YY/T 0567.4-2011Aseptic processing of health care products - Part 4: Clean-in-place technologies (English PDF)

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.

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.

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.