Medical ultrasound gel come into direct contact with the patient's skin, and in some special examinations (such as intracavitary ultrasound, intraoperative ultrasound, and ultrasound at skin lesions), they may even come into contact with mucous membranes or sterile tissues. Therefore, their safety is a crucial aspect that cannot be overlooked in medical practice.
The use of inferior raw materials or the production of coupling agents in non-clean environments can lead to skin irritation, allergic reactions, and even infections, resulting in serious medical consequences. Pingchuang Medical Group understands that safety responsibility is a matter of great importance and solemnly promises to use medical-grade raw materials in the production of OEM ultrasound gel and can provide sterile protection according to customer needs, thereby building a safety defense line for the product.
The safety commitment originates from the strict selection of raw materials. Pingchuang Medical insists on using high-quality medical-grade raw materials that meet relevant standards. This means that the water used is purified water or injection water grade that has undergone multiple purification treatments; thickeners (such as carbomer, hydroxyethyl cellulose, etc.), moisturizers (such as glycerin, propylene glycol), pH regulators, and preservatives are all prioritized for specifications with high purity, low impurities, and verified biocompatibility. Strict supplier audits and incoming inspection systems ensure that only high-quality raw materials that meet the standards can enter the production process, thereby eliminating safety hazards caused by raw materials from the source.
A clean production environment is the key to preventing exogenous contamination. The production of Pingchuang Medical's ultrasound gel is carried out in a 30,000-square-meter ten-thousand-grade clean room. Through an efficient air filtration system, strict personnel and material management, and standardized cleaning and disinfection procedures, the number of particles and microorganisms in the production environment is effectively controlled. This can maximize the purity of general-type ultrasound gel and reduce the risk of microbial contamination.
For application scenarios with higher safety requirements, Pingchuang Medical has the ability to provide sterile ultrasound couplant. The production of aseptic couplant is more demanding. In addition to formulation and filling in a clean environment of class 100,000 or higher, it is also necessary to use a proven terminal sterilization process (e.g., moist heat sterilization, irradiation sterilization, etc.) or aseptic manufacturing process. Packaging materials also need to be made of special materials and structures that can withstand the sterilization process and remain sterile (e.g. aseptic single packs). Pingchuang Medical has the relevant technical capabilities and experience, and can provide OEM products that meet the sterility requirements according to customer needs.
A strict quality control system provides a guarantee of safety commitment. Pingchuang Medical follows ISO 13485 medical device quality management system and GMP specifications. The independent QC department conducts a comprehensive inspection of the finished product, with microbial limits as the key monitoring item. For sterile products, sterility testing and endotoxin testing (if applicable) are also required to ensure that the product meets sterility standards. The perfect batch traceability system makes the production and quality information of the product available throughout the process.
Comprehensive qualifications are the definitive proof of our commitment to safety. Pingchuang Medical holds the China Class II Medical Device Registration Certificate, the US FDA 510(k), the EU CE and ISO 13485 certification. These require rigorous audits of product safety, including biocompatibility, and compliance with the manufacturing process. Obtaining these certifications itself means that the safety of the product has been recognized by domestic and foreign authorities.
For medical device brand manufacturers and medical institutions, choosing an OEM manufacturer of ultrasound gel that can provide medical-grade raw materials and sterile protection is crucial. This is not only responsible for patient safety but also for avoiding reputational and regulatory risks. Pingchuang Medical makes a solid safety commitment to all partners with its strict control over raw materials, high-standard clean production environment, ability to provide sterile products, comprehensive quality control system, and authoritative qualification certifications. Choosing Pingchuang Medical means choosing a high level of attention to patient safety and a reliable guarantee for product quality.
