Ceftriaxone Injection Manufacturing Process by Den Mark Pharmaceuticals Pvt. Ltd. (as per WHO GMP)
Top-quality Ceftriaxone Injection (100 mg) is a pharmaceutical product used primarily for treating bacterial infections. Ceftriaxone is a broad-spectrum cephalosporin antibiotic that interferes with the bacteria's cell wall synthesis, leading to their death.
Den Mark Pharmaceuticals Pvt. Ltd., a pharmaceutical exporter in India, manufactures Ceftriaxone Injection following strict WHO Good Manufacturing Practices (GMP) guidelines. This ensures a high-quality sterile product for patient use.
1. Starting Materials and Raw Material Management:
- All incoming raw materials (starting chemicals, solvents, filters) are thoroughly inspected against pre-defined specifications and accompanied by certificates of analysis.
- Materials are quarantined until qualified by the Quality Control (QC) department.
- A documented receiving procedure ensures proper labeling, storage under defined conditions, and traceability throughout manufacturing.
2. Ceftriaxone Synthesis:
- A designated clean area equipped with appropriate air handling and filtration systems is used for the synthesis.
- Following approved production instructions, trained personnel weigh and transfer accurate quantities of starting materials into a sterilized reaction vessel.
- The reaction proceeds under controlled temperature, pressure, and pH conditions.
- In-process controls are performed at defined stages to monitor reaction progress and ensure quality.
3. Isolation and Purification:
- Upon reaction completion, the crude Ceftriaxone undergoes a series of purification steps, such as filtration, crystallization, and washing, to remove impurities and unwanted byproducts.
- Specific solvents and techniques are employed to achieve high purity per pre-determined specifications.
- Specific solvents and techniques are employed to achieve high purity per pre-determined specifications.
4. Crystallization and Drying:
- The purified Ceftriaxone is crystallized under controlled conditions to achieve a uniform crystal size and ensure consistent dissolution properties for the final injection.
- The wet crystals are separated from the solution by filtration using pre-sterilized filters.
- The crystals are carefully dried in a controlled environment to remove residual solvents and moisture to a pre-defined level.
5. Filling and Finishing:
- A separate sterile filling line with isolators and automated equipment is used for aseptic filling.
- Vials and stoppers are pre-sterilized and dehydrogenated.
- Accurately weighed sterile Ceftriaxone powder is filled into sterilized vials under aseptic conditions.
- A vacuum is applied to remove air and ensure product integrity.
- Pre-sterilized stoppers are inserted into the vials using a crimping machine to form an airtight seal.
- Vials are labeled with product information, batch number, and expiry date.
6. Sterilization and Packaging:
- Depending on the formulation, filled and sealed vials undergo terminal sterilization using a validated method, such as steam sterilization or lyophilization (freeze-drying).
- The sterilization process ensures the complete elimination of any microbial contaminants.
- Sterilized Ceftriaxone Injection (100 mg) vials are inspected for leaks and visual defects.
- Ceftriaxone Injection (100 mg) Vials are then packed into cartons with desiccant inserts for moisture control and labeled with the secondary packaging information.
7. Quality Control and Release:
- Throughout manufacturing, QC performs extensive testing on samples according to pre-defined specifications.
- Testing includes chemical identity, purity (by chromatography), potency (by bioassay), sterility testing, and physical characteristics of the powder.
- The final Ceftriaxone Injection (100 mg) is released for sale only after all QC tests meet pre-defined acceptance criteria.
8. Documentation and Record Keeping:
- All manufacturing steps, including raw material usage, production logs, equipment calibration records, and QC results, are meticulously documented.
- These records are maintained for a defined period to ensure complete traceability and facilitate future audits.
Den Mark Pharmaceuticals Pvt. Ltd. continually manufactures sterile, high-quality Ceftriaxone Injections for patient usage by following these extensive processes and stringent WHO GMP criteria.