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Capsule Filling Process for Rabeprazole + Domperidone Capsules- Den Mark Pharmaceuticals Pvt. Ltd.

At Den Mark Pharmaceuticals Pvt. Ltd., we adhere strictly to the guidelines set forth by the World Health Organization's Good Manufacturing Practices (WHO GMP) to ensure the highest quality of pharmaceutical products. Our capsule filling process for Rabeprazole + Domperidone capsules integrates stringent quality control measures at every stage. Here's a comprehensive overview of our manufacturing process:

1. Raw Material Handling and Preparation:

  • Raw materials, including Rabeprazole and Domperidone, are sourced from approved suppliers and subjected to rigorous quality control checks upon arrival.
  • Materials are stored in designated areas with appropriate environmental conditions to prevent contamination or degradation.
  • Before use, materials undergo thorough inspection and testing to ensure compliance with specifications outlined in pharmacopoeial standards.

2. Formulation Preparation:

  • Validated procedures and documented batch records meticulously prepare the formulation for Rabeprazole + Domperidone capsules.
  • Precise quantities of active pharmaceutical ingredients (APIs) and excipients are weighed and mixed in a controlled environment to achieve uniformity and homogeneity.

3. Capsule Filling:

  • We utilize advanced capsule-filling machines equipped with precision dosing mechanisms to ensure the accurate filling of capsules.
  • Empty hard gelatin capsules, pre-inspected for defects, are loaded into the filling machine's hopper.
  • The formulated blend of Rabeprazole and Domperidone is fed into the dosing system, which dispenses the exact amount of powder into each capsule shell.
  • Machine parameters are monitored and adjusted throughout the filling process to maintain consistency and minimize variability.

4. Capsule Sealing:

  • Once filled, the capsules are carefully inspected to verify proper dosage and uniformity.
  • Capsule sealing is performed using a combination of mechanical and thermal processes to enclose the filled capsules securely.
  • Sealed capsules undergo additional visual inspection and weight checks to ensure compliance with specifications.

5. Quality Control and Assurance:

  • Quality control measures are integrated at every stage of the manufacturing process, from raw material procurement to finished product release.
  • Samples from each batch undergo comprehensive testing in our state-of-the-art laboratory, where they are evaluated for identity, potency, purity, and uniformity.
  • To verify product quality and performance, analytical techniques such as high-performance liquid chromatography (HPLC), Fourier-transform infrared spectroscopy (FTIR), and dissolution testing are employed.
  • Only batches that meet or exceed established quality criteria are approved for packaging and distribution.

6. Packaging and Labeling:

  • Approved batches of Rabeprazole + Domperidone capsules are packaged in tamper-evident containers under controlled conditions to maintain product integrity.
  • In compliance with regulatory requirements, each container is labeled with essential information, including product name, strength, batch number, expiration date, and storage instructions.

7. Storage and Distribution:

  • Finished Rabeprazole + Domperidone capsules are stored in temperature-controlled warehouses with appropriate humidity levels to prevent degradation and ensure stability.
  • Prior to distribution, Rabeprazole + Domperidone capsules undergo final inspection to confirm packaging integrity and adherence to labeling requirements.
  • Distribution is managed through a validated supply chain network to ensure timely delivery to healthcare providers and pharmacies.

8. Metal Detection:

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

9. 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.).

10. Documentation:

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

11.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.

Additional Notes:

  • 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 Rabeprazole + Domperidone capsules.
  • This process description is limited to 500 words and may not encompass all intricacies of the manufacturing process.

This is a general guideline for the Rabeprazole + Domperidone capsules filling process at Den Mark Pharmaceuticals Pvt. Ltd.