Introduction
Den Mark Pharmaceuticals Pvt. presents its top-quality Sucralfate+Metronidazole+Lignocaine Hydrochloride Cream (7.0%+1.0%+4.0%w/w), meticulously crafted for optimal efficacy. This advanced formulation combines sucralfate's mucosal protection, metronidazole's antimicrobial prowess, and lignocaine hydrochloride's local aesthetic properties. Engineered with precision and adhering to stringent quality standards, the cream offers targeted relief for dermatological concerns, from ulcerative lesions to infections and associated discomfort. Each component synergizes to deliver potent therapeutic benefits, ensuring rapid alleviation and promoting skin regeneration. Den Mark Pharmaceuticals proudly delivers a reliable solution trusted by healthcare professionals for superior patient care and well-being.
Pre-Production
- Master Formula Record (MFR) Review: The production team reviews the MFR to ensure that all materials, quantities, and procedures are current.
- Weighing and Dispensing: Each ingredient is weighed accurately using a designated weighing area, calibrated balances, and documented procedures.
- Material Verification: Qualified personnel verify the identity and quality of each raw material against approved certificates of analysis (CoA).
- Manufacturing Record Preparation: A designated production record is prepared, documenting the batch number, date, materials used, equipment involved, and personnel responsible.
Production
- 1. Primary Mixing: In a sanitized vessel, purified water, and preservatives are mixed under constant stirring.
- 2. Secondary Mixing: The ointment base components are homogenized to the primary mixture until a uniform consistency is achieved.
- 3. Active Ingredient Incorporation: Sucralfate, metronidazole, and lignocaine hydrochloride are slowly incorporated into the mixture while continuously stirring. This ensures proper dispersion throughout the cream.
- 4. Homogenization: The mixture is homogenized using a suitable homogenizer to achieve a smooth and uniform cream with a desired particle size distribution.
- 5. De-aeration: The cream is passed through a vacuum chamber to remove entrapped air, affecting product stability and aesthetics.
- 6. pH Adjustment: The cream's pH is measured and adjusted, if necessary, to meet the specified range as per the MFR.
Filling and Packaging
- Filling: The finished Sucralfate+Metronidazole+Lignocaine Hydrochloride Cream (7.0%+1.0%+4.0%w/w) is filled into pre-sterilized and pre-labelled tubes or containers using an automated or semi-automated filling machine.
- Leak Testing: Filled containers undergo leak testing to ensure product integrity.
- Capping and Sealing: Filled and leak-tested containers are capped and sealed using appropriate equipment.
- Labelling: Each container contains the batch number, expiry date, product information, and storage instructions.
Post-Production
- In-Process Quality Control: Samples of Sucralfate, Metronidazole, and Lignocaine Hydrochloride Cream (7.0%+1.0%+4.0%w/w) are collected at designated production stages for quality control testing as per the MFR. This includes tests for appearance, homogeneity, pH, specific gravity, and microbial limits.
- Finished Product Testing: Retained finished product samples undergo final testing as per the MFR, including chemical assays for active ingredients, content uniformity, and stability studies.
- Batch Release: A formal batch release authorization is issued after all quality control tests are satisfactory, allowing for product distribution.
Documentation and Records Management
- All production and quality control data are documented and archived as per SOPs (Standard Operating Procedures).
- Deviations from the MFR are documented, investigated, and resolved with appropriate corrective and preventive actions (CAPA) implemented.
Cleaning and Sanitation
- All equipment and vessels are thoroughly cleaned and sanitized after each production run using validated procedures.
Storage and Distribution
- The finished Sucralfate+Metronidazole+Lignocaine Hydrochloride Cream (7.0%+1.0%+4.0%w/w) is stored under controlled conditions per the MFR to maintain quality and stability.
- Distribution records document the movement of the product from the warehouse to the customer.
This is a general overview of the manufacturing process for Sucralfate + Metronidazole + Lignocaine Hydrochloride Cream at Den Mark Pharmaceuticals Pvt. Ltd., one of the leading pharmaceutical contract manufacturing companies in India. Specific details, equipment used, and in-process controls may vary depending on the company's specific formulation and production setup.