Understanding Pharmaceutical Welding Standards

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Pharmaceutical manufacturing plant practicing pharmaceutical welding standards

Advances in health care treatment over the past half-century are nothing short of amazing. We have eradicated diseases like polio from most of the world—once one of the most debilitating maladies. And the number of overall deaths from cancer continues to decline. Many people, including research and development (R&D) professionals and medical practitioners, are responsible for these accomplishments. However, innovative medical devices and increasingly more effective pharmaceuticals have also been instrumental. 

Our reliance on pharmaceuticals for daily health regimens—as well as life preservation and extension—requires production at large factories that must be able to efficiently and safely store, process, and distribute large volumes of fluids, capsules, and tablets. The primary consideration when manufacturing these products is safety: both for consumers and facility personnel. In addition to pressure vessels, pharmaceutical production systems are comprised of sanitary tubes and piping that must satisfy pharmaceutical welding standards to meet consumer and worker protection requirements. 

The Pharmaceutical Welding Standards You Need To Know

Processing system construction for a pharmaceutical plant is a high-spec welding project that may require adherence to many regulations and standards from various bodies, including the following.

STANDARDS THAT IMPACT PHARMACEUTICAL WELDING
Standard Organizations What is Covered
American Petroleum Institute (API) Pressure valve requirements. 
American Society of Testing and Materials (ASTM) Piping requirements, in-line component, gasket, etc.
American Society of Mechanical Engineers (ASME) – Bioprocessing Equipment (BPE) Design, fabrication, installation, cleaning-in-place (CIP) and sterilization-in-place (SIP) design, orbital weld, documentation, and legal requirements.
American Welding Society (AWS) Piping and weld standards, including cleanliness, corrosion, materials, quality, etc.
American Water Works Association (AWWA) Wastewater, stormwater, and sewer piping requirements.
FDA Good Manufacturing  Practice (CGMP) Regulations  Quality manufacturing process requirements.
Manufacturers Standards Society (MSS) Standards for piping supports.
OSHA Requirements for worker safety.

Although the above list is not exhaustive, it does demonstrate the range of essential regulatory oversight that manufacturers must consider for high-spec assembly projects such as production facilities for consumables like pharmaceuticals. From these, we can specify which pharmaceutical welding standards you should be very familiar with, as they are critically important for end-user and employee safety.

PHARMACEUTICAL WELDING STANDARDS FOR SAFETY

Consumer Safety Standards

  • AWS D 18.1 Specification for Welding of Austenitic Stainless Steel Tube and Pipe Systems in Sanitary (Hygienic) Applications
  • AWS D 18.2 GUIDE TO WELD DISCOLORATION LEVELS ON INSIDE OF AUSTENITIC STAINLESS STEEL TUBE
  • AWS D 18.3 Specification for Welding of Tanks, Vessels, and Other Equipment in Sanitary (Hygienic) Applications

Worker Safety Standards

The standards listed above directly target the safety of piping system assemblies for consumers and workers by providing rules and guidelines for weld quality that ensure the integrity of systems to prevent wear, deformation, cracks, breakages, and other hazardous contingencies. To ensure that these requirements are met, the best welding process should be implemented.

Pharmaceutical Standards Compliance With Orbital Welding

Reliable welds are an objective for any piping system. However, for systems where failure can be hazardous to workers and consumers, reliability is a mandate. Therefore, these hygienic piping systems require the best welding process. 

The most reliable, high-quality welding process is orbital TIG welding due to the consistency of the automated process, provided manufacturers employ proper welding parameters and a preventive maintenance schedule. If these criteria are met, the following advantages of GTAW orbital welding can help you meet the pharmaceutical welding standards for your project.

Why Orbital TIG Welding for Pharmaceutical Systems? 

Preferred process for austenitic stainless steel

Austenitic stainless steel is preferable for sanitary piping systems due to its high corrosion resistance. The capability to view and control the orbital TIG welding process enhances the operator’s ability to create strong, resilient, corrosion-free welds that enhance the system’s resistance to breakdown due to corrosion. As a result, an orbital TIG welding process can provide effective protection against product contamination.

Automation ensures consistent, high-quality welds

One of the most challenging aspects of welding, especially in tight spaces with little or no ventilation, is maintaining a consistent weld profile while making the necessary arc angle, feeder speed, and other adjustments throughout a weld. Orbital welding removes these environmental challenges, resulting in strong welds with the least possibility of breach and threat to workers.

Remote operation protects welders from toxic fumes

Perhaps the greatest danger for welders when working on sanitary piping systems is toxicity from chromium-based stainless steel. Orbital welding removes this hazard by allowing the welder to control the process at a safe distance from the weld puddle and immediate atmosphere. 

Meeting the requirements of pharmaceutical welding standards is critical. A well-managed orbital welding system that includes the best equipment and maintenance schedule is the most effective means of meeting these mandates. 

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Arc Machines, Inc. is an industry leader in supplying advanced and high-quality welding equipment and service, including orbital weld heads, welding machines, materials, and the expertise to aid you in meeting the requirements of pharmaceutical welding   standards. For inquiries regarding products, contact sales@arcmachines.com. For service inquiries, contact service@arcmachines.com. Arc Machines welcomes the opportunity to discuss your specific needs. Contact us to arrange a meeting.