Whenever you’re launching or changing your packaging, stability testing must also be performed on the product in its new packaging and expiration dating must reflect the results of the new stability testing. FDA cGMP (21 CFR Part 211) requires that all drug products have an expiration date determined by appropriate stability testing.
Stability needs to be evaluated over time in the same container-closure system in which the drug product is marketed. Ideally you should also create packaging for stability testing on the same production machinery… using equivalent manufacturing processes.
- We can produce packaging for stability studies in almost any format: PVC and cold-formed foil blister, child resistant blister packaging, bottling, strip packaging, and pouches and sachets.
- We produce packaging for assay testing within a cGMP-compliant environment.
- We carefully document all your required packaging specifications for your testing protocols.
- We manufacture stability packaging on actual production equipment so you have samples that ensure stability packaging duplicates real-world conditions and performance.
- We maintain strategic alliances with core materials vendors (films, foils, and adhesives) to assist in material selection to enhance stability and quality of your packaging.
- We can handle your stability packaging needs quickly without interrupting your internal production lines with our smaller footprint production-capable equipment. This unique capability can provide you with faster response and faster results for your stability studies.
Need to Find Packaging for
Stability Testing?
Stability Testing?
We offer high-quality, low-volume blister packaging, strip packaging, pouches, cans and bottles all delievered with exceptionally fast turnaround to meet your stability testing needs. Please call us today to review your stability packaging requirements.
