New "cut weapon" for clean compressed air microbial detection - fully automatic compressed air microbial sampler

With the continuous upgrading of pharmaceutical production technology, clean compressed air as a process source gas is more and more widely used in all walks of life in society. In addition to pharmaceutical manufacturing, clean compressed air is also widely used in food processing industries such as beer brewing. Due to direct contact with raw materials or inner packaging materials, the microbial limit of compressed air source is an important factor that directly affects product quality. Article 25 of the "Good Manufacturing Practices" (GMP) clearly states that "dry air, compressed air and inert gas in direct contact with pharmaceuticals should be purified and meet production requirements", but until now, at home and abroad There is no unified legal pharmaceutical-grade compressed air quality standard, and various enterprise standards and preparation techniques are uneven, which seriously affects the quality of drugs.

Since the application of compressed air to production, there are generally three methods for microbial detection :

Plate contact method

This method is a more traditional, original detection method. After the gas sampling port is sterilized, the gas flow rate is adjusted, the plate is placed under the sampling port, the plate medium is exposed to the gas stream for 2 minutes, and the plate is placed in a 37 ° C incubator for two days, and the colony count is performed.

2. Water absorption method

200 ml of 0.85% physiological saline was placed in a sample bottle and sterilized for use. The sampling port is sterilized and the gas flow rate is adjusted. The hose above the sampling bottle is connected, and the gas enters 0.85% physiological saline through the catheter. The microorganisms in the gas are dissolved in 0.85% physiological saline, and the washed air passes through the exhaust. The mouth was drained for 2 minutes, and after two days of incubation in a 37 ° C incubator, colony counts were performed.

3. Gas microbial sampler method

That is, the compressed air sampler is used to detect the microbial gas in the compressed air. The main reference of the compressed air sampler method is "ISO 8573-7 Compressed Air Standard". As mentioned in the slit sampler (ie, an embedded air tester) , air impinges on the plate through the air inlet and drops to the plate medium, recording the time the agar medium is exposed to the compressed air. (As shown below)

Note:

1 air inlet

2 Rotate the petri dish with agar

3 gas outlet

4 gas

Comparison of the advantages and disadvantages of the three methods

The plate contact method is simple and easy, but it has a large environmental impact factor, especially in humid and high temperature environments where bacteria are easy to breed. During the blowing process, there is no strong convection formed by decompression and ambient air, which affects the authenticity of the detection effect.

The water absorption method is more complicated in its preliminary preparation work, and the requirements for equipment must be specially made; the gas flow rate adjustment is unstable during sampling, and not all microorganisms are trapped in water, and the experimental results are insufficient to reflect the concentration of microorganisms in the compressed air.

The slit sampler sampling method has obvious advantages over the previous two methods. The compressed gas is depressurized and does not form convection with the external environment. Moreover, the culture dish is placed inside the instrument, and the external environment has less influence. However, it also has a significant disadvantage. The exposure method of the rotating petri dish is different because the angular velocity of the circumferential part of the culture dish and the center of the circle is large, so the exposure time of the center of the culture dish is longer than that of the circumferential part, resulting in The colony count is: the microbial colonies in the center of the circle will coincide.

How to solve the shortage of the slit sampler and obtain a more effective and accurate count of the total number of colonies?

In view of the shortcomings of the slit sampler, Guangdong Huankai Microbiology Technology Co., Ltd. has developed a new generation of pinhole compressed air microbial sampler. The Anderson impact principle is adopted, and after the compressed air is subjected to the pressure reduction and current limiting treatment, the microorganisms in the air flow collide to support the surface of the agar medium in the culture dish.

Unlike the slit-type compressed air microbial sampler, the ring-shaped CG100A compressed air microbial sampler adopts a porous sampling design, and the compressed air is pressure-reduced and uniformly distributed , and the microbe impacts on the plate medium, and the slit sampling The problem of uneven distribution of microorganisms was solved; and Feller's calibration showed that the larger the number of openings, the closer the number of colonies on the plate to the actual content of microorganisms in the compressed air.

In addition, thanks to the development of modern electronics, computer and communication technology, Huankai CG100A realizes automation of operation, and automatically sets sampling after setting parameters such as sampling volume and sampling speed.

Compressed air microbial sampler sampling head cover

At present, the ring CG100A compressed air microbial sampler is used to detect microorganisms in compressed gas; it can be widely used in the detection of compressed air in food, beverage, pharmaceutical and hospital industries.

principle:

The fully automatic compressed air microbial sampler CG100A is based on the Anderson impact principle. After the compressed gas is subjected to the pressure reduction and restriction treatment, the microorganisms in the gas stream collide with the surface of the agar medium attached to the culture dish. After the sampling is completed, the culture dish is transferred to an incubator for cultivation, and then the total number of colonies is determined.

Features:

1.Automatic design: the equipment is easy to operate and the operation is automated. After the sampling volume is set, the sampling can be stopped automatically.

2. Built-in airflow and pressure sensor: Detecting compressed gas pressure range between 0-1MPa, can easily achieve stable airflow speed, ie conventional 100 L/min and high flow rate 200 L/min, optimize impact speed and make false positive The results are controlled to ensure microbial collection efficiency;

3. The operation interface is friendly and intuitive: Chinese and English display menu, large screen LCD display sampling amount, set sampling location code, language (Chinese, English), date and other parameters, touch keyboard and easy to understand operation interface;

4. Efficient open system: no need to buy special test paper plates or filter paper;

5. Porous sampling head design: It can effectively reduce the possibility of dust and dust overlap during sampling and reduce the microbial counting error.

6. Strong traceability: Each sample is automatically generated and stored in the sampler after each sample run. It can store up to 8000 pages of data, and can quickly query the sample record: time, location, sample size and other parameters.

7. Long use time: It adopts large-capacity rechargeable lithium battery pack, no capacity memory effect, safe and durable; it can run continuously for 24h.

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