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BS EN ISO 9001 : 2000 REG. No. AJA 02/4327
CLEANROOM PROCESS
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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