case study

Blood Samples & Shelf Stability

A large medical products 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.

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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Blood Samples & Shelf Stability

Background

A 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. 

Finding a workable solution quickly was critical to the success of the new product.

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.

 

Approach

The material of construction was synthetic polyisoprene. Experiments were conducted employing alternative synthetic polyisoprene formulations, but in order 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. 

 

About RCA

lab testingRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

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

References

  1. ASTM International, “ASTM F1980-99, Standard Guide for Accelerated Aging of Sterile Medical Device Packages,” November 1, 1999.
  2. FDA Code of Federal Regulations, Title 21, Part 820.30, Design Controls, April 1, 2010.

Background

A 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. 

Finding a workable solution quickly was critical to the success of the new product.

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.

 

Approach

The material of construction was synthetic polyisoprene. Experiments were conducted employing alternative synthetic polyisoprene formulations, but in order 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. 

 

About RCA

lab testingRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® 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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