Production Facility Construction – Building the Future of Pharmaceutical Manufacturing

Polypharma Technologies & Sciences GmbH specializes in support for the design and construction of world-class pharmaceutical production facilities.

With deep expertise in engineering, regulatory compliance, and operational optimization, Polypharma partners clients in emerging markets to create GMP-compliant facilities that meet the highest standards of quality, safety, and efficiency.

Comprehensive Facility Construction Services

Polypharma’s professional and comprehensive service for the construction of new pharmaceutical plant is based on its many years’ experience in supporting private investors and companies in the development of pharmaceutical facilities in Middle East and Africa (MENA) region, including West and East Africa.

Pharmaceutical production is a complex process, involving multiple regulatory, quality and market considerations. Accordingly, Polypharma’s support for facility construction involves a series of necessary measures and phases, detailed below.

Conceptual Design and Feasibility Studies

Every successful project must begin with a clear vision. To form this vision, Polypharma can provide:

• Feasibility Studies to assess technical, financial, and operational viability.
• Conceptual Design to produce tailored layouts based on production needs and regulatory requirements
• Cost Estimation and Budget Planning to deliver realistic projections to ensure a project stays on track financially.

Facility Design and Engineering

Polypharma’s team of expert engineers and architects develops cutting-edge designs for pharmaceutical facilities, including:

• GMP-Compliant Layouts: Ensuring smooth material and personnel flow to minimize contamination risks.
• Cleanroom Design: Customizing cleanrooms to meet ISO and regulatory standards for sterility and hygiene.
• Utility and Infrastructure Planning: Designing robust HVAC, water systems, and electrical networks tailored to pharmaceutical needs.

Turnkey Solutions

Polypharma can handle every stage of facility construction:

• Procurement and Installation: Sourcing and integrating high-quality equipment and materials.
• Construction Management: Overseeing contractors, timelines, and budgets to ensure on-time delivery.
• Validation and Commissioning: Comprehensive testing to ensure the facility is operational and meets regulatory standards.

These are turnkey solutions that allow clients to focus on their core business.

Equipment and Process Integration

Seamless integration of production equipment is key to efficient operations. Here, Polypharma’s services include:

• Selection and installation of specialized pharmaceutical machinery.
• Process validation to ensure systems are calibrated for peak performance.
• Training for staff to maximize productivity and operational safety.

Regulatory Compliance and Certification

Navigating complex regulatory requirements is essential for facility approval. Polypharma provides:

• Expertise in meeting GMP, FDA, EMA, and WHO standards.
• Comprehensive documentation to support certification and audits.
• Ongoing support to maintain compliance during operations.

Pharmaceutical Facilities Key Features

• Scalable Design: Built to adapt to changing production needs.
• Energy Efficiency: Incorporating sustainable practices to minimize environmental impact and reduce costs.
• Operational Excellence: Optimized layouts for streamlined production and reduced downtime.
• Advanced Technology: Integration of automation, robotics, and data-driven systems for Industry 4.0 readiness.

Industries Served

Polypharma’s plant construction services have most recently been deployed to support a new entrant manufacturer in building a new facility for manufacturing of parenteral glucocorticoid products, such as methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

Polypharma’s facility construction expertise spans various sectors, including small molecule and API manufacturing, biopharma production, vaccine development and production, generic and branded drug manufacturing, and specialty drug formulation facilities.

Plant construction service benefits

Choosing plant construction support services from Polypharma Technologies & Sciences GmbH delivers a series of client benefits, including:

• End-to-End Expertise: Polypharma provide complete solutions, from initial planning to operational handover, ensuring a seamless process at every stage.
• Regulatory Mastery: Polypharma’s in-depth knowledge of global regulatory standards ensures the completed facility will be inspection-ready for any market.
• Customization: Polypharma can design facilities tailored to specific production goals and operational requirements.
• Proven Track Record: With years of experience in pharmaceutical facility construction, Polypharma has repeatedly shown it can deliver projects on time and within budget.

Resources

Click on Dossier development for production for further information.
Click on Raw material sourcing and supply for further information.
Click on Production plant construction for further information.
Click on Project planning for further information.