Infrastructure
Our Infrastructure
- Facility – Meets Global CGMP norms.
- Quality Assurance – Delivers un-compromised quality.
- Warehouse -Stores all products under all conditions.
- Quality Control – Works on Good Laboratory Practices.
- Microbiology -Moniter microbial contamination.
- Production -Equipped with advanced manufacturing technology.
- Granulation -Suits batches of any size.
- Compression -Ideal for products of varied size and speed.
- Coating -Performs all forms of coating.
- Encapsulation – Fills capsules of all sizes.
- Packing -Enables all types of packing.
- Engineering -Supports uninterrupted service for all process.
- HVAC -Achieves global environmental standard.
- Purified Water Plant – Generates Purified water.
Warehouse
Designed to store all products under Warehouse all conditions
Storage conditions conforming to cGMP norms to ensure quality throughout the shelf life of all materials. Stores active raw materials, diluents, packing materials, and finished goods under controlled temperature and humidity as per specific requirement. The material transfers through hoist and pass box to hold area. Sampling and dispensing of materials carried out under laminar air flow in class 100. Quarantine, under test, approved and rejected materials stored in a segregated area.
Quality Control
Designed as per good laboratory quality control practices
Qualified and competent personnel with sophisticated infrastructure forms the back bone of the quality control. Exclusive chemical, instrumentation and microbiology labs, for the testing of API, excipients, packaging, in-process materials and finished drug products. Furnished with automated and most ultra-modern apparatus. HPLCs ensures simultaneous analysis of multiple products.
Periodical monitoring to achieve the environmental compliance as per the GMP norms. Continuous review of stability data for the entire shelf life through 5000 liters Walk-in Stability Chamber for real time and 1000 liters movable chamber for Acc as per ICH specification The 24/7 Air conditioned retention sample room under prescribed storage conditions for quality audit of all products at any time.
Microbiology
Designed for microbial analysis microbiology as per cGMP norms
Dedicated microbiology lab for monitoring of microbial contamination from API to finished products. Microbial limit testing and validation of purified water and compressed air system at all stages. Incubation of environmental monitoring samples on continual basis. Assay and microbial limit testing under class 100 area. Routine water testing.
Granulation
Designed for granulation batches of any size
Equipped with sophisticated, GMP compliance equipment. Capable for both aqueous and non-aqueous process. Flame proof design for safety while using solvents. All required locations connected to utility lines like compressed Air, Potable and purified water. Dust extraction system for major powder generating equipment to avoid cross contamination.
Compression
Designed to make products of varied compression size and speed
Three Suits with capacity up to 8 Lakhs tablets a shift 20, 27, Stations with Bi Layer Options to suit the specific formulation requirement
Coating
Designed for all Coating forms of coating
Coating section with capacity ranging from 10 Kg to 120 Kg per lot Meets all coating requirements like film, enteric and sugar coating. Complete flame proof design for highest safety while handling solvents.
Encapsulation
Designed to fill capsules encapsulation of all sizes
Semi automated with a capacity up to 2 Lakhs per day. Additional feature of pellet filling and tablet in capsule.
Packing
Designed for all Packing types of packing
Three packing suits (Alu/Alu, Blister, Strip) for primary packing with a capacity to pack up to 8 Lakhs tablets and capsules per day. Exclusive change parts for physician samples
Engineering
Designed for uninterrupted service and support Engineering for all process
State of the art sophisticated detailed engineering of the entire plant is created to provide round the clock services and support the manufacturing requirements with respect to electrical, mechanical, steam, compressed air and allied engineering requirements.
HVAC
Designed to achieve global environmental HVAC standard
Exclusive service plant room for placing 13 AHUs and 8 FDV provides Air supply at designed class, temperature and humidity for the entire facility. Dedicated Air Handling Units for each process area to prevent cross contamination. The required classification of the area achieved through high efficiency filters, 10 micron Pre- filter with 90% efficiency, 3 micron Fine filter with 99% efficiency and 0.3 micron HEPA filter with 99.97% efficiency. Stringent validation protocols for the critical AHU parameters like filter integrity test, recovery, particle count, air-changes, and air velocity Validation and the re-validation program in regular frequency as part of the environmental monitoring quality norms.
Purified Water Plant
Designed to generate USP grade Purified Water Plant purified water
Installed capacity 500 L purified water per hour . Fully automated from primary treatment to delivery points. Purified water distributed continuously through loop system 24/7, to avoid microbial contamination. Periodical quality monitoring for chemical and microbiological testing at individual sampling points of pre-treatment, secondary treatment and in the loop system. A well-established sanitization and quality monitoring program to maintain the integrity of purified water for storage and distribution on a continual basis.
Environmental Safety
Designed to meet green environmental Safety environmental Norms
As a commitment to environmental health safety a well-designed ETP ensures the trade effluent and sewage from the facility complies with green environment norms
