Technical Requirements for the Application of Centrifuges in the Pharmaceutical Industry

Starting from the basic and targeted requirements of centrifuge applications in the pharmaceutical industry, ensuring the reliability, repeatability, consistency and safety of pharmaceutical centrifuges in the production process (when processing specific products). Centrifugal solid liquid separator has a wide range of applications in the pharmaceutical, chemical, food and other industries. The separation equipment is one of the main processing equipment in the pharmaceutical industry.

Before the transformation, most of the centrifuge used in pharmaceutical industry were traditional centrifuges, which were not much different from those used in the chemical industry, but only met the most basic separation requirements. In recent years, the pharmaceutical industry has implemented transformation, which has put forward higher requirements for centrifuges. According to the requirements for equipment in the quality management standard of pharmaceutical production, on the premise of maintaining the separation characteristics of the centrifuge, the requirements for the equipment in the quality management standard of pharmaceutical productionmust also be met. The requirements for the design, manufacture, selection and installation of the centrifuge separation equipment mainly include:

(1) The design, selection and installation of equipment should meet the production requirements of drugs. It should be easy to clean, sterilize, facilitate production operation, repair and maintenance, and prevent errors or reduce contamination.

(2) The surface of the equipment in direct contact with the medicine should be smooth, free of dead ends, easy to clean or disinfect, resistant to corrosion, and not chemically changed with the medicine or adsorbed.

(3) The lubricants and coolants used in the pharmaceutical centrifuge shall not contaminate the medicines or containers. The design and installation of piping should avoid dead ends and dead pipes. Personnel entering the clean room (area) should not make up or wear accessories, and should not directly touch medicines with their bare hands.

(4) Instruments, meters, measuring tools, weighing instruments, etc. used for production and inspection should meet the requirements of production and inspection in their scope of application and precision, with obvious qualification marks, and be regularly calibrated.

(5) The production equipment offered by centrifuge machine manufacturers should have obvious status signs and be regularly repaired, maintained and verified. The operation of equipment installation, repair and maintenance should not affect the quality of the product.

(6) Instruments and meters with special requirements should be placed in a special instrument room, and there should be facilities to prevent static electricity, vibration, humidity or other external factors.

In response to the above requirements, a series of measures must be fully considered in the design of the form of the structure, the selection of materials, and the realization of functions. In manufacturing, it has considerable processing capabilities and processing means to achieve requirements such as surface finish. In the selection, the actual production process, medium properties, and cleanliness requirements should be considered to select a suitable pharmaceutical centrifuge model. The convenience of maintenance and the reasonable configuration of the interface device with the centrifuge should also be considered during installation.

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