The state-of-the-art FRnD process is designed to develop various kinds of oral dosage forms like capsules and tablets (single and bi-layered) as well as uncoated, coated, dispersible, sustained, delayed release and sublingual formulations. Our FRnD is a miniature form of the production department, comprising processes ranging from capsulation and granulation to compression, coating and packing. It is also fully-equipped to handle various formulation processes like direct compression as well as aqueous and non-aqueous granulation. It is fully supported by an exclusive sophisticated Analytical Research and Developmental (ARnD) lab.
- Advanced GMP-compliant equipment to handle both aqueous and solvent-based processes
- Commensurate RMG and blending to suit the batch and lot sizes
- Automated and PLC based fluid bed dryer
- Capacity range from 1 kg to 5 kg for lab development
- Capable to handle Low RH products development
Compression & Encapsulation
- Mini tablet press with 8 stations
- Added advantage of D tooling
- Capable of handling both single and bi-layered tablets
- Ability to deliver punches of customised sizes
- Lab model encapsulation equipment designed for all sizes: 0, 1, 2 and 3
Coating & Packing
- Auto-coater with perforated pan principle
- Interchangeable pan with capacity range from 0.5 kg to 3.0 kg
- Designed for all types of coating, sugar, film and enteric coating
- Exclusive lab model blister packing with cam mechanism for flat forming, sealing and punching
- Designed to pack all customised punches and sizes
- Capable of handling a complete range of packing requirements
- Alu/alu blister pack with PVC-PVDC, aluminium strips and HDPE packing for stability studies
- Warehouse is designed to store raw materials and packing materials and finished goods in a suitable temperature and humidity as per CGMP international regulatory norms.
- Materials are stored in racks system and are handled by stackers and Hoists.
- Sampling and dispensing activities are carried out in classified area under class 100 environment under RLAF.
- Storing of solvents in dedicated flameproof area is in place.
- Dedicated areas for controlled temperature and relative humidity separately for the actives and in-actives
- Well defined Personnel & Material movement.
- Adequate airlocks between different zones.
- Primary and secondary change of linen for accessing production modules.
- Dedicated AHUs for process and packing area.
- Manufacturing areas are classified as ISO class 8 (class 100,000) with HEPA filters.
- Capable to handle Low RH products in below 25°C and below 25% RH from process t packing
- Flame proof area and equipment for solvent process.
- Materials handling by lifting devices.
- Dust extraction systems for air contaminants.
- Deep-rooted documentation practice.
- Ensured GMP concept.