Do surface particle analyzers have requirements for the inspection environment? Viscia Technology tells you

Surface particle analyzer is an intelligent precision instrument, many people think that precision instruments need special ambient temperature, in fact, not, the surface particle analyzer in the normal environment can be, according to T / CAMDI 009.
1-2020 sterile medical devices initial packaging cleanliness Part 1: particle pollution test method gas blow off the standard requirements, the planning level of the tester environment is not lower than the production environment of the sample, avoiding the inlet and outlet of the purified environment
.

In addition to surface particle analyzers, most of the medical device testing equipment can be tested in a normal environment, except for some instruments with special regulations
.

Get the instrument and follow the strict operation on the instructions
.

Surface particle analyzer is the sample that needs to be sampled, and then Viscia Technology will talk to you about the sampling.

1.
The batch variety is the same, and the characteristics are the same as the collection of primary packaging and/or primary packaging materials
.

The packaging unit of the batch is specified
according to the product standard.

2.
Sample a rectangular paper, coated paper, film, non-woven materials and coated nonwoven materials and other primary packaging materials or a / bag, cover material, blister box and hard sheet and other primary packaging or a paper-plastic composite coil cut according to the prescribed size, this rectangular sample is taken from the whole / whole / whole volume of primary packaging materials or primary packaging products
.

3.
All samples in the average sample set are average samples
.

4.
The specimen is used for a certain amount of paper, coated paper, film, non-woven materials and coated nonwoven materials and other primary packaging materials or bags, covers, blister boxes and hard sheets and other primary packaging or paper-plastic composite coils that are measured according to the prescribed inspection methods, and the sample is taken from the sample, sometimes it can also be the sample itself or several samples
.

5.
Random sampling should ensure that the sampling method used can make each part of the population have the same chance
of being selected.

6.
The extracted packaging unit shall be extracted in accordance with the relevant regulations, and the packaging unit shall be free of damage and have complete packaging
.

7.
The sampling environment requires that the sample needs to be kept flat, not wrinkled or folded, so as to avoid excessive environmental air flow or humidity fluctuations affecting the migration or change
of the original particles.

The hand can only touch the non-test surface of the sample, and should try to avoid affecting the original particle release state
on the sample.

8.
The marking of the specimen Each specimen should be marked, the marking should be clear, and the front and back sides
should be accurately marked.

9.
Resampling During sampling or testing, if there is an accident, it must be resampled
.

New samples should be taken
according to the method described above.

Unless otherwise indicated, specimens may be taken in the same packing
unit.

10, the sample packaging sample should be packaged immediately, packaging should be double-layer sealed packaging, packaging bag is made of polyethylene or polypropylene material, packaging bag should be prepared under the same environmental requirements as the sample, the actual experiment in the specified environment with the sample preparation sample
.

11.
Sampling of roll film, non-woven materials and coated nonwoven material samples removes all damaged material layers from the outside of the drum, removes a layer in the undamaged part, and cuts a knife along the full width of the drum, and its depth should be able to meet the number of sheets to be sampled, so that the cut film sample is separated from
the film roll.

From each stack of cut paper samples, the same number of paper samples
are taken randomly.

12, bags, lids, blister boxes and hard sheet samples of the sampling sample for the product itself, the surface area of the product is less than the instrument test head continuous test five times requirements, five products for a sample
.

When the surface area of the product is less than the requirement of the instrument test head test once, it is recommended to replace the equipment or use other methods to measure
.

Note 1: The size of the flat part of the inner wall of the blister box should meet the test requirements of the instrument test head, if the inner wall of the blister box has a lot of uplifts and depressions that cannot meet the test requirements, it is recommended to prepare the sample by washing the sample and use the photoresist counter for measurement
.