Production Application Case of Ointments & Gels in the Pharmaceutical Industry
A pharmaceutical enterprise in eastern Guangdong mainly engages in the production of external ointments, skin gels, traditional Chinese medicine (TCM) creams and other pharmaceuticals. Its production process must strictly comply with GMP pharmaceutical standards, with strict indicators for equipment tightness, cleanliness and active ingredient retention rate.
The enterprise’s original equipment had problems such as easy damage to TCM ingredients, uneven mixing and caking of ointments, and difficulty in equipment cleaning and sterilization, which made it impossible to pass the review of the drug supervision department and restricted the enterprise’s development.
Guangzhou Yuxiang customized a pharmaceutical-grade high-shear emulsifier and a sterile mixing tank for the enterprise. The equipment adopts a frequency conversion speed regulation system, which can realize gentle shearing and effectively protect heat-sensitive TCM active ingredients; the jacketed precise temperature control system has a temperature control error of ±0.5℃, avoiding high-temperature degradation of ingredients. A high-torque mixing structure is designed for high-viscosity ointments, with a circular arc transition and no dead angle design, resulting in extremely low material residue rate.
The equipment supports CIP online cleaning and SIP online sterilization, the whole machine is made of 316L medical stainless steel, and production is carried out in a vacuum and sterile environment. The production data is traceable throughout the whole process, fully complying with GMP certification standards.
After the equipment was put into operation, the effective ingredients of the ointment were evenly distributed, the bioavailability was increased by 25%, and the efficacy was stable and long-lasting. The enterprise successfully passed the GMP certification review, eliminating potential production compliance hazards. The daily output of a single equipment can reach 2 tons, which is 50% higher than that of the original equipment, and the equipment maintenance cost is reduced by 30%, becoming the core equipment of the enterprise’s pharmaceutical production line.
