case study

Medical Device Validation: Shelf Stability

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Medical Device Validation: Shelf Stability

Background

regulatory complianceA large medical device manufacturer was developing a new product to collect blood samples. Accelerated shelf age validation testing found that the protective sheath surrounding the needle in the device did not have adequate reseal characteristics. After aging, the sheath was not reliable in preventing leakage of the blood samples after needle puncture. Shelf stability became an immediate concern that could no longer go unaddressed. 

Challenge

The reseal failures came as a surprise since unaged test samples had not experienced failures. This led the program to fall behind schedule, and quickly finding a workable solution was considered critical to the success of the new product development.

What is Shelf Stability?

Shelf stability is a combination of the time it takes for your product to be unfit for use or consumption. It is tested by using artificial aging scenarios where changing the environment can help to predict the lifespan of a product. Additionally, real time aging studies can help provide data on how a product changed when packaging is exposed to different types of storage conditions. 

Approach

RCA’s medical device compliance team recognized that ISO 11607 requires a shelf life validation study to be conducted by a sterile medical device manufacturer. Further, shelf stability and packaging strategy must be examined when temperature and humidity levels are simulated to be higher than the norm. 

The material of construction to be tested was synthetic polyisoprene. Additionally, different experiments were conducted employing alternative synthetic polyisoprene formulations, but to achieve the proper reseal, it was necessary to change the material to natural polyisoprene (natural rubber latex).

Result

Design verification and validation testing was completed, and design review and design transfer were conducted. The design history file was updated, and ultimately the product was successfully launched employing the natural rubber latex sleeves. Shelf stability was immediately improved due to the proper reseal. 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Background

regulatory complianceA large medical device manufacturer was developing a new product to collect blood samples. Accelerated shelf age validation testing found that the protective sheath surrounding the needle in the device did not have adequate reseal characteristics. After aging, the sheath was not reliable in preventing leakage of the blood samples after needle puncture. Shelf stability became an immediate concern that could no longer go unaddressed. 

Challenge

The reseal failures came as a surprise since unaged test samples had not experienced failures. This led the program to fall behind schedule, and quickly finding a workable solution was considered critical to the success of the new product development.

What is Shelf Stability?

Shelf stability is a combination of the time it takes for your product to be unfit for use or consumption. It is tested by using artificial aging scenarios where changing the environment can help to predict the lifespan of a product. Additionally, real time aging studies can help provide data on how a product changed when packaging is exposed to different types of storage conditions. 

Approach

RCA’s medical device compliance team recognized that ISO 11607 requires a shelf life validation study to be conducted by a sterile medical device manufacturer. Further, shelf stability and packaging strategy must be examined when temperature and humidity levels are simulated to be higher than the norm. 

The material of construction to be tested was synthetic polyisoprene. Additionally, different experiments were conducted employing alternative synthetic polyisoprene formulations, but to achieve the proper reseal, it was necessary to change the material to natural polyisoprene (natural rubber latex).

Result

Design verification and validation testing was completed, and design review and design transfer were conducted. The design history file was updated, and ultimately the product was successfully launched employing the natural rubber latex sleeves. Shelf stability was immediately improved due to the proper reseal. 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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