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Sealing process validation—IQ/OQ/PQ—ISO 11607 part 2
Background
The package for a sterile medical device should protect the product and ensure the device remains in a sterile state until use. The validation of the sealing process used to create the package is critical to ensuring product sterility.
The objective of a seal process validation is to document the flow of events in which the process is established and proven; this documentation should show that the process will produce acceptable seals over time. ISO 11607 Part 2 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use.
General
Process validation should include the Installation Qualification (I.Q.), Operational Qualification (O.Q.), and Performance Qualification (P.Q.), in this order. Demonstration of compliance with the requirements set forth in ISO 11607 should be documented. Sampling plans used as part of process validation should be based on statistically valid rationale. Test methods used as part of process validation should be validated, and acceptance criteria, repeatability, and sensitivity should be documented.
Installation Qualification (I.Q.)
The Installation Qualification verifies that equipment is installed and calibrated correctly in order to ensure that the equipment can maintain critical process control. The I.Q. should be planned and documented.
Some items to consider during the I.Q. planning phase are:
- Equipment design features
- Installation conditions such as wiring, utilities, functionality, etc.
- Safety features
- Verification that the equipment operates within the stated design parameters
- Supplier documentation, prints, drawings, and manuals
- Spare parts list
- Software validation
- Environmental conditions
- Documented operator training
- Operation manual
The I.Q. should include verification of the following:
- Critical process parameters defined
- Critical process parameters controlled and monitored
- Alarms, warning systems, or machine stops challenged in the event that critical process parameters exceed predetermined limits
- Critical process instruments, sensors, displays, controllers, etc. are certified as calibrated and have written calibration procedures
- Written preventative maintenance and cleaning schedules
- Software systems (i.e. PLC, data collection, inspection systems) validated to ensure they function as intended
Operational Qualification (O.Q.)
The Operational Qualification verifies the process produces sterile barrier systems at the operating extremes that meet predetermined acceptance criteria. Sterile barrier systems should be produced at both the upper and lower parameter limits as part of the verification. Engineering studies should be performed to establish parameter limits. The O.Q. should be planned and documented.
The following sealing properties are typically considered:
- Intact seal for a specified width
- Seal strength
- Visual seal transfer
- Channels or open seals
- Punctures or tears
- Material delamination or separation
Performance Qualification (P.Q.)
The Performance Qualification demonstrates that the process will consistently produce acceptable sterile barrier systems under specified operating conditions. It consists of three (3) production runs produced at nominal machine settings evaluated for critical predetermined acceptance criteria. Using three (3) production runs allows for evaluation of the process to determine if and how normal variation can affect output. Normal variation can include variability within materials (lot to lot), operators (shift to shift) and environment (day to day). The P.Q. should be planned and documented.
Production runs should include challenges to the process that may include:
- Machine set-up and change-over procedures
- Process start-up and re-start procedures
- Power failure and variations
- Multiple shifts
The P.Q. should include:
- Actual or simulated product
- Process parameters established in the O.Q.
- Verification of product/package requirements
- Assurance of process control and capability
- Process repeatability and reproducibility
Summary
A formal review and approval of the process validation should be completed and documented as a final step in the validation program. Proper documentation summarizes and references all protocols and results, and states conclusions.
Processes should be revalidated if changes are made to the equipment, product, packaging materials, or packaging process which compromise the original validation and affect the sterility, safety, or efficacy of the sterile medical device.
Any of these changes could affect the status of a validated process:
- Raw material changes
- New equipment
- Transfer of process/equipment form one facility or location to another
- Sterilization process change
- Negative trends in quality
References
ISO 11607, Packaging for Terminally Sterilized Medical Devices, Part 2, International Organization for Standardization, Geneva, Switzerland (2006).
About the author
Kevin Zacharias manages Oliver OnSite package engineering services and oversees project management of new product development.
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