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Silverson mixers for Cleanroom processing

High shear mixers made to order with complete documentation

Silverson mixing equipment for use in Cleanroom manufacturing doesn’t just meet the requirements of regulatory bodies such as the U.S. Food and Drug Administration; in many cases, it exceeds them. Silverson is a pioneer in the concept of Ultra Sanitary mixing equipment, and offers a range of options for mixing under sterile conditions. Every unit for Cleanroom use is designed and built to the exacting standards of Silverson engineers, and customised to meet specific customer manufacturing requirements. “Because customer needs vary widely by what is being manufactured, the method of sterilisation being used and so on, our Cleanroom systems are generally made to order,” explains Peter Matthews, Silverson Machines’, technical manager. “Documentation and traceability are also a necessity for Cleanroom equipment, so we plan accordingly during our manufacturing process.”

Cleanroom manufacturing equipment background
The many standards and regulations applicable in this field cover a range of criteria. Essentially, process equipment must be easily cleaned, maintained and inspected; it must not contaminate the product either physically, chemically or microbiologically, nor must the equipment allow the product to contaminate other aspects of the process. Some standards also cover the selection of materials - for example, FDA requirements state that equipment must only be constructed from materials on the FDA master list.

Silverson High Shear mixers available for Cleanroom operation include In-Line, Bottom Entry, Top Entry and Flashblend powder/liquid mixing systems. To achieve the above criteria, a number of modifications would be incorporated.

These include:

  • “Crevice Free” design to eliminate dead areas and “bug traps”
  • Electropolishing or fine machined finish to all contact parts
  • Self-draining design to achieve as near zero retention as possible
  • All materials (including elastomers, o rings, etc.) are from product-compatible and traceable sources, selected from the FDA master list
  • Special “ultra sanitary” third-party components, such as motors, mechanical shaft seals, etc., are used

Silverson has provided mixers for a range of duties in Cleanroom installations, including use under laminar flow and units for Class 100 Cleanrooms. Typical applications include manufacture of tablet coatings, pharmaceutical syrups and dispersion of active ingredients and excipients for injectables and inhalants. More demanding applications such as the production of sterile suspensions and dispersion of sterile powders into sterile liquids are also carried out using specially modified units.

For more information on Silverson custom manufactured mixers and the full range of Silverson high shear mixers, click here to contact us.