YY/T 0567.6-2022Aseptic processing of health care products - Part 6: Isolator systems (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document is part 6 of YY/T 0567 "Aseptic Processing of Healthcare Products". YY/T 0567 has issued the following parts.

--- Part 1: General requirements;

--- Part 2: Sterile filtration;

--- Part 3: Freeze-drying;

--- Part 4: In-line cleaning technology;

--- Part 5: In-line sterilization;

--- Part 6: Isolator systems;

--- Part 7: Alternative processing of medical devices and combination products.

This document replaces YY/T 0567.6-2011 "Aseptic processing of healthcare products - Part 6: Isolator systems", and Compared with YY/T 0567.6-2011, in addition to structural adjustment and editorial changes, the main technical changes are as follows.

--- Changed the scope of the document (see Chapter 1, Chapter 1 of the 2011 edition);

--- Added the terms and definitions of "isolator auxiliary equipment" and "sterile barrier system" (see 3.1 and 3.7);

--- Deleted the "design qualification", "leak test", "risk assessment", "isolation device", "surrounding environment", "transfer device" and "worst case condition".

terms and definitions (see 3.2, 3.5, 3.7, 3.8, 3.9, 3.10 and 3.13 of the 2011 edition);

--- Changed the terms and definitions of "Isolator", "Safety Data Sheet" and "Transmission System" (see 3.4, 3.6, 3.9, 2011 edition of 3.3, 3.6, 3.12);

--- Changed the quality system elements of the document (see Chapter 4, Chapter 4 of the 2011 edition);

--- Added "Basic Principles of Isolator System" chapter (see Chapter 5);

--- Added the chapter "Isolator System Specifications" (see Chapter 6);

--- Delete the relevant provisions of "category of isolators" (see 5.2 of the 2011 edition);

--- Changed the relevant provisions of the isolator "structural material" (see 7.2, 5.3 of the 2011 edition);

--- Added the relevant overview of the air handling system (see 7.3.1)

--- Changed the relevant provisions of "ventilation rate" (see 7.3.2, 5.4.1 of the 2011 edition);

--- Changed the relevant provisions of "airflow model" (see 7.3.3, 5.4.2 of the 2011 edition);

--- Changed the relevant provisions of "temperature/humidity" (see 7.3.4, 5.4.3 of the 2011 edition);

--- Changed the relevant provisions of "recirculation of air" (see 7.3.6, 5.4.5 of the 2011 edition);

--- Changed the relevant provisions of the pressure difference between the components of the isolator system and (or) between the components and the external environment (see 7.3.7, 5.4.6 of the 2011 version);

--- Delete the relevant provisions of "filter maintenance" (see 5.4.7 of the 2011 edition);

--- Changed the relevant regulations for the design of isolator gloves and sleeves (see 7.4.1.1, 5.5.1.1 of the 2011 edition);

--- Changed the relevant provisions of the material in and out of the isolator (see 7.4.3, 5.5.3 of the 2011 edition);

--- Changed the relevant provisions of the transfer port (see 7.4.4, 5.6.2 of the 2011 edition);

--- Changed the relevant provisions of waste container design (see 7.5.1.2, 5.6.1.2 of the 2011 edition);

--- Changed the relevant provisions of the background room where the isolator system is installed (see 7.6, 6.1 of the 2011 edition);

--- Changed the relevant provisions of public facilities connected to the isolator (see 7.7, 6.2 of the 2011 edition);

--- Changed the relevant provisions of the design confirmation of the isolator system (see 8.2.1, 8.2 of the 2011 edition);

--- Change the relevant provisions of online cleaning and manual cleaning (see 8.2.4.2, 8.2.4.3, 7.3.2 and 7.3.3 of the 2011 edition);

--- Changed the relevant provisions of biological decontamination and selection of biological decontamination agents (see 8.2.5, 8.2.6, 8.2.7, 8.2.8, 8.2.9, 8.2.10, 8.2.11, 8.2.12, 7.4 of the 2011 edition);

--- Added relevant provisions for the development and verification of the sterilization process (see 8.2.13);

--- Delete the relevant provisions of the power supply when the installation qualification is interrupted [8.3.2n) of the 2011 edition];

--- Changed the relevant regulations for the performance confirmation of the isolator system (see 8.5, 8.5 of the 2011 edition);

--- Increase the relevant provisions if biological indicators (BI) or chemical indicators (CI) are used in the revalidation process (see 8.7.4);

--- Changed the relevant provisions of the isolator system integrity (see 9.2, 9.2 of the 2011 edition);

--- Changed the relevant provisions of biological decontamination process monitoring (see 9.3, 9.3 of the 2011 edition);

--- Changed the relevant provisions of environmental monitoring (see 9.4, 9.4 of the 2011 edition);

--- Changed the relevant provisions of maintenance and calibration (see 9.6, 9.6 of the 2011 edition);

--- Changed the relevant provisions of personnel training (see Chapter 10, Chapter 10 of the 2011 edition).

This document is equivalent to ISO 13408-6:2021 "Aseptic processing of healthcare products - Part 6: Isolator systems".

The following minimal editorial changes have been made to this document.

--- Added reference to Appendix C in Note 3 of 5.1.

Introduction

Healthcare products identified as "sterile" are manufactured using rationally designed, validated and controlled methods. If possible, the product is it is terminally sterilized in its final sealed package. If terminal sterilization is not possible, then the product is aseptically processed.

Aseptic processing is a rigorous process that ensures that all stages of pre-processing, production, filling and final package sealing remain free of Bacterial status. The process relies on many independent factors to prevent re-introduction of contamination into the product mix or filling into the process.

An effective risk management system addresses the design (including the use of barrier separation techniques), validation and control of aseptic processing, and can identify, assess, eliminate (where applicable) and control the risk of contamination that provides the necessary sterility assurance for aseptically processed products condition.

A variety of isolation systems are used to protect critical processing areas in aseptic processing areas from particulate and microbial contamination, and Isolate operators from critical processing areas.

Such isolation systems include controlled airflow devices based on pneumatic protection, and isolation barriers that combine physical and pneumatic protection to the external cleanroom environment is isolated from critical processing areas, minimizing operator contact in this area and reducing processing pollution opportunities.

The isolator system provides both physical isolation and at the same time facilitates the operator in isolation (usually through gloves on the isolator barrier).

mouth-attached glove-sleeve system) to operate in a controlled processing environment. To establish a controlled environment, generally through a confirmed, reproducible cleaning and biodecontamination process to remove microorganisms or particulate matter within the isolator. This process is mainly achieved by using automated methods.

In addition to the control of microorganisms and particulate matter, the isolator system can also integrate other control functions, which in combination with its operating specifications are the product provides an isolated environment to prevent cross-contamination of process contaminants and product batches, and to control the impact on operators.

risk.

Aseptic processing of healthcare products Part 6: Isolator Systems

1 Scope

This document specifies requirements for isolator systems for aseptic processing of healthcare products, including specification, selection, qualification, biological decontamination, Identify, operate and control aspects, and provide relevant guidance.

This document applies to isolator systems for aseptic processing of healthcare products.

This document does not specify requirements for Restricted Access Barrier Systems (RABS).

This document does not specify requirements for sterility check isolators, but some of the principles and information in this document may also be applicable to related applications.

This document does not apply to biosafety protection.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

ISO 11139:2018 Glossary of terms used in the standard for sterilization of healthcare products and related equipment and processes andprocessstandards) Note. GB/T.19971-2015 Terminology for Sterilization of Healthcare Products (ISO/T S11139.2006, IDT) careproducts-Part 1: Generalrequirements) Note. YY/T 0567.1-2013 Aseptic Processing of Healthcare Products Part 1: General Requirements (ISO 13408-1:2008, IDT) careproducts-Part 4: Clean-in-placetechnologies) Note. YY/T 0567.4-2011 Aseptic processing of healthcare products - Part 4: In-line cleaning technology (ISO 13408-4:2005, IDT) ISO 13408-7 Aseptic processing of healthcare products - Part 7: Alternative processing of medical devices and combination products) Note. YY/T 0567.7-2016 Aseptic Processing of Healthcare Products Part 7: Alternative Processing of Medical Devices and Combination Products (ISO 13408-7:2012, IDT) Note. GB/T 25915.1-2010 Cleanrooms and Related Controlled Environments Part 1: Air Cleanliness Classes (ISO 14644-1:1999, IDT) ISO 14644-7 Cleanrooms and related controlled environments Part 7: Isolation devices (clean hoods, glove boxes, isolators, microenvironments) gloveboxes, isolators and mini-environments)] Note. GB/T 25915.7-2010 Cleanrooms and related controlled environments Part 7: Isolation devices (clean hoods, glove boxes, isolators, microenvironments) (ISO 14644-7:2004, IDT) ISO 18362 Microbiological risk control during the production and processing of cell-based healthcare products (Manufactureofcel-