Pharmaceutical

GMP-compliant powder handling for
pharmaceutical manufacturing.

Pharmaceutical powder handling requires GMP-grade equipment, full batch traceability, and contained transfer to prevent cross-contamination. ENZAC engineers cGMP-compliant systems for API and excipient handling.

cGMP
Design standard for all pharmaceutical handling systems
100%
Batch traceability through every transfer point
IQ/OQ/PQ
Full validation documentation package
Industry Challenges

The problems that need engineering — not workarounds.

🔬
Cross-Contamination Prevention
API and excipient powders cannot mix between batches. Contained transfer systems, split-butterfly valves, and rigorous CIP/WIP procedures are required at every interface.
📋
GMP Documentation
FDA 21 CFR Part 11 and GMP Annex 15 require IQ, OQ, PQ validation documentation for all process equipment. ENZAC produces full validation packages as part of the project deliverable.
⚗️
Potent Compound Handling
Highly potent APIs (HPAPI) require OEL-rated containment systems. Gloveboxes, contained bag transfer, and continuous liner systems to OEB 4/5 can be specified where required.
ENZAC Solutions

How we solve them.

01
Contained Powder Transfer
Split-butterfly valves and continuous liner transfer systems for contained API and excipient transfer between vessels. OEB-rated options available for potent compounds.
02
Vacuum Conveying — GMP Grade
316L stainless steel vacuum conveying systems for pharmaceutical powders. Clean-in-place (CIP) design, full drainability, FDA-compliant gaskets, and surface finish Ra ≤0.8μm throughout.
03
Loss-in-Weight Feeding
High-accuracy loss-in-weight feeders for pharmaceutical batching. ±0.1% or better accuracy. Stainless steel contact parts. Full audit trail integration with batch management systems.
04
IQ/OQ/PQ Documentation
Complete installation, operational, and performance qualification documentation. FAT protocols, SAT protocols, calibration records, and training records delivered as part of project close-out.
Capability Focus · Pharmaceutical Handling
GMP powder handling systems — validation-ready from day one
Pharmaceutical clients engage ENZAC when their existing bulk handling equipment cannot satisfy regulatory auditors — whether that's documentation gaps, non-hygienic designs, or inadequate containment for potent compounds. We design to GMP from the first drawing and produce the validation documentation as part of the delivery.
  • GMP design from concept to commissioning
  • IQ/OQ/PQ documentation package
  • CIP/WIP capable design throughout
  • Full batch traceability integration
cGMP
Design standard maintained throughout
IQ/OQ/PQ
Validation package delivered as standard
Relevant Technology & Equipment

Technology that integrates with this solution.

VisionGuard™ Label CheckERIP MonitoringVacuum ConveyingWeighfeeding
Your bulk handling system needs to pass the next FDA audit.
Tell us your API, your OEB rating, and your containment requirement. We'll design to it.
Get a Quote →WhatsApp