored in an appropriate form to prevent damage, destruction, leakage, loss or theft. 4.4.3 The laboratory shall clearly define the retention period of various quality and technical records. The retention period shall be determined according to the nature of the inspection or the specific circumstances of each record and shall comply with the requirements of relevant laws and regulations. Quality and technical records may include:
a) inspection application form, letter of entrustment or sampling record; b)
inspection results and reports;
results printed out by the instrument;
test plan;
original work record book (record sheet);
test data statistical record;
quality control record;
complaints and measures taken;
internal and external audit records;wwW.bzxz.Net
proficiency testing or inter-laboratory comparison records; quality improvement records;
instrument use and maintenance records, including internal and external calibration records; environmental monitoring records of key areas such as sterile rooms (see 5.2.2 and Appendix B); m)
records of external service provision;
acceptance records of equipment and consumables;
error or accident records and response measures;
q) personnel training and capability records.
When errors occur in records, each error should be crossed out and the correct value filled in next to it, and the content before the change should be identifiable. 4.4.4
All changes to records should be signed or signed by the person making the change. Electronically stored records should also take the same measures to avoid loss or modification of original data.
4.5 Customer Service
4.5.1 The laboratory shall authorize senior personnel to provide customers with appropriate pre-test professional consulting services. 4.5.2 Authorized professionals in the laboratory may provide advice on the selection of inspection and services, including inspection items, test methods, required sample conditions, etc., at the request of customers. The laboratory shall clarify the customer's requirements and allow customers to enter the laboratory to monitor operations related to their work while ensuring the confidentiality of the laboratory and other customers. 4.5.3 Authorized professional technicians in the laboratory may provide explanations for test results when appropriate. 4.5.4 The laboratory shall notify customers of any delays and major deviations in the testing process. 4.5.5 The laboratory shall solicit feedback from customers, whether positive or negative. These opinions shall be used and analyzed and applied to improve the management system, testing activities and service levels. The laboratory shall keep complete records of feedback and corresponding measures taken, which can be used as one of the inputs to management review [see 4.11.2h)]. 4
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4.6 Complaint handling
GB/T27405-2008
The laboratory should have policies and procedures to handle complaints from customers or other parties, and the methods should be diverse and multi-channel. The laboratory should keep records of complaints and investigations and corrective actions taken in response to complaints. Customer complaints and their handling should be one of the inputs to management review [see 4.11.2h)1.
4.7 Control of nonconforming work
4.7.1 The laboratory should have specific procedures and regulations to identify and control nonconforming work during the inspection process. These procedures and regulations should ensure that:
A designated person is responsible for handling non-conforming work issues; a)
The measures to be taken are clearly specified;
Consider the possible impact of non-conforming work and notify the customer if necessary; c)
Terminate the inspection if necessary and do not issue the report; Correct immediately and take corrective measures if necessary; f
If the inspection results have been released, consider whether they need to be recalled or handled in an appropriate manner; g)
A designated person has the right to suspend (terminate) the inspection and approve the resumption of the inspection work; Record each occurrence of non-conforming work and archive it. These records should be reviewed regularly to identify trends and take preventive measures (see 4.9).
4.7.2 The laboratory should develop and implement relevant procedures to specify how to review and issue test reports when non-conforming work exists, and keep these work records.
4.8 Corrective Action
4.8.1 The corrective action procedure should include an investigation process to determine the root or potential cause of the problem. Corrective actions should be commensurate with the severity of the problem and the size of the risk it brings to avoid wasting resources. 4.8.2 If the corrective actions taken involve a change, these changes should be documented and issued to relevant personnel for implementation. 4.8.3 The results of each corrective action should be monitored to determine whether these measures are effective. 4.8.4 If the investigation and analysis of nonconforming work indicates that there may be problems with the management system, the laboratory should conduct additional audits or management reviews of the management system aimed at solving the existing problems. The results of corrective actions should be reviewed. 4.9 Preventive measures
The laboratory should develop special procedures to detect potential nonconforming work and prevent its occurrence: potential nonconformities and required improvements, including technical aspects and related management system aspects, should be identified. If preventive measures are required, they should be developed, implemented and monitored to reduce the possibility of similar nonconformities and take the opportunity to improve. The preventive measures procedure should include the initiation and control of measures. Preventive measures may also involve data analysis, trend and risk analysis, etc. b)
All operating procedures should be reviewed regularly to identify potential non-conformities, propose quality and technical improvement suggestions, formulate and implement improvement measures, and archive relevant documents and records. d) After the review is completed and the corresponding measures are implemented, the laboratory should evaluate the effectiveness of the above measures by tracking and monitoring relevant aspects or conducting key audits.
e) The results of the implementation of preventive measures should be analyzed and judged, including whether the management system needs to be changed and how to change it. 4.10 Internal Audit
4.10.1 In order to verify the compliance of the laboratory's inspection and related work with the management system, the implementation of each element of the management system should be reviewed regularly (at least once a year), that is, internal audits. Internal audits should include all elements of the management system and all relevant departments and personnel. 4.10.2 The quality manager or designated qualified personnel should be responsible for planning, organizing and implementing internal audits. As long as resources permit, the auditors should have no direct connection with the work being audited. The internal audit procedure document shall be formulated, including personnel responsibilities, frequency, basis, work flow, adopted methods and required related documents. 4.10.3 If non-conforming work is found during the audit, the laboratory shall correct it and formulate appropriate corrective measures if necessary, requiring the relevant departments to complete the rectification within the agreed time, and designate a person to be responsible for follow-up audit and verify the effectiveness of the rectification. If the problems found in the audit may affect the test results that have been issued, the customer shall be notified in writing. 4.10.4 The audit results shall be issued to all relevant departments and personnel in the form of documents. 4.10.5 The audit results and the rectification follow-up verification shall be recorded and used as the input of the management review [see 4.11.2e)]. 4.11 Management Review
4.11.1 The laboratory shall review the management system and other related work to ensure that the external conditions such as resource guarantee required for the continued applicability and effective operation of the management system are obtained, and necessary changes or improvements shall be made in a timely manner. The management review shall be conducted at least once every 12 months. 4.11.2
The management review shall be chaired by the top management. The management review shall at least consider the following aspects: the implementation of the improvements proposed in the last management review; the results of recent internal audits;
corrective measures, preventive measures and other improvement suggestions taken; reports from management or supervisory personnel;
the results of external reviews and participation in proficiency testing and inter-laboratory comparisons; changes in the workload and type of work undertaken, financial situation; inspection service quality, including complaints or related information from customers, internal employees and other parties; personnel training and effectiveness evaluation;
internal quality control results report;
evaluation of suppliers and service providers;
analysis of the applicability of policies and procedures;
the suitability of the quality policy and the analysis of the achievement of quality objectives. The management review results shall include an evaluation of the suitability of the management system, solutions to problems that affect the suitability, adequacy and effectiveness of the management system, and tracking of the implementation of solutions. 4.11.4 The management review results shall be communicated to relevant personnel, and the documents and records shall be archived. 4.12 Continuous Improvement
4.12.1 The laboratory shall continuously improve the laboratory management system by meeting the requirements of the test quality and customers. 4.12.2 The laboratory shall continuously improve the effectiveness of the management system by implementing quality policies, quality objectives, data analysis, communication, management review, internal audit, proficiency verification, preventive and corrective measures, customer complaint handling, etc. 4.12.3 The laboratory shall establish a quality indicator system to monitor and evaluate the effectiveness of the inspection work. If the evaluation results of the indicator indicate that there is a possibility of improvement, it should be considered so that the quality of laboratory work can be continuously improved. 5 Technical Requirements
5.1 Personnel
5.1.1 The laboratory shall be operated or guided by personnel with certain qualifications in microbiology or similar majors. 5.1.2 If the laboratory test result report contains opinions and explanations, the authorized person who signs the opinions and explanations should have relevant work experience and professional knowledge, including relevant regulations and technical requirements. 5.1.3 The management of the laboratory shall ensure that all personnel receive the necessary training in equipment operation, microbial testing skills and laboratory biosafety to perform their jobs, and have continuing education programs for all levels of testing personnel. 5.1.4 The laboratory shall objectively evaluate the capabilities of testing personnel by participating in internal quality control, proficiency testing or using standard strains, and retrain and re-evaluate them when necessary. When using a method or technology that is not frequently used, it is necessary to confirm the operational skills of microbial testing personnel before testing. 5.2 Facilities and environmental conditions
5.2.1 Facilities
5.2.1.1 The laboratory shall have appropriate and sufficient facilities and conditions for microbial testing, including testing facilities (dedicated to microbial testing and related activities) and auxiliary facilities (gates, corridors, management areas, sample rooms, cleaning rooms, storage rooms, document rooms, etc.). Special equipment should be installed in special 6
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Place and operate under a certain environment.
GB/T27405—2008
Based on the different levels of the microorganisms tested, the laboratory should take strict restriction measures for personnel authorized to enter the work area and clearly inform the relevant personnel of the following:
a) The specific purpose of special areas;
b) Restriction measures for special work areas;
c) The reasons for taking these restrictions;
d) Reasonable control level.
5.2.1.2 Incompatible business activities should be effectively separated according to specific testing activities (such as test types and quantities, etc.). Measures should be taken to minimize the risk of cross contamination. To achieve this goal, the following measures can be taken: a) The construction of the laboratory should comply with the provisions of GB19489 and the principle of "no loop"; effectively isolate various testing activities in time or space; b) To ensure the integrity of the test samples (such as using sealed containers), the operation should follow the prescribed procedures and take pretreatment measures. c) 5.2.1.3 In accordance with good operating practices, the following clearly marked isolation sites or clearly designated areas should be considered: a) Sample receiving and storage area; Sample pretreatment area (such as powdered products that are easily contaminated should be handled in an isolated area); Microbiological testing (including culture) of samples and identification of suspected pathogens: Storage area for standard strains and other strains; Culture medium and chemical reagent storage area (culture medium and chemical reagents are stored separately, and dangerous goods and toxic drugs should be stored in special counters); f
culture medium and equipment preparation and sterilization area; g)
sterile area;
cleaning room;
pollutant treatment area;
first aid area;
administrative area;
document processing area;
changing room;
warehouse;
rest room.
5.2.1.4 In the molecular biology laboratory, the use of pipettes, pipette tips, centrifuge tubes, test tubes, etc. should be limited to a certain work area. 5.2.1.5 The work area should be kept clean and dust-free, and the space should be commensurate with the needs of microbial testing and the overall layout of the laboratory. The laboratory space should comply with GB19489 and Relevant provisions of GB50346. 5.2.1.6 Maintain good ventilation and appropriate temperature through natural conditions or ventilation devices or use air conditioning. When using air conditioning, appropriate filtering equipment should be inspected, maintained and replaced according to different work categories. Pollution can be reduced in the following ways:
Walls, ceilings, floors and tables and chairs with smooth surfaces (the degree of smoothness should depend on the difficulty of cleaning them); there should be arcs at the joints between the floor, walls and ceilings, and the floor should be non-slip; doors and windows should be closed when testing;
Sun visors should be installed outdoors. If they cannot be installed outdoors, they should be easy to clean; unless they are sealed and packaged, liquid transport pipelines should not pass over the work area; f)
There should be air filtration devices in the ventilation system; g) || tt||Independent wash basin, non-manual control is better, preferably near the door of the laboratory; do not use rough and exposed wood blocks;
The wooden surface of fixed equipment and indoor installations should be sealed and wrapped;http:
GB/T27405-2008
i) When the test may pollute the air with low degree, the operation area should be equipped with a laminar flow biosafety cabinet;k) The storage facilities and equipment should be easy to clean;1) Only cabinets, documents or other items necessary for testing should be placed in the laboratory. 5.2.1.8 The ideal ceiling should have a smooth surface and sufficient lighting. If this is not possible, the laboratory should have written materials to prove that any risk of contamination has been effectively controlled, and effective measures to prevent and control contamination, such as cleaning surfaces and inspection procedures. 5.2.1.9 Laboratory staff should eliminate potential testing areas prone to contamination and prove that cleaning measures have been taken. 5.2.2 Environmental monitoring
5.2.2.1 The laboratory should establish a reasonable environmental monitoring program (see ISO18593 and see Appendix D). 5.2.2.2 Perform data analysis on the environmental monitoring results (see ISO18593 and ISO7218). Set acceptable background colony counts for different work areas and have documented procedures to deal with background colony counts exceeding the standard. 5.2.3 Hygiene
5.2.3.1 Develop documented procedures for cleaning laboratory fixtures, equipment and surfaces. The procedures should take into account the environmental monitoring results and the probability of cross contamination.
5.2.3.2 There should be procedures for handling harmful microorganisms when they occur. 5.2.3.3 Take the following measures to prevent the cleanliness of the room from decreasing: a)
Provide sufficient storage space;
b) Minimize document processing in the laboratory; c) Prohibit bringing plants and personal items into the laboratory work area; 5.2.3.4 Wear appropriate protective clothing in the laboratory (including protection for hair, beard, hands and shoes if necessary) according to the different hazard levels of the microorganisms being tested, and take off the protective clothing when leaving the work area. This is especially important for molecular biology laboratories and laboratories with hazard level II or above.
5.2.3.5 A sufficient number of hand washing facilities and first aid materials should be prepared. 5.2.3.6 The sterile room should be disinfected before and after use, and the disinfection effect of the sterile room should be monitored regularly (see Appendix B and Appendix D).
5.3 Equipment
5.3.1 General
5.3.1.1 The laboratory should develop and implement procedures for equipment maintenance, calibration and performance verification (see Appendix C). 5.3.1.2 The equipment should meet the specified performance parameters and comply with relevant test indicators. Whenever a failure is found in the equipment, it should be stopped immediately and the impact on previous results should be checked if necessary. 5.3.1.3 Each device should have a unique identification. 5.3.1.4 If the equipment is out of the direct control of the laboratory or is repaired, it should be inspected or calibrated before resuming use to ensure that its performance meets the requirements.
5.3.1.5 When using computers or automated equipment to collect, process, record, report, store or retrieve data, ensure that: computer software developed by the user should be documented in sufficient detail and its applicability should be appropriately verified; a
Develop and implement appropriate procedures to protect the integrity of data and records at all times to prevent unintentional or unauthorized access, modification, or destruction; b) Computers and automated equipment should be maintained to ensure their normal operation, and appropriate environmental and operating conditions should be provided. 5.3.1.6 To avoid accidental cross-contamination, laboratory equipment should not be moved frequently. 5.3.2 Maintenance
5.3.2.1 The installation and layout of equipment should be convenient for operation, easy to maintain, clean and calibrate. 5.3.2.2 Equipment should be verified and maintained regularly to ensure that it is in good working condition. Maintenance and performance verification should be performed at specific time intervals based on the frequency of use, and relevant records should be kept. 5.3.2.3 Newly purchased glassware should be soaked in 5% sodium hydroxide and 3% dilute acid for 24 hours respectively, and then cleaned before use.3 In accordance with good operating practices, the following clearly marked isolated sites or clearly designated areas should be considered: a) sample receiving and storage area;
sample pre-treatment area (for example, powdered products that are easily contaminated should be handled in an isolated area); sample microbiological testing (including culture) and identification of suspected pathogens: storage area for standard strains and other strains; culture medium and chemical reagent storage area (culture medium and chemical reagents are stored separately, and dangerous goods and toxic drugs should be stored in special counters); f) culture medium and equipment preparation and sterilization area; g) sterile area;
clean room;
pollutant treatment area;
first aid area;
administrative area;
document processing area;
changing room;
warehouse;
rest room.
5.2.1.4 In molecular biology laboratories, the use of pipettes, pipette tips, centrifuge tubes, test tubes, etc. should be limited to a certain work area. 5.2.1.5 The work area should be kept clean and dust-free, and the space should be commensurate with the needs of microbiological testing and the overall layout of the laboratory. The laboratory space should comply with the relevant provisions of GB19489 and GB50346. 5.2.1.6 Maintain good ventilation and appropriate temperature through natural conditions or ventilation devices or use of air conditioning. When using air conditioning, the appropriate filter equipment should be checked, maintained and replaced according to different work categories. Pollution can be reduced by the following ways:
Walls, ceilings, floors, tables and chairs with smooth surfaces (the degree of smoothness should depend on the difficulty of cleaning); the joints between the floor, walls and ceiling should have arcs, and the floor should be non-slip; when testing, doors and windows should be closed;
Sunshades should be installed outdoors. If they cannot be installed outdoors, they should be easy to clean; unless they are sealed and packaged, liquid transport pipelines should not pass over the work area; f)
There should be air filtration devices in the ventilation system; g) )
Independent wash basin, non-manual control is better, preferably near the door of the laboratory; do not use rough and exposed wood blocks;
The wooden surface of fixed equipment and indoor installations should be sealed and wrapped;http:
GB/T27405—2008
i) When the test may pollute the air with low degree, the operation area should be equipped with a laminar flow biosafety cabinet;k) The storage facilities and equipment should be easy to clean;1) Only cabinets, documents or other items necessary for testing should be placed in the laboratory. 5.2.1.8 The ideal ceiling should have a smooth surface and sufficient lighting. If this is not possible, the laboratory should have written materials to prove that any risk of contamination has been effectively controlled, and effective measures to prevent and control contamination, such as cleaning surfaces and inspection procedures, have been taken. 5.2.1.9 Laboratory staff should eliminate potential testing areas prone to contamination and prove that cleaning measures have been taken. 5.2.2 Environmental monitoring
5.2.2.1 The laboratory should establish a reasonable environmental monitoring procedure (see ISO18593 and see Appendix D). 5.2.2.2 Perform data analysis on the environmental monitoring results (see ISO18593 and ISO7218). Set acceptable background colony counts for different work areas and have documented procedures to deal with background colony counts exceeding the standard. 5.2.3 Sanitation
5.2.3.1 Establish documented procedures for cleaning laboratory fixtures, equipment and surfaces. The procedures should take into account environmental monitoring results and the probability of cross contamination.
5.2.3.2 There should be procedures for handling contamination by harmful microorganisms. 5.2.3.3 Take the following measures to prevent the cleanliness of the room from decreasing: a)
Provide sufficient storage space;
b) Minimize document processing in the laboratory; c) Prohibit bringing plants and personal items into the laboratory work area. 5.2.3.4 Wear appropriate protective clothing in the laboratory (including protective measures such as hair, beard, hands and shoes, if necessary) according to the different hazard levels of the microorganisms being tested, and take off the protective clothing when leaving the work area. This is especially important for molecular biology laboratories and laboratories with hazard levels above Level II.
5.2.3.5 A sufficient number of hand washing facilities and first aid materials should be prepared. 5.2.3.6 The sterile room should be disinfected before and after use, and the disinfection effect of the sterile room should be monitored regularly (see Appendix B and Appendix D).
5.3 Equipment
5.3.1 General
5.3.1.1 The laboratory should develop and implement procedures for equipment maintenance, calibration and performance verification (see Appendix C). 5.3.1.2 The equipment shall meet the specified performance parameters and comply with the relevant test indicators. Whenever a fault is found in the equipment, it shall be stopped immediately and the impact on previous results shall be checked if necessary. 5.3.1.3 Each equipment shall have a unique identification. 5.3.1.4 If the equipment is out of the direct control of the laboratory or is repaired, it shall be checked or calibrated before it is restored to use to ensure that its performance meets the requirements.
5.3.1.5 When using computers or automated equipment to collect, process, record, report, store or retrieve data, it shall be ensured that: the computer software developed by the user shall be documented in sufficient detail and its applicability shall be properly verified; a
Develop and implement appropriate procedures to protect the integrity of data and records at all times to prevent unintentional or unauthorized access, modification, or destruction; b) Computers and automated equipment shall be maintained to ensure their normal operation and appropriate environmental and operating conditions shall be provided. 5.3.1.6 To avoid accidental cross contamination, laboratory equipment should not be moved frequently. 5.3.2 Maintenance
5.3.2.1 The installation and layout of the equipment should be convenient for operation, maintenance, cleaning and calibration. 5.3.2.2 The equipment should be verified and maintained regularly to ensure that it is in good working condition. Maintenance and performance verification should be carried out at specific time intervals according to the frequency of use, and relevant records should be kept. 5.3.2.3 Newly purchased glassware should be soaked in 5% sodium hydroxide and 3% dilute acid for 24 hours respectively, and then used after cleaning. 8
Product Partner Network3 In accordance with good operating practices, the following clearly marked isolated sites or clearly designated areas should be considered: a) sample receiving and storage area;
sample pre-treatment area (for example, powdered products that are easily contaminated should be handled in an isolated area); sample microbiological testing (including culture) and identification of suspected pathogens: storage area for standard strains and other strains; culture medium and chemical reagent storage area (culture medium and chemical reagents are stored separately, and dangerous goods and toxic drugs should be stored in special counters); f) culture medium and equipment preparation and sterilization area; g) sterile area;
clean room;
pollutant treatment area;
first aid area;
administrative area;
document processing area;
changing room;
warehouse;
rest room.
5.2.1.4 In molecular biology laboratories, the use of pipettes, pipette tips, centrifuge tubes, test tubes, etc. should be limited to a certain work area. 5.2.1.5 The work area should be kept clean and dust-free, and the space should be commensurate with the needs of microbiological testing and the overall layout of the laboratory. The laboratory space should comply with the relevant provisions of GB19489 and GB50346. 5.2.1.6 Maintain good ventilation and appropriate temperature through natural conditions or ventilation devices or use of air conditioning. When using air conditioning, the appropriate filter equipment should be checked, maintained and replaced according to different work categories. Pollution can be reduced by the following ways:
Walls, ceilings, floors, tables and chairs with smooth surfaces (the degree of smoothness should depend on the difficulty of cleaning); the joints between the floor, walls and ceiling should have arcs, and the floor should be non-slip; when testing, doors and windows should be closed;
Sunshades should be installed outdoors. If they cannot be installed outdoors, they should be easy to clean; unless they are sealed and packaged, liquid transport pipelines should not pass over the work area; f)
There should be air filtration devices in the ventilation system; g) )
Independent wash basin, non-manual control is better, preferably near the door of the laboratory; do not use rough and exposed wood blocks;
The wooden surface of fixed equipment and indoor installations should be sealed and wrapped;http:
GB/T27405—2008
i) When the test may pollute the air with low degree, the operation area should be equipped with a laminar flow biosafety cabinet;k) The storage facilities and equipment should be easy to clean;1) Only cabinets, documents or other items necessary for testing should be placed in the laboratory. 5.2.1.8 The ideal ceiling should have a smooth surface and sufficient lighting. If this is not possible, the laboratory should have written materials to prove that any risk of contamination has been effectively controlled, and effective measures to prevent and control contamination, such as cleaning surfaces and inspection procedures, have been taken. 5.2.1.9 Laboratory staff should eliminate potential testing areas prone to contamination and prove that cleaning measures have been taken. 5.2.2 Environmental monitoring
5.2.2.1 The laboratory should establish a reasonable environmental monitoring procedure (see ISO18593 and see Appendix D). 5.2.2.2 Perform data analysis on the environmental monitoring results (see ISO18593 and ISO7218). Set acceptable background colony counts for different work areas and have documented procedures to deal with background colony counts exceeding the standard. 5.2.3 Sanitation
5.2.3.1 Establish documented procedures for cleaning laboratory fixtures, equipment and surfaces. The procedures should take into account environmental monitoring results and the probability of cross contamination.
5.2.3.2 There should be procedures for handling contamination by harmful microorganisms. 5.2.3.3 Take the following measures to prevent the cleanliness of the room from decreasing: a)
Provide sufficient storage space;
b) Minimize document processing in the laboratory; c) Prohibit bringing plants and personal items into the laboratory work area. 5.2.3.4 Wear appropriate protective clothing in the laboratory (including protective measures such as hair, beard, hands and shoes, if necessary) according to the different hazard levels of the microorganisms being tested, and take off the protective clothing when leaving the work area. This is especially important for molecular biology laboratories and laboratories with hazard levels above Level II.
5.2.3.5 A sufficient number of hand washing facilities and first aid materials should be prepared. 5.2.3.6 The sterile room should be disinfected before and after use, and the disinfection effect of the sterile room should be monitored regularly (see Appendix B and Appendix D).
5.3 Equipment
5.3.1 General
5.3.1.1 The laboratory should develop and implement procedures for equipment maintenance, calibration and performance verification (see Appendix C). 5.3.1.2 The equipment shall meet the specified performance parameters and comply with the relevant test indicators. Whenever a fault is found in the equipment, it shall be stopped immediately and the impact on previous results shall be checked if necessary. 5.3.1.3 Each equipment shall have a unique identification. 5.3.1.4 If the equipment is out of the direct control of the laboratory or is repaired, it shall be checked or calibrated before it is restored to use to ensure that its performance meets the requirements.
5.3.1.5 When using computers or automated equipment to collect, process, record, report, store or retrieve data, it shall be ensured that: the computer software developed by the user shall be documented in sufficient detail and its applicability shall be properly verified; a
Develop and implement appropriate procedures to protect the integrity of data and records at all times to prevent unintentional or unauthorized access, modification, or destruction; b) Computers and automated equipment shall be maintained to ensure their normal operation and appropriate environmental and operating conditions shall be provided. 5.3.1.6 To avoid accidental cross contamination, laboratory equipment should not be moved frequently. 5.3.2 Maintenance
5.3.2.1 The installation and layout of the equipment should be convenient for operation, maintenance, cleaning and calibration. 5.3.2.2 The equipment should be verified and maintained regularly to ensure that it is in good working condition. Maintenance and performance verification should be carried out at specific time intervals according to the frequency of use, and relevant records should be kept. 5.3.2.3 Newly purchased glassware should be soaked in 5% sodium hydroxide and 3% dilute acid for 24 hours respectively, and then used after cleaning. 8
Product Partner Network1. Develop documented procedures for cleaning laboratory fixtures, equipment and surfaces. The procedures should take into account environmental monitoring results and the probability of cross contamination.
5.2.3.2 There should be procedures for handling harmful microorganisms. 5.2.3.3 Take the following measures to prevent the cleanliness of the room from decreasing: a)
Provide sufficient storage space;
b) Minimize document processing in the laboratory; c) Prohibit bringing plants and personal items into the laboratory work area. 5.2.3.4 Wear appropriate protective clothing in the laboratory (including protective measures such as hair, beard, hands and shoes, if necessary) according to the different hazard levels of the microorganisms being tested, and take off protective clothing when leaving the work area. This is especially important for molecular biology laboratories and laboratories with hazard levels above II.
5.2.3.5 A sufficient number of hand washing facilities and first aid materials should be prepared. 5.2.3.6 The sterile room should be disinfected before and after use, and the disinfection effect of the sterile room should be monitored regularly (see Appendix B and Appendix D).
5.3 Equipment
5.3.1 General
5.3.1.1 The laboratory shall develop and implement procedures for equipment maintenance, calibration and performance verification (see Appendix C). 5.3.1.2 The equipment shall meet the specified performance parameters and comply with relevant test indicators. Whenever a failure of equipment is found, it shall be stopped immediately and the impact on previous results shall be checked if necessary. 5.3.1.3 Each device shall have a unique identification. 5.3.1.4 If the equipment is out of the direct control of the laboratory or is repaired, it shall be inspected or calibrated before resuming use to ensure that its performance meets the requirements.
5.3.1.5 When using computers or automated equipment to collect, process, record, report, store or retrieve data, ensure that: computer software developed by the user should be documented in sufficient detail and its applicability should be appropriately verified; a
Develop and implement appropriate procedures to protect the integrity of data and records at all times to prevent unintentional or unauthorized access, modification, or destruction; b) Computers and automated equipment should be maintained to ensure their normal operation, and appropriate environmental and operating conditions should be provided. 5.3.1.6 To avoid accidental cross-contamination, laboratory equipment should not be moved frequently. 5.3.2 Maintenance
5.3.2.1 The installation and layout of equipment should be convenient for operation, easy to maintain, clean and calibrate. 5.3.2.2 Equipment should be verified and maintained regularly to ensure that it is in good working condition. Maintenance and performance verification should be performed at specific time intervals based on the frequency of use, and relevant records should be kept. 5.3.2.3 Newly purchased glassware should be soaked in 5% sodium hydroxide and 3% dilute acid for 24 hours respectively, and then cleaned before use.1. Develop documented procedures for cleaning laboratory fixtures, equipment and surfaces. The procedures should take into account environmental monitoring results and the probability of cross contamination.
5.2.3.2 There should be procedures for handling harmful microorganisms. 5.2.3.3 Take the following measures to prevent the cleanliness of the room from decreasing: a)
Provide sufficient storage space;
b) Minimize document processing in the laboratory; c) Prohibit bringing plants and personal items into the laboratory work area. 5.2.3.4 Wear appropriate protective clothing in the laboratory (including protective measures such as hair, beard, hands and shoes, if necessary) according to the different hazard levels of the microorganisms being tested, and take off protective clothing when leaving the work area. This is especially important for molecular biology laboratories and laboratories with hazard levels above II.
5.2.3.5 A sufficient number of hand washing facilities and first aid materials should be prepared. 5.2.3.6 The sterile room should be disinfected before and after use, and the disinfection effect of the sterile room should be monitored regularly (see Appendix B and Appendix D).
5.3 Equipment
5.3.1 General
5.3.1.1 The laboratory shall develop and implement procedures for equipment maintenance, calibration and performance verification (see Appendix C). 5.3.1.2 The equipment shall meet the specified performance parameters and comply with relevant test indicators. Whenever a failure of equipment is found, it shall be stopped immediately and the impact on previous results shall be checked if necessary. 5.3.1.3 Each device shall have a unique identification. 5.3.1.4 If the equipment is out of the direct control of the laboratory or is repaired, it shall be inspected or calibrated before resuming use to ensure that its performance meets the requirements.
5.3.1.5 When using computers or automated equipment to collect, process, record, report, store or retrieve data, ensure that: computer software developed by the user should be documented in sufficient detail and its applicability should be appropriately verified; a
Develop and implement appropriate procedures to protect the integrity of data and records at all times to prevent unintentional or unauthorized access, modification, or destruction; b) Computers and automated equipment should be maintained to ensure their normal operation, and appropriate environmental and operating conditions should be provided. 5.3.1.6 To avoid accidental cross-contamination, laboratory equipment should not be moved frequently. 5.3.2 Maintenance
5.3.2.1 The installation and layout of equipment should be convenient for operation, easy to maintain, clean and calibrate. 5.3.2.2 Equipment should be verified and maintained regularly to ensure that it is in good working condition. Maintenance and performance verification should be performed at specific time intervals based on the frequency of use, and relevant records should be kept. 5.3.2.3 Newly purchased glassware should be soaked in 5% sodium hydroxide and 3% dilute acid for 24 hours respectively, and then cleaned before use.
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