Combining Targeted Delivery with GMP-Driven Contamination Control
Delayed-release capsules provide controlled delivery of APIs to specific regions of the GI tract, enabling therapeutic efficacy and patient convenience. But in multi-product or shared manufacturing setups, they also present unique cross-contamination risks due to complex coating processes and sensitive actives.
Sources of Contamination Risk
- Powder carryover during capsule filling or sealing
- Inadequate cleaning of coating or pan systems
- Shared encapsulation lines without product segregation
- Airborne particulate transfer between lots
Mitigation Strategies
- Use of closed transfer systems and contained equipment
- Dedicated or pre-validated equipment for enteric/delayed release lines
- Automated wash-in-place (WIP) or clean-in-place (CIP) capabilities
- Rigorous line clearance and visual inspection protocols
Validation and Regulatory Expectations
- Swab and rinse testing for residual actives
- Robust cleaning validation protocols across product families
- Real-time environmental monitoring and batch tracking
- Part 11-compliant equipment with audit trail and alarm logging
Design and Engineering Considerations
- Segregated air handling zones and pressure differentials
- Capsule materials and coatings resistant to cross-interaction
- Inline weight and seal integrity checks to prevent leakage
Applications
- Hormonal therapies, immunosuppressants, and allergenic compounds
- Multi-product lines with narrow therapeutic index APIs
- Products requiring spatial or temporal GI targeting
Delayed-release capsules are not just a formulation strategy—they are a contamination-sensitive technology that must be engineered with precision and protected through validated, compliant protocols.
