Understanding the nuances of package validations and testing — and emerging from the process successfully — is a high-stakes endeavor for manufacturers.
Ben White, Millstone Medical Outsourcing
The medical device manufacturing industry has never been more competitive. Rapid growth in the aging population worldwide and technological advancement have driven fast-paced product development as companies vie for market share.
This pressure makes time to market critical. Precious market share often goes to the manufacturers that can develop and launch products fastest without sacrificing quality or patient safety. Successfully navigating the demands of package design and validation often proves the crux of product development.
Without a clear understanding of the package validation process, the risk for manufacturers escalates. That risk is multifaceted, including the risk of being out of compliance as well as the possibility of costly time-to-market delays that can imperil profits. Ever-increasing regulatory oversight and tightening global standards add complexity to an already complicated process.
The package validation process: An overview
Package validation safeguards patient safety, ensuring medical devices arrive at the operating room ready to be placed into patients’ bodies with an effective aseptic transfer. The process entails creating a sterile package and ensuring its integrity despite the stresses of the transportation process. Establishing a package validation process is mandatory for compliance with regulatory oversight bodies and the global standards that cover packaging, including the ISO 11607 standard, Parts 1 and 2.
The traditional custom package validation process can be broken down into three phases, as defined by the ISO 11607 standard of a validated packaging system:
- Package design, which involves selecting materials and a sterile barrier system (SBS) that considers the product, user, and anticipated process. Usability evaluation takes place to demonstrate that the sterile contents can be aseptically removed from the sterile barrier system for presentation.
- Process validation, which includes qualification, validation and proof of stability of the SBS materials and seals.
- Performance and stability validation, which covers testing the integrity of the packaging and its sterile barrier for the stresses of distribution and aging.
Process validation is further broken down into installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), which together are intended to objectively demonstrate the mitigation of patient risk.
Because package design and validation can be complex with many variables and opportunities for error or delay, typical timelines for completed validation can vary from as few as six months to as long as 18 months or more. It’s easy to see how unanticipated delays or difficulties can threaten a manufacturer’s ability to realize R&D investment or first-to-market advantage.
Common mistakes and problems
Many manufacturers encounter common pitfalls in the package validation process. These can range from conceptual mistakes to functional errors.
The most common mistake also has the greatest potential to upend the product launch process. Manufacturers often fail to consider package design until late in the product development process, which can add months to the launch timeline. Best practice is to consider package design from the very earliest days of product development.
Another common package validation mistake concerns package design. The package’s sterile barrier system (SBS) must be able to withstand the distribution stresses that can occur between the warehouse and the operating room. Comprehensive testing must consider all nuances of the device’s journey, including the stresses of air and truck travel.
The third common package validation error involves package stability. Manufacturers must determine the length of a product’s shelf life and ensure the package can maintain a sterile barrier for the duration of this shelf life. To speed the package validation process, manufacturers sometimes subject packaging materials to aggressively accelerated aging stresses. Failure can set the package validation process back repeatedly, so it’s important to understand the ideal aging parameters for time-related package stability validation.
Manufacturers also have options to reduce risk and cut time to market in the package validation process. Engaging a partner with expertise can reduce risk, provide key knowledge of the regulatory landscape and its tightening compliance demands, and speed time to market while upholding patient safety. In addition, the recent rise of an array of robust pre-validated packaging solutions for particular medical device product lines — including spine and orthopedics — can cut time to market by as much as 50% while preserving quality and patient safety.
Medical device product development comes with great risk and even greater potential reward, especially in improving patient lives and outcomes. Success in the high-stakes package validation process hinges on understanding and executing all aspects of a complex, risky process to ensure the utmost in safety and quality with faster time to market.
Ben White is engineering manager of business development for Millstone Medical Outsourcing.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.