VESTAMID Care ML-GB30 – 30% Glass Bead Filled PA12 for Medical Devices

基础信息

品名
VESTAMID Care ML-GB30
牌号
ML-GB30
厂商
Evonik
材料类型
30% Glass Bead Filled Polyamide 12 (PA12)
产品形态
Pellets / Granules (Injection Molding Grade)
特点
30% microglass bead filled; USP Class VI & ISO 10993 compliant; high rigidity; low warpage; dimensionally accurate moldings; biocompatible for up to 30 days body contact; good chemical resistance; sterilizable

描述

VESTAMID Care ML-GB30 is a 30% microglass bead filled polyamide 12 (PA12) resin from Evonik Operations GmbH, specifically designed for the injection molding of rigid, low-warpage, and dimensionally accurate moldings. It belongs to Evonik’s VESTAMID Care product line, which offers USP Class VI certified materials for medical applications.

Polyamide 12 (PA12) is a high-performance engineering plastic known for its low moisture absorption, excellent chemical resistance, and good flexibility. It offers outstanding impact strength and dimensional stability over a wide temperature range. The addition of 30% glass beads to this PA12 base enhances rigidity and dimensional stability while maintaining the material’s inherent low moisture uptake and chemical resistance.

This grade is developed for medical technology applications, with biocompatibility tested following ISO 10993-1 recommendations for surface medical devices with up to 30 days body contact. The material fulfills the requirements of USP <88> Class VI and has been tested by independent, certified laboratories.

VESTAMID Care ML grades are polyamide 12 compounds that are resistant to body fluids and toxicologically safe. They meet the medical products requirements of the U.S. Food and Drug Administration and the European Union, and can be sterilized by conventional methods, including steam autoclaving. The specialty polyamide 12 compounds are especially resistant to chemicals, compatible with body fluids, and innocuous.

For more VESTAMID grades and technical information, please visit our PA12/Polyamide 12 product page.

Key Features of VESTAMID Care ML-GB30

# Feature Benefit
1 30% Microglass Bead Filled Enhanced rigidity, dimensional stability, and low warpage
2 USP Class VI Compliant Meets highest biocompatibility standards for medical applications
3 ISO 10993 Compliant Tested for cytotoxicity, sensitization, irritation, and acute systemic toxicity
4 Up to 30 Days Body Contact Approved for surface medical devices with up to 30 days body contact
5 Low Warpage Excellent dimensional stability for precision components
6 High Rigidity Rigid, dimensionally accurate moldings
7 Good Chemical Resistance Resistant to chemicals and body fluids
8 High Impact Resistance High impact and notched impact resistance
9 High Abrasion Resistance Excellent wear resistance for durable components
10 Low Friction Good sliding properties
11 Sterilizable Compatible with conventional sterilization methods, including steam autoclaving
12 Good Processability Suitable for injection molding

Biocompatibility & Regulatory Compliance

VESTAMID Care ML-GB30 has undergone comprehensive biocompatibility testing to ensure safety for medical applications:

Standard Test Description
USP Class VI Acute Systemic Toxicity, Intracutaneous Reactivity, Muscle Implantation
ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization (Maximization test according to Magnusson and Kligman)
ISO 10993-10 Irritation (Intracutaneous Reactivity)
ISO 10993-11 Acute Systemic Toxicity
ASTM F756-08 Hemocompatibility

Typical Applications for VESTAMID Care ML-GB30

Industry Typical Components & Considerations
Medical Devices Housing parts, monitoring and imaging equipment, durable medical equipment
Encapsulation Encapsulant for electronic components in medical devices
Medical Equipment Rigid structural components requiring biocompatibility and dimensional accuracy
Tubing & Catheters Reinforced components for medical tubing applications
Surgical Instruments Components for surgical and dental instruments
Healthcare Products Care products requiring biocompatibility and low warpage
Industrial Components Mechanical components such as cam followers requiring low friction

Typical Properties of VESTAMID Care ML-GB30

Property Value Test Method
Physical
Density (23°C) 1.25 g/cm³ ISO 1183
Water Absorption (Saturation, 23°C) 1.1% ISO 62
Moisture Absorption (23°C, 50% RH) 0.50% ISO 62
Molding Shrinkage – Parallel (2.00 mm) 1.2% ISO 294-4
Molding Shrinkage – Transverse 0.7% ISO 294-4, 2577
Melt Volume Rate (MVR) 100 cm³/10 min ISO 1133 (275°C/5 kg)
Mechanical
Tensile Modulus 2,000 MPa ISO 527
Tensile Stress at Yield (23°C) 47 MPa ISO 527-2
Tensile Strain at Yield (23°C) 5.0% ISO 527-2
Nominal Tensile Strain at Break (23°C) > 50% ISO 527-2
Impact
Charpy Notched Impact Strength (-30°C) Complete fracture ISO 179/1eA
Thermal
Melting Temperature ~178°C
Melt Density 1090 kg/m³
Thermal Conductivity of Melt 0.28 W/(m·K)
Specific Heat Capacity of Melt 2400 J/(kg·K)
Ejection Temperature 180°C

Important Notes on Typical Data

📌 Values are typical – The data listed above is sourced from manufacturer data sheets for reference only and does not constitute binding product specifications for VESTAMID Care ML-GB30.

📌 Batch variations – Batch-to-batch deviations may exist. For critical applications, validate performance with batch-specific COA certificates.

📌 Final performance – Actual performance depends on processing conditions and part design. Refer to ISO testing standards for detailed methodology.

📌 Authoritative reference – The manufacturer’s official TDS shall serve as the definitive technical reference for VESTAMID Care ML-GB30. Request the latest official TDS from our sales team.

📌 Regulatory Compliance – For medical applications, always verify current regulatory certifications (USP Class VI, ISO 10993) remain valid for your specific application and region.

Processing Guidelines for VESTAMID Care ML-GB30

Step Process
Processing Methods Injection Molding
Drying Recommended Yes
Drying Temperature 80 – 90°C
Drying Time 4 – 6 hours
Suggested Max Moisture ≤ 0.10%
Melt Temperature 230 – 270°C
Optimum Melt Temperature 250°C
Mold Temperature 40 – 80°C
Injection Pressure Medium to high
Hold Pressure 30 – 70 MPa
Injection Velocity Medium
Storage Store in original, sealed packaging in a cool, dry place away from direct sunlight

Critical Processing Warnings for VESTAMID Care ML-GB30

⚠️ Drying Requirement – VESTAMID Care ML-GB30 requires drying prior to processing to prevent hydrolytic degradation. The recommended drying conditions are 80–90°C for 4–6 hours.

⚠️ Moisture Control – Maximum residual moisture content should be ≤ 0.10%. Proper drying is essential to prevent void formation and ensure optimal part quality.

⚠️ Melt Temperature – The recommended melt temperature range is 230–270°C, with an optimum of 250°C. Avoid exceeding 270°C to prevent material degradation.

⚠️ Mold Temperature – A mold temperature range of 40–80°C is recommended. Higher mold temperatures promote higher crystallinity and better dimensional stability.

⚠️ Medical Grade – The “Care” designation indicates this grade is specifically developed for medical applications. For medical applications, ensure all processing and handling procedures maintain material purity and compliance.

⚠️ Reinforced Grade – Contains 30% glass bead reinforcement, which may require consideration for equipment wear and proper screw design.

⚠️ Sterilization – This grade is compatible with conventional sterilization methods, including steam autoclaving. For medical applications, validate sterilization methods with actual part geometry.

⚠️ Storage – Store in original, sealed packaging in a cool, dry place away from direct sunlight. For subsequent storage, the material should be stored dry until processed.

Comparison: VESTAMID Care ML-GB30 vs. Standard Unfilled PA12

Feature VESTAMID Care ML-GB30 Standard Unfilled PA12
Glass Bead Content 30% 0%
Key Feature Rigid, low warpage, dimensional accuracy Flexible, good toughness
Tensile Modulus 2,000 MPa ~1,300 – 1,500 MPa
Tensile Strength 47 MPa ~40 – 45 MPa
Density 1.25 g/cm³ ~1.01 g/cm³
Molding Shrinkage 1.2% ~1.5 – 2.0%
Warpage Low Higher
Rigidity High Standard
Biocompatibility USP Class VI, ISO 10993 Standard

Related Products

  • PA12/Polyamide 12 – View our full range of PA12 products

  • Engineering Plastics – Browse all engineering plastic materials

  • VESTAMID Care ML16 – Unfilled PA12 for medical tubing applications

  • VESTAMID Care ME71 – TPA-based medical grade for flexible applications

  • About Our Company – Learn more about our supply capabilities and quality assurance

Technical Documents for VESTAMID Care ML-GB30

Document Type Description & Source
Manufacturer Official TDS Complete physical, thermal, and mechanical properties of VESTAMID Care ML-GB30
Manufacturer Official SDS GHS-compliant safety documentation
COA (Certificate of Analysis) Batch-specific quality certification for VESTAMID Care ML-GB30
Biocompatibility Certification USP Class VI and ISO 10993 documentation
Medical Device Compliance FDA and EU medical device requirements documentation

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We reply within one working business day. Please clearly state product (VESTAMID Care ML-GB30) and document type you require.

FAQ about VESTAMID Care ML-GB30

Q1: What is VESTAMID Care ML-GB30?
A: VESTAMID Care ML-GB30 is a 30% microglass bead filled polyamide 12 (PA12) resin from Evonik, designed for the injection molding of rigid, low-warpage, and dimensionally accurate moldings.

Q2: What does the “Care” designation mean?
A: The “Care” designation indicates this grade is specifically developed for medical applications, with biocompatibility tested following ISO 10993-1 recommendations.

Q3: What are the key features of VESTAMID Care ML-GB30?
A: 30% glass bead filled; USP Class VI & ISO 10993 compliant; high rigidity; low warpage; dimensionally accurate moldings; biocompatible for up to 30 days body contact; good chemical resistance; sterilizable.

Q4: What are the typical applications for VESTAMID Care ML-GB30?
A: Medical device housings, monitoring and imaging equipment, durable medical equipment, encapsulation, and rigid structural components requiring biocompatibility.

Q5: What is the recommended drying condition for VESTAMID Care ML-GB30?
A: Dry at 80–90°C for 4–6 hours. Maximum residual moisture should be ≤ 0.10%.

Q6: What is the density of VESTAMID Care ML-GB30?
A: 1.25 g/cm³.

Q7: What is the tensile modulus of VESTAMID Care ML-GB30?
A: 2,000 MPa.

Q8: What regions is VESTAMID Care ML-GB30 available in?
A: North America, Europe, and Asia Pacific.

Q9: Is VESTAMID Care ML-GB30 USP Class VI compliant?
A: Yes, it fulfills the requirements of USP <88> Class VI.

Q10: Is VESTAMID Care ML-GB30 ISO 10993 compliant?
A: Yes, it has been tested for cytotoxicity, sensitization, irritation, and acute systemic toxicity following ISO 10993 recommendations.

Q11: What sterilization methods are compatible with VESTAMID Care ML-GB30?
A: It is compatible with conventional sterilization methods, including steam autoclaving.

Q12: What is the molding shrinkage of VESTAMID Care ML-GB30?
A: 1.2% parallel (2.00 mm) and 0.7% transverse.

Q13: Is VESTAMID Care ML-GB30 suitable for injection molding?
A: Yes, it is specifically designed for injection molding.

Q14: What is the melt temperature range for VESTAMID Care ML-GB30?
A: 230–270°C, with an optimum of 250°C.

Q15: Does VESTAMID Care ML-GB30 have good chemical resistance?
A: Yes, it offers good chemical resistance and is resistant to body fluids.

Q16: What is the difference between VESTAMID Care ML-GB30 and unfilled VESTAMID Care grades?
A: VESTAMID Care ML-GB30 is reinforced with 30% glass beads, providing higher rigidity, lower warpage, and better dimensional stability compared to unfilled grades.

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  • Samples of VESTAMID Care ML-GB30 are for laboratory validation tests only, not for production use.

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  • If bulk-product performance deviates from sample reference, the manufacturer’s official TDS serves as the authoritative benchmark.

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After-Sales Support

Service Details
Quality Inspection Period All quality-related claims must be submitted within 7 working days after delivery, supported by test data and photographic evidence.
Return / Exchange Policy Confirmed product defects caused by our side trigger replacement or refund. Terms and conditions apply.
Logistics Damage Report shipping damage directly to carrier immediately upon goods receipt. We assist with claim-document preparation.
Technical Support Remote technical guidance available. On-site troubleshooting can be arranged upon special request.
Export Documentation We supply commercial invoice, packing list, bill of lading, COA, and additional compliance certificates on request.

Disclaimer

DISCLAIMER: All technical data is referenced from original manufacturer typical values for VESTAMID Care ML-GB30. Our company acts as supplier/trader rather than original manufacturer. Final performance depends on processing conditions and part design. Buyers shall independently validate product suitability for individual applications, especially for medical applications where regulatory compliance must be verified for each specific use case. Our firm bears no liability for product failure caused by improper processing or improper usage. Always reference the latest manufacturer official TDS of VESTAMID Care ML-GB30 as the definitive specification.

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