During the encapsulation operation of Esomeprazole 20 mg, a large weight variation and poor distribution of pellets in the capsules were due to the presence of static electricity at the level of the pellets in the pellet feeder, thus affecting the final weight of the produced units.
To remove static electrical charges in pharmaceutical powders, consider using grounding techniques, implementing ionizers, and maintaining adequate humidity to prevent charge buildup, as well as proper handling and storage practices.
Here’s a more detailed explanation:
- Grounding:
- Ensure all metal equipment and objects involved in powder handling are properly grounded, providing a path for static electricity to flow to the earth.
- Use multi-strand braided copper or stainless-steel bonding wires for reliable grounding connections.
- Regularly inspect and test the grounding system to ensure its effectiveness.
- Ionizers:
- Employ ionizers (also known as static eliminators) to neutralize static charges on surfaces by emitting ions.
- Position ionizers strategically in areas where charge accumulation is likely, like near conveyor belts or in storage bins.
- Ensure the ionizers are producing both positive and negative ions to neutralize static charges of different polarities effectively.
- Humidity Control:
- Maintain an appropriate relative humidity (RH) level in the manufacturing area and in containers to prevent static buildup.
- Target an RH of 35% or higher to minimize the risk of static discharges.
- Anti-Static Additives:
- Incorporate antistatic additives into the process materials, if feasible, to improve their conductivity and facilitate the dissipation of static charges.
- Proper Handling and Storage:
- Use anti-static brushes to control static electricity during bulk solids mixing and prevent charges from accumulating.
- Implement appropriate grounding and sampling procedures during manufacturing.
- Use static meters to assess the polarity and severity of static charges on surfaces.
- Train personnel on safe handling and storage procedures to avoid static buildup.
- Other Considerations:
- Consider using antistatic floorings to help disperse any static electricity accumulated on the floor.
- Static electricity can cause cross-contamination and attract unwanted particles, so controlling static is crucial for maintaining product purity.
- Remember that static discharges can be a risk for product quality and personnel safety.
Also you can use glidant in permitted levels to avoid the friction in between the Pellets and to improve flowability.