Maximizing Efficiency and Safety in Pharmaceutical Research and Manufacturing with Stainless Steel
Everything you need to know from valve types and standards to materials and uses
Stainless steel’s versatility and durability have cemented its place as a material of choice in the pharmaceutical industry for decades.It offers many advantages over other materials, including corrosion resistance, easy cleaning, and simple maintenance, to name a few.
This guide will explore these benefits, common uses for stainless steel in the pharmaceutical industry, popular grades of stainless steel available today, and recommended best practices when using stainless steel.
After reading, you’ll have a solid foundation of the high-level considerations for your next stainless steel project.
Table of Contents:
- Overview of Stainless Steel in the Pharmaceutical Industry
- Common Uses for Stainless Steel in the Pharmaceutical Industry
- Popular Types of Stainless Steel Used in the Pharmaceutical Industry
- Recommended Best Practices for Using Stainless Steel in Pharmaceutical Research and Manufacturing
- Key Takeaways
Overview of Stainless Steel in the Pharmaceutical IndustryStainless steel is an alloy of iron, chromium, and other metals that work together when exposed to oxygen to create a passive layer on the surface of the steel which shields the underlying metal from oxidation and damage.
Foundries may add other elements, such as nickel and molybdenum, to enhance specific characteristics, such as formability or weldability.
While different grades will offer varying resistance levels, and many have strengths and weaknesses based on the environment in which the alloy will be used, stainless steel has been a cornerstone in the pharmaceutical industry since the early 1920s.
It’s earned this popularity due to its ability to resist harsh chemicals, extreme temperatures, and the harsh conditions of standard sterilization processes.
Furthermore, it’s minimally reactive with most drugs and various chemicals.
This makes it ideal for use in tanks, pipes, valves and other equipment components during manufacturing processes such as blending & filling operations or storage and transportation applications where manufacturers must avoid contamination.
This creates a material that isn’t just suited to the job's specific requirements exceptionally well but offers outstanding durability, service life, and cost-effectiveness when compared to other materials used in pharmaceutical research and manufacturing.
From researchers and manufacturers in pharmaceuticals to patients and medical professionals using said medicines in healthcare environments, virtually every aspect of modern medicine sees benefits from stainless steel.
The following section will explore typical pharmaceutical industry uses for this popular alloy.
Common Uses for Stainless Steel in the Pharmaceutical IndustryStainless steel is a popular material choice for the pharmaceutical industry due to its durability, corrosion resistance, and non-reactive properties.
Let’s explore common pharmaceutical applications for stainless steel.
Storage and Containment SolutionsStainless steel is ideal for short- and longer-term storage of sensitive materials used in pharmaceutical drug research, development, manufacturing, and transport.
Stainless steel’s non-reactive nature avoids creating unexpected reactions.
It produces consistent results time after time while its non-porous surface prevents contamination and makes cleaning and sanitization quick and easy.
This means that contamination risks are minimal when following proper procedures.
Stainless steel storage and containment solutions should offer exceptional service life with minimal downtime or maintenance costs.
Manufacturing Equipment and ProcessesLike many specialized industries, pharmaceuticals require equipment that must meet stringent safety regulations to produce quality products time after time.
Different varieties of stainless steel allow meticulous control over manufacturing and processing equipment characteristics and provide consistent quality control measures throughout repeat production cycles.
Whether you’re looking for an easy-to-clean vessel, a piping solution able to withstand extreme temperatures, instrumentation valves and fittings, or tanks to hold or blend compounds, there’s likely a prefabricated stainless steel product available for purchase.
And if there isn’t a product available to suit your needs, stainless steel’s affordability makes in-house or third-party fabrication also affordable.
Stainless steel for pharmaceutical use also plays an essential role as a material of choice inside everyday processing equipment items, such as centrifuges, chromatography columns, and filtration units.
Cleanroom Equipment and FurnitureStainless steel’s non-porous surface, simple cleaning and maintenance, and exceptional resistance to common sterilization processes make it a centerpiece in many cleanroom setups.
From the moment you step into the space, there’s a good chance you’ll see more stainless steel than not.
Popular stainless steel cleanroom equipment and furniture include:
- Workstations and tables
- Shelving and storage units
- Carts and trolleys
- Pass-through chambers
- Air showers
- Cleanroom doors and frames
- Changeroom benches
- Hand wash sinks
- Flooring and wall panels
Ventilation and Climate Control EquipmentPharmaceutical environments that are easy to clean and hygienic aren't just about surfaces—the air is important too.
Like many other drug research, design, and pharmaceutical manufacturing elements, stainless steel is central in many ventilation and climate control elements throughout professional facilities.
Common uses include:
- HVAC ductwork
- Air Handling Units (AHUs)
- Exhaust fans, hoods, and vents
- Stainless steel heat exchangers and coils
Laboratory and Testing EquipmentStainless steel plays a role in pharmaceutical processes almost from their start—including drug development's research and diagnostics phases.
Typical items using stainless steel in a pharmaceutical laboratory include autoclaves, incubators, and analytical instruments.
Popular Types of Stainless Steel Used in the Pharmaceutical Industry
Like most industries, a few stainless steel grades make up most of the use in the pharmaceutical industry due to their availability, cost, and flexibility.However, some different types of stainless steel are popular in pharmaceutical environments as well.
Some of the most common grades used include:
- 316L Stainless Steel: Commonly used in pharmaceutical equipment and process piping due to its hygienic properties, this low carbon grade of stainless steel also offers exceptional resistance to pitting corrosion and crevice corrosion while remaining affordable and easily accessible.
- 304 Stainless Steel: As one of the most popular grades of stainless steel worldwide and across nearly all industries, this versatile grade increases corrosion resistance while remaining easy to fabricate with or weld. Typical uses include pharmaceutical equipment, storage tanks, and piping.
- 316Ti Stainless Steel: Thanks to the inclusion of titanium in this alloy, it offers improved resistance to intergranular corrosion and sensitization in extreme temperatures—such as those encountered when welding. It is commonly used in high-temperature applications, such as pharmaceutical reactors and process equipment.
- 904L Stainless Steel: This high alloy austenitic stainless steel contains molybdenum, nickel, and copper. Including copper means that the alloy provides excellent corrosion resistance in aggressive or acidic environments, including but not limited to resistance against sulfuric acid, acetic acid, formic acid, and phosphoric acid. This makes it ideal for pharmaceutical equipment and piping systems involving strong acids or chloride-neutral aggressive environments.
- 2205 Duplex Stainless Steel: This duplex stainless steel contains both austenitic and ferritic phases. The result is an alloy with excellent strength and corrosion resistance equally suited to moulding and high-stress applications. Common applications in pharmaceutical processes include reactors and pressure vessels.
Regardless of the process, environment, or solution required, there’s a good chance a stainless alloy or part already exists to suit your needs.
Recommended Best Practices for Using Stainless Steel in Pharmaceutical Research and ManufacturingWith how stainless steel is often used in the pharmaceutical industry out of the way, let's take a look at some best practices for using it effectively.
Exact uses will depend on regulatory requirements and your specific processes.
Consulting with a qualified engineer or other professional is always recommended.
However, these practices should serve as a solid foundation for a range of processes and use cases.
Design Considerations for Optimal PerformanceWhen designing pharmaceutical production equipment using stainless steel, it is crucial to consider the application and environment.
While stainless steel is corrosion-resistant, it’s not entirely immune to corrosion.
More to the point, as outlined in the list of popular grades above, many grades excel at resisting specific types of corrosion while remaining susceptible to others.
For example, if the equipment you’re using will see regular contact with corrosive chemicals or extreme temperatures, the ideal grade of stainless will likely vary.
If they’ll often encounter both at once, that might indicate the need for yet another grade of stainless steel.
Additionally, engineers and systems designers should also keep fabrication and fastening concerns in mind.
Welding works better with some grades than others, and maintenance technicians and assemblers should properly treat all high temperature welds to prevent corrosion.
Fastener material should match the equipment and piping materials when possible to avoid galvanic corrosion.
The little details matter if you want to get the most out of your stainless steel parts.
Proper Maintenance and Cleaning ProceduresStainless steel is a highly versatile material with many advantages for pharmaceutical manufacturers and researchers.
It is durable, corrosion-resistant and non-toxic, making it ideal across nearly all steps in bringing a drug from the laboratory to the pharmacy shelf.
However, regular maintenance and cleaning of equipment made from stainless steel is essential—especially components that come in direct contact with the pharmaceutical products.
This ensures optimal performance and helps to maintain compliance with any relevant safety standards or regulations.
While exact needs will differ depending on your processes, components, materials, and location, the following can serve as a baseline for most areas.
If you have any questions about compliance requirements, always consult a professional familiar with standards in your region.
Essential maintenance and cleaning procedures include:
- Regularly inspect all components for signs of wear or damage—especially for pitting and crevice corrosion, which might not be immediately apparent but accelerates rapidly once initiated.
- Regularly ensuring all seals, gaskets, and connecting interfaces are intact and appropriately positioned.
- Cleaning up any spills or residual build-up immediately to minimize contamination risks and prevent corrosion onset.
- Creating scheduled maintenance routines for more involved processes that might require line shutdowns or disassembly.
- Developing quality control and sampling procedures to ensure that stainless steel is not contributing to bacterial or fungal contamination.
- Monitoring processes to ensure that stainless steel is not influencing reactions or leeching into products or processes.
- Stainless steel’s passive layer helps to reduce corrosion risks and aid in cleaning and sanitation of components and work areas.
- Different grades of stainless steel will offer different levels of corrosion resistance and often make one grade (or group of grades) better at resisting specific types of corrosion than others.
- Common uses for stainless steel in the production of pharmaceuticals include storage and containment solutions, manufacturing equipment and processes, cleanroom equipment and furniture, ventilation and climate control equipment, and laboratory and testing equipment.
- Popular grades of stainless steel the pharmaceutical industry uses include 316 and 316L, 304 and 304L, 316Ti, 904L, and 2204 Duplex.
- When designing pharmaceutical equipment using stainless steel, it is vital to consider the application and environment while matching these to an ideal grade.
- Regular maintenance and cleaning of pharmaceutical equipment made from stainless steel is essential.
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