The presence of black particles in ampoules is a serious quality issue in parenteral manufacturing. These particles can originate from various sources during the production, filling, sealing, or storage of ampoules. Risk Assessment for Black Particles observed in Ampoules shall be done. Here’s a structured overview of possible reasons for black particulate contamination:
1. Glass-related Sources
- Ampoule scorching during flame sealing
- Overheating of the ampoule neck while sealing forms soot-like black particles.
- Improper adjustment of burner flame.
- Glass delamination
- Surface degradation (especially in Type I glass) releasing flakes or black specks.
- Glass breakage or chipping
- Damage during washing, sterilization, or filling can introduce particles.
2. Machine and Equipment Sources
- Lubricant or oil contamination
- Carbonized grease or oil from filling, sealing, or conveying equipment.
- Burnt rubber debris
- From worn-out machine parts (e.g., gaskets, O-rings).
- Deposits in flame nozzles
- Accumulated carbon deposits blown into the ampoule.
3. Product-related Sources
- Charred formulation residues
- Thermal degradation of product residues in the neck or during sealing.
- Incomplete filtration of solution
- If solution filtration is inadequate, pre-existing particles pass into the ampoule.
4. Environmental and Handling Sources
- Environmental contamination
- Airborne particles from poorly controlled cleanroom environments.
- Operator-related contamination
- Fibers, soot, or particles introduced during handling.
How to Investigate
When you encounter black particles in ampoules, a structured root cause investigation typically involves:
✅ Visual and microscopic examination of particles (size, shape, composition).
✅ Checking flame settings and maintenance logs of sealing equipment.
✅ Inspecting ampoule washing and sterilization steps.
✅ Reviewing equipment cleaning and lubrication records.
✅ Verifying filtration and bulk solution sampling.
✅ Evaluating environmental monitoring results.
How to Prevent
- Ensure proper flame adjustment to avoid scorching.
- Use correct type and amount of lubricant, and maintain equipment.
- Implement effective filtration (e.g., 0.22 µm filters) of bulk solution.
- Regularly train operators on handling and contamination control.
- Enhance environmental controls and monitoring.
