Oral Solids Dosage
Oral Solids Dosage
Oral Solid Dosage (OSD) products are the most widely used pharmaceutical dosage forms and include tablets, capsules, powders, and granules intended for oral administration. OSD products are valued for their stability, dosing accuracy, patient convenience, and cost-effective manufacturing. Because production relies on the processing and transfer of powders and granular materials, OSD facilities have unique requirements for solids handling, containment, cleaning, and material flow. Facilities must accommodate a broad range of formulations, production scales, and potency classifications while consistently delivering high-quality products.
Key Issues
The handling of solid materials introduces challenges related to dust generation, product segregation, cross-contamination prevention, and operator protection. These considerations become increasingly important when processing highly potent compounds that require enhanced containment measures. Facilities must be designed to support efficient movement of raw materials, intermediates, and finished products while maintaining product quality, protecting personnel, addressing dust explosion hazards, and meeting regulatory expectations. Cleaning strategies, environmental controls, and containment systems are therefore key drivers of both facility design and operation. Hygroscopic powders, and particularly effervescents, require tighter control on environmental conditions such as moisture content (%RH) in the air.
How Fluor Helps
Fluor partners with pharmaceutical manufacturers to provide engineering, procurement, construction management and validation (EPCM) of OSD facilities across a broad range of product types and containment classifications. Our EPCMV capabilities support new facilities, expansions, modernization initiatives, and manufacturing optimization programs. By combining deep pharmaceutical industry experience with proven project execution practices, Fluor helps clients implement effective manufacturing and containment strategies, improve operational performance, and deliver facilities capable of supporting evolving product portfolios and business objectives. Our Technology Transfer capabilities help bridge the transition from facility delivery to operational readiness by integrating manufacturing processes and product knowledge with the facility, equipment, operating teams, validation activities, and regulatory requirements needed to bring manufacturing operations online efficiently and successfully.
Process Features
OSD manufacturing consists of a series of operations that convert active pharmaceutical ingredients and excipients into finished dosage forms. Depending on the product, these operations may include dispensing, granulation, extrusion, rolling compaction, blending, drying, spray drying, sachets filling, tablet compression or encapsulation, coating (including controlled release), and packaging. Industry trends continue to emphasize increased automation, continuous manufacturing, advanced process monitoring, and integrated material handling systems to improve product consistency, reduce cycle times, and enhance manufacturing efficiency.
Facility Features
OSD facilities are designed to support the controlled processing and transfer of solid materials while minimizing contamination risks and maintaining efficient operations. Key design considerations include dedicated dispensing areas, containment technologies, dust collection systems, and HVAC systems that maintain appropriate pressure relationships and environmental conditions. Facility layouts are often organized to promote logical material flow, including the use of gravity-assisted transfers where practical, while automated handling systems and modular manufacturing suites provide scalability and operational adaptability.
Fluor Projects
Nordic Naturals, Project Neptune
Location: Site Agnostic
Scope: Engineering
Fluor provided feasibility, site master planning, and site-selection services to support the development of a new softgel manufacturing facility aimed at increasing production capacity by sixfold while enhancing operational efficiency and enabling long-term business growth. The effort assessed current-state operations, future capacity requirements, infrastructure needs, and site utilization strategies to identify the most effective path forward including process technologies and automation approaches. Site selection services were performed to evaluate and recommend potential locations that best aligned with the client's operational, logistical, and growth objectives.
Haleon Transformation
Location: Guayama, Puerto Rico
Scope: Engineering
Fluor provided conceptual design engineering services for the oral solid dosage (OSD) lines to help transition the existing site from batch processing to a semi-continuous process.
Alza, PBOEL Performance-Based Occupational Exposure Limits (PBOEL)
Location: Vacaville, CA
Scope: Engineering
Fluor provided process and cleaning validation of a timed-release drug delivery oral solid dose operation that includes granulation, compression, sub-coating, membrane coating, drilling, drying, overcoating and printing unit operations.
Confidential Client, OSD Site Evaluation
Location: Confidential Location
Scope: Engineering
Fluor performed site selection & a conceptual study for this client's planned Greenfield Secondary Pharmaceutical facility for Product development laboratory suitable for technology transfer and clinical trial material. The capacity is approximately 1,000 tablets/capsules and 500 vials. Pilot plant scale production of oral solid dosage (OSD) and SVP.
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