compliance
COMPLIANCE & VALIDATION
Regulatory Compliance and Certification of CPC Equipment
Centrifugal Partition Chromatography (CPC) offers tailor-made solutions for industrial separation needs. With the growing demand for sustainable high-purity compounds in pharmaceuticals, cosmetics, food, and natural products, CPC is gaining traction as a reliable, scalable, and cost-efficient separation method. Today, industrial-scale CPC equipment is available with certifications and markings that meet stringent international standards, enabling smooth integration into regulated environments.
Full-Scale System Suitability and Reliability Assessment for CPC Platforms
Reliable scale-up in chromatography requires reproducible resolution, stable stationary-phase retention, and predictable performance across operating conditions and system sizes. Using well-defined model compounds, CPC can be benchmarked under varying centrifugal fields and load ranges to confirm robustness, linear scalability, and consistent separation quality from benchtop to pilot scale. Establishing these system suitability parameters ensures that CPC setups remain stable and reliable before transitioning to complex or high-value purification tasks.
The most common standards and what they mean for industrial CPC systems
GMP – Good Manufacturing Practice
GMP compliance guarantees that every aspect of the CPC system — from design through daily operation and maintenance — is built to deliver consistent quality, protect against contamination, and satisfy the rigorous standards of regulated applications, including full traceability and process validation. Key elements include, but not limited to:
URS, qualification phases (DQ, IQ, OQ)
GMP cleanroom, FAT, SAT
FDA 21 CFR part 11/Eudralex Volume 4 Annex 11 compliant software
FDA/GMP compliant wetted parts and material certificates
| Standards overview | ||||
|---|---|---|---|---|
| Compliance | Region | Focus | Impact on CPC equipment | Who needs it |
| Pharma GMP | Global (FDA, EMA, Eudralex Volume 4.) | Product quality, traceability, hygiene; cleanability | Requires hygienic design and cleaning validation, full traceability, qualification protocols (IQ/OQ/PV), and documentation; FDA 21 CFR Part 11 compliance | Pharma, biotech, API manufacturing |
CE Marking – EU Compliance
CPC meets the EU safety, health, and environmental requirements and validated through CE certification by accredited bodies such as Saasco Ltd. ensures:
The equipment meets EU directives.
Risk assessments and conformity evaluations have been performed.
The product can be freely sold and operated within the European Economic Area (EEA).
| Compliance | Region | Focus | Applies To | Impact on CPC Equipment | Who Needs It? |
|---|---|---|---|---|---|
| CE | European Union | Health, safety, and environmental protection | Electrical systems, pressure, vessels, mechanical safety | Equipment must meet EU directives (e.g., Low Voltage Directive, EMS, Machinery Directive); includes risk assessment and declaration of conformity | Any CPC system sold or operated in the EU |
ATEX – Equipment for Explosive Atmospheres (EU)
ATEX certification is required for equipment used in hazardous, potentially explosive atmospheres. Given that CPC processes involve flammable solvents under pressure and at elevated temperatures, systems must be designed and certified according to the applicable ATEX zone classification. This entails specific construction, sealing, and marking requirements. Compliance ensures both operational safety and regulatory acceptance in the EU and beyond.
Zone 0, 1, 2 refer to areas with increasing risk of gas or vapor explosion.
| Compliance | Region | Focus | Applies To | Impact on CPC Equipment | Who Needs It? |
|---|---|---|---|---|---|
| ATEX | European Union | Explosion safety | Equipment used in potentially explosive atmospheres( gases, vapors, dusts) | Requires flameproof enclosures, anti-static design, zone classification (e.g Zone 1, Zone 2), specific labeling (Ex symbols) | Plants using flammable solvents or powders (e.g, ethanol, acetone) |
HazLoc (IECEx) – Equipment for Explosive Atmospheres (USA)
HazLoc (IECEx) certification is mandatory for equipment used in potentially explosive atmospheres in the United States. Given that CPC processes involve flammable solvents at high pressure and elevated temperature, CPC systems must comply with the relevant hazardous area zone classification of the installation site.
| Compliance | Region | Focus | Applies To | Impact on CPC Equipment | Who Needs It? |
|---|---|---|---|---|---|
| HazLoc (IECEx) | United States | Explosion safety | Equipment used in potentially explosive atmospheres (gases, vapors, dusts) | Requires flameproof enclosures, anti-static design, zone classification (e.g., Class 1, Class 2), specific labeling (Ex symbols) | Plants using flammable solvents or powders (e.g., ethanol, acetone) |
UL / CSA – Certification for North America
In case of exporting CPC systems to the United States or Canada, UL (Underwriters Laboratories) or ULC/CSA (Canadian Standards Association) certification is often required. UL certification assures customers that the CPC system meets North American safety standards and can be legally installed and operated in these markets. These certifications focus on:
Electrical and fire safety
Mechanical integrity
Reliable industrial performance
| Compliance | Region | Focus | Applies To | Impact on CPC Equipment | Who Needs It? |
|---|---|---|---|---|---|
| NRTL (UL/TÜV/CSA) | United States (UL), Canada (CSA/ULC) | Electrical & fire safety | Electrical systems, control panels, mechanical components | Electrical components must be tested and certified; ensures safety and regulatory acceptance in North America | CPC systems exported to the US or Canada |
Tailor-Made Equipment for Industrial Use
Given the wide variety of compliance requirements across industries and regions, CPC systems are:
Modular, allowing for bespoke client specific customization.
Designed and manufactured to meet sustainability guidelines.
Upgradeable, to support optional compliance and regulatory requirements (CE/UL/NRTL/GMP and also design and safety directives, ATEX/IECEx).
| Research-scale instrument | Pilot-scale instrument | Industrial-scale instrument w/o solvent handling | |||||||
|---|---|---|---|---|---|---|---|---|---|
| CE | NRTL (UL/TÜV) | GMP | CE | NRTL (UL/TÜV) | GMP | CE | NRTL (UL/TÜV) | GMP | |
| Standard emergency shutdown | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Rotor dry-running protection | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Additional power supply unit | N/A | N/A | N/A | Yes | N/A | Yes | Yes | Yes | Yes |
| Enclosed preparative unit1 | N/A | N/A | N/A | N/A | N/A | YES | N/A | N/A | N/A |
| Counter cabinet design2 | N/A | N/A | N/A | Yes | Yes | Yes | Yes | Yes | Yes |
| Higher level of machinery safety | N/A | N/A | N/A | Yes | Yes | Yes | Yes | Yes | Yes |
| Modular design3 | N/A | N/A | N/A | N/A | N/A | N/A | Yes | Yes | Yes |
| Explosion proof design4 | N/A | N/A | N/A | Industrial version | Industrial version | Industrial version | Yes | Yes | Yes |
1 Can be taken to pharmaceutical clean room
2 With touch screen or keypad
3 Expandable with technologic sub units
4 Atex zone 2 / UL class 1 division 2