Pharmaceutical Hardware
THE MAGAZINE DEVOTED TO NICKEL AND ITS APPLICATIONS
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THE INTERIOR OF A FILTER dryer manufactured in Italy by 3V Cogeim in N06022 nickel alloy.
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SURFACES OF MANUFACTURING equipment which come into contact with pharmaceutical ingredients, such as this
filter dryer at Sepracor Canada's facility in Windsor, N.S., needs to be cleanable.
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THIS FILTER DRYER operates at temperatures ranging from –29°C to 150°C. Mother liquor is forced out under
pressures ranging from 2 to 4.5 bar.
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A high nickel alloy provides corrosion resistance and cleanability in the manufacture of
pharmaceutical drugs By Carroll McCormick
Nickel Magazine, March 2006 -- The global market for pharmaceutical and biotechnology products is very large and growing fast. Estimated to be nearly US$500 billion a year, it is growing at a rate of about 9% a year.
The U.S. market represents about 41% of the total while Europe and Japan account for an additional 39%.
To manufacture pharmaceutical ingredients requires extremely clean working conditions to which nickel-containing alloys play a vital role. Equipment needs to be cleanable on the product side and highly resistant to corrosive ingredients and cleaning solvents.
The alloy most widely used for pharmaceutical equipment is S31603 stainless steel. However, the material of choice for certain pieces of equipment is alloy N06022, which contains 59.5% nickel and is used in components where the surface comes into contact with pharmaceutical ingredients.
One such piece of equipment is used by Sepracor Canada, which manufactures active pharmaceutical ingredients and other drug products at its plant in Windsor, Nova Scotia. Many of these ingredients, once they have been chemically constructed in reaction chambers, are piped to a filter-dryer to separate out the waste liquid and dry the crystallized product.
Italian pharmaceutical equipment manufacturer 3V Cogeim uses large quantities of N06022 in the manufacture of its filter-dryers. In addition to pure N06022 plate, the company uses plate made of 6.35 millimetre (mm)-thick N06022 welded to a 6.35 mm-thick S30400 substrate. "We’re among the biggest users of N06022 in Europe," says Peter Studer, 3V’s business manager for North America. "We use N06022 in 80 to 90 percent of our filter-dryers." The company sells around 50 of these units a year.
Sepracor’s 3V Cogeim filter-dryer has two primary components: a cylindrical vessel with a filter screen near the bottom, through which "mother liquor" (the waste liquid part of the slurry piped over from the reaction chambers) is filtered out, and an agitator above the filter screen to stir and smooth the wet cake containing the product crystal.
The mother liquor is forced out under pressures ranging from 2 to 4.5 bar; then the cake is washed with solvents to remove impurities, and the vessel is put under high vacuum to remove residual solvents.
The filter-dryer operates at temperatures ranging from –29°C to 150°C.
Sepracor’s vessel has a working volume of 660 litres. The wet cake volume (the volume under the agitator paddle at its highest point) is 150 litres. The vessel is 1,830 mm high from the bottom flange to the top flange of the agitator, where it exits the vessel’s domed head. The outside diameter of the vessel, including insulation and pipes, is 1,124 mm; the vessel’s inside diameter, 900 mm; and its interior height, 1,025 mm.
Larger and less complex components, such as the vessel walls and large flanges, are formed from the N06022/S30400 plate and welded with N06022 consumables. This two-alloy stock exploits the corrosion-resistance of the N06022 and the low cost and corrosion-resistance of S30400 during washing.
3V Cogeim uses pure N06022 to fabricate small or complex components, such as the 0.6-metre-square filter screen and the agitator paddles, which contain heating pipes. Protecting the S30400 agitator shaft is a N06022 bellows that expands and contracts as the shaft raises and lowers the agitator at a maximum speed of about one centimetre every 15 seconds. A N06022 mechanical seal is used where the agitator exits the cylinder head.
Many exterior components of the filter-dryer are made of S30400 for complete washability, including the three support legs, the stainless mesh protecting the hydraulic hoses, and the filter canister.
Carroll McCormick is a Montreal-based freelance writer.
PHOTOS: Carroll McCormick for Nickel Magazine
3V Cogeim S.p.a. |
