How to Detect Leakage by DOP Method with High Performance Filter of Pharmaceutical Factory

The high efficiency filter is the key equipment for high purity air purification in pharmaceutical plant purification system. The detection of leakage from the high efficiency filter is to determine whether there is significant leakage in the high efficiency filter itself and the system installation, and to identify the shortcomings of the high efficiency filter and its installation in order to take remedial measures.

High-efficiency filters installed or replaced, and after a cycle is used, leaks must be checked for high-efficiency filters and installation connections.

At present, the DOP method is widely used internationally to detect leakage:

The instruments used in the DOP leak detection method are: DOP generator, aerosol photometer. The dust source detected by the DOP method is the DOP solvent, spray, and the particles are spherical. Since the leakage measurement principle of the DOP is to produce DOP aerosols as a dust source on the upper side of the highly efficient filter being measured, sampling is used on the downwind side of the wind, and the scattered light produced by the dust gas through the photometer is converted from the photoelectric effect linear magnification to the electricity, and is quickly displayed by the microammeter. The relative concentration of aerosols can be measured by photometers. Checking a filter can be done in 5 minutes.

The DOP method detects expensive instruments(no domestic equipment). According to statistics, the DOP method has omitted more applications in foreign capital and joint Ventures, such as Huarui Pharmaceutical Co., Ltd. and Famaxiya Pharmaceutical Co., Ltd.. This method is widely used by manufacturers of air conditioning purification equipment to detect leakage. Its characteristics are fast, simple, accurate and reliable.

However, according to international data, DOP solvents as dust sources have been pointed out to have the properties of mutants. Due to the need for regular leakage, the concentration of DOP solvents from dust sources in air purification systems has increased accordingly, resulting in new chemical pollutants., It has a new effect on air purification and brings difficult pollution to drug production. For this reason, the United States has sought new alternatives to the DOP solvent, the DOP leak detector.

At present, some domestic enterprises are suffering from lack of funds, and it is difficult to equip DOP detection devices. It is impossible to develop efficient filters and it is difficult to verify the purification system.

To this end, experts on clean air conditioning technology and drug production plant design will discuss how to solve the problem of leakage detection in purification systems for ordinary enterprises. It also studied the "Principles of Air Cleansing Technology", the "Drug Production Certification Guide" and the "GMP Learning Workshop Data Compilation" for Pharmaceutical Production Enterprises, and considered that the traditional dust particle counter method was used to detect leakage. It can also achieve the purpose of detecting the leakage of high-efficiency filters. The methods are described below:

Using dust particle counter to detect leakage is simple and feasible.

On the wind side of the high-efficiency filter, the atmosphere is used as the source of dust, and the dust particle counter sampling head is scanned on the lower wind side.

The specific detection method of the DOP method is as follows:

1. Test method: dust particle count scanning inspection method.

2. Test scope: filter material, filter frame seal and connection of filter group support frame, support frame and fixed wall connection

3. Detection instrument: Dust particle counter:

4. Detection principle: According to the principle of light flux scattered by floating particles under a certain intensity of light, the scattered light of the particles is converted into an electrical signal by photoelectric conversion, and the equivalent diameter of the particles is displayed after amplification and computer processing. And the corresponding number of particles.

5. Detection procedure:

5.1 Use dust particle counter sampling head to scan the embedded wind side of the filter, the sampling head is approximately 2cm away from the filter, and along the inside border of the filter, etc.. The scanning speed is less than 5cm/s.

5.2 When the detection period is 10 min, 0.5 U M particle number & amp; Gt; 20, the alarm sounds, indicating the amount of leakage starting. Need to repair or more Ling.

5.3 After plugging the leak or fastening the bolt with epoxy resin, a scanning inspection is conducted.

6. Detection cycle

6.1 Normal use. At least once every quarter;

6.2 New high efficiency filters should be tested.

Although the dust particle counter scanning method is used for long detection time, generally a filter leak inspection takes one hour to right, but the price of the test equipment is low. It is a commonly used test instrument in enterprises, and there is no potential for negative effects. It is more suitable for general drug production enterprises. Choose.

To sum up, using the DOP leak detector leak detection or dust particle counter leak detection two methods are qualified air conditioning purification system test methods, drug manufacturers can be selected according to specific circumstances.