Small Volume Injectables (SVI) are sterile pharmaceutical preparations intended for parenteral administration, typically with a volume of 100ml or less per container. The manufacturing of SVIs requires stringent quality control, sterile processing, and compliance with international regulatory standards.
What are Small Volume Injectables?
Small Volume Injectables include solutions, suspensions, and emulsions packaged in ampoules, vials, or pre-filled syringes. Common examples include antibiotic injections, anti-inflammatory injections, antacid injections, and vitamin injections.
SVI Manufacturing Process
1. Formulation Development
The process begins with formulation development, where active pharmaceutical ingredients (API) and excipients are carefully selected and tested for compatibility and stability.
2. Sterile Processing
SVI manufacturing requires aseptic processing in cleanroom environments. The facility must maintain ISO Class 5 (Grade A) conditions for filling operations and ISO Class 7 (Grade B) for background areas.
3. Filtration & Sterilization
Solutions are sterilized through 0.22 micron filtration. Terminal sterilization may be used when compatible with the product formulation.
4. Filling & Sealing
The sterile solution is filled into sterilized containers (ampoules/vials) under aseptic conditions, followed by sealing (ampoule sealing or vial stoppering and capping).
5. Inspection & Packaging
Each unit undergoes visual inspection for particulate matter, followed by secondary packaging with proper labeling and tamper-evident sealing.
Quality Control in SVI Manufacturing
Quality assurance is critical in injectable manufacturing. Key QC tests include:
- Sterility testing
- Endotoxin/LAL testing
- Particulate matter testing
- Assay and impurity testing
- Container closure integrity testing
Regulatory Compliance
WHO-GMP certification is essential for exporting SVIs to international markets. Compliance with USFDA, EMA, and other regulatory authorities may be required for specific markets.
Indus Pharma's Pharmaceutical Manufacturing
At Indus Pharma, we operate WHO-GMP certified facilities for Pharmaceutical Products manufacturing. Our state-of-the-art plant in Rajasthan is equipped with:
- Modern aseptic processing lines
- Automated filling and sealing machines
- Advanced quality control laboratory
- Validated sterilization processes
We manufacture a wide range of Pharmaceutical Products including Ceftriaxone, Diclofenac, Pantoprazole, and other sterile injectables for global markets.
Need Pharmaceutical Manufacturing Partner?
Contact Indus Pharma for third party manufacturing and contract manufacturing services.