The Importance of Clean-in-Place Systems to the BioPharmaceutical Industry
Large-scale industrial facilities including pharmaceuticals, biopharmaceuticals, and al...
When designing high-performance CIP (Clean-in-Place) systems for the world’s most demanding industries, biopharmaceuticals, life sciences, and high-containment labs, precision, hygiene, and compliance are non-negotiable. That’s why Suncombe designs and manufactures its CIP systems in accordance with the ASME BPE (BioProcessing Equipment) standard, the global benchmark for hygienic process design.
But what exactly is ASME BPE, and why does it matter for your cleaning systems?
The ASME BPE Standard, developed by the American Society of Mechanical Engineers, provides detailed requirements for the design, materials, fabrication, inspection, testing, and documentation of equipment used in bioprocessing, pharmaceutical, and personal care product manufacturing.
It covers:
Hygienic design and fabrication practices
Surface finishes and weld quality
Drainability and cleanability
Material compatibility and traceability
In short, ASME BPE defines what it means for equipment to be truly sanitary and fit for GMP-compliant environments.
ASME BPE mandates:
Crevice-free construction
Minimum internal surface roughness (≤0.5 µm Ra)
Orbital welds polished to pharmaceutical standards
These features reduce the risk of contamination, biofilm formation, and cleaning dead zones, essential for effective and validated CIP performance.
All Suncombe CIP systems are built to support regulatory compliance with:
FDA 21 CFR Part 11 (cleaning records & automation)
GMP and EU Annex 1
ISO 14644 and ISO 14001
ASME BPE provides the mechanical framework that aligns seamlessly with these regulatory requirements, from component traceability to full system documentation.
ASME BPE defines slope, orientation, and connection methods to ensure complete drainability, a critical factor for both cleaning efficacy and sterilisation. Combined with SIP (Sterilisation-in-Place), this guarantees systems are microbiologically clean post-CIP.
ASME BPE components are built to withstand:
High temperatures
Aggressive cleaning agents
Pressurised cycles
That means Suncombe systems remain robust and maintain their performance over decades of operation, lowering total lifecycle cost.
ASME BPE is the globally recognised standard in bioprocessing. By adhering to it, Suncombe ensures:
Ease of integration into international sites
Consistent inspection and documentation
Trusted quality by clients, auditors, and regulators
Using ASME BPE isn’t just about compliance, it’s about delivering CIP systems that are cleanable by design, efficient to operate, and sustainable over the long term. Combined with Suncombe’s custom engineering and automation expertise, this standard helps us build reliable systems that reduce waste, energy, and risk.
At Suncombe, we don’t just meet industry standards, we build to the highest ones. Incorporating ASME BPE into our CIP systems ensures our clients receive equipment that is safe, cleanable, compliant, and built for the future.
Whether you’re designing a new cleanroom facility or upgrading a legacy process, trust Suncombe to deliver ASME BPE-compliant CIP systems that stand up to the toughest environments and the most rigorous inspections.
We also offer an extensive product line, including GMP Washers, GMP Process Skids and Systems, and GMP Vessels. Contact us today to speak with our technical specialists. Email [email protected] or call +44 (0) 203 089 0280.
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