Manufacturing Process
We have modern and robust systems to facilitate the entire manufacturing process
Biosynergy Lifecare has evolved to manufacture vital drugs and medicines by utilizing modern and sophisticated technology. The state-of-the-art manufacturing facility is equipped with advanced machineries and equipment’s to manufacture products of Large Volume Parenteral. We are immensely dedicated to R&D, quality control and latest technologies which can improvise our manufacturing potential every day.
We are not only committed to manufacture and market quality drugs which are life-savers for the society, but we ensure safety and integrity during the manufacturing process and marketing.
Production Facility
- Specially designed with WHO-GMP to comply with international regulatory guidelines.
- The site has all its systems, procedures & relevant documentation formulated in a framework which ensure that facilities, processes & personnel comply with cGMP.
- Layout facilitates proper inventory management and material handling as per the process flow.
- The aseptic FFS (Form-Fill-Seal) technology ensures that any potential contamination by human intervention is avoided. It is a closed system with a single step process.
- The containment barrier technology, CRAB (Closed restricted access barrier) is used for material handling operations during production.
- Clean rooms are built with prefabricated panels.
- Filling is under grade “A” area having continuous particle monitoring with a background of grade “C”.
- UPS for filling LFR on all BFS machines.
- The terminal sterilization of products is done by “Superheated Water Spray Sterilizer”.
- The entire process is controlled by “SCADA” system.
- The factory unit has effective waste management techniques which ensure minimal discharge from the facility.
Environmental Control Systems
- There are separate Air Handling Unit systems for each of the processes.
- Each of the classified rooms have biometric access control to control human and material entry.
Quality Assurance
- Development of norms, standards and guidelines to provide quality assurance.
- Review, analysis and approval of all procedures related to production & maintenance.
- Continuous review of associated records.
- Auditing and conducting trend analysis.
Quality Control
- The fully-equipped quality control lab is lined up with world-class equipments to assure quality adherence at each stage of development.
- Continuous assessment of the suitability of incoming raw materials, closure labeling, in-process materials and finished products.
- Evaluation of the performance of the manufacturing process to ensure adherence to accurate specifications and determining the acceptability of each batch for release.