The purity of medical ultrasound couplant is critical to ensure the accuracy of ultrasound and patient safety. Impurities, particles, or microbial contamination in the product may not only interfere with the transmission of ultrasound signals and affect the quality of imaging, but also pose a risk of infection when used in specific areas (e.g., intraluminal, intraoperative, or skin breakage).
Therefore, the cleanliness of the production environment is one of the key indicators to measure the quality of ultrasonic couplant. Pingchuang Medical Group is well aware of this, and has invested heavily in the construction and strict management of 3,000 square meters of 100,000-level dustless vehicles to ensure that the ultrasound couplant it manufactures meets the high standard of purity.
A 100,000-level clean room (ISO Class 8) is a highly controlled production environment. Its core indicator is the strict limitation on the number of suspended particles in the air, with no more than 100,000 particles per cubic foot of air with a diameter ≥ 0.5μm. There are also clear control requirements for the concentration of microorganisms (bacteria, fungi) in the air. To achieve and maintain this clean level requires a series of complex engineering and management measures. Pingchuang Medical's 100,000-level workshop is equipped with efficient air purification systems (HEPA/ULPA filters) that can effectively filter dust and microorganisms in the air.
Personnel and materials entering the workshop must go through special channels and procedures. Staff need to change into special clean clothing, shoes, hats, and masks, and pass through air showers to remove dust particles carried on their bodies. Materials enter through transfer windows or airlock rooms and are cleaned on the surface. The workshop is internally decorated with dust-free materials, with a reasonable layout to avoid dead corners and dust accumulation. Strict cleaning and disinfection procedures are carried out regularly to ensure the continuous cleanliness of the workshop environment. At the same time, the temperature, humidity, and pressure difference of the environmental parameters in the workshop are also precisely controlled to maintain a stable clean state.
Producing ultrasound gel in such a high-standard ten-thousand-level clean room brings obvious benefits. Firstly, it maximally avoids contamination of the product at critical stages such as preparation, mixing, filling, and sealing by airborne particles and microorganisms. This is crucial for ensuring the physical purity (absence of visible foreign matter) and microbial purity (compliance with microbial limit standards, even reaching sterile requirements).
High-purity coupling agents are beneficial for ensuring the stable transmission of ultrasonic signals. Impurities and bubbles may scatter or attenuate ultrasound, affecting the clarity and resolution of the image. Production in a clean environment, combined with vacuum degassing and other processes, can produce more uniform, pure, and bubble-free coupling agents, thereby optimizing the imaging effect.
Thirdly, for special application scenarios that require sterile assurance (such as intracavitary ultrasound, interventional ultrasound, etc.), a ten-thousand-level clean room is the foundation for achieving sterile production or low initial contamination of terminal sterilized products. Only in a highly clean environment can the safety of the final sterile product be effectively guaranteed.
The ten-thousand-level clean room of Pingchuan Medical is complementary to the GMP specifications and ISO 13485 quality management system it follows. The environmental parameters of the room (cleanliness, temperature and humidity, pressure difference, microorganisms) are regularly monitored and verified, and there are complete records. Strict environmental management ensures that the production process is always in a controlled clean state.
For brand owners and medical institutions seeking high-quality, high-safety OEM/ODM cooperation in ultrasound gels, whether the manufacturer has and effectively operates a high-level clean room is an important consideration factor. Pingchuang Medical demonstrates its high regard for product purity and safety with its 3000-square-meter ten-thousand-level clean room hardware capabilities and strict environmental management. Choosing ultrasound gels manufactured by Pingchuang Medical means choosing a pure quality guarantee from a highly clean environment.
