World class infrastructure and plant manufacturing facilities:
- 1. Individual compression and coating cabins with separate air handling units to avoid cross contamination.
- 2. Facility includes Blending, Capsulation, Inspection and Sorting.
- 3. All section provided with 3-micron filter air and terminally 0.3 micron (HEPA) filter.
- 4. Temperature and humidity monitor & control.
- 5. Well Equipped I.P.Q.C. Lab.
- 6. Quarantine Areas.
- 7. All Sections having GMP compliance machineries.
- 8. Each zone has separate AHUs (Air Handling Units), dehumidification unit and dust extraction systems.
- 9. No wood or asbestos component.
- 10. A unidirectional flow of men and materials to promote optimum productivity
- 11. Accessibility of all utilities and maintenance areas from outside, for additional ease of operation.
- 12. Segregation of every critical processing activity in each zone, to avoid cross-contamination.
- 13. Respective zones, areas and even uniforms marked with specific colours to ensure total segregation.
- 14. Air environment conditioned in each area with respect to temperature, humidity, filtration, particle counts, etc.
- 15. Duo Pass Reverse Osmosis (RO) water system/ de-mineralization plant.
- 16. Zero-discharge Effluent Treatment Plant.
- 17. Separate air handling units for every production department, in addition to air conditioning with 2-micron filtration to ensure absolute product purity.
- 18. The complex also houses its own R &D facility for in house product development.
- 19. Air-conditioned stores for raw material, packing material and finished good.
- 20. Isolated and dedicated production facilities for β-Lactam and Cephalosporin dosage forms.
- 21. Facility includes Pulveriser, Sifter, Coating Pan, Tray Dryer and Blender.
- 22. All section provided 3 Micron Filter Air and Terminally 0.3 micron (HEPA) Filter.
- 23. Temperature and Humidity Monitor Control (HVAC).
- 24. Separate Quarantine Area.
- 25. Entire Section has GMP Compliance Machines.
- 26. All Process Steps Are Well Documented.
- 27. Dispensing of materials under an SS reverse laminar flow.
- 28. Alternative power generation system for uninterrupted production.
- 29. Ample segregated storage for raw materials and packaging materials, with a quarantine facility.
- 30. We house huge capacities for manufacturing round the clock (* Spare capacity available for all sections).
- 31. Equipped to Manage Total Supply Chain. i.e. receipts of RM/PM, Quarantine, Storage and Dispensing.
- 32. Capsulation section having Semi – Automatic & Automatic Filling, Sorting & Polishing Machines.
- 33. All Process steps are Well Documented.
- 34. Primary Cleaning by Vacuum on Receipt of Material.
- 35. Separate Quarantined, On Test and Released Storage Areas.
- 36. Locker System for Storage.
- 37. It is kind of GMP model Air Conditioner designed to maintain 24 0C ± 2 0C temperature and desired RH with 3-micron filtration and over 25 air changes. Supply Air Filtered through 10 and 3-micron filter.
- 38. All Core Process Area are provided with Dedicated AHU and Filtration of 10, 3 and 0.3 Micron Terminal Hepa filter.
- 39. Return Air rises with 20µ Filter are provided in Core Area.
- 40. Ancillary Area, Warehouses are provided with Controlled Environment with 10 and 3 Micron Filtration.
- 41. Pressure Gradient of 1 to 1 1/2 mm of Water from Room to Room to Passages as the case may be, which is demonstrated on Manometer.
- 42. Air Handling Systems are validated from time to time.
- 43. Primary packing section supplied with 3-micron filter air with terminally 0.3 micron (HEPA) filter.
- 44. Operation carried out under well controlled environment.
- 45. Leak testing facility for strips and blisters provided.
- 46. Primary section having three blister pack and strip pack machine.
- 47. Secondary packing area having air condition for comfort cooling. Conveyer belts provided for carton filling and shipper pack for each primary packing machine.
- 48. Line clearance procedure followed strictly before starting new batch or product.
- 49. Well trained supervisor and operators.
- 50. ALU/ALU blister pack machine.
- 51. Facility includes Granulation, Blending, Compression, Film Coating, Sugar Coating, Enteric Coating, Tablet inspection and Tablets over printing section.
- 52. Air handling systems conform to the cGMP requirements.
- 53. Temperature and Humidity Maintained as per Product Requirement.
- 54. Well Equipped I.P.Q.C. Lab.
- 55. Quarantine Area for each section.
- 56. All Section having Required Machinery with GMP Compliance Model.
- 57. Well Trained Supervisory Staff and Operators.
- 58. All Process Steps Well Documented.
