BUSINESS EXPERTISE 

Welcome to our Business expertise page, where you can explore detailed accounts of our past projects and see first-hand how our expertise in pharmaceutical plant design consultancy, maintenance services, and project management has benefitted our clients. Each case study highlights our approach, the challenges faced, and the solutions implemented to achieve optimal outcomes. One of our notable projects includes the design and implementation of a state-of-the-art pharmaceutical manufacturing facility for a leading UK-based company.  The project was delivered on time and within budget, resulting in increased production efficiency and significant cost savings for the client. In another example, we assisted a mid-sized pharmaceutical firm with the maintenance and upgrade of their existing plant. This proactive approach not only improved the plant's performance but also extended the lifespan of essential equipment. 

 

Experience and Expertise

Specializations:

• Facilities: Expertise in OSD, Pellet, Sterile, Injectable, Ointment, Liquid Oral, and API facilities.
• Quality Systems: Proficient in cGMP principles, quality systems, and documentation.
• Regulatory Compliance: Experienced in Validations, Pure Steam HVAC, Water, and critical systems as per ICH and WHO guidelines.
• Team Leadership: Skilled in leading and building Empowered Engineering & Maintenance (E&M) Teams, providing continuous support for quality output.

Key Competencies:

• Plant Operations: Comprehensive approach in delivering key results with plant energy conservation and cost-effectiveness.
• Documentation: Ensuring proper documentation/validation for equipment and utilities in coordination with quality control departments.
• SOP Preparation: Preparation of Standard Operating Procedures (SOPs) for plant operation and maintenance.
• Deviation Handling: Managing documentation for Deviation, Corrective and Preventive Actions (CAPA), and Out of Specification (OOS) for the engineering department.
• Equipment Validation: Expertise in production and utility equipment validation support, ensuring compliance with industry standards.
• Manufacturing Scale-Up: Proficiency in scaling up manufacturing processes using advanced engineering techniques to ensure efficiency and quality.
• Cost-Efficient Plant Design: Skilled in designing new pharmaceutical plants with a focus on cost efficiency and sustainability.

Project Executed 

Green Field Projects:

• GSK Nasik: Solid dose facility from definition phase to startup validation.
• GSK Nashik Plant: Injectable facility development.
• UCB India: Development of Metformin facility.
• Thame Laboratories UK: Installation and commissioning of Sterile facility and Water for Injection (WFI) system.
• Sun Pharma: Installation of purified water system (5M3) for the formulation plant.

Productivity and Energy Projects:

• Brine Chiller Installation: 40 TR capacity for API reactors and condensers.
• Productivity Improvement: Projects resulting in 50% and 100% productivity improvements, saving £0.50 million annually in packing material.
• Nutraceutical Facility: Installation and commissioning, including compression cubical remodeling.
• Dehumidification System: For low RH requirements in Sun Pharma INDIA.
• Liquid and Ointment Facilities: Installation and commissioning of packing lines, stirrer tanks, manufacturing equipment, and a 2T ointment plant.
• Cost-Efficient Design: Implementation of cost-efficient design strategies for new pharmaceutical plants, optimizing layout, materials, and processes for maximum efficiency and minimum cost.

Energy Conservation Projects:

• Boiler Efficiency: Preheat water project to improve boiler efficiency, VFD installation in air compressors, capacitor installation in chillers, cooling tower temperature sensor optimization.
• Chiller Flow Rate Optimization: Project saving up to £0.51 million.
• Water Conservation: Saving up to 5000 KL per year.

Pharmaceutical Utilities (Black & White) Calculations:

• Utility Calculations: Expertise in calculating pharmaceutical utilities, both black (non-GMP) and white (GMP) utilities, ensuring accurate resource allocation and cost management.
• Resource Optimization: Strategies to optimize the use of utilities, reducing operational costs and enhancing efficiency.

Clean Room Design:

• AutoCAD Design: Specializing in AutoCAD design for clean room facilities, ensuring optimal layout for efficiency and compliance.
• cGMP Compliance: Providing comprehensive cGMP compliance documents for regulatory audits.

EHS Management

Policy and Framework Development:

• EHS Policy Implementation: Ensuring compliance with the EHS policy on a day-to-day basis.
• Corporate Framework: Development of corporate framework for EHS, including guidelines and standards.
• Risk Assessments: Conducting risk assessments for all activities, identifying risks, prioritizing, and ensuring mitigation.

Safety and Compliance:

• Zero Accidents: Ensuring EHS procedures and practices are followed to achieve zero loss time accidents and zero non-compliances.

Productivity Improvement Plans

Strategic Initiatives:

• Lean Manufacturing: Implementing lean manufacturing techniques to reduce waste and increase efficiency.
• Process Optimization: Continuous assessment and optimization of processes to enhance productivity.
• Automation: Leveraging automation technologies to improve precision, reduce labor costs, and increase throughput.
• Training Programs: Developing and conducting training programs for staff to ensure high levels of competence and efficiency.
• Performance Monitoring: Establishing key performance indicators (KPIs) and monitoring systems to track progress and identify areas for improvement.