How to Strengthen Homogeneity, URS Development, and Compliance for Explosible Powders
U.S. pharmaceutical manufacturers are under more pressure than ever to deliver consistent product quality, minimise deviation risks, and meet increasingly demanding expectations from the FDA, auditors, and commercial stakeholders.
Whether you are formulating tablets, capsules, nutraceutical blends, intermediates, or R&D-scale batches, challenges often appear in three areas:
–Achieving repeatable blend homogeneity
–Creating a robust URS that truly defines what you need
–Safely handling explosible powders while meeting compliance expectations
At Terriva, these are the most common points raised by U.S. operations, quality, and engineering teams. Below, we break down what typically goes wrong—and how to build a stronger, more compliant, and more scalable blending process.
Homogeneity Challenges in U.S. Pharmaceutical Facilities
Why blends fail—and how to fix them
Inconsistent homogeneity is a major contributor to batch failure, rework, and regulatory exposure. The underlying causes are often predictable.
Common Root Causes
-Sensitive powders with diverse particle sizes/bulk densities
-Segregation during loading or discharge
-Incorrect fill ratios
-Poor IBC design (dead zones, insufficient flow)
-Inadequate blender RPM or blending profile
What U.S. manufacturers can do
1. Validate the optimum fill level, usually between 50–70% depending on material.
2. Use geometrically accurate blending containers, designed to reduce dead spots.
3. Introduce repeatable, documented blending profiles supported by 21 CFR Part 11.
4. Consider intensifier bars and internal baffles for difficult formulations.
5. Benchmark blend endpoint detection with sampling or NIR technologies.
Where Terriva supports:
Our Pharmatech blenders are designed around achieving predictable homogeneity, and many U.S. customers pair these with NIR validation or staged test blending before specifying a full-scale system.
Creating a URS That Sets Your Project up for Success
Avoid generic or incomplete specifications that cause delays
A User Requirement Specification (URS) is one of the most influential documents in any pharmaceutical equipment project. Yet, many U.S. manufacturers struggle with:
- – Missing compliance and safety parameter
– Overly generic URS templates - – Requirements copied from unrelated equipment
- – Lack of clarity about future expansion or scale-up
A high-quality blending URS should include:
– Batch sizes and powder characteristics (bulk density, cohesiveness, API potency) - – Homogeneity expectations and test methodology
- – Cleaning method & validation approach
- – 21 CFR Part 11 data expectations
- – ATEX/Div 1–2 environment classification (if applicable)
- – Room layout, operator access, and workflow
- – Material transfer method and containment expectations
Why this matters:
A precise URS is how you ensure the blender is engineered for your process—not for someone else’s.
How Terriva helps:
We routinely review draft URS documents for U.S. customers and hold free pre-URS consultations to ensure requirements are clear, realistic, and fully aligned with your compliance needs.
Handling Explosible Powders: Meeting U.S. Compliance Expectations
Understanding ATEX, NFPA, and hazardous-area classifications
Handling explosible powders in the U.S. requires strict alignment with NFPA and NEC guidelines. This area is often misunderstood, particularly when powders behave differently during blending, transfer, or discharge.
Typical concerns raised by U.S. manufacturers:
“Does my powder actually require explosion-protected equipment?”
“Do I need ATEX equipment even though I’m in the U.S.?”
“What documentation do auditors expect during a dust hazard analysis?”
“How do I avoid electrostatic discharge during blending and IBC transfer?”
Key points to understand:
– The U.S. relies on NFPA, OSHA, and NEC (Div 1/2) requirements.
– Many companies also source ATEX-certified systems because they provide a globally recognised safety standard for explosible powders.
– A Dust Hazard Analysis (DHA) is mandatory under NFPA 652.
– Equipment surfaces, seals, IBC design, and grounding systems play a critical role in mitigating ignition risks.
Where Terriva supports:
Terriva specialises in supplying equipment that is suitable for ATEX environments, and explosion-protected blending systems, dust-free connection solutions, and handling equipment that comply with U.S. NFPA/OSHA expectations.
Our Connection Systems range (Dust Cap Seals, Flexiducts, FlexiSieves, etc.) is commonly used to contain dust, eliminate spills, and reduce explosion risk during transfers.
What U.S. Manufacturers Gain by Strengthening These Three Areas
– Reduced batch failures caused by segregation or variability
– Shorter validation timelines with clearer URS documentation
– Greater compliance confidence during FDA, NFPA, and internal audits
– Enhanced operator safety and dust control
– A blending process that is scalable and future-proof
How Terriva Supports U.S. Pharmaceutical Manufacturers
Terriva (with our Pharmatech powder blenders and Connection Systems dust-free transfer equipment) supports manufacturers across the United States with:
– Consultation-led project scoping
– URS review and guidance
– ATEX and NFPA compliant systems
– Precision-engineered blenders from 5L to 1,200
– Dust-free transfer solutions that eliminate contamination
– Full FAT, SAT, and validation support
We have more than 40 years of global experience helping teams improve powder homogeneity, achieve compliance, and build reliable blending processes that perform for decades.
If you’re a U.S. pharmaceutical manufacturer experiencing challenges with homogeneity, compliance, or equipment specification, our engineering team is here to help.
Book a free technical consultation with Terriva
We’ll review your process, challenges, and URS—or help you build one from scratch.
