Nelipak has 12 cleanrooms, all of which meet ISO 14644 Class 7. This is equivalent to U.S. Federal Standard Class 10,000. The number of particles of 0.5 µ is limited to 10,000 per cubic foot. The raw materials are prepared in an adjacent Class 8 room and then transported under controlled conditions to the Class 7 cleanroom. Nelipak has six independent air handling plants. This helps to prevent interruption of the operations. The cleanrooms operate around the clock and are monitored according to the relevant procedures. The average over the past 11 years was less than 1000 particles smaller than 0.5 µ per cubic foot of air. This underlines Nelipak's excellent performance.
Nelipak is a specialist and leader in the use of cleanrooms in the European packaging industry. Practically all the production operations in the cleanrooms are carried out by robots. Manual operations are minimised. Nelipak guarantees that 100% of the sealed blisters will be leakproof. The medical packaging produced in these cleanrooms is at least double-bagged in PE bags and identified by unique labels. Each cleanroom has its own label printer. The label on the packaging specifies the cleanroom where it was produced, and other relevant details. These products are usually boxed outside the cleanroom. Each box has a unique number to ensure traceability. This system means that traceability is ensured down to the lowest level.
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