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February 11, 2016

High Purity Vacuum Chamber (20Ra Finish per SDSR-52230) for Pharma/Biotech Applications

by LACO Technologies
High Purity Vacuum Chamber (20Ra Finish per SDSR-52230) for Pharma and Biotech Applications

A manufacturer of ingredients for global pharmaceutical and biotechnology clients offering therapeutics used in the treatment of cancer, kidney disease, cardio-vascular disease, multiple sclerosis, and many other serious diseases came to LACO Technologies seeking a vacuum technology solution.

They required a high purity vacuum chamber with a 20Ra finish per SDSR-52230, rated for use in the pharmaceutical industry. The Ra value of a surface reflects the average height or irregularities on a surface from a mean line. The lower the Ra, the smoother the surface. Smooth, crevice and pit free surfaces are essential to ensure there are not entrapment areas where product can build up and grow contaminants. Entrapment areas can be difficult to clean, allowing bacteria to accumulate. This is obviously undesirable in high purity applications. 32 Ra has been the standard sanitary surface finish for the high purity industry. With the advent of stricter regulation of the pharmaceutical and biotechnology markets, increasingly smoother surfaces are being required. Now, process equipment used in a pharmaceutical application will generally need to comply with ASME BPE standards that dictate a maximum surface roughness of 20 Ra or better.

Pharmaceutical and Biotech Applications

LACO was able to meet the challenging surface finish demands of the customer by producing the high purity vacuum chamber they required for their pharmaceutical vacuum drying process.

In accordance with the manufacturer’s requirements, the vacuum chamber was constructed from 316L stainless steel with a 20” cube-shaped design. The chamber was also built with two sanitary ports (vacuum and venting), one NPT port with a five psig 316 stainless steel pressure relief valve installed, and two ISO 100 borosilicate glass viewports. To optimize the internal usable space, two shelves were installed.

In order to produce the high purity chamber the customer required, we implemented various manufacturing methods. We carried out the following welds: full penetration (vacuum), smooth and flush (external), and smooth (internal). We gave the chamber a 20Ra finish on the inside and the outside. It was then helium leak tested to the 10^-8 atm.cc/sec range and given an operating pressure range of 5 psig down to 10^-6 Torr.

LACO High Purity Vacuum Chamber for Pharma and Biotech Applications

LACO engineers a broad range of standard and custom vacuum chambers for an array of vacuum processes including, but not limited to: Vacuum Coating, Brazing, Package Testing, Leak Testing, Drying, Space Simulation, and Vacuum Degassing.

Contact us to learn more about our capabilities or to discuss your specific vacuum chamber needs. We look forward to hearing from you!

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