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You get a #483 non-conformance citation from the FDA. You have a very limited time to resolve issues of ferrous particles in sterile areas.
What do you do?
HURST rapid response team of stainless steel experts in seven states is ready to offer immediate assistance. ALL of our ISO certified manufacturing sites feature state-of-the-art Salvagnini laser cutting and forming machinery. Three of our manufacturing sites feature laser TIG welding. Three sites feature electro-polishing and laser engraving.
Our standard first response is an immediate on-site visit
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We assess the condition of your stainless steel vial tray sets and carts. Using profilometers we measure the depth of scratches and ascertain damage.
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We normally recommend that all on-hand stainless steel vial tray sets be sanded
and electro-polished. The FDA may or may not accept this temporary measure.
Vial tray cart tracks are a frequent source of particulate. We normally recommend
track sanding and polishing. Alternately we may replace cart tracks with a unique
low friction patterned stainless steel.
Initial part turn-around time: 3 days after material receipt.
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We robotically manufacture new hardware including vial trays, gates, rings and
covers to exacting requirements. Using certified 316L stainless steel with a 2B two sides initial finish, we produce stainless steel vial tray sets unequalled in quality.
All of our products are electro-polished to produce a 7 RA finish or better.
We laser engrave all hardware to provide base line information in a meaningful
stainless steel maintenance and replacement program. Initial parts delivery: 2 weeks
What is stainless steel?
Stainless steel is an iron based metal which contains low carbon levels and various levels of chromium. When chromium is exposed to air it forms a protective layer of chromium oxide which keeps stainless steel from rusting.
What type of stainless steel should we use?
Type #316L is a stainless steel which contains 2 to 3% molybdenum, a high heat additive. Type #316L is indicated for use in depyrogenating. Type #316L is generally non-corrosive and a best choice when used in contact with distilled water or chlorides.
Why does stainless steel scratch and wear so quickly?
Look what’s in the tray – Glass! Glass hardness averages between 68 and 72 Rockwell ‘C’ scale. 316L is barely on the ‘C’ scale at 17. Because it is four times harder than stainless, glass cuts through stainless steel like the proverbial knife through butter. Scratches of .002” and deeper produce elevated ridges. The ridges are unstable and easily broken off into particles.
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