OPTHALMICS EQUIPMENTS QUALIFICATIONS

Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Opthalmics (Eye drops) are liquid drops that are often applied in small volumes, such as one or a few drops, directly to the surface of the eye. Saline is typically present in eye drops to match the salinity of the eye. For a long time, ophthalmic medication forms have been one of the most significant and developed areas of pharmaceutical technology. The issue of reduced medicinal material bioavailability following application to the eyeball is the primary driver of scientists’ ongoing, intense interest in these medication forms. The convoluted anatomical structure of the eye, the cornea’s limited absorptive surface and poor transparency, the metabolism, the lipophilicity of the corneal epithelium, and other factors all contribute to its development. The aforementioned defence mechanisms and low conjunctival sac capacity of 30 L without blinking result in a drop in drug concentration at the site of application and a reduction in the amount of time the active component spends there. To achieve the requisite drug concentration at the site of absorption and maintain it for a sufficiently long period, which in turn leads to a smaller application frequency, ocular drug forms were developed.

1. Design Qualification for Sterilizing & Depyrogenation Tunnel
2. Installation Qualification for High Pressure High Vacuum Steam Sterilizer
3. Operational Qualification for High Pressure High Vacuum Steam Sterilizer
4. Performance Qualification Protocol for High Pressure High Vacuum Steam Sterilizer
5. Design Qualification for Bottle Torque Tester
6. Installation Qualification for Bottle Torque Tester
7. Operational Qualification for Bottle Torque Tester
8. Performance Qualification Protocol for Bottle Torque Tester
9. Performance Qualification Report for Bottle Torque Tester
10. Design Qualification for CIP-SIP Module
11. Installation Qualification for CIP-SIP Module
12. Design Qualification for HI-Cart Coding Machine
13. Design Qualification for HPHV Steam Sterilizer
14. Design Qualification for Integrated 3 Piece Vial Filling Machine
15. Design Qualification for SS Jacketed Manufacturing Vessel
16. Design Qualification for Sticker Labeling Machine
17. Installation Qualification for Automatic Sel Adhesive Vertical Labeling Machine
18. Installation Qualification for Automatic Self Adhesive Horizontal Labeling Machine
19. Installation Qualification for Check Weigher Machine
20. Installation Qualification for HI-Cart Coding Machine
21. Installation Qualification for Integrated 3 Piece Vial Filling Machine
22. Installation Qualification for Online Airborne Particle Counter
23. Installation Qualification for Packing Conveyor
24. Installation Qualification for SS Jacketed Manufacturing Vessel
25. Operational Qualification for Automatic Self Adhesive Vertical Labeling Machine
26. Operational Qualification for Check Weigher Machine
27. Operational Qualification for HI-Cart Coding Machine
28. Operational Qualification for HPHV Steam Sterilizer
29. Operational Qualification for Integrated 3 Piece Vial Filling Machine
30. Operational Qualification for Manufacturing Vessel
31. Operational Qualification for Shrink Wrapping Machine
32. Operational Qualification for Sticker Labeling Machine
33. Performance Qualification Protocol for Automatic Self Adhesive Vertical Labeling Machine
34. Performance Qualification Protocol for Biochallenge Study for HPHV Steam Sterilizer
35. Performance Qualification Protocol for Bio-Challenge Study for High Pressure High Vacuum Steam Sterilizer
36. Performance Qualification Protocol for Checkweigher Machine
37. Performance Qualification Protocol for CIP-SIP Module
38. Performance Qualification Protocol for HI-Cart Coding Machine
39. Performance Qualification Protocol for Integrated 3 Piece Via Filling Machine CFL-120
40. Performance Qualification Protocol for S.S. Jacketed Manufacturing Vessel (500 Liter)
41. Performance Qualification Protocol for Sticker Labeling Machine
42. Performance Qualification Report for Autoclave Cum Bung Processor
43. Performance Qualification Report for Automatic Self Adhesive Vertical Labeling Machine
44. Performance Qualification Report for Bio Challenge
45. Performance Qualification Report for Bottle Torque Tester
46. Performance Qualification Report for Check Weigher Machine
47. Performance Qualification Report for CIP-SIP Module (250 LITER)
48. Performance Qualification Report for CIP-SIP Module
49. Performance Qualification Report for HI-Cart Coding Machine
50. Performance Qualification Report for Integrated 3 Piece Vial Filling Machine CFL-120
51. Performance Qualification Report for S.S. Jacketed Manufacturing Vessel (500 LITER)
52. Performance Qualification Report for Sticker Labeling Machine
53. Performance Qualification Report for Biochallenge Study of HPHV Steam Sterilizer