Storage Conditions

Finished intraocular lenses are stored in designated areas within the manufacturing facility under controlled environmental conditions. Temperature, humidity, and light exposure are carefully monitored and maintained within specified ranges to prevent degradation of the lenses.

Packaging Integrity

The integrity of the packaging materials used to encase the intraocular lenses is verified to ensure protection against physical damage, contamination, and tampering. Packaging materials are inspected for defects, leaks, and breaches that could compromise the sterility and quality of the products.

Labeling and Identification

Each finished intraocular lens is labeled with essential product information, including the product name, lot number, expiration date, and manufacturing details. Barcoding or serialization may be used for accurate identification and traceability throughout the distribution chain.

Inventory Management

An inventory management system is employed to track the quantity, location, and status of finished intraocular lenses within the manufacturing facility. Inventory levels are monitored, and stock levels are replenished as needed to meet customer demand and production requirements.

Quality Control Checks

Finished intraocular lenses undergo final quality control checks to verify compliance with established specifications, standards, and regulatory requirements. Visual inspection, dimensional measurements, and functional testing may be performed to ensure product integrity and performance.

Sterility Assurance

Finished intraocular lenses are maintained in sterile packaging to preserve their sterility until use. Sterility tests may be conducted periodically to confirm the absence of microbial contamination and ensure compliance with regulatory standards.

Handling and Transportation

Proper handling and transportation procedures are followed to prevent physical damage and contamination of finished intraocular lenses during storage, loading, unloading, and transit. Protective measures such as cushioning, shock-absorbing materials, and temperature-controlled containers may be utilized for sensitive products.

Documentation and Recordkeeping

Comprehensive documentation and recordkeeping systems are maintained to record all activities related to the maintenance of finished goods. This includes inventory logs, inspection reports, packaging records, and distribution records for traceability and regulatory compliance purposes.

Non-Conformance Management

Any deviations, discrepancies, or non-conformities identified during the maintenance of finished goods are promptly documented, investigated, and addressed through corrective and preventive actions (CAPAs). Root cause analysis is conducted to identify the underlying causes and prevent recurrence of similar issues in the future.

Regulatory Compliance

The finished goods maintenance procedure adheres to regulatory requirements and quality standards governing medical device manufacturing, such as Good Manufacturing Practices (GMP), ISO 13485, and applicable regional regulations (e.g., FDA regulations in the United States, CE marking requirements in Europe).

Overall, the finished goods maintenance procedure in Sap & Pap intraocular lens manufacturing unit ensures the preservation of product quality, sterility, and safety throughout the storage, handling, and distribution process, thereby contributing to the overall reliability and performance of the manufactured intraocular lenses.