case study

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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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 blood 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

Shelf stabilityWhether you are building a new facility or expansion to your existing operations; installing new capital equipment; re-validating existing equipment / utilities or you have been challenged with compliance deficiencies with your manufacturing operations / equipment, facility or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate validation program to help.

Manufacturing Support

  • We can assist with the entire validation life cycle continuum—starting with validation strategy / validation master plan through purchase, qualification, and commissioning
  • We have validation experts that can help and guide you from design qualification, user requirement definition through factory / site acceptance and through commissioning and qualification. We have experts in: user requirement specification (URS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification / process qualification (IQ/OQ/PQ) summary reports
  • Expertise in validation of: equipment, facilities, utilities, computer systems and controls supporting the areas of: manufacturing, laboratory, utilities, and processes
  • Re-validation of existing equipment and operations
  • Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility

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 blood 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

Shelf stabilityWhether you are building a new facility or expansion to your existing operations; installing new capital equipment; re-validating existing equipment / utilities or you have been challenged with compliance deficiencies with your manufacturing operations / equipment, facility or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate validation program to help.

Manufacturing Support

  • We can assist with the entire validation life cycle continuum—starting with validation strategy / validation master plan through purchase, qualification, and commissioning
  • We have validation experts that can help and guide you from design qualification, user requirement definition through factory / site acceptance and through commissioning and qualification. We have experts in: user requirement specification (URS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification / process qualification (IQ/OQ/PQ) summary reports
  • Expertise in validation of: equipment, facilities, utilities, computer systems and controls supporting the areas of: manufacturing, laboratory, utilities, and processes
  • Re-validation of existing equipment and operations
  • Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility

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