Functional SOPHISTICATION

With its Biosafety Level 3 (BSL-3) containment manufacturing facility, future-powered technologies and proclivity to upgrade in tandem with advancements in the biotech world, Brilliant’s manufacturing facilities have earned for it international accreditations and certifications. The manufacturing process leverages the synergy of advanced facilities, latest technologies with proven processes, and strict quality assurance practices.

HIGHLIGHTS

• All viral, bacterial vaccines are produced using state-of-the-art automated bioreactors or fermentation technology in fermenters
• Propagation of mammalian cell cultures in suspension from 100 L to 10 KL, and dedicated systems for adherent cells
• Fully automated 500 L to 10 KL bioreactors for propagation of Foot-and-Mouth-Disease (FMD), Bluetongue (BT) and Rabies viruses
• FMD Vaccine manufactured in modern BSL-3 manufacturing facility having advanced Bio-Kill system for de-contamination of liquid waste within the facility
• Independent suites earmarked for manufacturing of various vaccines
• World's most advanced vaccine manufacturing systems including - cell propagation, virus culture, bacterial fermentation, mechanical separation, efficient purification by tangential flow filtration, freeze drying, plant automation, data collection and CIP/SIP systems
• Automatic PLC/SCADA controlled operations performed with high quality automatic aseptic valves to operate aseptic and sterile processes
• Continuous monitoring equipment in place to ensure that the key quality characteristics of the products are actively controlled
• Production lines complemented with suitable tanks for media preparation, upstream processing, harvesting, inactivation, downstream processing, filtration, purification etc.
• Ultramodern engineering utilities for Water-for-Injection (WFI), purified water, chilled water and pure steam, raw steam, compressed air etc.
• Plant is ISO 9001:2015 certified and fully compliant with cGMP, GLP and OIE guidelines

Filling & Blending

• Dedicated vaccine blending area
• Automated vial-filling line 60,000 PP vials per day capacity (equivalent to 3 million doses of vaccine), fully enclosed in open RABS, ensuring an aseptic filling environment; the line is flexible to fill 10 ml to 100 ml fill volumes
• Product and component pass-throughs and unidirectional flow to comply with current Good Manufacturing Practices (cGMP) and processes
• Automated filling line including aseptic core operations such as sterilising, filling, stoppering and capping, entirely fit for the ‘in operation’ cleanliness grades prescribed in Pharmacopoeias

While the Grade B and Grade A/B areas are located in the core zone of the inner circle, the Grade D area is located in the outer circle, thus forming a perfect gradient to control bio-burden. The entire facility is built in a homocentric design with an outer inspection corridor that is convenient for monitoring and inspection.