In the world of pharmaceutical and bioprocessing manufacturing, cleaning isn’t just a task; it’s a validated, regulated, and auditable process. At Suncombe, we understand that effective Clean-in-Place (CIP) systems must go beyond mechanical function. They must deliver repeatable performance, full traceability, and data integrity every time.
That’s why we design our CIP systems with advanced control platforms that are fully ticks the FDA 21 CFR Part 11 compliance checklist, the gold standard for electronic records and electronic signatures in regulated industries.
What is 21 CFR Part 11?
21 CFR Part 11 is a regulation issued by the U.S. FDA that sets out the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records. For cleaning systems, this means:
- Secure, tamper-evident data logging
- Electronic audit trails
- Unique user credentials and access control
- Electronic batch record generation and review
Why Repeatability is Critical in CIP
In GMP-regulated environments, CIP repeatability is not optional, it’s a regulatory requirement. Each cleaning cycle must consistently deliver the same validated results, ensuring that:
- No product residues remain
- Microbial and cross-contamination risks are eliminated
- Batch-to-batch integrity is preserved
- Cleanroom operations remain compliant and auditable
- Suncombe control systems are designed to enforce and record these cycles precisely, cycle after cycle.
How Suncombe’s Control Systems Support Compliance and Reliability
1. Validated Cleaning Logic
Every Suncombe CIP skid includes programmable logic (PLC/SCADA) that enforces validated cleaning parameters:
- Time, temperature, flow, pressure, and conductivity
- Detergent dosing and recovery sequences
- Alarm and failure handling procedures
This ensures each cycle meets pre-approved protocols, with no operator variation.
2. 21 CFR Part 11-Ready HMI/SCADA Platforms
Our operator interfaces are designed for whole Part 11 compliance, including:
- Audit trails for all user actions
- Electronic signatures for batch approvals
- Secure login with unique user credentials
- Data backup and encryption capabilities
Whether connected to a standalone unit or a centralised plant network, these systems are ready for audit at any time.
3. Electronic Batch Records (EBR)
Our control systems generate real-time cleaning cycle reports that can be:
- Archived digitally
- Reviewed remotely
- Printed or integrated into a plant-wide MES (Manufacturing Execution System)
This supports both internal QA review and external regulatory inspections.
4. Customisable and Future-Proof
Suncombe systems are engineered with flexibility in mind, allowing for:
- Multi-channel CIP control
- Recipe management for different product lines
- Remote access and diagnostics
- Integration with IoT, Industry 4.0, and digital twin tools
- We ensure your CIP controls grow with your facility, not against it.
Trusted in Validated Facilities Worldwide
Suncombe’s CIP systems are used in some of the world’s most regulated and complex production environments, from pharmaceutical and vaccine manufacturing to advanced biologics, CDMOs, and research laboratories. Our control systems are a key reason why clients trust our equipment to clean right, log right, and pass inspection every time.
Contact Suncombe For Validated CIP Systems
We have been a trusted provider of industrial sanitary processing systems since 1961. Our 21 CFR Part 11 compliance checklist helps clients reduce risk, improve audit readiness, and maintain product quality across every batch.
Our CIP, GMP Washers, GMP Vessels, and other processing equipment ensures your manufacturing line is free of contaminants and sustainable.
Contact us today for more information on our CIP solutions. Email [email protected] with your requirements or call +44 (0) 203 089 0280 to speak to one of our specialists.
