Procedure

4.1 Sterile Packaging Material Selection
4.1.1 Choosing Sterile Packaging Materials
– Select packaging materials that are suitable for maintaining the sterility of the medical device. These materials should:
– Be Sterilizable: The material must be able to withstand the sterilization process without compromising the device or packaging.
– Provide a Barrier: The material should prevent the ingress of microorganisms and environmental contaminants.
– Be Compatible with Sterilization Methods: Ensure compatibility with sterilization processes such as:
– Steam Sterilization (Autoclaving): Packaging must withstand high-temperature steam without degradation.
– Ethylene Oxide (EO) Sterilization: Ensure the material does not release harmful chemicals when exposed to EO.
– Gamma Radiation: Verify that packaging materials maintain their integrity when exposed to gamma radiation.
– Hydrogen Peroxide Plasma Sterilization: Ensure the material is suitable for low-temperature plasma sterilization.

4.1.2 Material Requirements
– Sterile packaging materials must meet the following requirements:
– Durability: The material must be able to withstand handling and transport without compromising sterility.
– Clarity: The packaging must be transparent or have clear labeling to allow for easy identification of the device.
– Safety: Ensure that the material does not react with the device or release harmful substances when exposed to sterilization or during shelf life.

4.1.3 Supplier Selection
– Select approved suppliers for sterile packaging materials, ensuring that:
– Material Specifications: Suppliers provide material certificates and data sheets confirming that the materials meet regulatory standards for sterile packaging.
– Supplier Audits: Conduct regular audits and quality checks to ensure that suppliers consistently provide materials that meet the required standards.

4.2 Packaging Process for Sterile Devices
4.2.1 Packaging Procedure
– The following steps should be followed when packaging medical devices to ensure sterility:
– Clean Environment: Perform packaging in a cleanroom or controlled environment to minimize contamination.
– Proper Handling: Ensure that devices are handled with clean gloves and sterile techniques to prevent contamination during packaging.
– Sealing: Ensure that packaging is properly sealed to maintain sterility. Use methods such as heat sealing or ultrasonic welding, depending on the material.
– Tamper-Evident Features: Use tamper-evident seals to ensure that any attempts to open the package are easily identifiable.

4.2.2 Validation of Packaging Integrity
– Perform tests to validate that sterile packaging maintains sterility and integrity:
– Seal Integrity Testing: Perform tests to verify that the seals are strong and leak-proof.
– Sterility Maintenance Testing: Ensure that the packaging maintains sterility throughout the device’s shelf life, including during shipping and storage.
– Barrier Testing: Ensure that packaging materials provide an effective barrier against contaminants.

4.2.3 Environmental Controls During Packaging
– Ensure that packaging environments, such as cleanrooms, meet the required cleanliness levels, as defined by ISO 14644 or other applicable standards:
– Monitor temperature, humidity, and particulate levels to ensure compliance with sterile packaging standards.
– Use proper ventilation and air filtration systems to prevent contamination.

4.3 Sterilization Process for Sterile Packaging
4.3.1 Sterilization Method Selection
– Choose the appropriate sterilization method based on the device’s material and intended use. Common sterilization methods include:
– Steam Sterilization (Autoclaving): Suitable for heat-resistant devices.
– Ethylene Oxide (EO): Used for devices that cannot withstand high temperatures.
– Gamma Radiation: Ideal for heat-sensitive devices that can withstand radiation.
– Hydrogen Peroxide Plasma: Used for low-temperature sterilization of sensitive devices.

4.3.2 Sterilization Monitoring
– Regularly monitor the sterilization process to ensure that it is effective:
– Use biological indicators to confirm that sterilization has been achieved.
– Perform chemical indicator testing to verify that the correct sterilization conditions have been met.
– Track sterilization cycle data, including time, temperature, and pressure, to confirm proper conditions.

4.3.3 Post-Sterilization Packaging Integrity
– After sterilization, verify that the packaging is intact and has not been compromised:
– Inspect the integrity of the sterile barrier.
– Perform random sampling to ensure that all sterilized products meet packaging and sterility standards.

4.4 Labeling of Sterile Packaging
4.4.1 Sterile Packaging Labeling Requirements
– Ensure that labels on sterile packaging meet the following requirements:
– Sterility Status: Clearly label the packaging with the sterility status of the device (e.g., “Sterile” or “Non-Sterile”).
– Sterilization Method: Include information about the sterilization method used (e.g., “Sterilized by EO” or “Sterilized by Gamma Radiation”).
– Expiration Date: Include the expiration date of the sterile packaging if applicable.
– Lot Number/Serial Number: Ensure that the lot number or serial number is included for traceability purposes.

4.4.2 Regulatory Compliance Symbols
– Include internationally recognized symbols for sterile packaging on labels:
– Sterile Barrier System Symbol (ISO 11607): To indicate the presence of a sterile barrier.
– Expiration Date Symbol: To indicate the expiration of sterility.
– Sterilization Method Symbol: To indicate the sterilization method used, such as steam, EO, or gamma.

4.5 Documentation and Record Keeping
4.5.1 Sterile Packaging Records
– Maintain detailed records of sterile packaging processes, including:
– Packaging material specifications and certificates.
– Sterilization process records, including cycle times, temperatures, and biological indicator results.
– Packaging verification and inspection logs.
– Label approval records, including compliance with regulatory standards.

4.5.2 Record Retention
– Retain sterile packaging records for a minimum of five years or as required by regulatory authorities to ensure traceability and compliance during audits.

4.6 Compliance and Regulatory Requirements
4.6.1 Compliance with Sterile Packaging Standards
– Ensure that sterile packaging complies with the following regulatory requirements:
– FDA 21 CFR Part 820: Quality System Regulation for medical devices.
– ISO 13485: Quality management systems for medical devices.
– ISO 11607: Packaging for terminally sterilized medical devices.
– EU MDR (Regulation (EU) 2017/745): Requirements for sterile packaging in the EU.

4.6.2 Regulatory Audits and Inspections
– Provide records of sterile packaging compliance during regulatory inspections or audits:
– Maintain records of sterilization cycles, packaging integrity tests, and labeling verifications.
– Ensure that records are easily accessible for audit purposes.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization
– EO: Ethylene Oxide
– UDI: Unique Device Identification

6) Documents

– Sterile Packaging Material Specifications
– Sterilization Process Records
– Packaging Integrity Test Records
– Sterile Packaging Label Approval Records

7) Reference

– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 13485: Medical Devices – Quality Management Systems
– ISO 11607: Packaging for Terminally Sterilized Medical Devices
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Sterile Packaging Validation Log Template

Date	Device Name	Sterilization Method	Lot Number	Seal Integrity Test Results
DD/MM/YYYY	Device ABC	Gamma Radiation	Lot-123	Pass

Annexure 2: Sterilization Cycle Record Template

Date	Cycle ID	Temperature	Time	Biological Indicator Result
DD/MM/YYYY	Cycle-001	121°C	30 minutes	Passed