Pipe systems are conduits for liquids, gases and solid substances all through industrial plants, with the primary purpose of carrying raw materials, finished products and other utilities like steam, water or cleaning fluids from one place to another. Used across industries, sanitary and otherwise, they are generally considered to be a comprehensive, interconnected network including all pipes and associated components like connectors, pumps, valves and a lot more.
What is the role of pharmaceutical process piping?
You may have equipped your pharmaceutical or biotech facility with the most cutting-edge tanks and machines but without high quality pharmaceutical process piping, all of those expensive CAPEX investments are worthless. After all, your APIs and excipients are only worthwhile when they are carried through the complex network of your plant in the process of preparing your final product.
Pharmaceutical piping is critical to your manufacturing plant’s operations. While similar to process piping in other industries, pharmaceutical process piping has its own set of functions and design and engineering specifications. In terms of sanitation and quality, pharmaceutical piping has extremely stringent requirements. And then there are also tremendous gains in efficiency that good pharmaceutical piping design can give you. In a world where your competitors are neck and neck with you to bring the next big drug to the market, it’s always smart to invest in the highest quality infrastructure so that you can compete with them on more than just price.
Why is having quality process piping so critical?
Process piping in pharma and biotech is extremely critical to ensure products move from one place to another safely, quickly and efficiently. Not just because of stringent pharmaceutical piping specifications, but also because this extensive network interacts with so many elements in your manufacturing process.
Pharmaceutical process piping comes in contact with raw materials and final products, so you want to make sure it doesn’t pose any contamination risks or affect the integrity of your end product in any other way. In order to maintain this high level of sterility, the multiple bends and curves in your pipes of various diameters need thorough cleaning at regular intervals to make sure residue from previous production batches, cell debris, cleaning agents or any other substance are cleared.
Just as the case is with process vessels and machines, your pharmaceutical piping must also be designed to withstand fairly high temperatures and pressures. Plus, the risk of corrosion from pipe materials must be eliminated. As must any other potential unforeseen blockages – something the video boroscopes in TSA process piping systems help you monitor regularly.
Sanitary standards in pharma are exceedingly high, as they should be. So we’re sure you don’t want to compromise on any of the above factors, do you? But then, additionally, you also want to optimise your pharmaceutical piping design for process efficiency. Poor pharmaceutical piping design can have extreme consequences, but carefully considered piping has the potential to radically enhance the productivity of your plant.
Your pharmaceutical process piping can be designed with care, with precision, in such a way that minimises waste and cycle times, maximises throughput and yield, and ensures repeatability and reliability. In short, your pharmaceutical piping can be customised to optimise the flow of people, materials and information.
Pharmaceutical piping specifications
As with all other aspects of pharmaceutical production, pharmaceutical process piping also has its fair share of regulatory standards and specifications to comply with. For starters, irrespective of the country in which you are producing or installing your process piping, complete qualification and validation is a non-negotiable.
Pharmaceutical piping specifications also include complete QA/QC procedures which are well-defined and approved by third parties. Finally, internationally recognised standards, like current Good Manufacturing Practices (cGMP), American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) standards, and 3-A give your customers the confidence that your piping can serve their needs in the best way possible.
At TSA, all process piping complies with cGMP, 3-A, and ASME-BPE standards.
Pharmaceutical piping design
Considering the scale of pharmaceutical piping, building the entire piping network in your plant is an expensive affair, second only to your investment in sophisticated equipment. This is why you want to make sure that even before you begin to install piping, you have a solid design which will assure you of quality, safety and efficiency.
Every pharmaceutical process piping system is uniquely tailored to its application and site. Given the highly specific nature of each piping system, there are some important things to consider while in the design process:
- Limitations and opportunities in the physical space
- Access for maintenance
- Integrated CIP and SIP functionalities
- Drainage points
- Temperature of the substances being transported
- Pressure at which the liquid or gaseous substance flows through the piping system
- Viscosity of the products being transported
- Product’s corrosiveness
- Desired flow rate
Properly designed and engineered systems are not just a boon, but a necessity in the pharma and biotech industries. They allow manufacturers to produce consistent, high quality pharmaceutical preparations. This is all the more reason to ensure your process piping is a good investment.
This involves a stress analysis – governed by international regulatory agencies – in the design phase to make sure that the pharmaceutical piping, loads and supports are appropriately placed so that you don’t shoot over allowable pipe stress under diverse conditions like pressure testing and operating loads.
Other things to keep in mind about your pharmaceutical piping
There are a few other things to keep in mind about the importance of the role of pharmaceutical process piping to ensure efficiency in your manufacturing plant:
- Weather and climatic conditions
The external environment naturally has an effect on pharmaceutical piping systems’ performance. A pipe transporting fluids heated to extremely high temperatures in a location with a cold climate risks bursting or fracturing. Meanwhile, transporting cold substances in pipes during hot weather can have adverse impacts on the piping system’s strength. Some of the factors mentioned below will address this concern.
All pharmaceutical process piping must be fully cleanable, sterilisable and drainable. It cannot afford to have any dead legs. Surfaces, especially the inside ones which come into contact with raw materials and final products, must be electropolished and comply with industry standards. At TSA, our orbitally welded piping systems available with CIP/SIP integrations tackle all these concerns.
- Material of Construction
Stainless steel 316L is the best metal out there to make sure your pipes are strong, stable, easily cleanable, and resistant to corrosion that might affect your raw materials and final product. However correct choice of material has to be taken in to consideration with respect to the products being transferred
- Pipe connections must be leak proof
Leaks not only compromise the safety of your personnel and the larger environment in which you are situated, but they also allow contaminants to find their way into your system. This is an absolute no-no.
- Pipe supports
Your pharmaceutical process piping system must be supported adequately while also ensuring that the combined weight of the pipes, supports and other allied products does not cause the line to sag. You also want to design them in such a way that permits expansion and contraction of the pipes under varied temperature and pressure conditions.
- Pipe insulation
As mentioned in the first point here, your piping should be able to handle the climate of the region your plant is situated in. Insulation is a good solution for this problem. Good insulating materials have properties like being vermin-proof, having high insulation value, corrosion-resistance and long life.
Pipe sizing is of utmost important. This will help the system to run to optimum capacity as wrongly designed pipe sizes may cause disruption in production. The correct sizing in turn ensures right quantity at the time of productions
At TSA, all process piping is of the highest quality, customisable to your specific site and application needs. They comply with internationally-recognised standards and will ensure a smooth process for you from design and fabrication to installation, operation and maintenance. If you’re looking to install or upgrade your pharmaceutical process piping, get in touch with us now. We love solving your toughest challenges.
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