USP <661.1> Plastic Materials Of Construction

The first printing of the USP (United States Pharmacopoeia) occurred over 200 years ago, in 1820. The goal was simple: Ensure public safety and build trust by establishing quality standards for medicines, additives, and food.

USP <661> “Plastic Packaging Systems and Their Materials of Construction” establishes testing standards and parameters for the thermoplastic resins used in manufacturing containers and packaging to store medicines and pharmacopeial articles.

While other plastics are listed in USP <661>, the main thermoplastic resins include Low-Density Polyethylene (LDPE), High-Density Polyethylene (HDPE), Polypropylene (PP), Polyethylene Terephthalate (PET), and a thermoplastic polyester — Polyethylene Terephthalate Glycol (PETG).

As an FDA-registered, cGMP-compliant, and ISO/IEC 17025-accredited pharmaceutical testing laboratory, BA Sciences brings over 25 years of experience in repeatable and reliable raw materials identity testing and validation.

The thoroughness, accuracy, and repeatability of BA Sciences testing help customers become cGMP and FDA-compliant by adhering to the stringent regulatory requirements found in USP <661>.

New USP Chapters

In 2016, USP <661> was amended to include two additional chapters that will become official on December 1, 2025. BA Sciences works with clients to enact proactive testing schedules and validation programs to ensure compliance well in advance of the official launch date.

USP <661.1> “Plastic Materials of Construction” was added to define more specific testing procedures for the plastic/polymer materials used in containers and packaging.
USP <661.2> “Plastic Packaging Systems for Pharmaceutical Use” was added to define testing procedures of the finished plastic/polymer container or packaging system.

Importance of USP <661.1>

The 2016 USP <661.1> amendment is critical, given how easy it is to encounter material contamination in certain thermoplastic production processes. It designates extensive testing and validation criteria that confirm the quality of thermoplastic resin material, its composition, identification, chemical testing, biological reactivity, identifiable additives, metals, and other elements.

While the polymers listed in USP <661.1> are safe, there is the potential for residual solvents, polymers, chemicals (phthalates), dust, vapors, and microscopic fragments from previous or adjacent production runs to contaminate material used in pharmaceutical container and packaging production.

In addition, thermoplastic resins include color additives, lubricants, and stabilizers that require constant testing and analysis. BA Sciences ensures customer compliance with USP <661.1> by ensuring that no material contamination has occurred in the materials they’ve chosen for pharmaceutical packaging.

USP <661.1> Additional Materials

USP <661.1> chapter includes several changes and additions to ensure a given polymer/plastic is suitable for packaging and use and adheres to FDA-established guidelines.

Aside from the thermoplastic resins outlined in USP <661>, the new chapter outlines test specification for additional materials.

New USP <661.1> Materials

Polycarbonate
Polyethylene-Vinyl Acetate
Polyamide 6
Polyvinyl Chloride
Cyclic Olefins
Polyvinyl Chloride (Plasticized)

Existing Materials

Low-Density Polyethylene (LDPE)
High-Density Polyethylene (HDPE)
Polyethylene Terephthalate (PET)
Polyethylene Terephthalate G (PETG – thermoplastic polyester)
Polypropylene

BA Sciences Testing Capabilities

BA Sciences is a data-driven life science and pharmaceutical testing laboratory with state-of-the-art testing equipment and capabilities. These capabilities — coupled with a highly skilled, experienced, and dedicated team of technicians, engineers, and chemists — make BA Sciences the go-to resource for high-quality, accurate, and time-critical pharmaceutical testing, validation, and analytical analysis.

As an integrated partner within the pharmaceutical industry, BA Sciences complies and excels with all USP <661.1> testing requirements, guidelines, and procedures. Here is a small sample of the testing that validates plastic and polymers to USP <661.1>.

Material Characterization and Identification Testing

Fournier Transform Infrared Detector (FTIR)
Elemental Analysis via ICP-MS
Differential Scanning Calorimetry (DSC)

Chemical Testing

Ultraviolet / Visible (UV/VIS) Spectroscopy
Acidity/Alkalinity
Total Organic Carbon (TOC)
Elemental Analysis via ICP-MS
Plastic Additives