Abstract
The application of the elastomer-aluminum seal for a parenteral product requires definition of all the parameters involved. The sealing parameters not only include a complete understanding of elastomer physical properties such as modulus durometer and dimensional variability, but also includes a determination of the forces applied during the sealing operation. The physical forces applied to the closure system are directly dependent upon the operational parameters established for the sealing equipment. The primary parameter which must be determined, set, and maintained is the compressive force applied to the elastomer during the application of the aluminum seal. A strain-gage based system has been developed which allows in use measurement of the sealing compression force. The design, construction, and performance of the system are described.
- Received February 9, 1987.
- Accepted April 7, 1987.
- Copyright © Parenteral Drug Association. All rights reserved.
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