ISO 18362:2016/Amd 1:2022

Overview

ISO 18362:2016/Amd 1:2022 is an important amendment to the international standard addressing the manufacture of cell-based health care products with a focus on the control of microbial risks during processing. Developed by ISO Technical Committee ISO/TC 198, which specializes in sterilization of health care products, this amendment updates key processes and requirements essential to ensure the safety and quality of advanced cellular therapies and related health care products.

This amendment clarifies processes related to sterilization, microbial risk control, and quality management, reinforcing the framework necessary for consistent production quality. It highlights the importance of validation, routine control, and effective management responsibility in the sterile processing environment.

Key Topics

• Sterilization Process Management
  The amendment emphasizes the development, validation, and routine control of sterilization processes as critical elements of product realization. It requires organizations to establish, implement, and maintain comprehensive sterilization protocols aligned with best practices.

• Process Control Requirements
  Key process controls include documentation management, assignment of roles and responsibilities, provision of competent resources, external product control, traceability, and handling of non-conforming products.

• Calibration and Equipment Maintenance
  A process must be specified to calibrate all equipment and instrumentation involved in microbial control to ensure consistent measurement accuracy compliant with this standard.

• Containment and Cleanroom Design
  The updated clauses clarify that national or regional regulations may apply to containment facility design. The amendment references ISO 14644-4 for cleanroom specifications surrounding negative pressure areas or biological safety cabinets.

• HVAC Systems
  Heating, ventilation, and air conditioning systems must not interfere with the airflow of biological safety cabinets, ensuring protection of product sterility and personnel safety during processing.

• Waste Disposal
  Disposal of contaminated materials, including solid, liquid, and condensate waste, should follow applicable national or regional regulatory requirements to minimize microbial contamination risks.

• Procurement and Storage
  Documented procedures for the procurement and storage of cell-based starting materials must conform with relevant GMP and quality management system standards, such as ISO 13022 and ISO 22442 series.

Applications

ISO 18362:2016/Amd 1:2022 serves as a crucial reference for manufacturers involved in the production of cell-based health care products, including:

• Cell and Gene Therapy Manufacturers
  Ensuring microbial risk controls during production of advanced therapies involving living cell materials.

• Biopharmaceutical Companies
  Implementing validated sterilization and environmental controls in bioprocessing of cellular materials.

• Quality Assurance and Regulatory Compliance Teams
  Aligning quality management systems with international standards to meet global regulatory expectations.

• Sterilization Validation Specialists
  Defining and executing sterilization cycles to guarantee sterility assurance levels during cell-based product processing.

• Facility Design and Maintenance Professionals
  Designing HVAC and containment solutions that comply with standardized cleanroom and airflow requirements.

This amendment enhances product safety, process reliability, and regulatory compliance across the lifecycle of cell-based health care products.

Related Standards

Organizations implementing ISO 18362:2016/Amd 1:2022 should consider aligning with the following related standards for comprehensive quality and sterilization management:

• ISO 13485 – Quality management systems for medical devices, which covers lifecycle quality controls relevant to health care product manufacturers.

• ISO 14644-4 – Specifications for cleanroom design and operational requirements, critical to environments where microbial control is paramount.

• ISO 13022 – Specific guidance for biological evaluation of medical devices involving cellular products.

• ISO 22442 Series – Focused on biomaterial evaluation and safe use of products in regenerative medicine and cell therapy.

• ICH Q7 – Good manufacturing practices for active pharmaceutical ingredients, relevant where cell-based materials intersect with pharmaceutical development.

By integrating these standards, manufacturers can create a robust framework for microbial risk management throughout the production of sophisticated cell-based therapies.