Omperazole 20 mg Capsules

1. Preparation:

• All personnel involved must wear appropriate cleanroom garments and gloves.
• The manufacturing area must be sanitized according to GMP protocols.
• Documents for batch number, expiry date, and bill of materials (BOM) are reviewed and verified.

2. Weighing and Blending:

• Omeprazole API and excipients are accurately weighed according to the pre-determined formulation for 20mg capsules.
• Weighing is performed using calibrated balances.
• All materials are transferred to a designated blending vessel.
• Blending is carried out for a predefined time using a blender to ensure a homogenous distribution of the mixture.

3. Milling and Granulation (Optional):

• Depending on the formulation, the blended mix may undergo milling to achieve a uniform particle size suitable for capsule filling.
• Granulation may also be employed to improve flowability and ensure consistent capsule weight.

4. Capsule Loading:

• The blended or granulated mix is transferred to the capsule-filling machine hopper.
• Empty hard gelatin capsules are loaded into the machine's capsule feeding magazine.
• The capsule filling machine is calibrated to ensure the accurate filling of 20mg of the formulation blended into each capsule body.
• During filling, capsule weight and integrity are continuously monitored through automated checks.

5. Capsule Closing and Polishing:

• Filled capsules are transferred to the machine's capsule-closing unit, where the capsule tops are securely sealed.
• Filled capsules are then polished using a gentle tumbling process to remove any loose powder and create a uniform appearance.

6. In-Process Quality Control:

• Throughout the process, samples are collected for weight uniformity testing to ensure capsules meet the specified weight range.
• Disintegration testing may also be performed to confirm capsules disintegrate within the desired timeframe.

7. Metal Detection:

• Filled capsules are passed through a metal detector to ensure no foreign metallic objects are present in the final product.

8. Packing and Labeling:

• Acceptable capsules are transferred to designated containers and labeled with product name, batch number, expiry date, and manufacturer details (Den Mark Pharmaceuticals Pvt. Ltd.).

9. Documentation:

• The batch production record documents all process parameters, weight data, and quality control results for future reference.

10.Quarantine and Release:

• Finished capsules are quarantined until the final product release is authorized after the successful completion of all quality control testing, as per regulatory requirements.

• The capsule-filling process may vary slightly depending on the specific equipment and formulation used.
• Den Mark Pharmaceuticals Pvt. Ltd. is committed to adhering to the latest WHO GMP guidelines to ensure the production of high-quality and safe Omeprazole 20 mg capsules.
• This process description is limited to 500 words and may not encompass all intricacies of the manufacturing process.