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Sildenafil Citrate Sachets 4.8 Gms

Sildenafil Citrate 4.8 Gms (100 mg) Sachet Manufacturing Process by Den Mark Pharmaceuticals Pvt. Ltd. as per WHO GMP Guidelines

Top-quality Sildenafil citrate 4.8 grams (100 mg) sachets are a pharmaceutical product primarily used to treat erectile dysfunction (ED) in men. Sildenafil citrate is the active ingredient in popular medications like Viagra. These sachets contain a precise dosage of sildenafil citrate, typically 100 milligrams per sachet, a standard dose for treating ED.

Sildenafil citrate works by increasing blood flow to the penis, facilitating an erection when sexually stimulated. These sachets offer convenience and ease of use, as they come in individual pre-measured doses, making them suitable for on-the-go use.

WHO-GMP Certified Pharmaceutical Manufacturing Company, Den Mark Pharmaceuticals Pvt. Ltd. manufactures top-quality Sildenafil citrate 4.8 Gms (100 mg) sachets following strict WHO GMP guidelines. This ensures consistent product quality, safety, and efficacy.

Material Preparation (Weighing and Dispensing):

  • Preparation Area: A designated weighing and dispensing area that is well-maintained and contamination-free is used. Trained personnel adhere to proper aseptic techniques and perform all operations.
  • Raw Material Inspection: Incoming raw materials, including Sildenafil citrate API (Active Pharmaceutical Ingredient) and excipients, undergo thorough inspection against approved specifications and certificates of analysis.
  • Weighing: Approved weighing balances calibrated at regular intervals are used for accurate material measurement. Sildenafil citrate API and each excipient are weighted individually based on a pre-determined الكميه (Kamiya) (Arabic for quantity) as per the approved formulation.
  • Dispensing: Weighed materials are dispensed into suitable, pre-labeled containers. Dispensing records are maintained for traceability.

Blending and Granulation:

  • Blending: The weighed Sildenafil citrate API and excipients are transferred to a blender. Blending time is based on established parameters to achieve a homogenous mixture.
  • Granulation (Optional): A granulation process might be employed to improve flowability and tableting characteristics depending on the formulation. This involves wetting the blend with a granulating solution and processing it through a granulator to form granules.
  • Milling: Granules, if formed, are milled to a uniform particle size using a calibrated mill.

Sachet Filling and Sealing:

  • Filling Machine Setup: A validated sachet filling machine is set up with the approved film reel and calibrated for accurate dosing of the blend or granules.
  • Filling: The machine fills each sachet with the pre-determined quantity of the blend or granules.
  • Nitrogen Purging: Inert gas purging with Nitrogen may remove oxygen and moisture, ensuring product stability.
  • Sealing: The sachets are securely sealed using a heat seal or other validated methods.
  • Coding and Labeling: Each Sildenafil citrate 4.8 grams (100 mg) sachet receives a printed code indicating batch number, manufacturing date, and expiry date. Labels are applied as per design, following labeling regulations.

In-Process Quality Control:

  • Sampling: Representative samples are collected for quality control testing throughout the process.
  • Testing: Sildenafil citrate 4.8 grams (100 mg) Sachets Samples undergo weight verification, blend uniformity testing, and other parameters as per the product specification.
  • Release Criteria: Batches of Sildenafil citrate 4.8 grams (100 mg) Sachets are released for further processing after meeting all pre-defined quality control specifications.

Packaging and Labeling:

  • Packaging: Sildenafil citrate 4.8 grams (100 mg) Sachets are placed in cartons or other approved secondary packaging materials.
  • Labeling: Cartons are labeled with product information, including brand name, dosage form, batch number, manufacturing date, expiry date, storage conditions, and dosage instructions. All labeling adheres to regulatory requirements.

Finished Product Storage and Release::

  • Finished Products Warehouse: Packaged products are transferred to a designated finished product warehouse under controlled storage conditions.
  • Final Release: Authorized personnel review and approve batch records and quality control data before final product release for distribution.

Documentation and Records Management:

  • Batch Records: Detailed batch records are maintained for each batch, documenting all manufacturing steps, material quantities, process parameters, and quality control results.
  • Standard Operating Procedures (SOPs): All manufacturing processes are guided by written and approved SOPs.
  • Deviation Management: Any deviations from SOPs are documented and investigated.

This is a general overview of the Sildenafil citrate sachet manufacturing process following WHO GMP guidelines. Den Mark Pharmaceuticals Pvt. Ltd. is generic Drug Manufacturer who implements additional steps or adaptations based on specific product characteristics and regulatory requirements.