Global Implementation for
Testing for
Release Testing
Automated Dissolution
Commercial
21Sep2022
Outline • Benefits to Automated Dissolution and ROI Evaluations • Strategies for Implementation • Current Automated Dissolution Instruments
Benefits to Automated Dissolution Testing
Efficiency & Cost Savings
Precision
3
• ≥60 dissolutions per analyst/instrument per week • Cost savings and more valueadded analyst time
• Consistent tablet drop and experiment initiation • Consistent priming, purging, sampling, and filtration • Gravimetric media addition and/or verification Data Integrity • Every action & method version captured in audit trail • Controlled user accounts • Increased information for investigations Safety • Ergonomics • Potent compound handling
Return
Required Inputs
Evaluations
Cost
Break Even Point Calculation
(Automated Instrument Price +
Number
Capacity *
Operational Cost Savings+
Cost Savings)
Return on Invesment Calculation
Price
on Investment
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1. Investment A. Automated Instrument Cost B. Implementation 1. Method “Validation” 2. Instrument Qualification 2. Capacity and Demand A. Number of Batches Tested per Year B. Capacity of Automated Instrument per Year 3. Operational Costs A. Static (per Year) 1. Routine Calibration 2. Preventative Maintenance 3. Traditional Instrument Wear and Tear B. Dynamic (per Dissolution) 1. Analyst touch time and cost 2. Reagents 3. Consumables 4. Waste Handling
Implementation) (Annual
of Batches or Automated Instrument
Dynamic
Static
(Automated Instrument
+ Implementation) –((Annual Number of Batches or Automated Instrument Capacity * Dynamic Operational
Savings+ Static Cost Savings) * Projected Life of Instrument)
Timeline for Implementation of Automated Method
HQ + Site: Method
Strategic Experimental
HQ + Site: Initial Business Case Evaluation HQ: Feasibility Testing
“Validation” Study Design and Protocol HQ: Method Development and Optimization
Site: Method “Validation” Testing
HQ + Site: Data Analysis and Report Authoring
HQ + Site: Implementation (Analytical Method and/or Cover Sheet)
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Automated
Part
“Validation” Testing
Development Phase Implementation
Core
of Method
Method
6
• Minimal automated vs. tradition comparison • Intermediate Precision • Method Robustness (impact of variation to paddle speed, media composition, etc.) Supply Phase Implementation: • Sample Selection • Potencies • Manufacturing extremes • Acceptance Criteria • Full Profile Evaluation, Acceptance Criteria @ Q Timepoint • Precedents: Method Validation or Transfer Criteria • Product/Method Variability • Specification Safe Space • Sample Size (statistically driven)
1:
“Validation”
Part 2: Cleaning/Carryover Evaluation • Assay of Vessel Blanks following Maximum Number of Consecutive Dissolutions • Consideration for Products with Multiple Potencies
Automated Dissolution Instruments
Sotax Multi-Dose
Sotax AT70
-Configuration: Floor model, not modular
-Media: Calibrated pump, end gravimetric verification
Sampling: Center shaft or fixed cannula
-Capacity: 6-10 Consecutive Paddle, 10 Consecutive basket -Pre-set vessel and lines cleaning program
-Configuration: Benchtop, modular
-Media: Gravimetric addition
-Sampling: Center shaft or mobile cannula
-Capacity: 8 Consecutive Dissos (Paddle and Basket)
-Customizable vessel and lines cleaning program
Sotax ATF
-Configuration: Floor model, modular
-Media: Calibrated pump, initial gravimetric verification
-Sampling: Center shaft or mobile cannula
-Capacity 6-8 Consecutive Paddle, Unlimited Consecutive Basket -Customizable vessel and lines cleaning
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