Pharmaceutical & cGMP Facilities
Pharmaceutical sterile and solid dosage manufacturing demands zero tolerance for microbiological contamination, pressure cascade loss, or punch binding. A single cleanroom pressure reversal or tablet punch seizure reject...
Aristopharma / Incepta Sterile & Solid Dosage Plant
📍 Dhamrai Industrial Zone, Dhaka, Bangladesh
Industrial Facility Profile & Technical Baseline
WHO cGMP & US FDA-ready facility: Grade A/B/C/D Cleanrooms, 24 Air Handling Units (AHU), 3,000 L/h Purified Water (PW/WFI) Generation Loop, 8 High-Speed Rotary Tablet Presses, 4 Blister Packaging Lines.
Sector-Specific Operational Vulnerabilities
Pharmaceutical sterile and solid dosage manufacturing demands zero tolerance for microbiological contamination, pressure cascade loss, or punch binding. A single cleanroom pressure reversal or tablet punch seizure rejects a batch worth 15M BDT, while paper-based calibration records invite severe DGDA, WHO, or US FDA warning letters.
The Wrysto Industrial CMMS Solution
Wrysto CMMS provides 21 CFR Part 11 compliant immutable electronic signatures, tracks tablet press stroke cycles to trigger punch polishing and dust cup replacements, monitors AHU running hours for automated PAO HEPA leak tests, and manages pure water hot loop sanitization logs with cryptographic audit trails.
Pre-Configured CMMS Modules for Pharmaceutical & cGMP Facilities
21 CFR Part 11 Audit Trail
Every checklist sign-off, technician calibration entry, and part replacement is cryptographically timestamped and immutable.
Tablet Press Stroke Cycles
Track turret stroke cycles to schedule lubrication every 500,000 strokes and punch tip optical length checks every 2,000,000 cycles.
Cleanroom HEPA & Pressure Logs
Automate differential pressure logging across Grade A/B/C cleanrooms and attach PAO integrity certificates to AHU cards.
WFI Sanitization Run-Logs
Enforce weekly 85°C pure water loop hot sanitization sign-offs before manufacturing shifts commence.
Why Leadership Chooses Wrysto Enterprise
“If a tablet press punch binds or the cleanroom pressure drops mid-batch, an entire 1,000,000-tablet batch of antibiotics worth 15M BDT is rejected. With Wrysto CMMS cycle tracking and pre-emptive punch lubrication schedules, punch binding is stopped before it starts.”