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YY/T 0567.3-2011: Aseptic processing of health care products. Part 3: Lyophilization
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0567.3-2011 | English | 254 |
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Aseptic processing of health care products. Part 3: Lyophilization
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YY/T 0567.3-2011
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Basic data | Standard ID | YY/T 0567.3-2011 (YY/T0567.3-2011) | | Description (Translated English) | Aseptic processing of health care products. Part 3: Lyophilization | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 13,194 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 19001; YY/T 0567.1; YY/T 0567.4; YY/T 0567.5 | | Adopted Standard | ISO 13408-3-2006, 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 provides for the freeze-dried as aseptic processing and confirmation process control equipment, processes, procedures, and requirements for procedures and guidelines. This section does not freeze during the physical/chemical purposes for exposition. | YY/T 0567.3-2011: Aseptic processing of health care products. Part 3: Lyophilization---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 3. Lyophilization
ICS 11.080.01
C47
People's Republic of China pharmaceutical industry standards
Aseptic processing of health care products
Part 3. Lyophilization
Part 3. Lyophilization
(ISO 13408-3.2006, 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 30567 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 13408-3.2006 "aseptic processing of health care products - Part 3. Lyophilization" and
ISO 13408-3.2006 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, Shandong Xinhua Medical Instrument shares
Limited copies.
The main drafters of this section. Huangmin Ju, Zheng Yan, Yan Lin, Huang new, Wang Li Shan.
Introduction
YY/T 0567 This section discusses the freeze-dried for the removal of aqueous and non-aqueous solvent system, the solvent to obtain a product or
Physical and chemical stability of the material drying process. Lyophilization involves freezing aqueous system and solvent was removed, first by sublimation (primary drying)
Then desorption (secondary drying), chemically modified so as to no longer support or biological activity levels. It is generally believed that through this process
Product processing can maintain their biological or other activity, while the rapid dispersion and dissolution. Since this is usually a sterile process last
Step, it has a direct impact on product safety, quality, features, performance and purity, therefore lyophilization is a key processing step.
If you have completed the requirements of the lyophilized product is sterile, aqueous drying system is required should have been sterilized. Therefore,
All will affect the product or material activities as an extension of sterile products or sterile aseptic processing materials. In general, to ensure that the product or
The main challenge material during lyophilization sterile filling operations between prevention and freeze-drying process is complete microbial and particulate contamination. & DESIGN
Preparation of relevant special consideration is to protect the product inside or lyophilized material from microbial contamination.
Aseptic processing of health care products
Part 3. Lyophilization
1 Scope
YY/T 0567 provisions of this section as a sterile lyophilized for process control and verification equipment, processes, procedures and process
Sequence-specific requirements and guidelines. This section does not freeze-drying process of physical/chemical for the purpose of discussion.
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 19001 quality management system requirements (GB/T 19001-2008, ISO 9001.2008, IDT)
Aseptic processing Part 1 YY/T 0567.1 medical products. General requirements (YY/T 0567.1-2005, ISO 13408-1.
1998, IDT)
Aseptic processing YY/T 0567.4 health care products - Part 4. Online cleaning technology (YY/T 0567.4-2011,
ISO 13408-4.2005, IDT)
YY/T 0567.5 aseptic processing of health care products - Part 5. Online sterilization (YY/T 0567.5-2011,
ISO 13408-5.2006, IDT)
3 Terms and Definitions
YY/T 0567.1 and as defined in the following terms and definitions apply to this document.
3.1
Lyophilization lyophilization
Removal of water by sublimation and desorption and the non-aqueous solvent system of physical - chemical drying process.
3.2
Leak test leaktest
In repeatable test conditions can provide quantifiable physical test leakage rates.
4 quality system elements
4.1 General
4.1.1 YY/T 0567.1 requirements apply.
4.1.2 should develop and implement lyophilizer development, validation, routine monitoring, control and maintenance phases of the documented procedures.
4.1.3 This section shall specify the person to the requested documents for review and approval.
4.1.4 should be saved for development, validation, routine control and monitoring records as evidence of compliance with the requirements of this section.
4.2 Management Responsibilities
4.2.1 should provide for implementation and enforcement of the procedures in this section of the responsibilities and privileges.
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