尘埃粒子监测常见问题|制药环境监控 - 维远化工论坛

只看楼主更多操作楼主发表于: 2010-12-24

Each week we receive several phone calls and emails from individuals asking a variety of questi***** related to particle counter monitoring systems.  Many people looking for particle counter monitoring systems for their cleanroom procedures seem overwhelmed by all of the variables involved in particle counting to meet ISO Cleanroom Standards.  You have chosen your particle counter and now you need to determine the best monitoring system for your particular application.  Hopefully the questi***** from our customers listed below are some of the same questi***** you need to have answered.

What is a Facility Monitoring System?

Facility Monitoring Systems (FMS) are used to allow all of your particle counters, manifolds, sensors, samples and other assessment equipment to communicate with each other within a central monitoring system.  This process allows you to collect and analyze the particle data.  This allows you to correlate the particle counts with acti***** like a filter failure or an open door.  Facility Monitoring Systems are typically used in cleanrooms and associated areas.  Although a FMS cannot be used to classify an area, they perform a monitoring function to provide evidence that an area’s environmental conditi***** have been maintained within the required specificati*****.  The FDA and other regulatory agencies accept that if you’re using a Facility Monitoring System, the period of reclassification can be extended (ISO 14644-2).

How do I determine how many particle counters or monitoring locati***** I need?
This can be calculated by determining the square root of the square meters of the room you’re monitoring.  An example would be a room that is 25 square meters.  Square root (25) (square meters) = 5M² or 5 monitoring points.  Always round up.

How can I collect particles in one area and count them in another area?
This can be done by using a tube or duct.  You should remember that 2 things happen when a sample medium is conducted from the sampling area to the particle counter by tubing: 1) you will experience some loss of pressure; 2) some particles will adhere to the tubing.

How can I avoid particle dropout?
The rule of thumb for this is "the shorter the sampling tube, the more accurate the reading".  Ideally, if you’re using .1 CFM, don’t allow the sampling tube to be longer than 2 feet.  With 1 CFM, you can go up to 10 feet, but it is better to keep it between 3-4 feet.

Does size matter?
Particle size, yes, depending on your particular application, particle size range may be important because they may cause specific types of damage during your process.

What is the difference between Real Time particle monitoring and Sequential particle monitoring?
Using Real Time particle monitoring involves placing a single cleanroom particle counter or particle sensor at a specific location in your cleanroom.  The sensor is committed to monitor particles only at a designated location, where every event is detected and counted.  There are no gaps in the particle counting data and particles are monitored in particles per cubic foot or per cubic meter.  The Real Time system is well suited for use at critical locati***** where sensitive processes can be adequately monitored.  You can use a stand alone particle counter that is a dedicated counter with a built-in vacuum pump.  Another option is a remote particle counter.  This instrument has no display; a process vacuum is provided for sampling or you can use a separate pump dedicated to particle counting.

Sequential Particle Monitoring is also referred to as Pneumatically Multiplexed Particle Counting or a Manifold Monitoring System.  This system involves using a single particle counter to monitor multiple points.  This can be accomplished by adding a Sequential Manifold Sampler that connects the particle counter to different sampling tubes.  Each individual tube is sampled in sequential order; when a tube is sampled, the manifold moves to the next tube to be sampled.

During this tube change, the particle counter stops counting particles until the change is complete, then it delays to allow any air from the prior sample to be purged.  A blower continuously pulls air through all the sample tubes, avoiding any "air hammering" that may free particles in the sample tubing from the start and stop of the air flow.  The frequency of each sample is determined by the number of monitoring points.  In a typical application, each location is sampled for 60 seconds then purged for 10 seconds as the sampling arm moves to the next location.

What things should I c*****ider when determining what type of monitoring system to use?

The number of points you want to monitor
The size of the particles that need monitoring – between .5-5 micron
How critical the location is in your process
Product volume at your monitoring location
Amount in your budget
What are you going to do with the particle counter monitoring system data?  (interface?, pulse out?, MODBUS?).
What are the advantages of Real Time particle monitoring?

Excellent for sensitive monitoring at lower detection limits > 0.1 micron
Provides continuous detection of all particle events
Works well for equipment monitoring for failure and preventative maintenance at higher detection limits > 0.2 micron
Provides immediate notification of yield destroying particle excursi*****
Allows for emergency reaction to particle events
Provides immediate feedback after shut down to verify of the area is in spec
What are the advantages of Sequential (Manifold) particle monitoring?

Central location of the particle counter offers easier service
Fewer particle counters can be used to cover a specific area
Low calibration costs
No need to correlate data between particle counters