STANDARD OPERATING PROCEDURE Title: Sterile Area Particle Counting

1. Scope

It is established to provide guideline for the use of particle counter.

2. Purpose

It is applicable for counting of particles in sterile area

3. Responsibilities

1. Manager Q.C
2. Microbiologist.

4. Procedure

Personal entering in sterile area should wear first sterilized uniform goggles, surgical gloves and wipe off equipment before caring in sterile area.

1. Press blue colour on/off button on right side of the instrument.
2. Main menu shows table having different particle size e “zero values”
3. Set main statistics sampling set up icons for specific location, as during the statistical certification process.
Process we will move the unit to different locations for sampling. The (LASAIR ll) particle counter allow us to choose one of the two following option for identifying different locations.
1. Auto incrementing names/numbers.
2. Manual user selection of the location name or number and our choice of numbering method will determine the setting. We must made in statistical set up page.
3. To edit the statistics set up main screen press the enter button to enable the edit mode.
4. Use the Tab forward / Tab backward keys to move to the desired location, select the particle size, type of flow (unidirectional or multidirectional), Purge time, area/volume (sample vol can not be changed while the statistics mode is enabled)
5. First when we have set up the (lasair ii) for sampling, operation is a simple matter.
6. Press the green button on the control panel after fixed the sampler in sample prob for purging and sampling in particular area.
7. After a purge the unit will begin sampling and the results of sampling can be observed on the main display. When the sampling is complete the pump will stop.
When all samples are complete the dialog box with following comments”statistics sampling is complete” will appear.
8. Take print out of results through statistics “print icon soft keys” and compare with following different class limits.


Classes 0.1 0.2 0.3 0.4 1.0 5.0
1 10
2
2 100
24 10 4
3 1000
237 102 35 8
4 10,000
2370 1020 352 83

5. Precaution:

1. Keep close sampler prob after use.
2. Never wipe the display screen with anything that is hard or sharp

6. Cleaning:

For cleaning purpose tested cleaning chemicals which can be use are.

1. 50—90% sol of IPA in deionized H2O
2. 30% Amonia sol can also be use
3. Ethyl alcohol in a sol of <50%