Manufacturing Process of Meropenem + Sulbactam Injection by Den Mark Pharmaceuticals Pvt. Ltd.
Meropenem + Sulbactam Injection is a potent combination antibiotic that offers broad-spectrum coverage against many resistant bacteria, making it a valuable tool in treating severe bacterial infections. However, its use should be reasonable, guided by susceptibility testing, and accompanied by close monitoring for adverse effects.
Den Mark Pharmaceuticals Pvt. Ltd. is a Trusted Pharmaceutical Brand that follows WHO GMP guidelines in producing top-quality Meropenem + Sulbactam Injection, ensuring efficacy and safety for patients worldwide. This comprehensive manufacturing process encompasses stringent quality control measures at every stage, from raw material procurement to final packaging.
Step 1: Raw Material Procurement
- The manufacturing process begins with the procurement of high-quality rawThe process begins with procuring high-quality raw materials from approved suppliers, ensuring compliance with pharmacopeial standards. Meropenem and Sulbactam, the active pharmaceutical ingredients (APIs), are sourced with meticulous attention to purity and potency.
Step 2: Dispensing and Weighing
- The weighed quantities of Meropenem and Sulbactam are dispensed accurately in a designated area under controlled conditions to prevent contamination. This step is crucial to ensure the correct dosage of each API in the final formulation.
Step 3: Preparation of Formulation
- The dispensed APIs are transferred to a sterile environment for formulation. They are dissolved in sterile water for injection, followed by adding excipients such as stabilizers and buffers to ensure stability and compatibility.
Step 4: Sterilization
- The formulation undergoes sterilization using validated processes such as filtration or autoclaving to eliminate microbial contaminants effectively. This step is critical to maintaining the product's sterility throughout its shelf life.
Step 5: Filling and Sealing
- The sterile formulation is filled into vials under aseptic conditions using state-of-the-art filling equipment. Each vial is sealed with a rubber stopper and aluminum cap to prevent contamination and maintain product integrity.
Step 6: Inspection and Quality Control
- Every filled vial undergoes rigorous inspection for visual defects, including cracks, leaks, or particulate matter. In addition to visual inspection, samples are tested for potency, purity, and sterility according to established specifications.
Step 7: Labeling and Packaging
- Once the product passes all quality control tests, it is labeled with essential information such as product name, strength, batch number, and expiry date. The labeled vials are then packed into secondary packaging, ensuring protection during transportation and storage.
Step 8: Final Quality Assurance
- Before release for distribution, a final quality assurance review is conducted to verify compliance with WHO GMP guidelines and regulatory requirements. This includes reviewing all documentation, batch records, and test results to ensure consistency and traceability.
Step 9: Storage and Distribution
- The finished Meropenem + Sulbactam Injection, is stored in a controlled environment to maintain stability until distribution. Proper storage conditions prevent degradation and ensure product efficacy.
Step 10: Post-Market Surveillance
- Den Mark Pharmaceuticals Pvt. Ltd. remains committed to post-market surveillance to monitor the safety and efficacy of its products. Adverse events are promptly investigated, and corrective actions are implemented if necessary to uphold patient safety.
In conclusion, Den Mark Pharmaceuticals Pvt. Ltd. follows a meticulous Meropenem + Sulbactam Injection manufacturing process following WHO GMP guidelines. By prioritizing quality and compliance at every stage, the company ensures the production of safe, effective, and reliable medication for needy patients.