Lean Six Sigma Black Belt certified. The One When streamlines and enhances your Drug Product (API & Specialty Chemical) and Formulation processes.
What. When. Why.
The One When Pharm Services LLC employs our Once and Done™ system to provide bullet proof Corrective and Preventive Actions to your difficult to resolve deviations. We have Drug Product (API) and Formulation trouble-shooting experience at over 20 sites. We provide cogent, succinct reports which answer auditor’s questions and resolve 483’s. Let us help you resolve your deviations and return your sites to efficient, compliant production.
Unit Operation Expertise
- Mixing, blending, sieving
- Milling
- Roller compaction
- High shear granulation
- Low shear granulation
- Fluid bed granulation
- Compression
- Coating
- Capsule operations
- Chemical reaction equipment design and control
- Tolhurst and Heinkel centrifugation
- Filter Drying
- Liquids
- Ointments
- Creams
- Dust Containment
The One When also provides Lean Six Sigma guidance to:
- Enhance process yield
- Analyze and minimize cycle times
- Guide operation planning
- Eliminate micro contamination issues
- Design, implement, and streamline cleaning systems
Jim Bonner has also designed and installed, qualified, and validated ~ $20 million of solids handling equipment, including designs capable of meeting stringent 1 to 10 µg/m3 exposure limits.