Role of Stainless Steel in Pharmaceutical Manufacturing
Industries We Serve
Stainless Steel Tanks
The pharmaceutical industry is constantly growing and evolving, but some basic tenets of the manufacturing process remain the same. For instance, stainless steel is uniquely appropriate for pharmaceutical and biotech equipment due primarily to its resistance to high temperatures and chemical corrosion. Stainless steel is most practical for applications that require frequent sanitation and low chemical reactivity. Stainless steel containers – from bottles to storage tanks – are perfect for processing, storing, and transporting pharmaceutical materials, whether liquid or dry. They’re also excellent for research and pharmaceutical manufacturing applications.Preparing machine for work in pharmaceutical factory.
Quality Standards for Pharmaceutical Manufacturing
Strict quality standards and regulations highlight the importance of stainless steel in the pharmaceutical industry. Some of the more pertinent points include:
Sanitary: Since sanitization is vital for safety in the pharmaceutical process, any equipment must be easy to clean and be able to stand up to harsh sanitation chemicals or intense heat. Stainless steel (when properly formulated) can withstand both of these severe variables.
Non-Reactive: Containers and instruments used in pharmaceutical manufacturing will be in close proximity and contact with medications. Therefore, FDA regulations require that equipment materials cannot react with or add to the medication, nor can any material seep into the drug product. The strength, identity, purity, safety, and quality of the medications must be maintained and cannot be affected by the equipment. Medical-grade stainless steel ensures that these standards are met.
Stable: The pharma and biotech industries require containers that support the shelf-life stability of products to minimize loss due to waste. The non-porous, non-reactive nature of medical-grade stainless steel is uniquely qualified to ensure this standard is met.
Types of Stainless Steel
Though all stainless steel is an iron and chromium-based alloy, the specific exact composition can vary – meaning that not all stainless steel is appropriate for these applications. Multiple systems exist for categorizing and grading steel, but one of the most commonly known comes from the Society of Automotive Engineers (SAE). In the SAE system, the two most widely used grading categories are the 300 and 400 series. Each has its own application-specific advantages and disadvantages which highlights the diversity of this material. 400 series: This series is comprised of ferritic steels which exhibit higher carbon and lower nickel content than other steel types. This composition allows the steel to withstand physically harsh and abrasive conditions, such as in motors while remaining affordable. However, the 400 series may be susceptible to corrosion from chemicals, salts, and flowing water, and it is magnetic – making it inappropriate for most pharma and biotech settings. 300 series: This series is comprised of austenitic stainless steel which contains nickel and molybdenum to improve chemical and corrosion. The 300 series is resistant to chlorides, including salts often used in these types of applications. The 300 series is typically more expensive, but it is considered the superior material for pharma and biotech companies. Medical-grade stainless steel is primarily from the 300 series, with 304, 316, and 316L being commonly used grades.
The Fabrication of Stainless Steel
Stainless steel fabrication often involves custom innovations, including modifications to vessels, dip tubes, dish bottom mixing vessels, hoppers, custom buckets, and sanitary containers. Our professional fabricators are skilled in welding, engraving and automated and manual mechanical polishing to ensure your stainless-steel equipment is high-quality. Zwirner Equipment Company has been fabricating, refurbishing, and reselling quality stainless steel products for over 30 years, and we are a preferred provider for hundreds of manufacturing plants across the Southeast. For superior customer service and industrial expertise, look no further than Zwirner Equipment – we can help you locate the right equipment, ensure its quality, and even deliver, install, repair, and maintain your new equipment. Call today to learn more about our inventory and services.
