ASTM F1925 - 17

    Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

    Active Standard ASTM F1925 | Developed by Subcommittee: F04.11

    Book of Standards Volume: 13.01


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    Abstract

    This specification covers virgin poly(L-lactic acid) resin (PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric compositions based on various D, L, or DL copolymer ratios. This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material. The virgin polymer shall be a homopolymer of L-lactide with the prescribed density. The molecular mass of the virgin polymer shall be indicated by relative solution viscosity (in chloroform). In addition, the weight average molecular mass and molecular mass distributions may be determined by gel permeation chromatography The virgin polymer shall be identified as a polylactide by infrared or 1H-NMR spectroscopy. Typical infrared transmission and 1H-NMR spectra are shown. The virgin polymer shall have a specific optical rotation (in dichloromethane) and residual monomer content within the prescribe values, and shall conform to the chemical and physical property requirements specified for: residual solvent, residual water, residual tin, heavy metals, and sulfated ash. The following test methods shall be used: (1) Karl-Fischer titration and (2) atomic absorption-emission (AA) spectroscopy or inductively coupled plasma (ICP) spectroscopy. Considerations for biocompatibility of the material from a human implant perspective is also given.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This specification covers virgin semi-crystalline poly(l-lactide) or poly(d-lactide) homopolymer resins intended for use in surgical implants. This specification also covers semi-crystalline resins of l-lactide copolymerized with other bioabsorbable monomers including, but not limited to, glycolide, d-lactide, and dl-lactide. The poly(l -lactide) or poly(d-lactide) based homopolymers and copolymers covered by this specification possess lactide segments of sufficient length to allow potential for their crystallization upon annealing.

    1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic dl-lactide based polymers and copolymers as well as the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Inclusion of stereoisomeric specificity within the lactic acid based acronyms results in the following: poly(l-lactide) as PlLA for poly(l-lactic acid), poly(d-lactide) as PdLA for poly(d-lactic acid), and poly(dl-lactide) as PdlLA for poly(dl-lactic acid).

    1.3 This specification is applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization. Such polymers typically possess nominal mole fractions that equal or exceed 50 % l-lactide. This specification is particularly applicable to isotactic-lactide based block copolymers or to polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5 % of total moles). This specification is not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction), which are covered by Specification F2313. This specification is not applicable to amorphous polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by less than 1.5 total mole percent (1.5 % of total moles) as covered by Specification F2579.

    1.4 This specification covers virgin semi-crystalline poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide:glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide-based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions (see Specification F2313).

    1.5 Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm after annealing above the glass transition temperature. While other copolymeric segments may also crystallize upon annealing (for example, glycolide), specific characterization of crystalline structures other than those formed by lactide are outside the scope of this specification.

    1.6 This specification addresses material characteristics of the virgin semi-crystalline poly(lactide) based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials.

    1.7 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to assure safety and efficacy.

    1.8 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices.

    1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.10 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.11 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    Other Document

    ICH Q3C(R5) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline: Impurities: Residual Solvents Available from ICH Secretariat, c/o IFPMA, 30 rue de St-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland. Available online at http://www.ich.org/LOB/media/MEDIA423.pdf.

    ASTM Standards

    D1505 Test Method for Density of Plastics by the Density-Gradient Technique

    D2857 Practice for Dilute Solution Viscosity of Polymers

    D3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)

    D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

    D4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer

    D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography

    E473 Terminology Relating to Thermal Analysis and Rheology

    E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry

    E794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis

    E967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers

    E968 Practice for Heat Flow Calibration of Differential Scanning Calorimeters

    E1142 Terminology Relating to Thermophysical Properties

    E1252 Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis

    E1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry

    E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

    E2977 Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F2313 Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

    F2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

    NIST Publication

    NIST Special Publication SP811

    United States Pharmacopeia

    USP, 26th Edition United States Pharmacopeia:

    USP <232> Elemental Impurities Limits

    USP <233> Elemental Impurities Procedure

    USP <781> Physical Tests Optical Rotation

    Code of Federal Regulations

    21CFR820 United States Code of Federal Regulations, Title 21Food and Drugs Services, Part 820Quality System Regulation

    ISO Standards

    ISO 80000-9


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.20 (Thermoplastic materials)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products); 13102000(Thermoplastic plastics)


    Referencing This Standard
    Link Here
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    DOI: 10.1520/F1925-17

    Citation Format

    ASTM F1925-17, Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants, ASTM International, West Conshohocken, PA, 2017, www.astm.org

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