Medical Grade PHA Granules | PHB PHBV PHBHHx P34HB Biodegradable Polymer

Product Name：Medical Grade PHA Granules
Material Types：PHB, PHBV, PHBHHx, P34HB
Appearance：White to off-white granules
Purity：≥99%
Biodegradability：Fully biodegradable
Processing Methods：Injection molding, extrusion, 3D printing
Applications：Tissue engineering, drug delivery, biodegradable medical devices
Production Capacity：5000 Tons / Year
Origin：China

CATEGORY

What is PHA?

Polyhydroxyalkanoates (PHA) are intracellular polyesters synthesized by many bacteria. In organisms, they primarily function as carbon and energy storage substances. They possess physicochemical properties similar to synthetic plastics, but also exhibit many superior properties not found in synthetic plastics, such as biodegradability, biocompatibility, optical activity, piezoelectricity, and gas barrier properties. PHAs show broad application prospects in biodegradable packaging materials, tissue engineering materials, sustained-release materials, electrical materials, and medical materials.

Product picture:

Difference Between PHB / PHBV / PHBHHx / P34HB

Medical Applications of PHA

Advantages of Medical Grade PHA

Medical-grade PHA (Polyhydroxyalkanoates) is an advanced biodegradable biomaterial produced through microbial fermentation. Compared with traditional petroleum-based plastics and some conventional biodegradable polymers, PHA offers unique advantages in both biomedical and sustainable material applications.

Technical Properties：

Category	Test Item	Testing Method SOP	Quality Standard
Physicochemical Tests	Appearance	QA-SOP-007	White to off-white powder
Physicochemical Tests	Moisture	QA-SOP-007	≤0.4%
Physicochemical Tests	Assay	QA-SOP-002	≥99.5%
Physicochemical Tests	Viscosity	QA-SOP-004	Actual value
Physicochemical Tests	Ignition Residue	QA-SOP-008	≤0.2%
Physicochemical Tests	Organic Solvents	QA-SOP-003	≤0.053%
Physicochemical Tests	Heavy Metals	QA-SOP-018	≤10 ppm
Physicochemical Tests	Chloride	QA-SOP-021	≤10 ppm
Physicochemical Tests	Protein Content	QA-SOP-006	≤0.1%
Physicochemical Tests	Nucleic Acid Content	QA-SOP-005	OD260nm < 0.1
Physicochemical Tests	Bacterial Endotoxins (Gel Clot)	QA-SOP-016	< 0.2 EU/mg
Safety Tests	Microbial Limits	QA-SOP-013	Total aerobic microbial count ≤10 cfu per 1g of product
Safety Tests	Microbial Limits	QA-SOP-013	Total yeast and mold count <10 cfu per 1g of product
Safety Tests	Microbial Limits	QA-SOP-012	Not detected in 1g of product: Escherichia coli
Safety Tests	Microbial Limits	QA-SOP-012	Not detected in 1g of product: Pseudomonas aeruginosa
Safety Tests	Microbial Limits	QA-SOP-012	Not detected in 1g of product: Staphylococcus aureus
Safety Tests	Microbial Limits	QA-SOP-012	Not detected in 10g of product: Salmonella

Package:

1g / 1kg bag

Palletized Shipping

Lead Time: 1-7 Days

Shipping Methods: Sea/Air/Express delivery

FAQ:

Is PHA biodegradable?

PHA (Polyhydroxyalkanoates) is a fully biodegradable biopolymer produced by microbial fermentation. It can naturally degrade in soil, marine environments, compost, and biological systems without generating toxic residues, making it an environmentally friendly alternative to conventional plastics.

What is the difference between PHB and PHBV?

PHB is a highly crystalline PHA polymer with high stiffness and strength but relatively low flexibility. PHBV is a copolymer modified from PHB by introducing hydroxyvalerate (HV) units, which improve toughness, flexibility, and processability. PHBV is therefore more suitable for applications requiring better mechanical performance.

Is PHA suitable for medical applications?

Yes. PHA offers excellent biocompatibility, biodegradability, and bioresorbability, making it highly suitable for medical and biomedical applications such as tissue engineering, drug delivery systems, surgical sutures, wound dressings, and implantable medical devices.

Is PHA FDA approved?

Certain PHA-based medical products, including surgical sutures and biodegradable implants, have received FDA approval for specific medical applications in the United States. Regulatory approval depends on the material grade, formulation, and intended use.

Can PHA replace PLA?

PHA has the potential to replace PLA in many applications due to its superior biodegradability, better biocompatibility, and wider environmental degradation capability, including marine degradation. Compared with PLA, PHA generally offers improved flexibility and broader end-of-life options, especially for medical and sustainable packaging applications.

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