Question 1

How about after-sales?

Accepted Answer

The whole machine is guaranteed for two years, and the laser is guaranteed for 10 years. Regarding repairs, we are guaranteed to solve the problem within 2 weeks.

Question 2

How does the particle counter meet the data integrity requirements? Does it meet the 21CFR Part 11 requirements?

Accepted Answer

APC has three levels of management authority, audit trail, data storage, and meets the requirements of 21CFR Part 11.

Question 3

Do I need to add an isokinetic sampling head when sampling?

Accepted Answer

1. The cross-sectional area of the isokinetic sampling head of different flow particle counters is different. The larger the flow, the larger the cross-sectional area of the isokinetic sampling head. GMP requires a unidirectional flow velocity of 0.36-0.54m/s. Therefore, when the particle counter is sampling, the flow velocity of the air flow through the isokinetic sampling head needs to be controlled at 0.36-0.54m/s.
2. Sampling in the unidirectional flow area needs to be equipped with an isokinetic sampling head, and it is best to add it in the non-unidirectional flow area.

Question 4

Is the dust particle counter resistant to VHP?

Accepted Answer

The outer surface of the dust particle counter is made of 316L stainless steel, and the surface of the internal sensor chamber is gold-plated, so it can withstand VHP sterilization.

Question 5

How to judge whether the sensor of the dust particle counter is polluted?

Accepted Answer

The zero-clearing filter can be used for self-cleaning test. If it can be cleared, it means that the sensor chamber is not contaminated. Otherwise, it is recommended to contact the manufacturer to investigate the cause. The frequency of replacement of the zero-clearing filter depends on the cleanliness of the environment used by the customer and the frequency of use.

Question 6

How to deal with the annual calibration of the dust particle counter?

Accepted Answer

The dust particle counter is recommended to be calibrated once a year. It can be sent to the Metrology Institute or the manufacturer for calibration. The Metrology Institute's measurement standard is JJF1190, and the manufacturer's measurement standard is ISO21501-4. The content of the two measurement standards is different. ISO14644-2015 clearly stipulates that the particle counter needs to be calibrated, and the measurement standard is ISO21501-4.

APC FAQ