Cleanroom Manufacturing

100% focused on Healthcare, Nelipak produce Sterile Barrier packaging manufactured to ISO:13485 standards in ISO class 8 cleanrooms across our operations.

A leader in the design, development and manufacture of medical and pharmaceutical packaging, Nelipak supplies products manufactured to exacting specifications under cleanroom conditions. Our cleanrooms are accredited to ISO 14644 with the majority to class 8 standard (Class 100,000).

In-house tool production ensures precision thermoformed parts are manufactured to exacting tolerances. Statistical process control for temperature, cycle time and pressure is achieved through computer control on each thermoformer providing traceability and repeatability of all formed components.

Double wrapped raw material ships to production suites where in-line cleaning systems remove residual particulate prior to forming. Precision cutting tools eliminate angel hair presenting trays and blisters which are glove and pouch friendly. Practically all the production operations in the cleanrooms are carried out by robots, to minimize manual intervention.
In line inspection and data recording provides documented evidence product conforms to agreed tolerances and checks.

Machines and ISO class 8 cleanrooms are duplicated across regions to ensure we can always supply and that tool transfers and revalidations are as quick and easy as possible.

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