Compliance Capability

EU-GMP & Certifications

Our extraction equipment is engineered to support the world's most demanding regulatory standards. From configurations designed to support EU-GMP facility compliance to hazardous-location options, systems can be built to support your certification requirements. Certification status varies by product and configuration and is confirmed in writing with the quote.

Tailoring solutions to meet your country's regulations—wherever in the world you operate.

EU-GMP facility support
ASME code construction
UL-recognized components
C1D1-ready design

Certifications & Configurations

Decimal systems can be configured to support a range of international safety and quality standards. Available certifications and configurations vary by product and are confirmed in writing with the quote.

EU-GMP
European Good Manufacturing Practice

Decimal extraction systems are designed to support EU-GMP facility compliance for pharmaceutical-grade cannabis production, with documentation and validation packages available to support your qualification in European markets.

Key Benefits:

  • Access to European pharmaceutical markets
  • Highest quality assurance standards
  • Full documentation and validation
  • Batch tracking and traceability

Industries: Pharmaceutical, Medical Cannabis

ASME
American Society of Mechanical Engineers

ASME code construction with a U-stamp is available as an optional configuration on qualifying pressure vessels, providing documented safety and quality in vessel design and fabrication.

Key Benefits:

  • Pressure vessel safety
  • Code-compliant construction
  • Regulatory documentation
  • Optional U-stamp on qualifying vessels

Industries: All Industries

UL-Recognized Components
Underwriters Laboratories

Decimal control systems are built using UL-recognized electrical components, providing third-party-evaluated safety for the individual parts that make up the electrical panel.

Key Benefits:

  • Electrical safety verified
  • Fire hazard prevention
  • Insurance compliance
  • Building code compliance

Industries: All Industries

C1D1
Class 1 Division 1

Qualifying hydrocarbon extraction systems are designed to support operation in C1D1-classified areas where flammable gases or vapors may be present. Designed to support facility compliance; final classification is determined by your facility and local authority.

Key Benefits:

  • Designed for hazardous-location facilities
  • Supports state licensing documentation
  • Explosion-protection design features
  • Supports fire marshal review

Industries: Cannabis Extraction

Industry Insight

Why GMP Matters Now

As cannabis moves to Schedule III, more states reform their regulations, and new markets open around the world, GMP is quickly becoming the rule rather than the exception.

Good Manufacturing Practices (GMP) certification is becoming the standard for cannabis product manufacturing. The regulations ensure products are made consistently, reliably, and are safe for consumers. By following GMP guidelines and using qualified equipment, cannabis companies demonstrate compliance and obtain the licenses necessary to compete globally.

1

Ensures Product Quality

GMP certifications ensure that the manufacturing process follows strict quality guidelines, leading to high-quality, consistent, and safe products.

2

Regulatory Compliance

GMP compliance is mandatory for manufacturers of pharmaceuticals and medical cannabis. Non-compliance can result in legal consequences and product recalls.

3

Reduces Contamination Risk

GMP guidelines outline specific procedures to minimize contamination during manufacturing, storage, and distribution, preventing impurities that compromise product safety.

4

Enhances Traceability

GMP requires detailed records of processes including raw material sourcing, production, and distribution, ensuring products can be traced back to their source.

5

Improves Process Control

GMP emphasizes process control and monitoring, helping identify and address deviations from established standards for a safer manufacturing environment.

6

Builds Consumer Trust

GMP certification demonstrates commitment to producing safe and effective products, enhancing consumer trust and brand recognition.

7

Facilitates Global Trade

GMP certification is recognized globally, making it easier to export products to other countries and expand market opportunities.

8

Encourages Improvement

Regular audits and assessments help manufacturers identify areas for improvement, encouraging a culture of continuous enhancement.

9

Mitigates Liability

By adhering to GMP guidelines, manufacturers reduce liability in the event of product-related issues or recalls, protecting financial interests.

10

Protects Public Health

Ultimately, GMP certification ensures products meet rigorous safety and quality standards, protecting public health and well-being.

The Importance of Qualified Equipment

Any GMP certification process includes analysis of facility processing equipment to ensure cannabis products are safe for consumption and free from harmful contaminants. Equipment designed to support GMP compliance helps control variables such as temperature, humidity, and pressure to ensure each batch meets required specifications.

Compliance Services

Beyond the equipment itself, we provide comprehensive compliance support to help you navigate complex regulatory requirements.

GMP Turnover Package

Complete step-by-step Validation Guide with all protocols, specifications, and testing required to qualify your equipment for GMP certification.

International Regulatory Support

Expert guidance on meeting regulatory requirements in any jurisdiction worldwide, from US state regulations to EU-GMP standards.

Facility Compliance Design

Turnkey facility design services ensuring your extraction lab meets all local, state, and international compliance requirements.

IQ/OQ/PQ Validation

Installation, Operational, and Performance Qualification documentation packages with audit-ready records for regulatory inspections.

Global Regulatory Expertise

We tailor equipment configurations and documentation to the regulatory requirements of each jurisdiction, wherever you operate.

United States

Serving states with licensed cannabis programs; equipment and documentation to support facility licensing

European Union

Designed to support EU-GMP facility compliance and documentation for qualifying systems

Canada

Health Canada compliant equipment and documentation

Australia

TGA-ready equipment for therapeutic goods

Latin America

Colombia, Uruguay, and emerging markets

Asia Pacific

Thailand, South Korea, and regional markets

From Raw Steel to Finished System

As a full manufacturer, we start from rolled raw stainless steel and control every step of the fabrication process. This vertical integration ensures consistent quality and complete traceability—essential for regulatory compliance.

Welds, components, and systems are documented and verified against our quality management system. Documentation packages are available by product and configuration, with the scope confirmed in writing with your quote.

USA Manufactured
Full Documentation
Rapid Response
Limited Warranty — see coverage

ASME Code Construction

Optional U-Stamp on qualifying vessels

Need Certified Equipment for Your Market?

Whether you're building a pharmaceutical-grade facility in Europe or launching a licensed extraction operation in the US, we have the equipment configurations and expertise to help you support your compliance goals.

Decimal Engineered Systems
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