Los Angeles Passivation Services

Passivation is an important process in the Los Angeles biopharmaceutical and pharmaceutical industries, making sure that stainless steel surfaces remain free from contaminants and corrosion. All Los Angeles biopharma and pharma companies must meet strict regulatory standards, and proper passivation services help maintain equipment, prevent contamination, and improve overall product safety. At GL Technologies, our team of passivation experts will come to your facility to provide the necessary services and make sure your organization meets regulatory guidelines and requirements.

To speak with the GL team about your passivation needs, please fill out our online form or give us a call!

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What is Passivation?

Passivation is a chemical treatment process that removes free iron and other contaminants from stainless steel surfaces. By forming a protective oxide layer, it increases the metal's resistance to corrosion and degradation, maintaining the longevity and cleanliness of biopharma and pharmaceutical processing equipment.

Key Steps in Passivation

Pre-cleaning – Removal of organic and inorganic contaminants.

Acid Treatment – Application of nitric or citric acid to dissolve free iron.

Rinsing and Neutralization – Making sure all chemicals are thoroughly removed.

Validation Testing – Verification through analytical methods, such as water immersion and high-purity water testing.

Benefits of Passivation for Biopharma Companies

1. Regulatory Compliance

Passivation plays an important role in meeting regulatory compliance across various industries, particularly in biopharma and pharma industries, where strict material integrity standards are mandated. By removing free iron and other contaminants from stainless steel surfaces, passivation enhances corrosion resistance and prevents contamination that could compromise product safety. This process helps businesses adhere to industry regulations such as ASTM A967, AMS 2700, and FDA guidelines, reducing the risk of non-compliance penalties and improving overall product reliability. Maintaining regulatory compliance through passivation not only protects consumer safety but also strengthens a company's reputation and market trust.

2. Increased Equipment Longevity

Passivation significantly increases equipment longevity by creating a protective oxide layer on metal surfaces, preventing corrosion and rust. This process is especially crucial for stainless steel and other alloys exposed to harsh environments, chemicals, or moisture. By reducing the risk of surface degradation, passivation minimizes maintenance needs, extends operational life, and ensures consistent performance over time. Equipment that undergoes passivation experiences fewer failures and requires less frequent replacements, leading to long-term cost savings and improved reliability in industrial and commercial applications.

3. Improved Product Purity

Passivation improves product purity by removing free iron and contaminants from stainless steel surfaces, creating a clean, non-reactive oxide layer. This process prevents corrosion, rust formation, and unwanted chemical reactions that could compromise the integrity of the final product. In the biopharma and pharmaceutical industries, maintaining high levels of purity is critical to maintaining product safety, quality, and regulatory compliance. By increasing the material’s resistance to contamination, passivation helps prevent unwanted impurities from leaching into sensitive products, ultimately improving performance and reliability.

4. Peak Performance

Passivation increases the performance of metal components by forming a protective oxide layer that prevents corrosion, contamination, and surface degradation. This process improves the longevity and reliability of stainless steel and other alloys, making sure they maintain their strength and resistance in harsh environments. By eliminating free iron and other contaminants, passivation minimizes the risk of rust formation, reduces maintenance needs, and increases efficiency in industrial applications. As a result, machinery and equipment function at peak performance, reducing downtime and increasing productivity.

Frequently Asked Questions

What is passivation?

Passivation is a chemical process that enhances the corrosion resistance of metal surfaces, particularly stainless steel and other alloys. It involves treating the metal with an acid solution, typically nitric or citric acid, to remove free iron and other surface contaminants that could lead to rust or corrosion. This process forms a thin, protective oxide layer that prevents further oxidation and extends the metal's lifespan. Passivation is commonly used in industries such as aerospace, medical, and manufacturing to ensure the durability and reliability of metal components.

Why is passivation important in the biopharmaceutical industry?

Passivation is important in the biopharmaceutical industry because it increases the corrosion resistance of stainless steel equipment used in manufacturing processes. By removing free iron and other contaminants from the surface, passivation creates a uniform, inert oxide layer that prevents metal ion contamination and microbial growth, maintaining product purity and compliance with strict regulatory standards. This process helps maintain the integrity of biopharmaceutical products, reduces the risk of cross-contamination, and extends the lifespan of critical processing equipment.

How does passivation improve stainless steel surfaces in bioprocessing equipment?

Passivation improves stainless steel surfaces in bioprocessing equipment by removing free iron and other contaminants from the surface, creating a uniform, passive oxide layer that enhances corrosion resistance. This process reduces the risk of contamination, pitting, and rouging, ensuring that the equipment maintains its integrity and cleanliness in highly regulated environments. By enhancing the material’s resistance to chemical attack and microbial adhesion, passivation helps maintain product purity, extends equipment lifespan, and supports compliance with stringent industry standards such as FDA and cGMP requirements.

What standards and regulations apply to passivation in biopharmaceutical manufacturing?

Passivation in biopharmaceutical manufacturing must comply with industry standards and regulations to ensure equipment surfaces remain corrosion-resistant and free of contaminants. Key standards include ASTM A967 and ASTM A380, which outline methods for passivating stainless steel, as well as ASME BPE (Bioprocessing Equipment Standard), which sets requirements for materials, surface finishes, and cleaning procedures in biopharmaceutical applications. Additionally, regulations from the FDA (Food and Drug Administration) and EMA (European Medicines Agency) require validation of passivation processes to prevent product contamination. Compliance with Good Manufacturing Practices (GMP) ensures that passivated surfaces meet cleanliness and biocompatibility requirements, critical for maintaining product purity and patient safety.

What chemicals are used in the passivation of stainless steel?

Passivation of stainless steel typically involves the use of nitric acid (HNO₃) or citric acid (C₆H₈O₇) to remove free iron and other contaminants from the surface, enhancing its corrosion resistance. Nitric acid passivation is a traditional method that not only cleans but also helps in forming a protective oxide layer. Citric acid, a more environmentally friendly alternative, chelates iron particles while leaving the chromium-rich surface intact. Sometimes, additional inhibitors or oxidizers like sodium dichromate may be used to improve passivation effectiveness, depending on the specific alloy and application.

How long does passivation take?

The time required for passivation depends on the specific process, chemical solution, and material being treated. Typically, stainless steel passivation using nitric or citric acid takes between 20 to 60 minutes, though some processes may be shorter or longer depending on factors like temperature, concentration, and desired corrosion resistance. Additional rinsing and drying steps may add to the total processing time.

Can passivation remove existing contaminants from stainless steel?

No, passivation cannot remove existing contaminants such as embedded iron, grease, oil, or other surface impurities from stainless steel. Passivation is a chemical treatment that enhances the natural oxide layer on stainless steel, improving its corrosion resistance. However, before passivation, thorough cleaning and descaling processes, such as pickling or mechanical cleaning, are necessary to remove contaminants. If contaminants are present during passivation, they can interfere with the formation of a uniform passive layer, potentially leading to corrosion issues.

What is the difference between passivation and electropolishing?

Passivation and electropolishing are both surface treatments for stainless steel, but they serve different purposes. Passivation is a chemical process that removes free iron and contaminants from the surface, enhancing corrosion resistance by forming a thin, protective oxide layer. It does not change the metal’s appearance or smoothness. Electropolishing, on the other hand, is an electrochemical process that removes a thin layer of metal, smoothing and brightening the surface while also improving corrosion resistance. Unlike passivation, electropolishing reduces surface roughness, removes burrs, and enhances cleanliness, making it ideal for applications requiring high-purity finishes.

How is passivation effectiveness tested in biopharma applications?

Passivation effectiveness in biopharma applications is typically tested using techniques such as surface analysis, corrosion resistance tests, and iron contamination assessments. Common methods include the ASTM A967 and A380 tests, which use nitric or citric acid solutions to evaluate passivation layers. Water contact angle measurements, X-ray photoelectron spectroscopy (XPS), and Auger electron spectroscopy (AES) help analyze surface chemistry and oxide layer integrity. Additionally, rouging and biofilm resistance tests are conducted to ensure long-term performance in cleanroom environments. These tests confirm that stainless steel surfaces remain inert and free from contamination, ensuring compliance with regulatory standards.

How often should biopharma equipment undergo passivation?

Biopharma equipment should typically undergo passivation every 6 to 12 months, depending on usage, cleaning frequency, and exposure to corrosive substances. Passivation helps maintain the stainless steel's corrosion resistance by removing free iron and enhancing the protective oxide layer. However, high-purity environments or processes involving aggressive chemicals may require more frequent passivation. Regular monitoring through surface analysis and rouging assessments can help determine the optimal schedule for passivation.

Choosing GL Tec as Your Service Provider

When selecting a passivation service provider for your biopharma company, consider the following factors:

Industry Experience – GL Tec is equipped with the expertise in the biopharmaceutical sector and knowledge of regulatory requirements.

Certification & Compliance – We follow ASTM, ASME, and FDA guidelines.

On-site vs. Off-site Services – Depending on your facility's needs, GL Tec offers flexible service options.

Validation & Documentation – We offer thorough validation and documentation to meet compliance standards.

Passivation is an essential process for biopharma companies, ensuring equipment longevity, regulatory compliance, and product purity. By partnering with a reliable passivation service provider, businesses can maintain the highest standards in pharmaceutical manufacturing while reducing operational risks.

Looking for expert Los Angeles passivation services? Contact us today to protect your biopharma operations and maintain compliance with industry standards.

About GL Technologies

As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations. GL Tec specializes in IQ OQ PQ services for clients throughout San Diego, San Francisco, Los Angeles, Orange County, and Riverside! We also provide passivation services to clients in, San Diego, San Francisco, Los Angeles, and Orange County.

To request more information or a quote, please fill out our online Request Information form or call!