Pharmaceutical production workshops have strict requirements for air cleanliness. Suspended particles in the air may contaminate pharmaceutical raw materials, semi‑finished products and finished preparations, bringing hidden risks to drug safety. Chinese new‑version GMP specifies both static‑state and dynamic‑state cleanliness‑monitoring requirements for clean areas. Traditional handheld particle‑sampling instruments can only conduct intermittent spot‑check, unable to realize uninterrupted 24‑hour continuous monitoring. Installed online dust‑particle‑counting equipment can collect particle‑concentration data all the time, automatically judge cleanliness grade and trigger alarm for abnormal conditions, which has become important supporting equipment for pharmaceutical clean‑area management. YUNTANG YT‑CA2 online dust particle counter complies with GB/T6167‑2007, JJF1190‑2008, ISO14644 and GMP related specifications.

The instrument adopts imported semiconductor laser diode light source with service‑life longer than 30 000 hours. Optimized optical‑scattering sensor structure effectively suppresses stray light inside cavity and greatly improves signal‑to‑noise ratio. It supports six particle‑size channels simultaneously: 0.3 μm, 0.5 μm, 1.0 μm, 3.0 μm, 5.0 μm, 10.0 μm. Sampling flow rate is 2.83 L/min. The maximum allowable sampling concentration reaches 35 000 particles per liter for particles ≥0.5 μm. According to cleanliness classification standards, the device can automatically evaluate and output cleanliness‑grade results for static‑state and dynamic‑state conditions of clean rooms. Besides particle counting function, it integrates built‑in temperature, humidity and atmospheric‑pressure sensors, synchronously recording clean‑area environmental parameters together with particle data.

The 7‑inch color touch screen based on Android 7.1 system provides friendly man‑machine interaction. It is configured with sound‑light alarm function. Users can set threshold values for each particle‑size channel. When particle quantity exceeds preset limit, sound‑light warning will be activated in time to remind workshop management personnel to take intervention measures. Abundant communication interfaces include USB, Wi‑Fi, LAN and RS485. Monitoring data can be uploaded to cloud management platform through wired or wireless mode, or copied out by U‑disk without driver installation. The local memory can store up to 100 000 groups of monitoring records for historical traceability and quality‑system audit. Sampling modes support timing detection and continuous long‑term detection. Sampling period and delay parameters can be flexibly configured according to actual production‑workshop management requirements.

In practical application inside pharmaceutical preparation workshops, YT‑CA2 online particle counters were installed at key monitoring points such as raw‑material weighing area, filling room and packaging clean area. The equipment keeps long‑term stable online operation. When abnormal particle‑concentration rise occurs caused by personnel entering‑exiting or equipment maintenance, the system gives timely sound‑light alarm and stores complete record sequence. The data can be exported for GMP quality‑management review. Attention should be paid to regular self‑cleaning and periodic calibration for on‑line particle counter. The self‑cleaning time of this instrument is ≤10 minutes, which helps reduce background interference. Apart from pharmaceutical workshops, this equipment can also be applied to semiconductor precision‑manufacturing workshops, food‑processing clean rooms and biological‑engineering laboratories for continuous air‑cleanliness monitoring.