YY/T 0567.3-2011Aseptic processing of health care products - Part 3: Lyophilization (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 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.

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.

4 Quality system elements