CASE STUDY
Pharmaceutical Formulation Plant
General & Cephalosporin Products
Sands Active by Melwa
Colombo, Sri Lanka | 2021 – 2023
Project Overview
JD Pharma & Consultant was appointed by Sands Active by Melwa to deliver comprehensive engineering design and equipment selection services for the development of a state-of-the-art pharmaceutical formulation plant in Colombo, Sri Lanka. The facility encompasses two distinct manufacturing wings: a General Formulation section and a fully contained Cephalosporin section, both designed and engineered in strict conformance with EU-GMP and WHO-GMP regulatory standards.
The project spanned 2021 to 2023 and represents one of the most technically comprehensive pharmaceutical engineering engagements undertaken by JD Pharma & Consultant in South Asia. The facility is equipped to produce a wide range of pharmaceutical dosage forms including granulated solid oral products and advanced sterile cephalosporin formulations meeting the dual compliance bar of European and WHO regulatory frameworks.
2 Years
Project Duration
120–240 kg
Granulation Capacity
120 vials/min
Dry Injection
EU-GMP / WHO-GMP
Regulatory Standard
Project Snapshot
Project Title | Pharmaceutical Formulation Plant General & Cephalosporin Products |
Client | Sands Active by Melwa |
Project Type | Greenfield Pharmaceutical Manufacturing Facility |
Location | Colombo, Sri Lanka |
Project Start | 2021 |
Project Completion | 2023 |
Duration | Approximately 2 Years |
Regulatory Standards | EU-GMP (European Union Good Manufacturing Practices) & WHO-GMP |
Services Provided | Engineering Design, Equipment Selection & Procurement Support, Full Engineering Services |
Project Status | Successfully Completed |
Product Portfolio & Manufacturing Capacity
Dosage Forms & Output Rates
General Formulation Granulation | 120 kg & 240 kg batch capacity |
Cephalosporin Dry Injection | 120 vials per minute |
Cephalosporin Dry Syrup | 80 bottles per minute |
Manufacturing Capacity Summary
General Formulation Granulation | 120 kg & 240 kg per batch |
Dry Injection (Cephalosporin) | 120 vials/min |
Dry Syrup (Cephalosporin) | 80 bottles/min |
Engineering Design & Services Provided
JD Pharma & Consultant provided a full-spectrum pharmaceutical engineering service encompassing facility design, cleanroom engineering, utility systems, equipment selection, containment design, and regulatory documentation. The scope covered all engineering disciplines required to develop and commission a dual-zone GMP-compliant manufacturing facility as detailed below:
# | Engineering Area | Description of Services |
01 | GMP Facility Layout & Zoning Design | Developed a dual-zone GMP layout segregating General Formulation and Cephalosporin manufacturing areas with dedicated airlocks, personnel change rooms, pass-through hatches, and buffer zones. Room classification (ISO Class 7 & 8) was defined in conformance with EU-GMP Annex 1 and WHO-GMP guidelines. |
02 | HVAC & Cleanroom Engineering | Designed dedicated HVAC systems for each zone including Air Handling Units (AHUs), HEPA H13/H14 filtration, recirculation and fresh air balancing, differential pressure cascades, temperature/humidity control, and room pressurisation schemes. An entirely separate, negatively pressurised HVAC system was engineered for the cephalosporin section to ensure zero cross-contamination. |
03 | Process & Material Flow Engineering | Established unidirectional process flows for raw materials, in-process materials, intermediates, and finished goods. Personnel flow was separated from material movement pathways. Flow diagrams were prepared for both the General and Cephalosporin sections aligned with EU-GMP Annex 15 and WHO TRS principles. |
04 | Equipment Selection & Procurement Support | Provided detailed User Requirement Specifications (URS) and technical evaluation support for all key process equipment including: Granulation line Rapid Mixer Granulator (RMG) and Fluid Bed Dryer/Processor (FBD/FBP) for 120 kg and 240 kg batch capacities; Tablet compression, film coating, and capsule filling equipment; Dry Injection filling line rated at 120 vials/min (vial washing, depyrogenation tunnel, filling and stoppering, capping); Dry Syrup blending and filling line rated at 80 bottles/min; Blister packaging and carton packing equipment. |
05 | Utility System Design | Engineered all GMP-critical and non-critical utility systems including: Purified Water (PW) generation (RO + EDI) and distribution loop; Water for Injection (WFI) system with hot-loop recirculation; Clean Steam and Pure Steam generation; Oil-free compressed air system with point-of-use filtration; Nitrogen supply for product protection; Chilled water system for process cooling; Electrical distribution and instrumentation layout. |
06 | Containment Engineering Cephalosporin Section | Designed a fully self-contained cephalosporin manufacturing wing incorporating negative pressure suites, dedicated gowning routes, HEPA-filtered exhaust systems, independent utilities, and dedicated waste streams. Engineering controls were established to prevent any beta-lactam contamination of the general formulation area, fully conforming to EU-GMP Annex 2 and WHO contamination control strategy requirements. |
07 | Dry Injection (Parenteral) Line Engineering | Provided specialised engineering for the sterile dry powder injection line including aseptic core design (Grade A/B zones), vial washing machine, depyrogenation tunnel (dry heat sterilisation), powder filling and stoppering under Grade A LAF, automatic capping, and 100% inspection conveyor. The design complied with EU-GMP Annex 1 sterile manufacturing guidelines. |
08 | Quality, Safety & Environmental Systems | Integrated environmental monitoring (EM) sampling points, viable and non-viable particle monitoring locations, drain design with cleanability, wash-in-place (WIP) and clean-in-place (CIP) provisions, spill containment for cephalosporin area, emergency eyewash and safety stations, and fire suppression and evacuation planning. |
09 | Validation & Qualification Engineering Support | Prepared Design Qualification (DQ) documentation for the facility and critical systems. Provided engineering inputs for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for HVAC, utilities, and process equipment, ensuring the site is inspection-ready for EU-GMP and WHO regulatory audits. |
10 | Engineering Documentation & Deliverables | Produced a complete engineering documentation package including: Architectural GMP layout and zoning drawings; P&IDs for all process and utility systems; HVAC layout drawings and AHU schedules; Equipment list, specifications, and URS documents; Room data sheets (classification, pressure, finish, temperature/humidity); Utility flow diagrams and isometrics; Design Qualification (DQ) reports. |
Regulatory Compliance Framework
The facility was designed to satisfy the dual compliance requirements of EU-GMP and WHO-GMP one of the most stringent regulatory frameworks applicable to pharmaceutical manufacturing globally. Key compliance elements integrated at the engineering design stage include:
- EU-GMP Annex 1 compliance for sterile manufacturing (Dry Injection line design)
- EU-GMP Annex 2 specific requirements for biological, immunological and similar products (Cephalosporin containment)
- WHO TRS GMP guidelines facility design, air handling, water systems and equipment
- ISO 14644-1 cleanroom classification (Grade A/B/C/D aligned with EU-GMP)
- Contamination Control Strategy (CCS) embedded in engineering design per EU-GMP Annex 1 (2022 revision)
- Design Qualification (DQ) documentation for all critical systems and equipment
- Unidirectional personnel, material and waste flows to maintain GMP segregation
- Dedicated utility systems per zone to prevent cross-contamination
Scope of Services Summary
The complete scope of engineering and consultancy services delivered by JD Pharma & Consultant for this project is summarised below:
- GMP Facility Layout and Zoning Design
- HVAC and Cleanroom System Engineering (General & Cephalosporin zones)
- Sterile Dry Injection Manufacturing Line Engineering (EU-GMP Annex 1)
- Dry Syrup Manufacturing Line Engineering
- General Granulation Line Design (120 kg & 240 kg capacities)
- Equipment Selection, URS Preparation & Technical Procurement Support
- Utility System Design PW, WFI, Clean Steam, Compressed Air, Nitrogen
- Cephalosporin Containment Engineering
- Quality, Safety & Environmental Systems Integration
- Validation Engineering Support (DQ/IQ/OQ/PQ)
- Complete Engineering Documentation & Drawing Package
Project Outcome & Value Delivered
The successful delivery of engineering design and related services by JD Pharma & Consultant enabled Sands Active by Melwa to establish a world-class dual-compliance pharmaceutical manufacturing facility. Key outcomes achieved through this project include:
- A fully functional General Formulation section with 120 kg and 240 kg granulation capability for solid oral dosage forms
- A high-speed, EU-GMP Annex 1 compliant sterile Dry Injection line operating at 120 vials/min
- A high-output Dry Syrup filling line at 80 bottles/min for the cephalosporin product range
- A self-contained cephalosporin manufacturing zone with complete containment engineering
- Engineering documentation suitable for EU-GMP and WHO regulatory inspection and pre-qualification
- A facility capable of serving both regulated export markets and the domestic Sri Lankan pharmaceutical market
- A scalable design architecture allowing for future capacity expansion with minimal facility disruption
About JD Pharma & Consultant
JD Pharma & Consultant is a leading pharmaceutical engineering and consultancy firm specialising in GMP-compliant facility design, cleanroom and HVAC engineering, utility systems, equipment selection, validation support, and regulatory documentation. Our projects span General Formulation, Sterile Manufacturing, Cephalosporin/Beta-Lactam, Biopharmaceutical, and API facilities across South Asia, Middle East, and Africa.
We deliver end-to-end engineering solutions aligned with EU-GMP, WHO-GMP, US-FDA, PIC/S, and other international regulatory frameworks, ensuring our clients achieve first-time inspection success.
JD Pharma & Consultant
Pharmaceutical Engineering & Consultancy Services
