CIP/SIP Heat Exchangers for Aseptic Filling Line Nozzle Cleaning

Aseptic filling nozzles are the final barrier to sterility — any residue or bioburden risks product contamination. Our ASME-BPE CIP/SIP heat exchangers supply pure steam for 135°C sterilization, hot WFI circulation, and validated cleaning — ensuring zero microbial ingress, complete residue removal, and full Annex 1 compliance for vials, syringes, and bags.

Critical Aseptic Filling Line Nozzle Cleaning Applications

  • Filling Needle SIP: 135°C pure steam sterilization of nozzles and manifolds with double-tubesheet exchangers and full condensate drainage.
  • Hot WFI Circulation: 80–90°C WFI loops for pre- and post-fill cleaning of nozzle tips and product pathways with Ra = 15 µin surfaces.
  • Product Residue Removal: Aggressive caustic/acid CIP eliminates protein, lipid, and API residues from high-precision nozzles.
  • Multi-Product Changeover: Validated CIP/SIP removes previous batch residues for safe switching between biologics and small molecules.
  • Sterile Hold Validation: Pure steam hold ensures sustained lethality on nozzle interiors with riboflavin and bioburden testing.
  • Annex 1 Compliance: Zero dead-leg designs and documented SIP cycles meet EU GMP Annex 1 requirements for aseptic processing.
Shell & Tube
CIP/SIP Aseptic Exchangers
  • Double Tubesheet ASME-BPE
  • Pure Steam Compatible
  • Fully Drainable SIP
Shell & Tube for Aseptic Pure Steam
Plate & Frame
CIP/SIP Aseptic Exchangers
  • High Regeneration Efficiency
  • Ra = 15 µin Electropolish
  • Fast CIP & Validated SIP
Plate & Frame for Aseptic WFI

The Critical Role of Sanitary CIP/SIP Heat Exchangers in Aseptic Filling Line Nozzle Cleaning

Aseptic filling nozzles are the last defense against contamination — any residue or bioburden risks sterile product integrity. Non-compliant exchangers fail to deliver sustained pure steam or hot WFI, leading to sterility failures.

Our ASME-BPE exchangers eliminate that risk with double-tubesheet designs, electropolished surfaces (Ra = 15 µin), full drainability, and proven resistance to 135°C pure steam SIP — ensuring validated nozzle sterilization and zero microbial ingress.

A global biologics filler achieved Annex 1 compliance and zero sterility failures after installing our pure steam systems. A vaccine manufacturer reduced SIP time 50% with our high-efficiency plate exchangers for WFI circulation.

With third-party validation, full traceability, and decades of performance in aseptic lines worldwide, our CIP/SIP heat exchangers are the trusted standard for safe, compliant nozzle cleaning.

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