Importance and Methods of Cleanroom Testing

A cleanroom is a special place where the cleanliness of the air meets prescribed standards and is widely used in medical, pharmaceutical, food processing, and other fields. In a cleanroom, the number of airborne particles and microorganisms is strictly controlled to ensure that the production environment meets the relevant standards. Therefore, it is essential that cleanrooms are tested on a regular basis.

Cleanroom testing primarily involves instruments such as dust particle counters, planktonic bacteria samplers, and sediment bacteria samplers. These instruments can detect the number of particles in the air, planktonic bacteria, settled bacteria and other indicators to assess the cleanliness and hygiene of the cleanroom.

Dust particle counter is one of the important instruments for cleanroom testing. It evaluates the cleanliness of a cleanroom by sampling airborne particles and counting their number. The models and functions of particle counters vary according to different applications and regulatory requirements. Common models include light scattering type, laser type, and condensation type.

Plankton samplers are used to detect airborne microorganisms. It does this by collecting airborne planktonic bacteria and placing them on a culture medium for subsequent microbial analysis. There are many types of bacterioplankton samplers, including impaction, centrifugal, and filtration types.

When conducting cleanroom testing, the following points must be considered: first, select testing instruments that comply with national or industry standards to ensure the accuracy and reliability of test results; second, operate and maintain the instruments correctly according to the instrument manuals to prolong their service life; and finally, analyze and evaluate the test results to find and solve the problems in the cleanroom in a timely manner to ensure that the cleanliness and hygiene of the production environment meets the standard requirements.

In conclusion, cleanroom testing is of great importance to ensure the safety of the production environment in medical, pharmaceutical, food processing and other industries. Through regular use of proper cleanroom testing instruments and methods, the hygienic condition of the production environment can be effectively monitored, and potential problems can be detected and resolved in time to ensure product quality and safety.

Product Recommendation

FKC-III Microbial Air Sampler is a porous inhalation type dust bacteria sampler, which adopts the principle of isotonic sampling, sampling is direct, and the wind speed of the sampling port is basically the same as the wind speed in the cleanroom, which can reflect the microbial concentration in the cleanroom more accurately.

When sampling, the air with dust bacteria passes through the micropores of the sampling head mouth at high speed, and is uniformly impacted on the agar.

When sampling, the air containing dust bacteria passes through the micropores of the sampling head mouth at high speed and is uniformly impacted on the agar surface inside the Petri dish; these living microorganisms receive complete and uniform nutrition on the agar surface, and in the process of cultivation, the dynamic rehydration process occurs rapidly and grows at high speed, so that the results can be obtained faster.

Relevant standards

GMP (Good Manufacturing Practice of Medical Products)

ISO 14698-1/2 Cleanrooms and associated controlled environments

Biocontamination control

GB/T 16293-2010 Test method for airborne microbe in cleanroom(zone) of the pharmaceutical industry