HARDGEL CAPSULES QUALIFICATIONS

Hardgel Capsules Qualifications plays important role in pharma. Hardgel Capsules are solid dose forms that contain one or more active ingredients and/or inert fillers inside of a tiny shell. They are mostly made of gelatin and have two parts: a body that is intended to hold the medication and diluent and a cap that is roughly half as long as the body. In addition to gelatin, it may also include additives including plasticizers, colorants, opacifying agents, and preservatives that either facilitate the creation of capsules or enhance their functionality. In addition, 12–16% of Hardgel capsules are made of water.

1. Design Qualification of Softgel Encapsulation Machine
2. Installation Qualification for Capsule Filling Machine
3. Operational Qualification for Capsule Filling machine
4. Performance Qualification Protocol for Capsule Filling Machine
5. Design Qualification for Automatic Capsule Filling Machine with Powder, Pellet and Tablet Filling Attachment
6. Installation Qualification for Automatic Capsule Filling Machine with Powder, Pellet and Tablet Filling attachment
7. Operational Qualification for Automatic Capsule Filling Machine with Powder, Pellet and Tablet Filling Attachment
8. Design Qualification for Automatic Capsule Filling Machine
9. Installation Qualification for Automatic Capsule Filling Machine
10. Operational Qualification for Automatic Capsule Filling Machine
11. Performance Qualification Protocol for Automatic Capsule Filling Machine
12. Design Qualification for Capsule Polishing Machine & Unfilled Capsule Separator
13. Installation Qualification for Capsule Polishing Machine & Unfilled Capsule Separator
14. Operational Qualification for Capsule Polishing Machine & Unfilled Capsule Separator
15. Design Qualification for Empty Capsule Sorter Elevator
16. Installation Qualification for Empty Capsule Sorter Elevator
17. Operational Qualification for Empty Capsule Sorter Elevator
18. Design Qualification for Filled Capsule Sorter with Mini Capsule Sorter
19. Installation Qualification for Filled Capsule Sorter with Mini Capsule Sorter
20. Operational Qualification for Filled Capsule Sorter with Mini Capsule Sorter

STANDARD OPERATING PROCEDURE

1. SOP for Issuance and Retrieval of Change Parts for Hard Gelatin Capsule Filling Machine
2. SOP for Operation and Cleaning for Capsule Polishing Machine
3. SOP for Operation and Cleaning of Automatic AF 150 Capsule Filling Machine
4. SOP for Operation and Cleaning of Automatic Capsule Filling Machine (A-60) and its accessories
5. SOP for Operation and Cleaning of Automatic Capsule Filling Machine (A-120) and its Accessories
6. SOP for Operation and Cleaning of Semiautomatic Capsule Filling Machine
7. SOP for Operation and Cleaning of Roto Cube Mixer