Den Mark Pharmaceuticals Pvt. Ltd. follows WHO GMP guidelines to ensure the production of top-quality itraconazole capsules, a vital antifungal medication. The capsule-filling process is a critical stage in pharmaceutical manufacturing, requiring precision, cleanliness, and adherence to strict protocols to guarantee the safety and efficacy of the final product.
1. Material Handling and Preparation:
- Raw Materials: Pharmaceutical-grade itraconazole powder, excipients (such as lactose, starch, or microcrystalline cellulose), gelatin capsules (size as per specifications), and any additional ingredients required.
- Equipment: Deduster, metal detector, sieves, capsule filling machine, polishing machine, and labeling machine.
- Preparation: All raw materials undergo thorough testing and inspection for quality assurance. They are stored in designated areas under controlled conditions to prevent contamination or degradation.
2. Capsule Formulation:
- Weighing and Mixing: Precise quantities of itraconazole powder and excipients are weighed according to the formulation recipe. They are then thoroughly mixed using a blender to achieve homogeneity.
- Granulation (if required): In some cases, granulation of the powder mixture may be necessary to improve flow properties and uniformity. This step involves adding a binder solution, granulating, drying, and milling to obtain granules of the desired size.
3. Capsule Filling:
- Machine Setup: The capsule filling machine is calibrated and validated according to the specified capsule size and fill weight.
- Filling Process: Empty gelatin capsules are loaded into the filling machine's hopper. The machine accurately fills each capsule with the itraconazole mixture, ensuring uniformity and precision.
- Visual Inspection: Filled capsules undergo visual inspection to detect defects or irregularities.
4. Polishing and Dedusting:
- Polishing: Capsules may undergo a polishing process to remove any surface imperfections or excess powder, enhancing their appearance and eliminating potential sources of contamination.
- Dedusting: Capsules pass through a deduster to remove loose particles or debris, maintaining cleanliness and quality standards.
5. Metal Detection and Quality Control:
- Metal Detection: Filled capsules are subjected to metal detection to identify and remove any metallic contaminants that may have inadvertently entered the production process.
- Quality Control Checks: Random samples of filled capsules are collected and tested for various parameters, including weight variation, disintegration time, dissolution rate, and microbial content, to ensure compliance with quality standards.
6. Packaging and Labeling:
- Packaging: Finished capsules are carefully packed into blister packs, bottles, or other appropriate containers, ensuring proper sealing and protection from light, moisture, and environmental factors.
- Labeling: Each container contains essential information, including product name, strength, dosage instructions, manufacturing date, expiry date, batch number, and relevant regulatory information.
Conclusion: By WHO GMP guidelines, the top Pharmaceutical Company Den Mark Pharmaceuticals Pvt. Ltd. implements a meticulous capsule-filling process for manufacturing top-quality itraconazole capsules. By adhering to rigorous standards at every stage, the company ensures its pharmaceutical products' safety, efficacy, and consistency, contributing to the well-being of patients worldwide.