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Understanding the Options:

Final Aseptic Fill




Final Sterile Filtration

Essential Process Requirements
  • High sterility assurance
  • Highly validated and reliable technology
  • Ensure product purity
  • High flow rate
  • Easily Integrity tested preand post-sterilization
  • Robust construction to withstand demanding sanitization cycles
  • Low hold-up volume

Recommended FilterFilter Characteristics

Durapore 0.22 µm Filters
Cartridge Filters
Optiseal Cartridge Filters
Opticap Capsule Filters
Optiseal Capsule Fitlers
  • Low protein-binding sterilizing-grade PVDF membrane
  • Bacterial retentive membrane has been the proven industry standard for decades
  • Very low extractables preserve product purity and yield
  • High flow rate at low pressure drop for reliable economic processing
  • 100% integrity testing and thousands of applications assures proven performance
  • Validated for multiple SIP and hot water sanitization cycles
  • Integrity testable on-site
  • Available in Millipak stacked disc format which allows minimal hold-up volume
  • Although 0.22 µm membrane is ideal for this application, Durapore filters are available in several pore sizes and in single-layer or multi-layer configurations to accommodate the needs of each user. Choice should be based on small-scale testing.

ALTERNATIVE: For high flow applications or if a PES membrane is requested, sterilizing-grade Millipore Express PES Filters are available.

Prefilter

Essential Process Requirements
  • Typically needed only for more concentrated solutions (>10 mg/mL)
  • Must prevent plugging of downstream sterilizing-grade
  • Preserves product purity
  • High flow rate
  • Robust construction to withstand SIP

Recommended FilterFilter Characteristics

Milligard Filters
(Grade SS, 0.5 µm + 0.2 µm)
Cartridge Filters
Opticap Capsule Filters
Optiscale Capsule Filters
  • Available in double-layer pleated configurations for increased particle and colloid loading capacity
  • Mixed esters of cellulose filter material with low protein-binding characteristics
  • Low extractables and non-fiber releasing
  • High flow rate at low pressure drop
  • Validated for multiple SIP cycles
  • Decades of proven performance protecting membrane filters
  • 100% integrity tested
  • Although grade SS, 0.5 µm + 0.2 µm is commonly used to protect downstream 0.22 µm sterilizing-grade membrane filters, Milligard filters are available in several pore sizes and in single-layer or multi-layer configurations. Choice should be based on small-scale testing.