Sorrento Valley Passivation Services
In the biopharmaceutical and pharmaceutcal industries, cleanliness isn’t just important, it’s vital. Every component that comes into contact with drug products must meet strict industry standards for purity and integrity. One important process that validates this is passivation. With GL Technologies, our team of experts provide passivation services for clients both large and small. Using industry-standard techniques, we remove surface contaminants and promote the formation of a protective oxide layer. We help our clients maintain compliance with ASTM and other relevant specifications.
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Why Passivation Is Critical in Biopharmaceutical Manufacturing
Corrosion Resistance
Biopharma environments often use aggressive cleaning agents like CIP (Clean-in-Place) and SIP (Steam-in-Place) systems. Passivation strengthens the stainless steel’s resistance to corrosion, preventing pitting, rust, and surface degradation.
Contamination Control
Unpassivated or poorly maintained stainless steel surfaces can harbor microscopic iron particles and other contaminants. These impurities pose serious risks to product safety and can lead to batch contamination. Passivation removes these particles and enhances surface purity.
Regulatory Compliance
Regulatory bodies like the FDA, EMA, and USP require clean, non-reactive process surfaces. Regular passivation helps maintain compliance and minimizes the risk of costly regulatory issues or product recalls.
Improved Equipment Longevity
Passivated equipment lasts longer, operates more reliably, and requires less frequent replacement or maintenance. This translates into lower operating costs and better overall efficiency.
How the Passivation Process Works
Passivation for biopharma-grade stainless steel typically involves:
Cleaning the surface to remove oils, grease, and dirt.
Acid treatment, often using nitric or citric acid solutions, to dissolve free iron.
Rinse and neutralization to remove all chemical residues.
Validation testing, such as high-purity water rinse and surface analysis (e.g., TOC, conductivity, or iron ion testing), to confirm the surface meets cleanliness standards.
When Should Biopharma Companies Perform Passivation?
Passivation is typically recommended:
After new equipment fabrication or installation.
Following mechanical damage or welding.
During scheduled maintenance intervals.
After exposure to harsh chemicals or unexpected contaminants.
Routine passivation should be part of your GMP (Good Manufacturing Practices) maintenance schedule.
GL Technologies Passivation Services
Biopharma companies must select a provider experienced in cleanroom protocols, GMP standards, and documentation for validation. A good passivation service includes:
On-site or off-site service options.
Documentation and validation support (IQ/OQ/PQ).
Knowledge of ASME BPE, ASTM A967, and other relevant standards.
What Is Passivation?
Passivation is a chemical process that removes free iron and other contaminants from the surface of stainless steel. This process enhances the formation of a passive oxide layer — a thin, protective film that prevents corrosion and maintains the material's integrity.
In the biopharma industry, stainless steel is widely used in process equipment, piping, and cleanroom infrastructure. Passivation ensures that this equipment remains inert, clean, and compliant with industry regulations such as those from the FDA and USP.
About GL Technologies
GL Technologies, based in San Diego, is a specialized service provider catering to the highly regulated industries of biopharmaceuticals, pharmaceuticals, medical devices, and government sectors. The company focuses on delivering expert solutions in equipment calibration, validation, and compliance services, ensuring that clients meet stringent GMP (Good Manufacturing Practice) and FDA regulations. GL technologies is a trusted partner from commissioning new plants to decommissioning with compliance. GL can place dedicated motivated quality personnel on site anywhere. A program can be designed or revamped for the customers needs from design of CMMS to SOP development, specification development and performance of calibrations.
With a dedicated team of 29 technicians, GL Technologies offers precision calibration, preventative maintenance, and qualification services for laboratory and production equipment used in critical manufacturing and research processes. The company’s expertise is supporting its clients in maintaining regulatory compliance and operational efficiency. Our passivation services service San Diego, San Francisco, and Los Angeles.
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!