Pre-operational Cleaning Processes for Biopharmaceuticals

With more than 60 years of experience, Astro Pak knows that bio-burden, corrosion, rouge, and other surface contaminants pose a severe threat to drug production and quality control.

To address these concerns, Astro Pak has developed proprietary chemical cleaning processes and custom-designed chemical circulating pump skids in compliance with FDA standards required for biopharmaceutical manufacturers.

Astro Pak’s pre-operational cleaning processes removes surface contaminants from metal manufacturing, fabrication, and installation. Its maintenance cleaning processes remove rouge, biocontamination, and product or by-product contamination to ensure clean, passivated, and sanitized contact surfaces and product purity.

Whether expert technical crews are deployed to a plant or parts are processed at one of its nine shop locations, Astro Pak can meet stringent cleaning requirements and provide cGMP documentation with every job performed.

Clean and Passivate Used Chromatography Column Screens (Frit Filters)

It is common in the Biotechnology industry to replace and discard chromatography column screens, also known as Frit Filters, after use. Astro Pak’s chemical cleaning and passivation services offer restoration and extend the life of these screens, mitigating the need for expensive replacements.

Key benefits of chemical cleaning and passivation include:

  • Remove resin buildup
  • Remove stains, rouge, and residues
  • cGMP documented process
  • Enable product change over

Pre-operational cleaning processes for biopharmaceuticals

Image Credit: Astro Pak Corporation

As with other stainless steel parts, chromatography screens are subject to corrosion, such as staining and rouging. The nature of chromatography leads resin to become trapped, impeding the flow of the product, which provides an additional challenge.

In addition to the expenses of replacing clogged filters, the buildup makes the chromatography process less efficient - directly affecting the bottom line.

Another cause for concern arises when the column needs to produce a different product. Frit filters that are clogged must be removed during a product change-out to prevent the material caught in them from coming loose and contaminating the new batch.

For companies who claim agile production capabilities as a strength, the need to throw out filters before reaching the end of their usefulness is an unwelcome cost.

It is possible to clean and restore frit filters exclusively at one of Astro Pak’s nine nationwide shop facilities, where any issues with the filters are identified through manual inspection.

First, surface contamination, including resin, is removed, followed by a thorough pressure washing and steam sanitization. Any hidden damage is found via a second manual inspection, ensuring the success of the preliminary cleaning process.

The cleaning is followed by passivation, which restores the stainless steel to its chemically non-reactive state. Several things can impact the screens and damage the passive layer of stainless steel while in use, exposing the chemically reactive layers below, encouraging corrosion, and contaminating the product.

The process is completed with a final rinse, and samples of the water are sent out to test for organic carbon. Multi-layer screens are further validated using the highest standards. The filter is returned to an “as-new” state by removing residual resin and restoring the stainless steel. The frit filters are then dried thoroughly and carefully packaged, ensuring a safe return to the customer’s facility.

About Astro Pak Corporation

Astro Pak is the leader in providing Passivation, Precision Cleaning and High-Purity Chemical Cleaning services for a wide variety of “cleanliness sensitive” critical systems and components. Many of our customers have external agencies that drive their cleaning requirements, such as the FDA, NASA and others. We service such industries as Pharmaceutical, Biotechnology, Aerospace, Laser, Semiconductor, Water Treatment and more, including Industrial markets. Our services and products leverage decades of experience to deliver the most effective chemistries and techniques, resulting in increased equipment longevity, reduced corrosion-related downtime and regulatory compliance in client facilities.

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Last updated: Nov 15, 2022 at 10:21 AM


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