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James R. Rickloff  M.S.
 

EXPERIENCE:

Advanced Barrier Concepts, Inc. – Cary, North Carolina
(1994 – Present)

Vice President / Scientific Director: Co-founded Advanced Barrier Concepts, Inc. in order to provide direct technical assistance to the pharmaceutical and biotechnology industries regarding the microbiological aspects and validation requirements for sterile isolator applications. Expertise used to managed more than 20 isolator validation projects that dealt with sterility testing, clinical manufacturing, sterile bulk packaging and high-speed production filling operations. Responsibilities include project management, process design reviews, document generation (validation master plans, user requirement specifications, FAT/SAT/IQ/OQ/PQ protocols, SOPs, final reports), protocol execution, and regulatory support regarding process application. Co-authored two chapters on engineering and microbiological aspects related to isolator sterilization in a 1995 Interpharm book, entitled Isolator Technology. A listing of publications and presentations are attached.

AMSCO International – Apex, North Carolina, North Carolina
(1989 – 1994)

Systems Engineer: Duties included Applications Engineering assignments (as below) plus direct sales responsibility of three AMSCO hydrogen peroxide sterilant generators and a line of flexible-wall isolators for use in sterility testing laboratories. Responsibilities also included providing technical support to customers in the Northeastern United States.Responsible for providing engineering support and project management capabilities to the life science / biopharmaceutical customer for applying hydrogen peroxide gas sterilization to isolation equipment and freeze dryers. Demonstrated technical feasibility of new applications performed training sessions on the safety and operational aspects of equipment, assisted customers with sterilization validation and operational performance issues, and prepared and presented technical publications for emerging technologies.

Applications Engineer:

American Sterilizer Company – Erie, Pennsylvania 
(1982 – 1989)

Senior Scientist: Responsibilities included sterilization efficacy testing on Vaporized Hydrogen Peroxide sterilizer development projects, assisted in the testing for and the preparation of regulatory submittals, provided technical support to Marketing and Engineering and gave presentations on VHP sterilization applications in the healthcare marketplace. Position also required managing the daily activities of two scientists.

Scientist: Part of a research and development team assembled to rapidly develop a VHP Table-Top Sterilizer. Primary microbiologist responsible for preparing test protocols and performing the biological efficacy tests required by the regulatory agencies. Assisted in the preparation of regulatory submittals and the equipment manual. Regulatory approval was granted for the sterilizer without requests for additional information. Managed the daily activities of another scientist.

EDUCATION:

Virginia Polytechnic Institute and State University - Blacksburg, Virginia
Master of Science, Environmental Sciences and Engineering, 1982.

Gannon University
- Erie, Pennsylvania Bachelor of Science, Biology, 1979.

PATENTS:

U.S. Patent No. 4,648,978: Process for the Continuous Preparation of Sterile Depyrogenated Solutions.

U.S. Patent No. 4,863,688:
Method for Decontaminating Surfaces on or Near Living Cells with Vaporized Hydrogen Peroxide.
 
U.S. Patent No. 4,935,371:
Sterilizable, Gas Permeable Container for Use in Culturing Living Cells.

U.S. Patent No. 5,445,792:
Optimum Hydrogen Peroxide Vapor Sterilization Method.

U.S. Patent No. 5,508,009:
Optimum Hydrogen Peroxide Vapor Sterilization System.

PROFESSIONAL AFFILIATIONS:

International Society for Pharmaceutical Engineering (ISPE)
Parenteral Drug Association (PDA)
American Glovebox Society (AGS)

PUBLICATIONS and PRESENTATIONS

Rickloff, J.R., “Current Trends and Concepts in Validating Sterility Testing Isolators”, Serentec Workshop on Isolators for Sterility Testing: Current Issues and Trends, Raleigh, NC, May 25-26, 2000.

Rickloff, J.R., “Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems”, Journal of Validation Technology, 5:61-71, 1998

Rickloff, J.R., “Validation Approach for Sterility Test Isolators”, AAI Seminar on Moving Pharmaceutical Microbiology into the 21st Century, Wilmington, NC, April 1997.

Rickloff, J.R., “Hydrogen Peroxide Based Sterilization and Validation”, Pharm Tech Conference, San Juan, Puerto Rico, June 1996.

Rickloff, J.R. and L.M. Edwards, " Modern Trends in Sterilization of Enclosures ", chapter in Isolator Technology: Applications in the Pharmaceutical and Biotechnology Industries, edited by Carmen Wagner and James Akers, Interpharm Press, 1995.

Rickloff, J.R. and Eddington, D.L., “Hydrogen Peroxide Gas Sterilization Trials Performed on a Prototype Enclosed Vial Filler”, PDA/ISPE Joint Meeting on Advanced Barrier Technology, Atlanta, GA, January 17-18, 1995.

Edwards, L.M. and J.R. Rickloff, "Engineering and Project Management Issues for a Hydrogen Peroxide Sterilized Filling System", chapter in Isolator Technology: Applications in the Pharmaceutical and Biotechnology Industries, edited by Carmen Wagner and James Akers, Interpharm Press, 1995.

Rickloff, J.R. and Eddington, D.L., “Hydrogen Peroxide Gas Sterilization Trials Performed on a Prototype Enclosed Vial Filler”, PDA/ISPE Joint Meeting on Advanced Barrier Technology, Atlanta, GA, January 17-18, 1995.

Rickloff, J.R., J.P. Dalmasso, and L.W. Lyhte, “Hydrogen Peroxide Gas Sterilization: A Review of Validation Test Methods”, 1993 Isolation Technology Users Group Meeting, 1993 ISPE Sterilization Techniques Seminar and 1992 PDA Annual Meeting.

Rickloff, J.R., and P.A. Orelski, “Resistance of Various Microorganisms to Vapor Phase Hydrogen Peroxide in a Prototype Dental Handpiece / General Instrument Sterilizer”, ASM Annual Meeting, 1989.

 
 

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