Medical Package Testing

A divsion of Life Science Outsourcing, Inc.

Medical Package Testing (MPT) is a division of Life Science Outsourcing, Inc. (LSO), which is an ISTA certified packaging test lab (ID Number ST-2339). MPT is devoted to the validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. Our testing and validation services are based on ISO 11607-1:2006 and are designed to assure compliance with FDA, ISO, EN and CE Mark requirements.

Stability Testing Includes Accelerated Aging & Real-Time Aging. These tests are conducted to determine that the packaging configuration is sufficient to maintain product sterility for the intended shelf life period.

Distribution Simulation Involves a series of tests specifically designed to measure the sturdiness of the outer/secondary packaging. This is to ensure that the packaging can meet industry standards and can safely contain the devices during shipping, handling and storage.

Package Integrity Testing Focuses on the device’s primary packaging/ pouch. Tests are designed to check the pouch’s ability to maintain sterility and its robustness.

Package Validation & Quality Assurance Package Validation Services include creating validation protocol(s) and preparation of documentation and final report for submission to appropriate regulatory bodies. The Quality Assurance system at MPT is constantly monitored and refined to provide our customers with exceptional and high quality performance. We strictly adhere to all relevant standards such as ISO, ASTM and ISTA. We are ISO 13485:2003 certified and registered as an ISTA certified packaging test lab (ID Number ST -2339).

This online resource provides general information about the field of medical package testing and about our services in particular. If you don’t find the information you’re looking for, please contact us to discuss your specific needs.