Excellence in OSD & External Preparation Manufacturing

Granulation in Pharmaceutical Manufacturing
Granulation in Pharmaceutical Manufacturing

The Engineering Department at Taj Pharma’s Sarigam facility plays a critical role in ensuring the seamless functioning, compliance, and efficiency of the Oral Solid Dosage (OSD) and External Preparation manufacturing units. The department is structured to support GMP-compliant operations, address technical challenges, and deliver continuous improvement across utility systems, process equipment, and production infrastructure.


Key Responsibilities & Capabilities

1. Plant Design & Layout Optimization

  • The engineering team contributes to the architectural and mechanical design of the plant to ensure optimal material and personnel flow, cleanroom zoning, and cross-contamination control.
  • The OSD and External Preparation units are designed with modular, scalable layouts, allowing flexibility for future expansion and regulatory upgrades (e.g., EU-GMP, PIC/S).

2. Equipment Selection, Installation & Commissioning

  • The facility houses high-speed granulators, tablet compression machines, capsule fillers, blenders, coating pans, and external preparation mixers.
  • Engineering services include IQ/OQ/PQ documentation for each machine as per validation protocols.
  • Precision in equipment calibration ensures adherence to batch-to-batch consistency and compliance with regulatory standards.

3. Preventive & Breakdown Maintenance

  • Scheduled preventive maintenance (PM) ensures minimal downtime, optimal equipment lifespan, and uninterrupted production.
  • An in-house team performs real-time troubleshooting, root cause analysis (RCA), and corrective actions (CAPA) using tools such as SCADA and automated diagnostics.

4. Utilities & Cleanroom Systems Management

  • Engineering oversees the HVAC systems (AHUs, HEPA filtration) to maintain controlled environments (ISO Class 7/8 areas for OSD and External Products).
  • Manages compressed air, purified water (PW/WFI), steam, chilled water, and effluent treatment systems with energy-efficient practices and sustainability goals.

5. Automation & Monitoring

  • Integrated control systems such as SCADA (Supervisory Control and Data Acquisition) and BMS (Building Management Systems) enable real-time monitoring of critical parameters like temperature, humidity, differential pressure, and utility performance.
  • Data from production and utilities are seamlessly recorded via 21 CFR Part 11-compliant systems, ensuring traceability and audit-readiness.

OSD & External Preparation Focus Areas

OSD Plant

  • Manufacturing of tablets, capsules, granules, and powders in controlled conditions.
  • Uses advanced automation for blending, granulation, compression, and coating to achieve uniform content and dissolution profiles.

External Preparation Plant

  • Production of creams, ointments, gels, and lotions using homogenizers, mixers, and tube-filling lines.
  • Designed with dedicated cleanroom areas and closed-loop transfer systems to minimize contamination and cross-contact risks.

Regulatory & Compliance Assurance

  • The engineering team aligns every utility and equipment function with WHO-GMP, ISO, GLP, and upcoming EU-GMP standards.
  • Engineering logs, calibration records, and system performance data are systematically maintained for regulatory audits.

The Engineering Services and Design department at Taj Pharma’s Sarigam plant is not just a support function—it is a strategic enabler of high-quality pharmaceutical manufacturing. Through precision engineering, preventive care, automation, and regulatory alignment, it ensures that the OSD and External Preparation plants run efficiently, compliantly, and safely—delivering world-class products to global markets.