Manufacturing Sodium Valproate Injection 100mg/ml at Den Mark Pharmaceuticals Pvt. Ltd. - A WHO GMP Compliant Process.
Top-quality Sodium Valproate Injection 100mg/ml is a medication primarily used to treat seizures, bipolar disorder, and migraine headaches.
Den Mark Pharmaceuticals Pvt. Ltd., a Reliable Medicine Supplier, follows WHO GMP (Good Manufacturing Practice) guidelines to ensure the consistent production of high-quality Sodium Valproate Injection 100mg/ml. This process prioritizes quality control and minimizes contamination risks at every step.
1. Raw Material Acceptance and Storage:
All incoming raw materials, including Sodium Valproate API (Active Pharmaceutical Ingredient), excipients (inactive ingredients), and sterile water for injection, undergo rigorous testing against predetermined specifications.
Qualified materials are assigned a unique batch number and stored in the quarantine area under designated conditions.
2. Weighing and Dispensing:
A designated weighing area, with calibrated balances, ensures accurate dispensing of Sodium Valproate API and excipients according to the pre-approved formulation.
Each component is weighed and documented by a qualified technician.
3. Dissolving and Filtration:
In a designated cleanroom environment, the API and excipients are dissolved in sterile water for injection within a sanitized mixing vessel.
The solution is filtered through a sterile membrane filter to remove particulate matter.
4. Filling and Sealing:
The sterile solution is transferred to a filling line within the aseptic processing area. The filling line is equipped with automated equipment to minimize human intervention and contamination risks.
Vials are pre-sterilized and dehydrogenated to ensure sterility. The solution is filled into vials under aseptic conditions, followed by immediate stoppering and sealing.
5. Lyophilization (Freeze-Drying):
Filled vials are transferred to a lyophilizer, where the solution is frozen at a controlled temperature.
Under a high vacuum, the frozen water is sublimated (converted directly from solid to gas) without melting, resulting in a sterile cake of Sodium Valproate within the vial.
This process preserves the stability and potency of the medication.
6. Labeling and Inspection:
Upon completion of lyophilization, vials are transferred to a designated labeling area.
Pre-printed labels containing product information, batch number, expiry date, and manufacturer details are affixed to each vial using tamper-evident labeling.
Each vial undergoes a thorough visual inspection for defects like cracks, leaks, or particulate matter.
7. Sterilization:
Sealed and labeled Sodium Valproate Injection 100mg/ml vials are then subjected to a validated sterilization process, typically using a steam sterilization autoclave.
The sterilization cycle parameters (time, temperature, pressure) are precisely controlled and documented.
8. In-Process and Final Product Testing:
Throughout manufacturing, samples of Sodium Valproate Injection 100mg/ml are collected at designated checkpoints for in-process quality control testing.
Parameters like sterility, pH, clarity, and potency are rigorously evaluated against pre-defined specifications.
After sterilization, a final batch sample undergoes comprehensive testing per the pre-approved protocol. This ensures the finished product meets all quality and safety standards
9. Packaging and Quarantine:
Approved finished Sodium Valproate Injection 100mg/ml batches are packaged in sterile containers with product leaflets containing essential information for healthcare professionals.
Packaged batches are placed under quarantine until final release approval is granted.
10. Batch Release and Distribution:
Upon completing all testing and documentation, a qualified person reviews the entire batch history and authorizes its release.
Released batches are stored under designated warehousing conditions before distribution to healthcare providers.