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YY/T 0567.4-2011: Aseptic processing of health care products. Part 4: Clean-in-place technologies
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0567.4-2011 | English | 314 |
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Aseptic processing of health care products. Part 4: Clean-in-place technologies
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YY/T 0567.4-2011
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Basic data | Standard ID | YY/T 0567.4-2011 (YY/T0567.4-2011) | | Description (Translated English) | Aseptic processing of health care products. Part 4: Clean-in-place technologies | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 16,120 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 19003; YY/T 0567.1 | | Adopted Standard | ISO 13408-4-2005, IDT | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies requirements for the process according to the production of health care products sterile equipment product contact surfaces to be cleaned (CIP) process, the basic requirements, and provides identification, validation, operation and control of the guidelines. This standard applies to the design of the CIP -compatible devices may be in contact with the inner surface of the product to use cleaner process. This section does not apply to disassemble the device and washing machine in the washing process. This section does not replace or supersede national regulatory requirements, such as the attribution to a particular country or region Manufacturing Practices (GMP) and/or the pharmacopoeia requirements. | YY/T 0567.4-2011: Aseptic processing of health care products. Part 4: Clean-in-place technologies---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 4. Clean-in-place technologies
ICS 11.080.01
C47
People's Republic of China pharmaceutical industry standards
Aseptic processing of health care products
Part 4. Online Cleaning Technology
Part 4. Clean-in-placetechnologies
(ISO 13408-4.2005, IDT)
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0567 "aseptic processing of health care products" is divided into the following sections.
--- 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 40567 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 13408-4.2005 "aseptic processing of health care products - Part 4. Online Cleaning Technology
Surgery, "and ISO 13408-4.2005 compared to the main editorial changes are as follows.
--- For other international standards cited in this section, if it has converted to our standards, replace the International Standard In this section, references to
Corresponding national standard number, and indicate the degree of consistency in the second chapter.
This part is proposed by the State Food and Drug Administration.
This part of the National Standardization Technical Committee centralized disinfection technology and equipment.
This part of the National Standardization Technical Committee disinfection technology and equipment responsible for the interpretation.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Zhangjiagang Hualing Medical Equipment
Manufacturing Co., Ltd., Shandong Xinhua Medical Instrument Co., Ltd.
The main drafters of this section. Hu Xianghua, Huang Xiulian, the new Mr Wong, Ye Xiaoyan, Zhoujian Fang, Wang Hongmin.
Introduction
In the development of YY/T 0567.1 in the process, we found that some items, such as filtration, lyophilization and online sterilization techniques need to add a large number of letters
Interest rates, if the description of the content in the corresponding appendix excessive.
YY/T 0567 This section contains the line cleaning process should pay attention to the requirements and guidelines. YY/T 0567 This section is intended to make
Health care products to achieve standardization in the field with the validation and routine control line cleaning process.
Online cleaning equipment can be cleaned without having to dismantle part of or the entire process of the system, thereby reducing removed under clean conditions
Unloading and connections. For example, for tanks, vessels, piping and other freeze-dried production and processing equipment to be cleaned.
Typically online sterilization process (such as YY/T 0567.5 a) online after the cleaning process. Online cleaning and sterilization methods in online technology
There are significant differences on the operation, but the concept is similar to the processing line.
The entire system design consideration is to ensure that online cleaning technology successfully applied in cleaning production equipment in order to achieve the desired level of cleanliness
The essential.
Aseptic processing of health care products
Part 4. Online Cleaning Technology
1 Scope
YY/T 0567 provisions of this part of the process for aseptic production of health care products equipment product contact surfaces to be cleaned
Basic requirements (CIP) process, and provides identification, validation, operation and control guidelines.
This section applies to the use of the surface within the device is designed to be compatible with CIP, may come into contact with the product cleaner process.
This section does not apply to equipment disassembly and cleaning machine cleaning process.
This section does not replace or supersede national regulatory requirements, such as belonging to a specific country or region Manufacturing Practices (GMP) and/or the pharmacopoeia
Requirements.
2 Normative references
The 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.
GB/T 19003 software engineering GB/T 19001-2000 apply to computer software guide (GB/T 19003-2008,
ISO /IEC 90003.2004, Softwareengineering-GuidelinesfortheapplicationofISO 9001.2000tocom-
putersoftware, IDT)
YY/T 0567.1 aseptic processing of health care products - Part 1. General requirements (YY/T 0567.1-2005,
ISO 13408-1.1998, IDT)
3 Terms and Definitions
YY/T 0567.1 and define the following terms and definitions apply to this document.
3.1
Cleaners cleaningagent
Organic or inorganic chemicals, including water, detergent, or mixtures thereof, aid in the cleaning process cleaning apparatus.
3.2
Line cleaning (CIP) clean-in-place
In the case of little or removed without disassembly of the inner part of or the entire process system equipment surface cleaning methods.
NOTE. CIP also includes removing residual detergent to reach based on the nature of products and processes and tolerances defined acceptable level process.
3.3
Blind deadleg
Sufficient contact area can not be cleaner design.
3.4
Design qualification designqualification
Design facilities, equipment or system proposed in line with the intended use of the document verification.
3.5
Material Safety Data materialsafetydatasheet
It specifies the properties of the material, human and environmental file potential hazards, safe handling and disposal of the necessary preventive measures.
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