CIP & utility systems
The systems everything else depends on.
CIP & utility systems
Designed for the process and documented for qualification.
In pharmaceutical manufacturing, CIP and utility systems are the foundation every GMP process is built on. When they are designed without qualification in mind, the consequences show up at commissioning, during audit and at scale-up.
CIP systems
Cleaning that performs in every cycle.
A CIP system that underperforms puts cleaning validation at risk. Systems are designed, fabricated and installed to your specific process requirements, with full documentation and validation support from day one.
Engineering & design
P&ID development, flow calculations and equipment sizing based on your process and cleaning validation strategy.
Fabrication & installation
Skid-mounted or site-built systems in AISI 316L with orbital TIG welding, full weld documentation and material traceability.
Commissioning & validation support
FAT, SAT and IQ/OQ documentation prepared and executed in close collaboration with your validation team.
Built to pharmaceutical standards.
Parameter
Specification
Material
AISI 316L with full EN 10204 3.1 certification
Surface finish
Mechanical or electropolished, typically Ra ≤ 0.8 µm
Welding
Orbital TIG with digital weld logs and inspection documentation
Design
Hygienic design, self-draining geometry, no dead legs
Documentation
FAT/SAT, weld logs, material certificates, calibration records, P&IDs
Standards
cGMP, ASME BPE, EHEDG, GAMP 5
Utilities & infrastructure
From clean steam to cooling water.
Clean utilities
PW, RO, WFI and Clean Steam systems designed and installed to meet Ph. Eur. and FDA requirements, with full IQ/OQ/PQ documentation as part of the standard scope.
Black utilities
Cooling, condensate return and drainage solutions engineered for stable, continuous operation in demanding production environments.
HVAC systems
Heating, ventilation and air conditioning systems designed for cleanroom classification, differential pressure control and energy efficiency in regulated environments.
Waste & neutralization
pH neutralization of process effluents before discharge. Chemical waste collection and drainage designed for safe containment, segregation and environmental compliance.
Utilities & Infrastructure
The engineering decisions made in week two of a project are the ones your QA team will still be living with in year three.
Quality & Documentation
Qualification Starts at the Design Table.
Every CIP and utility system is delivered with complete GMP documentation as part of the standard scope. P&IDs, weld logs, material certificates and IQ/OQ/PQ protocols are built in from day one, not added at the end.
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Rene Dyrlund
Senior Technical Sales & Construction Manager - Kalundborg
