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GRANULATION & SOLID DOSAGE PREPARATION • cGMP OEM INDENTING

Pharmaceutical Fluid Bed Dryers & Integrated Granulation Suites
cGMP High-Shear Granulation, Drying & Sizing Lines across Pakistan

BTI engineers complete, dust-free turnkey oral solid dosage granulation suites pairing Rapid Mixer Granulators (RMG), conical wet mills, Fluid Bed Dryers / Processors (FBD/FBP), and dry sizing mills. Featuring 2-bar or 10-bar explosion pressure shock design, 100% pneumatic sealing, and HEPA-filtered air preparation skids compliant with WHO cGMP and DRAP guidelines.

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TECHNICAL PARAMETERS

Certified cGMP Engineering Specifications

Design & Operational Parameter Factory Indenting Specification
Working Bowl Capacity 30 Liters up to 1,200 Liters per batch
Explosion Pressure Shock 2-bar or 10-bar rated pressure shock design with explosion venting
Air Preparation Skid 3-stage filtration (G4 Pre, F9 Fine, H13/H14 HEPA) with face velocity monitoring
Process Versatility Drying, Top Spray Granulation, Bottom Spray Wurster Pellets, Tangential Coating
Contact Metallurgy Certified AISI 316L (Internal Ra ≤ 0.4 µm mirror electropolish)
Exhaust Filtration Multi-chamber pneumatic shaking anti-static filter bags or automated stainless cartridge CIP
Control Architecture Siemens S7-1500 PLC with Pro-face Touch HMI, 21 CFR Part 11 compliant
COMMERCIAL VALUE MATRIX

Direct Factory Indenting vs. Local Stockist Markups

Evaluation Parameter BTI Factory Direct Indenting Traditional Local Stockist
Capital Expenditure (Capex) Direct Ex-Works (EXW) Factory Net (Zero middleman markup; 30%–50% savings) Heavily inflated price with hidden storage and financing margins
Custom URS Compliance Custom fabricated to exact client batch dimensions, tooling, and cycle parameters Fixed shelf stock with obsolete PLC software and rigid non-custom sizes
Metallurgy & Finish Certified AISI 316L Contact (Ra ≤ 0.4 µm) with official material test certificates (MTC) Uncertified metallurgy; risk of lower SS 304 or inferior grade substitution
Pre-Shipment FAT Full high-definition FAT video, dry/wet cycle logging, and boroscopy inspection No pre-shipment FAT logs; client accepts whatever arrives at the warehouse
Validation & Licensing (DRAP) Turnkey DQ, IQ, OQ, PQ dossiers compliant with WHO, 21 CFR Part 11, and DRAP Generic user manual only; no qualification dossiers for DRAP licensing
FREQUENTLY ASKED QUESTIONS

Engineering & Procurement FAQ

Can BTI supply an integrated vacuum transfer closed granulation line?
Yes. We supply fully integrated closed granulation systems where powder is loaded into the RMG via vacuum transfer, wet milled directly into the FBD bowl, dried, and dry milled into intermediate bulk containers (IBCs) without human contact or airborne dust.
What is the typical drying time for an FBD batch?
Depending on moisture content and binder chemistry, fluid bed drying is typically accomplished in 20 to 45 minutes, representing an 80% reduction in drying time compared to conventional vacuum tray ovens.
How does BTI handle local commissioning in Pakistan?
BTI field engineers provide complete mechanical erection, ductwork integration, utility hookup (steam/chilled water/compressed air), DQ/IQ/OQ validation protocols, and on-site operator training across Lahore, Karachi, Hattar, and Islamabad.

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Connect directly with BTI Technical Indenting Desk. Receive an itemized factory EXW proforma, boroscopy logs, and landed customs calculations.

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