Oral Solid Dosage (OSD) Experience

Case Studies

Project Profile: Oncology Formulation Facility

Objective
Construct a new Oncology Formulation Facility for the production of both Oral Solid Dosage (OSD) and sterile injectable drugs.

Capabilities
The formulation plant will be a grass-root facility and will be designed to conform to U.S., European, TGA and WHO compliance requirements. The facility will have oral solid dosage (both tablets and capsules) as well as sterile injectable products (liquid and lyophilized presentations). API’s handles will include Band/Category 5 cytotoxic compounds with OEL’s down to 100 nano-grams/m3. Cross-contamination and personnel protection issues will be addressed utilizing various isolation technologies including integrated closed processing systems and isolators. The facility will house incoming docks, incoming material (actives, excipients, others) warehousing, sampling, dispensing, weighing, oral solid dosage unit operations, parenteral unit operations, packaging and labeling in the same facility. In addition, Formulation R&D, Supporting Labs, Locker/Change Rooms, Offices, Cafeteria and other necessary amenities will be housed in the facility.

Location
India

Size
44,000 Square Feet

Services
Facility Design Philosophy, Containment Consulting, Process Equipment URS and pre-purchase specifications, OEL establishment, Conceptual Design, Detail Design