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Class 10 Packing Room
This area was
designed as a "room within a room" so that
it would be easier to maintain ultra clean
conditions. The room is 100% ULPA filtered
with perforated work benched and seating.
Gloves that passed our specification testing
will be pass in to the packing room. At the
work station the gloves will be weight and
placed into clean poly lined plastic totes.
Each tote will contain 100 gloves by weight.
The totes will be passed down the center of
each bench to packing operators. The packing
operators will flat pack the gloves into 2
stacks of 50 gloves. Both stacks will then
be packed into a clean poly bag. The gloves
will then be passed to the vacuum pack
operator for sealing and labeling.
Class 100 Cleanroom Laboratory
The
laboratory is located in the class 100
holding area. DI water is tapped in from the
DI holding tank. Here we will randomly test
each batch (4 gloves per 6 cases or 6,000
gloves) for particles. We use a PMS particle
counter with software specially written to
analyze gloves. We will follow a modified
IES RP5 test procedure for particle
analysis. We have Dionex DX80 ion
chromatographs...one will be set to test
anions, the other to test cations. We will
randomly test each batch for 13 different
anion and cation extractable ions. This test
takes about 13 minutes.
Test procedures for particles are set in the
computer as a "Pass" or "Fail". If the batch
passes, it will be sent for packing. If it
fails, we will see how far if falls out of
the specification. If it is minimally out of
the specification, we will test another 4-6
gloves. If it is critically out of the
specification, it will be sent back for full
re-processing.
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