Den Mark Pharmaceuticals Pvt. Ltd. prides itself on adhering to WHO GMP guidelines to manufacture top-quality pharmaceutical products. Here’s a comprehensive process for producing Diclofenac Diethylamine + Oleum Lini + Menthol + Methyl Salicylate + Benzyl Alcohol Gel (1.16% + 3% + 10% + 5% + 1% w/w + 3% w/w + 3% + 5% + 10% + 1% w/w).
Step 1: Raw Material Inspection and Storage
- All raw materials, including Diclofenac Diethylamine, Oleum Lini, Menthol, Methyl Salicylate, and Benzyl Alcohol, are sourced from approved suppliers.
- Upon arrival, each raw material undergoes rigorous quality inspection to ensure compliance with established standards.
- Approved materials are stored in designated areas with appropriate labeling to prevent contamination and ensure traceability.
Step 2: Preparation of Gel Base
- The manufacturing process begins by preparing the gel base.
- Water, carbomer, triethanolamine, and preservatives are accurately weighed and mixed in a stainless steel vessel under controlled conditions.
- The mixture is stirred continuously until uniform dispersion is achieved.
- Heating and cooling cycles are applied to achieve the desired viscosity and consistency of the gel base.
Step 3: Addition of Active Ingredients
- Diclofenac Diethylamine, Oleum Lini, Menthol, Methyl Salicylate, and Benzyl Alcohol are added to the prepared gel base in calculated quantities.
- Each active ingredient is carefully weighed and added to the gel base, strictly following formulation specifications.
- Mixing continues until homogenous dispersion of all ingredients is achieved, ensuring uniform distribution throughout the gel matrix.
Step 4: Homogenization and Degassing
- The gel formulation undergoes homogenization to ensure uniformity and stability further.
- High-speed homogenizers are used to break down any agglomerates and achieve a smooth, uniform texture.
- Degassing is performed to remove any entrapped air bubbles, which could affect the product’s appearance and efficacy.
Step 5: Quality Control Testing
- Samples of Diclofenac Diethylamine + Oleum Lini + Menthol + Methyl Salicylate + Benzyl Alcohol Gel (1.16% + 3% + 10% + 5% + 1% w/w + 3% w/w + 3% + 5% + 10% + 1% w/w)from each batch are subjected to comprehensive quality control testing to verify compliance with established specifications.
- Tests include, but are not limited to, assays of active ingredients, pH measurements, viscosity determinations, and microbial analyses.
- Only batches that meet or exceed predetermined quality criteria proceed to the next manufacturing stage.
Step 6: Packaging and Labeling
- Once quality control testing is completed, the gel is transferred to designated packaging areas.
- Suitable packaging materials, such as aluminium tubes or jars, are filled with the gel using automated filling equipment.
- Each container contains all required information, including product name, strength, batch number, expiration date, and usage instructions.
Step 7: Final Inspection and Release
- Finished Diclofenac Diethylamine + Oleum Lini + Menthol + Methyl Salicylate + Benzyl Alcohol Gel (1.16% + 3% + 10% + 5% + 1% w/w + 3% w/w + 3% + 5% + 10% + 1% w/w) undergo a final inspection to verify packaging integrity, labelling accuracy, and overall product presentation.
- Authorized personnel review all documentation and test results before distributing the batch.
- Finished Diclofenac Diethylamine + Oleum Lini + Menthol + Methyl Salicylate + Benzyl Alcohol Gel (1.16% + 3% + 10% + 5% + 1% w/w + 3% w/w + 3% + 5% + 10% + 1% w/w) are stored in controlled environments to maintain stability and efficacy until they are dispatched to customers.
By following these meticulous steps and adhering to WHO GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd., A WHO-GMP Certified company, Pharmaceutical Manufacturing Company, ensures the consistent production of high-quality Diclofenac Diethylamine + Oleum Lini + Menthol + Methyl Salicylate + Benzyl Alcohol Gel, meeting the healthcare needs of patients worldwide.