Biopharmaceutical

With almost 60 years of experience, Astro Pak understands that corrosion, bio-burden, rouge and other surface contaminants pose a significant threat to drug production and quality control. To address these concerns, we developed proprietary chemical cleaning processes and custom designed chemical circulating pump-skids to meet FDA compliance standards required for biopharmaceutical manufacturers.

Our pre-operational cleaning processes remove surface contaminants from metal manufacturing, fabrication and installation. Our maintenance cleaning processes remove rouge, product / by-product residue and biocontamination to ensure clean, passivated and sanitized contact surfaces and product purity. Whether we deploy our expert technical crews to your plant or process parts at one of our 11 shop locations, Astro Pak can meet your stringent cleaning requirements and provide cGMP documentation with each job we perform.

Clean and Passivate Used Chromotography Column Screens (Frit Filters)

In the Biotechnology industry, it is common practice to replace and discard used chromatography column screens – also known as Frit Filters.  Astro Pak’s chemical cleaning and passivation services can restore and extend the life of these screens, eliminating costly replacement.

Key benefits of chemical cleaning & passivation include:

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

Frit Filter Cleaning

 

Like any other stainless steel part, chromatography screens are subject to rouging, staining and other examples of corrosion. The very nature of chromatography leads to the additional challenge of trapped resin that impedes the flow of product. In addition to the cost of replacing clogged filters, the buildup creates inefficiencies in the chromatography process that directly affect the bottom line.

Another area of concern comes when the column is tasked with producing a different product. Clogged frit filters cannot be left in place during a product change-out for fear that the material caught in them could come loose and contaminate the new batch. For companies that pride themselves on their agile production capabilities, having to throw out filters before they’ve reached their end of usefulness is an unwelcomed expense.

Fortunately, frit filters can be cleaned and restored exclusively at one of Astro Pak’s 10 nationwide shop facilities. There, the filters are manually inspected to identify any issues. Surface contamination, including resin, is first removed followed by a thorough pressure washing and then a steam sanitization.  A second manual inspection looks for hidden damage as well as to ensure the success of the preliminary cleaning process.

The cleaning is followed up with passivation which restores the chemical non-reactivity of the stainless steel itself. During use, any number of things can impact the screens and damage the passive layer of stainless steel, exposing the chemically reactive layers below and encouraging corrosion, which can in turn, contaminate the product. A final rinse – with water samples sent out to test for organic carbon – completes the process. Multi-layer screens are further validated using the highest standards. By removing residual resin and restoring the stainless steel, the filter has been returned to an “as-new” state. The frit filters are then thoroughly dried and carefully packaged to ensure safe transport back to the customer’s facility.

Capabilities

  • Vacuum Bake
  • High Pressure Wash Spray
  • Solvent Dryness Testing
  • Hydrostatic Testing
  • Dew Point
  • Descaling
  • Disinfection
  • Alkaline, Solvent, Detergent Cleaning
  • Room & Equipment Sterilization

Systems & Equipment Processed

  • Water for Injection (WFI) Tanks
  • WFI Stills
  • Bioreactors, Fermenters, Lyophilizes
  • Clean Steam Generators and Clean Steam Systems
  • Sterilizers and Autoclaves
  • Reverse Osmosis, DI, Pure Water
  • Clean in Place (CIP)
  • Boilers
  • Filters
  • Vessels, Tanks
  • Heat Exchangers
  • Process Piping, Tubing, Hoses
  • Valves (Relief, Ball, Butterfly, Needle, Gate)
  • Gauges (Pressure, Flow meter, Hydraulic, Cryogenic)
  • Fittings, Fasteners, Flanges, Gaskets
  • Components and Hardware
  • Transducers and Sensors
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