YY/T 0567.1-2013 English PDFUS$854.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0567.1-2013: Aseptic processing of health care products. Part 1: General requirements Status: Valid YY/T 0567.1: Historical versions
Basic dataStandard ID: YY/T 0567.1-2013 (YY/T0567.1-2013)Description (Translated English): Aseptic processing of health care products. Part 1: General requirements Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 43,433 Older Standard (superseded by this standard): YY/T 0567.1-2005 Quoted Standard: ISO 9001; ISO 11135.1; ISO 11137.1; ISO 11137.2; ISO 13408.2; ISO 13408.3; ISO 13408.4-2005; ISO 13408.5; ISO 13408.6; ISO 13485; ISO 14160; ISO 14644.1; ISO 14644.2; ISO 14644.3; ISO 14644.4; ISO 14644.7; ISO 14698.1; ISO 14698.2; ISO 14937; ISO 14971; I Adopted Standard: ISO 13408.1-2008, IDT Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the development of bacteria on through the manufacturing process of health care products processing, validation and routine control of processes, procedures and steps of the general requirements and guidelines. This section covers YY/T 0567.1-2013: Aseptic processing of health care products. Part 1: General requirements---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Aseptic processing of health care products.Part 1. General requirements ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Replacing YY/T 0567.1-2005 Aseptic processing of health care products Part 1. General requirements Part 1. Generalrequirements (ISO 13408-1.2008, IDT) Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released Table of ContentsPreface Ⅰ Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Quality Management System Elements 6 5 aseptic processing definitions 7 6 9 Manufacturing Environment 7 device 17 8 people 19 Production of 219 products 10 simulated production 25 11 sterility testing 29 Appendix A (informative) Example 30 flowchart Typical elements of Annex B (informative) aseptic processing defined 31 Annex C (informative) Example 32 specific risk Annex D (informative) grades of clean room 33 Appendix E (normative) process water Technical Specifications 34 Annex F (informative) aseptic processing region 36 References 37ForewordYY/T 0567 "aseptic processing of health care products" is divided into six parts. --- Part 1. General requirements; --- Part 2. Filter; --- Part 3. lyophilization; --- Part 4. Online cleaning technology; --- Part 5. Online sterilization; --- Part 6. Isolator systems. This section YY/T Section 10567 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This section instead of YY/T 0567.1-2005 "aseptically processed medical products - Part 1. General requirements", and YY/T 0567.1- The main changes compared to 2005 are as follows. --- Modify the "Introduction"; --- Modify the "scope"; --- Added "normative references"; --- Modify the terms and definitions section; --- Modify the "quality system elements"; --- Added "aseptic processing definition"; --- Modify the "manufacturing environment", "device", "People", "production", "simulated production" and "sterile test" part of the contents; --- Deleted the original Appendix A, an increase in Appendix A, Appendix B, Appendix C, Appendix D, Appendix E and Appendix F. This section uses the translation method identical with ISO 13408-1.2008 "aseptic processing of health care products - Part 1. General requirements." Consistency correspondence between this part of international documents and normative references of our files are as follows. GB 18280.2-2011 Radiation Sterilization of health care products - Part 2. Establish sterilization dose (ISO 11137-2.2006, IDT) GB/T 19001-2008 quality management system requirements (ISO 9001.2008, IDT) Characteristics of GB/T 19974-2005 Sterilization of health care products and medical equipment sterilization factors set sterilization process, validation and often General requirements for regulatory control (ISO 14937.2000, IDT) GB/T 25915.1-2010 cleanroom and associated controlled environments - Part 1. air cleanliness level (ISO 14644-1.1999, IDT) GB/T 25915.2-2010 cleanroom and associated controlled environments - Part 2. prove continued compliance with the GB/T 25915.1 detection Monitoring and technical conditions (ISO 14644-2.2000, IDT) GB/T 25915.3-2010 cleanroom and associated controlled environments - Part 3. Detection method (ISO 14644-3.2005, IDT) GB/T 25915.4-2010 cleanroom and associated controlled environments - Part 4. Design, construction, start (ISO 14644-4.2001, IDT) GB/T 25915.5-2010 cleanroom and associated controlled environments - Part 5. run (ISO 14644-5.2004, IDT) GB/T 25915.7-2010 cleanroom and associated controlled environments - Part 7. isolation device (clean hoods, glove boxes, isolators, Microenvironment) (ISO 14644-7.2004, IDT) GB/T 25916.1-2010 cleanroom and associated controlled environments Biological Pollution Control Part 1. General principles and methods (ISO 14698-1.2003, IDT) GB/T 25916.2-2010 cleanroom and associated controlled environments Biological Pollution Control Part 2. Evaluation of biological contamination data And analysis (ISO 14698-2.2003, IDT) YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT) YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2007, IDT) YY/T 0567.2-2005 aseptic processing of health care products - Part 2. Filters (ISO 13408-2.2003, IDT) YY/T 0567.3-2011 aseptic processing of health care products - Part 3. lyophilization (ISO 13408-3.2006, IDT) Aseptic processing YY/T 0567.4-2011 health care products - Part 4. Online cleaning technology (ISO 13408-4.2005, IDT) YY/T 0567.5-2011 aseptic processing of health care products - Part 5. Online sterilization (ISO 13408-5.2006, IDT) This part is proposed by the China Food and Drug Administration. This part of the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized. This section is drafted. Hangzhou Tailin Biotechnology equipment Co., Ltd., Guangzhou, the State Food and Drug Administration Medical Devices Quality supervision Governor Inspection Center. The main drafters of this section. Zheng Yan, Xia group letter, Zhao Zhenbo, Yeda Lin, Huang Xiulian. This part of the National Standardization Technical Committee disinfection technology and equipment responsible for the interpretation. This section instead of YY/T 0567.1-2005.IntroductionLogo with the words "sterile" of health care products, you should use the appropriate provisions of the quality system and proven methods of production, and Strict implementation of the provisions of the quality system control requirements. For pharmaceuticals and medical devices, the need to comply with other regulatory requirements, such as. standard Accurate, regulations and requirements of the pharmacopoeia. Terminally sterilized using sterile health care products, should be in the package into the final container, and then sterilized. ISO /TC198 has Been developed for a variety of health care products terminal sterilization processes relevant standards, including. radiation sterilization (GB 18280), moist heat sterilization (ISO 17665-1), dry heat sterilization (ISO 20857) and ethylene oxide sterilization (GB 18279). When a medical care products require sterile but can not be the final sterilization, aseptic processing can be used as an alternative. All with Aseptic processing of products in direct contact with the products, parts and/or components and all equipment should be pre-sterilized. Aseptic processing aimed at Pre-sterilization of products and parts during the assembly remains sterile. So that the package in the final product in the container reaches no Bacteria requirements. Aseptic processing can be used to prevent biological products or biological system (e.g.. biological tissue, vaccine) contamination. Terminally sterilized sterilization process clear, you can control the sterilization process for sterilization of the final product reaches a certain force to kill. and Sterilization data can be inferred from a sterility assurance level (SAL) value. However, this does not apply to aseptic processing. Aseptic processing application examples include. --- Solutions, suspensions, semisolids and powders aseptic processing and aseptic filling; --- Solid products (including solid medical devices) aseptic processing and aseptic packaging aseptically transferred; --- Combination aseptic processing and aseptic packaging aseptically transferred; --- Biological tissue or biological products, aseptic processing system. As a prerequisite for sterile processing sterilization program component and/or components can be treated as a separate program, and should be divided Do not be assessed and verified. Minimize and/or risk parts sterilization program components is very important. Aseptic processing ranging from product Sterilization and packaging components until the final product all the production steps in containers or packaging. In order to define the aseptic processing of clear, Line, YY/T 0567 devoted to this part of the risk to maintain sterility. Control of all possible sources of contamination is very important for maintaining sterility of the various components. To do this, define the aseptic processing should be covered by each Products, and based on risk analysis; in the application, considering the product, packaging design, process design and production environment. Processing should be controlled Environment is carried out, the level of microbial and particulate levels in the controlled environment should be maintained at the lowest level that is given, while minimizing human intervention Pre. Using proven systems, fully trained personnel, controlled environment and has a complete file system of the production process to ensure that Finished sterile condition. Aseptic processing is divided into a plurality of unit operations (for example. sterilization of products or components, including sterile filtration, parts assembly, sterilized products Handling and storage). Also, it should be considered and minimized from the materials, parts, products, personnel, facilities, equipment and public media (such as aqueous EC) of potential contamination. Only when all the risks have been identified, and has been minimized as far as possible, be eliminated or controlled and After final assessment is considered acceptable, aseptic processing control to be deemed acceptable. The need for aseptic processing of targeting elements into Line properly validated, which process simulation studies are required. The revised YY/T 0567.1 standard is intended to make the standard applicable to the current situation in the field of technology. Aseptic processing of health care products Part 1. General requirements1 ScopeYY/T 0567 provisions of this section concerning the development of the manufacturing process through aseptic processing of health care products, validation and routine control System processes, procedures and general requirements for the implementation of procedures and guidelines. This section covers the entire aseptic processing on the general requirements and guidelines. The other part is specified on the filter, lyophilized, line cleaning, Specific requirements and guidelines for online sterilization and isolation systems of various special/specialized processes and methods. Note. YY/T 0567 This section does not supersede or replace national regulatory requirements, such as "Good Manufacturing Practices (GMPs)" and/or belonging to a particular Country or region within the jurisdiction of the pharmaceutical requirements.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. ISO 9001 quality management system requirements (Qualitymanagementsystems-Requirements) ISO 11135-1 Sterilization of health care products of ethylene oxide sterilization of medical devices - Part 1 process development, validation and routine control System Requirements (Sterilizationofhealthcareproducts-Ethyleneoxide-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices) ISO 11137-1 Sterilization of health care products developed radiation - Part 1 radiation sterilization of medical devices, validation and routine control Requirements (Sterilizationofhealthcareproducts-Radiation-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices) ISO 11137-2 Radiation Sterilization of health care products - Part 2. Establish sterilization dose (Sterilizationofhealthcare products-Radiation-Part 2. Establishingthesterilizationdose) Aseptic processing - Part 2 ISO 13408-2 health care products. filters (Asepticprocessingofhealthcareprod- ucts-Part 2. Filtration) ISO 13408-3 Aseptic processing of health care products - Part 3. lyophilization (Asepticprocessingofhealthcare products-Part 3. Lyophilization) ISO 13408-4.2005 Aseptic processing of health care products - Part 4. Online Cleaning Technology (Asepticprocessingof healthcareproducts-Part 4. Clean-in-placetechnologies) Aseptic processing - Part 5 ISO 13408-5 health care products. Online sterilization (Asepticprocessingofhealthcare products-Part 5. Sterilizationinplace) ISO 13408-6 Aseptic processing of health care products - Part 6. Isolator systems (Asepticprocessingofhealth careproducts-Part 6. Isolatorsystems) ISO 13485 medical device quality management system for regulatory requirements (Medicaldevices-Qualitymanagement systems-Requirementsforregulatorypurposes) ISO 14160 sterilization of disposable medical devices containing animal-derived materials, the use of a liquid chemical sterilant sterilization validation and often Timing Control (Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin-Validation androutinecontrolofsterilizationbyliquidchemicalsterilants) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0567.1-2013_English be delivered?Answer: Upon your order, we will start to translate YY/T 0567.1-2013_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0567.1-2013_English with my colleagues?Answer: Yes. 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