Testing is performed to assess the chemical regulatory compliance of packaging systems and materials.
USP <661>, <661.1> and <661.2> detail the test programs required for plastic packaging systems and their materials of construction for pharmaceuticals. USP <661> is valid until 2020 and early adoption of <661.1> and <661.2> is allowed before then.
USP <661.1> and <661.2> testing
The testing required for <661.1> is dependent on the material and may include extractions into organic solvents, acids, bases and/or water. This is then followed by analysis and/or physicochemical testing, depending on the material. Analysis techniques include: GC, LC, titration, TOC, acidity or alkalinity etc.
USP <662.2> includes an evaluation of the materials, testing and may incorporate extractables and leachables studies as part of a chemical risk assessment.
Products and materials tested:
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USP <661.1> |
USP <661.2> |
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All plastic materials used in the construction of pharmaceutical packaging, including: COC, PE, PP, polyamide 6, polycarbonate, PET, PETG, EVA, PVC, plasticized PVC and other “unaddressed materials” |
Pharmaceutical packaging covers all packaging types, including: inhalation, nasal, parenteral, oral, topical etc. |
Expert support for USP testing
Smithers are experts in materials, testing and have the capability to perform all physicochemical, chemical and physical testing detailed in USP <661>, <661.1> and <661.2>.
Standards and Accreditation
All our work is performed to the requirements of ISO 17025:2017 and to the principles of cGMP. We are an FDA registered laboratory.