SN EN ISO 11607-2:2020

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2019)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

INB

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Publikation: 2020-07-0121 SeitenICS: 11.080.30

ISO 11607-2:2019 compliance requirements are crucial for organizations adopting SN EN ISO 11607-2:2020 as they ensure the safety and effectiveness of packaged terminally sterilized medical devices. This guide provides a comprehensive overview of the key steps and considerations for achieving compliance.

Why implement SN EN ISO 11607-2:2020 now

Implementing SN EN ISO 11607-2:2020 is essential for organizations in the Healthcare Technology industry, driven by multiple factors. One significant driver is customer requirements, as healthcare providers increasingly demand compliance with recognized standards to ensure the safety of their medical devices. Additionally, regulatory pressure from authorities like the FDA and European Medicines Agency (EMA) compels manufacturers to adhere to strict packaging standards. Moreover, organizations often set internal quality goals aimed at enhancing product reliability and reducing risks associated with non-compliance, thereby fostering a culture of continuous improvement. With these drivers in mind, adopting SN EN ISO 11607-2:2020 not only meets regulatory requirements but also strengthens market position.

Prerequisites and readiness check

Before embarking on the journey to achieve ISO 11607-2:2019 compliance, organizations should ensure they are adequately prepared. Key prerequisites include:

• Management Commitment: Leadership must endorse and support the compliance initiative.
• Resource Allocation: Allocate necessary resources, including personnel, budget, and time.
• Current Process Documentation: Maintain comprehensive documentation of existing processes related to packaging and sterilization.
• Training Programs: Implement training programs to educate staff on the standards and requirements.
• Risk Management Framework: Establish a framework to identify and mitigate risks associated with packaging processes.

Step 1: Gap analysis

Performing a gap analysis against SN EN ISO 11607-2:2020 is the first critical step in compliance. The process involves assessing current practices against the standards outlined in the document. Key inputs include existing process documentation and relevant regulatory requirements. The analysis should cover the following:

1. Inputs: Gather current process maps, documentation, and quality management system records.
2. Process: Evaluate each requirement of ISO 11607-2:2019, identifying discrepancies between current practices and compliance needs.
3. Outputs: Document findings, including areas of non-compliance and necessary actions to address gaps.

Common findings might include inadequate validation of packaging processes or insufficient documentation practices. Utilizing tools such as checklists and compliance software can facilitate this analysis effectively.

Step 2: Design and documentation

Once the gap analysis is complete, the next step is to design and document the management system aligned with ISO 11607-2:2019. Essential components to document include:

• Scope Statement: Define the scope of the management system, specifying boundaries and applicability.
• Policy: Establish a compliance policy that outlines the organization’s commitment to meeting ISO standards.
• Objectives: Set measurable objectives related to packaging processes and compliance.
• Procedures: Develop procedures that detail how packaging processes will be executed and validated.
• Records: Ensure that records are maintained to demonstrate compliance and facilitate audits.

Link each documented element back to the relevant clauses in SN EN ISO 11607-2:2020 to ensure comprehensive coverage of all requirements.

Step 3: Implementation and training

Implementing the compliance framework requires effective change management and staff training. Key strategies include:

• Change Management: Develop a structured approach to managing change, ensuring minimal disruption during the transition.
• Staff Training: Conduct thorough training sessions to familiarize employees with new processes and compliance requirements. This training should cover validation processes, documentation standards, and quality control measures.
• Process Adoption: Encourage staff to embrace the new processes through clear communication and support.

Typical pitfalls include resistance to change, inadequate training, and failure to document processes correctly. Addressing these issues early can enhance the likelihood of successful implementation.

Step 4: Internal audit and certification

Conducting internal audits is vital for assessing compliance with SN EN ISO 11607-2:2020. The audits should be structured as follows:

• Purpose: Ensure that the packaging processes are compliant with ISO standards and identify areas for improvement.
• Timing: Schedule audits periodically, preferably before the certification audit, to allow time for corrective actions.
• Structure: The certification audit consists of two stages:
  • Stage 1 (Documentation): Review all documentation to ensure alignment with ISO standards.
  • Stage 2 (Implementation): Evaluate whether the documented processes are implemented effectively and functioning as intended.

Successful completion of these audits will prepare the organization for the external certification process.

Common pitfalls

1. Inadequate Management Support: Ensure top management endorses compliance initiatives.
2. Insufficient Training: Provide comprehensive training to all staff involved in the packaging processes.
3. Poor Documentation Practices: Maintain thorough records of processes and validations to support compliance.
4. Neglecting Risk Management: Implement a proactive risk management approach to address potential issues.
5. Ignoring Feedback: Actively seek and address feedback from internal audits to improve processes.

By recognizing and addressing these common pitfalls, organizations can streamline their journey toward ISO 11607-2:2019 compliance.