GSK Biologicals Belgium required hygienic door solutions for their new manufacturing plant. Solution Dortek supplied hygienic fire rated hinged and sliding doors throughout the facility. The doors unique smooth, hygienic and non absorbent properties make them ideal for pharmaceutical facilities. Dortek have supplied multiple projects across both Wavre and Rixensart sites.
Orbital welding operators installing a stainless steel piping system in a pharmaceutical plant in the UK. Photo courtesy of A.
Services The capability of making a smooth, crevice-free inner weld bead on a repeatable basis, has led, over the past decade, to orbital welding becoming the preferred joining technology for biopharmaceutical process piping.
The expanding biopharmaceutical industry in the USA has placed Fast track pharmaceutical facilities increasing emphasis on quality standards and documentation in order to expedite the approval process for new therapeutic products by the FDA United States Food and Drug Administration.
The approval process requires that the facility in which a new drug is produced must be designed, constructed and commissioned so that it meets the criteria for process validation. Failure to achieve validation on the first attempt can be very costly to the facility owner, so maintaining quality from the design phase throughout the construction process is essential.
The quality inherent in orbital welding joining technology is consistent with the goals of the CGMP Current Good Manufacturing Practices for achieving hygienic pharmaceutical piping Fast track pharmaceutical facilities that will have no adverse affect on the products that pass through them.
It should be noted that a code is required by law, while a standard provides generally accepted industry practices. Welding is an important aspect of piping system design and fabrication.
Inrepresentatives of the emerging bioprocess industry came together with the realisation that existing standards did not adequately meet the need for design and construction of equipment to be used in critical bioprocess piping systems.
A consensus was reached on the need for equipment design that would be both cleanable and sterilizable. Special emphasis was placed on the quality of weld surfaces once the required strength was present.
Stainless steel piping system installed with orbital welding at a UK pharmaceutical installation. Tank bottoms and piping are sloped for drainability.
Orbital welding is ideal for this application, as shown on this orbital weld of a short sanitary ferrule to a pulled tee. This requires that a Q. To meet this requirement sample welds are subjected to bend tests to verify weld ductility, and tensile testing is done to assure that welds meet the minimum tensile strength specified for the base material.
Welder tests require six linear inches of weld or multiple coupons, but not more than four. Weld and inspection criteria for this category are more stringent than for normal fluid service.
Clearly, orbitally welded stainless steel meets these criteria. A deadleg is defined as a pocket, tee, or extension from a primary piping run that exceeds a defined number of pipe diameters from the I.
Deadlegs are undesirable because they are difficult to clean and maintain in a sterile condition and may represent an unacceptable bioburden to the system. Where they exist, they should be designed so that it is possible to flush through them. Intelligent use of orbital welding Figure 4.
Note lack of penetration, misalignment, discoloration, crevices and protruding material on the product contact surface. Note uniform, even, fully penetrated weld bead and essentially flat weld profile with no concavity or convexity.
Parts are well-aligned and the weld has minimal discoloration of the HAZ, meeting most biopharmaceutical specifications. The intelligent use of orbital welding technology can help to keep deadlegs to the required minimum.
Some orbital weld heads have provisions for locating the tungsten electrode close to the edge of the head to accommodate parts with short "stick-outs" such as welding short sanitary ferrules to stubs on transfer panels or to pulled tees, as shown in Figure 3. Narrow weld heads are now in use with reduced axial clearances that make it possible to orbitally weld fittings-to-fittings that could not be welded with standard weld heads.
For areas with limited radial clearances it is important to use a weld head that is as small as possible for the tubing being welded.
Contractors tent to use a single weld head to accommodate all sizes from 1 inch to 4 inches, which is practical for most situations. However, some of the joints on smaller tube sizes that have inadequate radial clearance for a large weld head might be accessible with a smaller weld head.
In designing piping systems, allowances should be made to allow for placement of orbital weld heads and eliminate insofar as possible the need for manual welds. The intent is to document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices and to avoid unnecessary spending on facility features that have no impact on product quality.
Water and Steam Guide recommends the use of orbital welding for the installation of pharmaceutical water systems, citing the smooth inner weld bead. A smooth internal surface finish of the piping system, including the welds, is important for controlling the buildup of biofilm that could contaminate the product.
Welds must be fully penetrated with good alignment, with a flat OD and ID profile. An unpenetrated weld has a crevice which may not be reached by CIP cleaning and becomes a refuge for bacteria. Discoloration of the weld Any discoloration of the weld or HAZ as a result of oxidation during welding must be held to a minimum.
Discoloration has been shown to be proportional to the amount of oxygen and moisture in the ID purge gas which is usually argon.
A cryogenic source dewar or bulk gas supply is recommended for urging during welding of high purity pharmaceutical water systems.GREENVILLE, N.C. – Metrics Inc. is making significant investments in its facilities and equipment for the benefit of contract services clients by opening a new laboratory to better support fast-track development of pharmaceutical products.
Rank Company Location Year end 2-yr av intl sales growth pa Intl sales £s Total sales £s Staff; 1: Lincoln & York Coffee manufacturer: Lincolnshire: Jan %: 7, 32, Pharmaceutical Industry Benchmarking Group. The Pharmaceutical Industry Benchmarking Group (PIBG™) is an association of pharmaceutical companies that conducts benchmarking studies to identify the practices that improve the overall operations of its members.
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pharmaceutics, pharmaceutical chemistry and biopharmaceutics. Pharmaceutical formulation may therefore be correctly viewed as an essential and unique component of the pharmaceutical sciences and, accordingly, the Pharmacy undergraduate degree. Due to the interdisciplinary nature.