ASTM F2579-24 PDF

Full title and description

Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants — specification covering virgin amorphous poly(lactide) (dl-PLA) homopolymers and poly(lactide-co-glycolide) (PLGA) copolymer resins intended for use as raw-material resins in the manufacture of surgical implants; includes chemical and physical property requirements and test methods for identification, molar mass, residual monomer/solvent, heavy metals and related material characteristics.

Abstract

This ASTM standard (F2579-24) defines requirements for amorphous lactide‑based resins (PLA and PLGA) in virgin resin form intended for implantable medical devices. It specifies which polymer compositions are covered and excluded, required analytical tests (for example infrared and NMR identification, specific rotation, molar mass), and limits/acceptance criteria for residual monomer, residual solvent, heavy metals and related attributes; it is directed at material suppliers and device manufacturers rather than finished, packaged or sterilized implantable devices.

General information

• Status: Active (current ASTM designation F2579-24).
• Publication date: December 1, 2024 (published / made available December 2024).
• Publisher: ASTM International.
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: F2579-24 (2024 revision).
• Number of pages: 12 pages.

Scope

Covers virgin amorphous poly(lactide) homopolymers (predominantly dl‑PLA) and amorphous poly(lactide‑co‑glycolide) copolymers intended for surgical implant manufacture. The specification applies to resins that are fully solvated at or near room temperature by dichloromethane or chloroform, and it excludes polymer grades with crystallinity potential (semi‑crystalline or high l‑PLA content), block copolymers, and copolymers with glycolide mole fractions ≥ 70 %, which are covered by a different specification (F2313). The standard addresses material characteristics and test methods for raw resins and does not prescribe biocompatibility testing of finished devices (final device testing remains the responsibility of the device manufacturer).

Key topics and requirements

• Definitions and classification of amorphous lactide‑based resins (dl‑PLA, PLGA) and stereoisomeric specificity (distinguishing dl‑PLA from l‑PLA or d‑PLA).
• Solubility criterion: resins must be fully solvated at ~30 °C by methylene chloride or chloroform for applicability.
• Required identification tests: infrared spectroscopy, proton (1H) and carbon‑13 (13C) NMR for chemical identity.
• Physical/chemical property tests: specific rotation, molar mass (molecular weight) characterization, and related measurements.
• Contaminant and residuals limits: residual monomer, residual solvents, heavy metals; optional or supplementary tests for residual catalyst and residual water content as specified.
• Exclusions and cross‑references: not for semi‑crystalline lactide polymers (see F1925) or for copolymers with high glycolide content (see F2313).
• Guidance on processing effects: the standard notes that processing (molding, sterilization, etc.) can change properties and that fabricated forms should be evaluated with appropriate test methods.

Typical use and users

Primary users include raw‑material suppliers of PLA/PLGA resins, medical device and implant manufacturers using lactide‑based polymers, polymer R&D and formulation teams, quality control and analytical labs, procurement/specification authors, and regulatory/CE/510(k) submission teams where material specifications are required. The standard is commonly used during material selection, supplier qualification, incoming inspection, and specification writing for implantable device components.

Related standards

Relevant cross‑references and complementary documents include: ASTM F2313 (specification for poly(glycolide) and glycolide‑rich copolymers), ASTM F1925 (for high l‑lactide content materials and related stereochemical issues), Supplementary Requirement S1 and Guide F2902 (biocompatibility guidance referenced in the specification), and general biocompatibility standards such as the ISO 10993 series for biological evaluation of medical devices.

Keywords

PLA, PLGA, poly(dl‑lactic acid), poly(lactide), poly(lactide‑co‑glycolide), polylactic acid, polyglycolic acid, amorphous lactide resins, implantable resins, residual monomer, molecular weight, NMR, FTIR, ASTM F2579.

FAQ

Q: What is this standard?

A: ASTM F2579-24 is a material specification that sets chemical and physical requirements and test methods for virgin amorphous poly(lactide) and poly(lactide‑co‑glycolide) resins intended for use in surgical implants.

Q: What does it cover?

A: It covers amorphous dl‑PLA homopolymers and amorphous PLGA copolymers (resins that are fully solvated in dichloromethane or chloroform at ~30 °C), including required identification and purity tests and exclusion criteria for semi‑crystalline or glycolide‑rich compositions.

Q: Who typically uses it?

A: Material suppliers, device manufacturers, QC/analytical labs, R&D teams, procurement/spec writers, and regulatory personnel working with implantable medical devices.

Q: Is it current or superseded?

A: Current — the 2024 revision (F2579-24) is the active edition, published December 2024, and replaces earlier versions (for example F2579-18).

Q: Is it part of a series?

A: It is part of a family of ASTM material specifications for lactide/glycolide polymers and is cross‑referenced with related specifications such as F2313 (glycolide‑rich copolymers), F1925 (stereochemical/crystallinity considerations), Supplementary Requirement S1 and Guide F2902 for biocompatibility guidance.

Q: What are the key keywords?

A: PLA, PLGA, poly(dl‑lactic acid), polylactide, polylactide‑co‑glycolide, amorphous resin, implantable resins, residual monomer, molecular weight, NMR, FTIR.