Please schedule onePoint consulting with Seungyil “Daniel” Yoon, Ph.D.
“onePoint consulting” provides focused, concise, and actionable advice to clients. If you need quick, specific guidance on particular issues, please contact me for onePoint consulting.
Benefits of onePoint Consulting
- 1. Efficiency: Enables quick decision-making and implementation.
- 2. Focus on high impact areas: specialized knowledge in a particular area, allowing businesses to tap into expert advice and solutions for specific problems or projects.
Implementing onePoint Consulting
1. Identify the Key Issue
2. Gather Information
3. Develop the One Point Advice
4. Follow-Up
Examples of onePoint Consulting
- Problem solving for urgent situations
- Risk assessment for deviations, packaging and device design change, and others
- Modeling
- CCIT
- Validation
- Cold Chain
- CFR, FDA guidance, USP, ASTM, Directive, EMA guidance, EP, ISO standard, ICH guidance, WHO guidance etc.
Philosophy
If I am unable to articulate a theoretical explanation, it indicates a lack of understanding on my part. Rather than solely depending on experimental outcomes, it’s crucial to first develop a theoretical understanding and then conduct experiments to validate the hypothesis. Performing these experiments is essential, regardless of whether the hypothesis is ultimately proven correct or incorrect. This methodical approach not only enhances confidence but also broadens our knowledge base.
Scope
- small molecules to large molecules
- chemical drug to biologics
- drug product manufacturing process, device design verification to assembly process, packaging design to manufacturing
- liquid fill/finish, lyophilization fill/finish, solid (tablet, capsule) bottle, blister and sachet packaging
- syringe, syringe with safety, eye drop bottles, autoinjector, insulin pen devices
- aseptic, component sterilization (gamma, EO, e-beam), syringe surface sterilization (VHP, NO2)
- plastic, rubber, metal, glass, paper/paperboard materials
Capabilities
- Product-Packaging stability modeling: Excel/Macro program development, CSV, product kinetic study design, product stability estimation, WVTR testing method development
- Device design verification: DV management, risk management, technical evaluation using FEA, tolerance stack-up analysis, syringe dosing model and functionality tests
- Packaging component and system qualification to meet material safety, compatibility, functionality and protection
- DP development management: formulation, DP process, device and packaging
- Sterilization method and process development: method selection, PCD design
- GDP system development: SOP, cold chain shipping qualification, strategy development for temperature excursion
Publications
- The Role of Container-Closure Systems in Stability Testing for Climate Zone IV, USP Pharm Forum, March-April issue, 2006
- A Discussion of Net Water Gain for Water Vapor Transmission Rate Determinations, USP Pharm Forum, May-June issue, 2008
- Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems, PDA J of Pharmaceutical Science and Technology, Sep-Oct issue, 2012
- An Assessment of the Impact on Pharmaceutical Product Quality Resulting from Humidity Exposure during Distribution by Modeling Moisture Ingress, USP Pharm Forum, Nov-Dec issue, 2012
- Ophthalmic Product Development Book – Packaging Development Chapter, AAPS, 2021
Presentations
- Recent trends of biopharmaceutical product and packaging development, Seoul Cold Chain Forum in 2018, South Korea
- Best practices for modeling – finite element analysis for combination product design verification, MD&M west conference in 2018, CA, USA
- Introduction of GDP system development, Seoul Cold Chain Forum in 2017, South Korea
- Finite element analysis modeling applications to pre-filled syringe and autoinjector system design, prefilled syringe forum in 2016, PA, USA
- Designing Pharmaceutical Packaging for Solid Oral Dosage Forms and Injectable Products, Yonsei Medical and Pharmaceutical Packaging Symposium in 2014, South Korea
- Packaging Process Validation & Container Closure Integrity Testing Strategy and Method Development, Korea Pharm in 2014, South Korea
- Designing Pharmaceutical Packaging Using Product-Packaging Stability Modeling, AIChe (American Institute Chemical Engineers) annual meeting in 2011, MN, USA
- Pharmaceutical Container-Closure Qualification, COPHEX (Cosmetic & Pharmaceutical Machinery Equipment Exhibition) in 2007, South Korea