The latest USP/NF requirements effective May 1, 2016 mandate that the suitability of plastic packaging systems and material used for their construction must be established for therapeutic products. The new requirements primarily affect the pharmaceutical products which are yet to be approved by the regulator for marketing, or are approved and in use but have undergone any modification.

VIMTA provides testing of packaging material as per USP 661.1 and USP 661.2. The tests offered include:

USP 661.1

• IR
• Thermal analysis
• Extraction (using water, toluene, alcohol or other suitable solvents)

• Acidity or alkalinity
• Absorbance
• TOC
• Metals (ICP- MS), HPLC (as required for the additive composition)
• Biocompatibility (biological reactivity)

USP 661.2

• Water extraction
• Acidity or alkalinity
• Absorbency
• TOC
• Extractables / Leachables profiling and toxicological risk assessment of the test data.
• Biocompatibility (biological reactivity)