Disposal Tags
Under the Controlled Substances Act, this Schedule III opioid analgesic required an extra level of safety that included a secure disposal method for the spent transdermal pain reliever. FDA approval for the drug was contingent on validating that the disposal solution permanently safeguarded against unintended use or handling by instructing patients on proper disposal, concealing the identity of the final product, and preventing post-disposal abuse.
Drawing on our experience with nicotine patches, labels, adhesives, and materials science, the MPS Product Realization Team worked closely with the customer and our vendor network to develop and test a range of possible solutions, finally validating and qualifying the FDA-approved solution.
Significant pre-launch development and testing achieved the tear resistance, strength, and durability required. Building on prior intellectual property and understanding of drug abuse profiles, the joint team explored various materials combinations.
48
months from development to drug approval
6
rounds of package design, including prototypes for lab testing, samples runs for high speed converting trials, production line trials, and mock-ups for testing and FDA submission
12
months of accelerated durability testing
The final package delivered a safe, convenient, permanent disposal method for patients, safeguarding their families and communities. The drug launched with unsurpassed disposal security, including a tamper-resistant muti-ply barrier, permanent adhesion, superior burst strength, and tear resistance.
>30,000
pounds of tensile strength for durability and tear resistance
1
integrated solution in the form of pre-pouched disposal systems with exceptional shelf life measured in years, not months
In further support of the project, MPS invested in form-fill-and-seal equipment, visual and other detection equipment to deliver finished pouches to the customer filling lines. Four disposal systems are packed in each pouch.
8
stages of full-scale production including:
- Coating and laminating materials
- Printing labels on large format presses
- Printing pouches on narrow-web flexo presses
- Die-cutting
- Folding
- Filling
- Sealing
