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