ABOUT EPOTSE

EPOTSE was formed between industry experts to address the unmet need in using science and engineering to improve the cost and quality of development, tech transfer, and supply chain operations.  Our goal is to bring value to you, so that we partner with you to improve product quality while bringing down the cost.

EPOTSE is a simple acronym of the following words

E - electronic/everything

P - Process/Pharmaceutical

O - Operations

T - Technology

S - Science

E - Engineering

E---E - end-to-end supply chain

PCTS, Inc. was founded in 2003 with the vision to bring coating technology solutions to the scientists, we now offer turnkey solutions to businesses.  The belief that science and engineering should be at the core of product manufacturing remains our main focus.  Services offered bring manufacturing sciences into business processes.

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ADVISORY BOARD/TEAM

Committed to Excellence

 

PUBLICATIONS

DELIVERING SOLUTIONS: HOW FILM-COATING TECHNOLOGY IS ADDRESSING MODERN PHARMACEUTICAL INDUSTRY TRENDS

Stuart C. Porter, et al.,Tablets & Capsules, 2019

APPLICATIONS OF PROCESS THERMODYNAMICS IN PHARMACEUTICAL COATING

M. Choi, lead article in Tablets and Capsules, April, 2007.

TROUBLESHOOTING APPEARANCE-RELATED PROBLEMS OF FILM COATED TABLETS

Stuart C. Porter, Tablets & Capsules, 2008

IMPLEMENTATION OF QUALITY BY DESIGN (QBD) USING MANUFACTURING EXECUTION SYSTEM (MES)

M. Choi, et al., Pharmaceutical Engineering, January, 2015.

MANUFACTURABILITY OF DRUG-LAYERED TABLETS

M. Choi, Pharmaceutical Manufacturing, April, 2007.

TECHNIQUES TO EVALUATE FILM COATINGS AND ASSESS FILM-COATED PRODUCTS

Stuart C. Porter, et al., Drug Dev. & Ind. Pharm., 2009

CONTINUOUS FILM COATING PROCESSES: A REVIEW

Stuart C. Porter, Tablets & Capsules, 2007

SIMULATION OF TABLET COATING UNIFORMITY FOR A PAN-COATING PROCESS

M. Choi, 2004 AIChE conference, Austin, TX.

 

STU PORTER, PH.D.

President of PPT

  • Globally recognized leader in tablet-coating technology

  • Technical Consultant at Ashland Specialty Ingredients

  • Vice President, Colocon

  • 40+ years of experience with film-coating applications

  • Member of Royal Pharmaceutical Society (RPS) of Great Britain

  • Member of American Association of Pharmaceutical Scientists (AAPS)

  • Member of American Pharmacists Association (APA)

Expertise

  • Design of immediate- and modified-release coating products

  • Oral solid dosage forms and oral drug delivery

Key Accomplishments and Focus

  • Continuous processing as it relates to the manufacture of oral solid dosage form

Relevant Publications

  • Stuart C. Porter, “Aqueous film coating: an overview” Pharm. Technol. 3 (9), 54-59, (1979)

  • Stuart C. Porter, “The effects of additives on the properties of an aqueous film coating”, Pharm. Technol., 4(3). 66-75, (1980).

  •  S.C. Porter * & K. Ridgway, “The permeability of enteric coatings and the dissolution rates of coated tablets”, J. Pharm. Pharmacol., 34, 5-8, (1982).

  •  S.C. Porter, “The practical significance of the permeability and mechanical properties of polymer films used for the coating of pharmaceutical solid dosage forms”, Int. J. Pharm. Tech. & Prod. Mfr., 3(1), 21-25, (1982).

  •  S.C. Porter, “Film coating equipment”, Int. J. Pharm. Tech. & Prod. Mfr., 3(1), 27-32, (1982).

  • S.C. Porter * & K. Ridgway, “An evaluation of the properties of enteric coating polymers; measurement of glass transition temperature”, J. Pharm. Pharmacol., 35, 341-344, (1983).

  •  Stuart C. Porter * & Kathleen Saraceni, “Opportunities for cost containment in aqueous film coating”, Pharm. Technol., 12(9), 62-76, (1988).

  •  Stuart C. Porter, “Controlled-release film coatings based on ethylcellulose”, Drug Dev. & Ind. Pharm., 15(10), 1495-1521, (1989).

  •  Gurvinder S. Rekhi *, Robert W. Mendes, Stuart C. Porter, & Sunil S. Jambhekar, “Aqueous polymeric dispersions for controlled drug delivery: Wurster process”, Pharm. Technol., 13(3), 112-125, (1989).

  •  Nilesh H. Parikh, Stuart C. Porter, & Bhagwan D. Rohera *, “Tensile properties of free films cast from aqueous ethylcellulose dispersions”, Pharm. Res., 10(6), 810-815, (1993).

  •  Gurvinder S. Rekhi *, Stuart C. Porter, & Sunil S. Jambheker, “Factors affecting the release of propranolol hydrochloride from beads coated with aqueous polymeric dispersions”, Drug Dev. & Ind. Pharm., 21(6) 709-729, (1995).

  •  Stuart C. Porter *, Richard P. Verseput, & Charles R. Cunningham, “Process optimization using design of experiments” Pharm. Technol., 21(10), 60-70, (1997).

  •  Christopher T. Rhodes * & Stuart C. Porter, “Coatings for controlled-release drug delivery systems” Drug Dev. & Ind. Pharm., 24(12), 1139-54, (1998).

  •  Stuart C. Porter & Linda A. Felton, “Techniques to evaluate film coatings and assess film-coated products” Drug Dev. & Ind. Pharm., Early On-line Edition, 1-15 (2009)


  • Stuart C. Porter, “A review of trends in film-coating technology,” American Pharm. Review, 2(1), 32-41, (1999).

  •  Stuart C. Porter, “Novel Drug Delivery: Review of Recent Trends with Oral Solid Dosage Forms,” American Pharmaceutical Review, 4(3), 28-35, (2001).

  •  Porter SC et al. Modified-release tablets coated with a modified- release film coating: comparison of regular tablets with mini- tablets as an alternative t0 pellets. 17th Annual Meeting and Exposition of AAPS. (2002)

  •  Stuart C. Porter, “Continuous film coating processes: A review” Tablets & Capsules, 4, 26-29, (2007).

  •  Porter SC, Terzian L. Predicting coating performance and solving common film-coating problems using a formulation database created using statistical D.o.E. 22nd Annual Meeting and Exposition of AAPS. (2007).

  •  Porter SC. Troubleshooting appearance-related problems of film coated tablets. Tablets & Capsules; 6(3): 16–22. (2008)

  •  Stuart C. Porter, “The role of high-solids coating systems in reducing process costs” Tablets & Capsules, 8 (3), 10-16, (2010).

  •  Porter, SC, et al. Examination of the benefits of the use of high-solids film-coating systems as a means of reducing the costs of aqueous film-coating processes.  26th AAPS Annual Meeting & Convention (November 2011)

  •  Porter, SC, et al. The application of an aqueous film-coating system at low bed temperatures (M1074) 26th AAPS Annual Meeting & Convention (November 2011)

  •  Porter, SC, et al. The preparation of pantoprazole 40 mg delayed-release tablets exhibiting good stability and drug release characteristics. 27th AAPS Annual Meeting & Convention (November 2012)

  •  Porter, SC, et al. Delayed release diclofenac sodium tablets: scaling up the coating process (T2225) 29th AAPS Annual Meeting & Convention (November 2014)

  • Porter, SC, et al. Extended-release venlafaxine pellets: scaling up the coating process

  • (T2226) 29th AAPS Annual Meeting & Convention (November 2014)

  •  Porter, SC, et al. Extended-release venlafaxine pellets; influence of coating process conditions (T3184) 30th AAPS Annual Meeting & Convention (November 2015)

  •  Porter, SC, et al. Investigating stability challenges associated with aqueous film-coated tablets. (T2058) 32nd AAPS Annual Meeting & Convention, San Diego, CA (November 2017)

  •  Porter, SC, et al. Facing the taste masking challenges with pediatric oral solid dosage forms (M5051) 32nd AAPS Annual Meeting & Convention, San Diego, CA (November 2017)

  •  Porter, SC, et al. Delivering solutions: how film-coating technology is addressing modern pharmaceutical industry trends: Tablets & Capsules; 4: 16–23. (2019)

 

BETSY MACHT, DBA, MBA, BS CE

Adjunct Professor at Waldon University

  • Supply chain Operations and Quality engineering expert

  • Quality & Compliance lead at J&J

  • 25+ years of cross-functional supply chain experience

Expertise

  • Quality engineering

  • Global Quality systems

  • Compliance/Consent Decree

  • Process engineering and facilities management

  • Environment, health, and safety

  • Tech transfer

  • Supply chain operations

  • Digital technologies

Key Accomplishments and Focus

  • Process analytical technologies

  • Risk management

  • Operations optimization and business strategy

  • Transform global manufacturing and quality to

    • Optimize processes

    • Ensure compliance

  • Transforming the organization to meet the needs of a digital future

Certifications

  • Quality Engineer 

  • Quality Auditor

  • Six Sigma Green Belt

  • Regulatory Affairs

  • Sustainable Operations

  • Capabilities Risk Reduction Leader

Relevant Publications

  • Macht, B. and Davis, A., “Strategies to Influence a Quality and Compliance Culture”, IJAMT, v17, pp68-82.

 

JACK CHU, P.E.

Principal Consultant and Key Account Manager for Merck and MSD.

  • Extensive engineering and applications knowledge with 35+ years Bio-pharm and Medical Device Industries experience

  • 25 years service at Merck & Co., Inc.

  • Licensed Professional Engineer

  • Chair, ISPE Oral Solid Dosage (OSD) Baseline Guidance 3rd Revision

  • Vice Chairman of Industrial Advisory Group (IAG) at Widener University

  • Associate Professor, Pharmaceutical Manufacturing Engineering and Economics Analysis

Expertise

  • Commissioning and Qualification (C&Q)

  • Project management

  • Thermodynamics, hydraulics and aerodynamics

Key Accomplishments and Focus

Designing, repurposing, and/or building processing and utility equipment to meet the new agency expectations including applying

  • Process-analytical technology (PAT) to advance OSD manufacturing

  • Quality by Design (QbD) in C&Q of OSD HVAC systems by re-qualification against critical process parameters

  • Science- and risk-based methodology in retrospective qualification

  • Heat Mapping Validation Strategy that established an achievable critical path for the industry to evaluate and qualify the process equipment

Relevant Publications

  • “GMP Compliance, Productivity, and Quality – Achieving Synergy in Healthcare Manufacturing” 1998

  • “Oral Solid Dosage Baseline Guide 1st Edition” 1999

  • “GDP for GMP Pharm Manuf. Facility 1st Edition” 2005

  • “Oral Solid Dosage Baseline Guide 2nd Edition” 2007

  • “SBP Capital Management” 2012

  • “SBP Fixed Asset Lifecycle Management” 2013

  • “SBP Project Management” 2013

  • “GEP - Engineering Handbook” 2014

  • “Good Design Practice for GMP Pharm Manufacturing Facility 2nd Edition” 2016

  • “Oral Solid Dosage Baseline Guide 3rd Edition”2017

MICHAEL M. CHOI, PH.D.

President PCTS, Inc.

  • Expert in Wurster, fluid-bed, and pan coating process and operation

  • General Manager at Janssen (Johnson & Johnson)

  • Head of Technical Operations at Teva

  • Executive Director of Operations at Hercon Pharmaceuticals

  • Coating expert at Merck & Co., Inc.

  • 25+ years of R&D and Supply Chain experience across pharmaceutical, chemical, nuclear, and agricultural industries

Expertise

  • Wurster and film-coating technologies

  • End-to-end supply chain operation

  • Tech transfer and process engineering

  • Product development

  • Lifecycle product and asset qualification and management

Key Accomplishments and Certifications

  • US Patent #10/981,812 on “Pan Coating Simulation for Determining Tablet Coating Uniformity”

  • Process simplification by inventing thermodynamics analysis for coating processes

  • Special Achievement Award at Merck & Co., Inc. for troubleshooting complex and recurring coating problem

  • J&J Leadership Development Program

Key Focus Areas

  • Coating and fluid-bed process characterization, troubleshooting, and scale up

  • Process engineering, design, and Operations analysis

  • Knowledge and risk management

Relevant Publications

  • M. Choi, M. Mirian, P. Bruen, and G. Ruklic, “Implementation of QbD using MES”, Pharmaceutical Engineering, January, 2015.

  • M. Choi, “Process Capability: Understanding the Science and the Statistics”, FDA-invited presentation at IFPAC, Jan 2014.

  • M. Choi (Contributor), “ISPE Guide Series: PQLI from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of Pharmaceutical Quality System”, 2012.

  • M. Choi, D. Kim, M. Sarkari, R. Simko, D. Unger, and S. Tsinontides, “Evaluation of Process Capability and Robustness for a Lyophilized Product”, presented at the 2012 AIChE Conference, Pittsburg, PA.

  • M. Choi, “Is tablet coating ready for QbD?”, Tablets and Capsules, April, 2009.       

  • M. Choi, R. Schick, and K. Cronce, “Effect of Fan Air Flow Rate on the Spray Distribution”, ILASS Conference, Chicago, IL, May, 2007.

  • M. Choi, “Applications of Process Thermodynamics in Pharmaceutical Coating”, lead article in Tablets and Capsules, April, 2007.

  • M. Choi, “Manufacturability of Drug-Layered Tablets”, Pharmaceutical Manufacturing, April, 2007.

  • M. Choi, “Simulation of Tablet Coating Uniformity for a Pan-Coating Process”, Presented at the 2004 AIChE conference, Austin, TX.

  • M. Choi and S. Johnston, “Hydrodynamics of Wurster:  A 2-D bed study”, Presented at AIChE conference at the 2000 AIChE Conference, Los Angeles, CA.

  • M. Choi, R. Olivero, G. Barr, “Precision Tablet Coating”, Presented at the 2000 AIChE Conference, Los Angeles, CA.

  • M. Choi, “Hydrodynamics of Commercial-scale Wurster Coaters”, Presented at the 1998 AIChE Conference, Miami Beach, FL.

  • M. Choi and A. Meisen, “Sulfur Coating of Urea in Shallow Spouted Beds”, Chemical Engineering Science, v52, p1073 (1997).