dry vacuum pump in medical device

The pharmaceutical field occupies a very important position in the national economy. In the process of pharmaceutical production, the medium such as liquid medicine, intermediate, pure water, acid and reducing agent is transported by pump to meet the requirements of process production. According to the different devices and transport media, some typical medical devices in China. Generally, centrifugal pump, dry vacuum pump, rotor pump, metering pump and vacuum pump are selected. Dry vacuum pump accounts for 90% of the total medical pump. The dry vacuum pump has its own special properties, no leakage, zero pollution, environmental protection and other characteristics, which is very suitable for the pharmaceutical industry.

1. Particularity of dry vacuum pump for medical device

Pharmaceutical industry is a special industry. Due to the complex characteristics of the medium in the pharmaceutical production process (most of the pumps are used for the transportation of toxic, harmful, flammable, explosive and corrosive media), the dry vacuum pump, as a key supporting equipment, has attracted more and more attention. Its particularity mainly lies in the following aspects.

(1) The quality of pumps for medical devices is very strict. Although petroleum, chemical and other industries also have quality requirements, it is difficult to compare with drugs.

(2) Pharmaceutical industry has high requirements in all aspects of the production process. In drug production, flammable, explosive, toxic and harmful solvents and intermediates are often encountered. Therefore, the pump used in medical device must be selected according to the medium and application situation.

(3) There are many kinds of drugs and the renewal is fast. When the batch number is changed, the equipment pipeline should be cleaned and disinfected, and the pump for medical device should be easy to clean and disinfect.

2. Requirements for parameters and working conditions of dry vacuum pump for medical devices

(1) Parameter range: the parameter range of pump for medical device is smaller than that for petroleum and chemical plant. According to statistics, the parameters of the pump for medical devices are roughly as follows.

Flow rate ≤ 100m3 / h

Lift ≤ 100m

Temperature ≤ 100 ℃

Outlet pressure ≤ 1.6Mpa

(2) Working condition: Petroleum and chemical plants usually operate continuously, and the continuous operation period of pumps is required to be no less than 8000h, while that of medical devices is generally intermittent operation. The continuous operation period of pumps is lower than that of pumps used in petroleum and chemical plants, which is generally 4000H.

3. Special requirements for pumps for medical devices

The drugs produced by medical devices are closely related to people’s health, so the pumps used have the following special requirements.

(1) General requirements

a. The pump for pharmaceutical production should have reliable performance, good sealing, compact structure and small size to facilitate operation, cleaning and maintenance.

b. The relevant test data shall be provided for the pump used to transport liquid medicine, intermediate, pure water and other media, so as to determine that the use of the pump and materials will not affect the drug quality. Materials used for flow passage parts shall be provided with test reports approved by the health department for use in pharmaceutical production.

c. The pumps used to transport liquid medicine, intermediate, pure water and other media should be able to be disinfected and cleaned. The materials, media and devices used for cleaning should not cause new pollution.

d. For the pumps used in the clean area, in order to facilitate the comprehensive cleaning, it is better to adopt active connection between the pump and the pipeline, and its base should also adopt foot support to make the base separate from the ground.

(2) Structural requirements

a. The surface of the flow passage parts of the pump shall be smooth, free of dead corners, easy to clean and corrosion resistant, and the castings shall be free from sand holes, depressions and cracks that are not easy to clean.

b. On the premise of ensuring performance and reliability, the pump structure should be simplified as far as possible, and the installation and disassembly should be simple, so as to facilitate cleaning treatment and maintenance.

(3) Shaft seal requirements: the leakage limit of pumps for medical devices is relatively strict, because the leakage will not only affect the cleanliness of the plant floor, can not meet the requirements of GMP, but also cause corrosion of equipment and ground, causing damage to the environment. Therefore, dry vacuum pump is one of the first choice of environmental protection pumps for medical devices.

(4) Material requirements

a. The metal materials used in the flow passage parts of the dry vacuum pump for medical devices should be prevented from chemical reaction with the liquid medicine, absorption penetration, oxidation and stripping, and the non-metallic materials should be the materials that do not react with the liquid medicine, can coexist with the conveying medium and do not release additives in long-term operation.

b. The material of flow passage parts of pump for medical device shall be filled in the pump data sheet after being determined by the buyer. If the seller thinks that other materials can be replaced, it shall be confirmed by the buyer.

c. Ultra low carbon austenitic stainless steel, fluoroplastics F46 and other materials should be used for the flow passage parts of the pump used in medical devices.

d. For pumps used in clean area, stainless steel materials shall also be used for non flow parts, and painting is not allowed.

e. The auxiliary sealing material of the pump can choose PTFE coating material and pure PTFE material.

f. The use of materials containing asbestos fibers is strictly prohibited.

g. When transporting organic solvents, it is strictly forbidden to use rubber materials.