Amoxicillin Capsule

2. Dispensing

• The accurately weighed quantity of Amoxicillin trihydrate powder is transferred to a stainless steel container under controlled conditions. Other excipients, such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, are also dispensed according to the formulation requirements.

3. Mixing:

• The dispensed materials are blended thoroughly in a high-capacity blender to distribute the active pharmaceutical ingredient (API) and excipients uniformly. The blending process is carefully monitored to prevent segregation and ensure homogeneity.

4. Granulation:

• The blend is then granulated using a wet process. A binder solution is added slowly while mixing until the desired granule size is achieved. The damp mass is then dried in a fluid bed dryer to remove moisture and enhance flow properties.

5. Milling:

• The dried granules are milled to the appropriate particle size using a cone mill or oscillating granulator. This step ensures uniformity in particle size distribution and facilitates optimal capsule filling.

6. Blending:

• The milled granules are blended again with any additional excipients or lubricants required for capsule formulation. The blending process is conducted under controlled conditions to maintain consistency and uniformity.

7. Capsule Filling:

• The blended granules are filled into hard gelatin capsules using automatic capsule-filling machines. The filling process is carefully monitored to ensure accurate dosing and uniform capsule weight.

8. Capsule Polishing:

• The filled capsules undergo polishing to remove excess powder from the surface and ensure a smooth, glossy appearance. This step improves the capsules' aesthetic quality and enhances patient satisfaction.

9. Quality Control:

• Rigid quality control checks are performed at various stages throughout the manufacturing process to ensure compliance with WHO GMP guidelines and product specifications. This includes in-process testing, finished product testing, and stability testing to evaluate product integrity and shelf life.

10. Packaging:

• The finished Amoxicillin capsules are packed into blister packs or bottles according to customer requirements. Packaging materials are selected to protect against moisture, light, and physical damage during storage and transportation.

11. Labeling and Storage:

• Each pack of Amoxicillin capsules is labeled with all relevant product information, including dosage instructions, batch number, expiry date, and manufacturer details. The packaged capsules are stored in a controlled environment that meets WHO GMP standards to maintain product stability and quality.