Every bioreactor, buffer tank, purification skid, and filling line must achieve validated sterility and zero pyrogen levels. Our ASME-BPE, electropolished CIP/SIP heat exchangers deliver precise WFI heating, pure steam generation, and complete clean/sterilize-in-place — eliminating endotoxins, bioburden, and cross-contamination while meeting the strictest cGMP, FDA, EMA, and Annex 1 requirements.
Pharmaceutical and biotech facilities operate under zero-tolerance for bioburden, endotoxins, and cross-contamination. Non-compliant or poorly designed heat exchangers become permanent sources of contamination, risking patient safety and batch failure.
Our ASME-BPE exchangers eliminate that risk with electropolished 316L surfaces (Ra = 15 µin), zero dead legs, full drainability, and proven resistance to daily CIP and 135°C pure steam SIP cycles — delivering validated sterility assurance for WFI systems, bioreactors, purification skids, and aseptic filling lines.
A global vaccine manufacturer achieved Annex 1 compliance and zero sterility failures after installing our double-tubesheet pure steam systems. A leading biologics CDMO reduced CIP/SIP time 50% using our high-regeneration plate exchangers for buffer preparation.
With third-party validation, full material traceability, and decades of performance in the world’s most critical pharma/biotech plants, our CIP/SIP heat exchangers are the trusted foundation for safe, compliant, and efficient sterile manufacturing.