Jinghan Medical Materials' Application of PP Material in Biopharmaceuticals for Experimental Consumables

Jinghan Medical Materials' Application of PP Material in Biopharmaceuticals for Experimental Consumables

Jinghan Medical Materials' use of PP (Polypropylene) material in biopharmaceutical applications—for consumables like centrifuge tubes, cryovials, and pipette tips, as well as for equipment like single-use bioreactors, storage bags, and filters—offers distinct advantages and benefits that can be analyzed from several key perspectives:

In the Field of Experimental Consumables (Centrifuge Tubes, Cryovials, Pipette Tips)

1. Excellent Chemical Inertness and Purity

Advantage Analysis: PP material exhibits exceptional chemical stability. It resists strong acids, strong bases, and various organic solvents (such as ethanol). When in contact with diverse biological reagents or cell culture media, it does not undergo chemical reactions or leach impurities.

Core Benefit: This ensures the purity of experimental samples, preventing foreign substances from interfering with experimental results or affecting cell growth. This is particularly critical in molecular biology experiments.

2. Superior Low-Temperature Performance

Advantage Analysis: PP has a very low glass transition temperature. It maintains good toughness even in ultra-low temperature environments like -80°C or liquid nitrogen (-196°C), unlike other plastics that may become brittle and crack.

Core Benefit: This is fundamental for cryovials to safely store cells and tissue samples. It guarantees that sample containers will not fracture under ultra-low temperature conditions, ensuring the long-term, safe preservation of valuable biological materials.

3. Good Transparency and Hydrophobicity

Advantage Analysis: While PP is not as transparent as glass or PS, it offers good translucency, facilitating liquid level observation. Additionally, the PP surface is naturally hydrophobic.

Core Benefit: During pipetting, the hydrophobic surface helps minimize the retention of expensive reagents (such as antibodies or enzymes) on the inner walls of pipette tips. This improves pipetting accuracy and reduces experimental errors.

4. Resistance to High-Temperature and High-Pressure Sterilization

Advantage Analysis: PP has a melting point exceeding 160°C, allowing it to withstand autoclave sterilization at 121°C.

Core Benefit: Experimental consumables can be sterilized and reused safely, ensuring an aseptic operating environment while reducing the cost of repeated purchases. This is vital for experiments requiring strict sterility, such as cell culture.

In the Field of Pharmaceutical Equipment (Single-Use Bioreactors, Storage Bags, Filters)

1. Core Carrier for Single-Use Systems, Eliminating Cross-Contamination

Advantage Analysis: Single-use storage bags and bioreactors made from PP film (or multilayer films containing PP) are central to single-use technologies in biopharmaceutical manufacturing. They are designed for one-time use and then discarded, eliminating the need for cleaning and sterilization validation.

Core Benefits:

Reduced Contamination Risk: Completely avoids batch-to-batch cross-contamination that can occur with traditional stainless steel vessels due to inadequate cleaning. This is especially beneficial for multi-product manufacturing lines.

Increased Production Efficiency: Eliminates the tedious steps of Clean-in-Place (CIP) and Sterilization-in-Place (SIP), significantly shortening production turnaround times between batches.

2. Ensures the Activity and Stability of Biological Products

Advantage Analysis: PP material is inherently non-toxic, has no leachables, and offers good gas barrier properties (especially when combined with materials like EVOH in multilayer films).

Core Benefit: When in direct contact with cell culture media, buffers, or drug substance (DS), PP does not inhibit cell growth or adsorb proteins. This ensures the activity and stability of critical biomolecules like monoclonal antibodies and vaccines.

3. Weldability and Mechanical Strength

Advantage Analysis: PP exhibits excellent heat-welding properties, allowing it to form strong, sealed connections with tubing, connectors, and other components.

Core Benefit: Guarantees the integrity and leak-proof nature of the entire single-use bioprocess system, from liquid preparation, filtration, and storage to transport. The bag material can withstand certain mechanical stress from pumping or agitation without easily rupturing.

4. Regulatory Compliance and Stable Supply Chain

Advantage Analysis: PP materials provided by specialized medical material suppliers like Jinghan typically meet stringent biocompatibility standards, such as USP Class VI or ISO 10993, and come with full traceability documentation.

Core Benefit: This provides robust support for pharmaceutical companies during regulatory inspections by agencies like the FDA (U.S. Food and Drug Administration) or NMPA (National Medical Products Administration) , significantly reducing compliance risks associated with drug registration.