Aseptic Processing Training Agenda (EST)

Join the conversation 7:45 -8:00 AM

Time of commencement of the Seminar: 8:00 AM

 

Aseptic Processing – Introduction

▪         The Disinfected Quantity Form

▪         Conservation and control of serious surroundings

▪         Expansion of procedures for process, standardization, Preventive Maintenance, CAPA, etc.

▪         Exercise of workers to include gowning

▪         Certification and assessment of variations

 Break 9:45 – 10:00 AM

 

▪         Adulteration Sources in Sterile Manufacturing

o  Subdivision Content Controls, Cross Pollution Hazards

▪         Cleaning Process and Agents for Sterile Production

 

Questions-Answer Session: 11:15 AM

End of Seminar 11:30 AM

Day 2

Join the conversation 7:45 – 8:00 AM

Time of Commencement of the Seminar: 8:00 AM

 

▪         Developing Media Fill Requirements in An Aseptic Environment

o  Form FDA 483s

o  Equipment set up

o  Sterilization process

 

 Break 9:45 AM. – 10:00 AM

●       Media fills

●       Smoke studies and their emphasis in Aseptic Production (ISO Class 5 facilities)

●       Endotoxin sources

 

Answering Questions: 11:15

End of Seminar 11:30 AM


Objectives of Learning

By the end of the Seminar, the participants will be able to do the following:

●       Decrease inspectional observations

●       Get the right knowledge about the basic ideas or principles and skills that are mandatory for conducting Aseptic Dispensation of Sterile Drug Products while maintaining minimum risks

●       Avoid Cautionary Letters and Agreement Rulings

●       Obtain the skills essential for controlling the procedure setting

●       Diminish media fill failures to license manufacture throughput

●       Examine subjects affecting Aseptic Processing to contain the situation, workers, gowning, and cleansing

●       Learn the best repetition techniques for decisive media fill sizes

●       Understand the "critical factors" required to maintain compliance

●       Determine how to develop media fill simulations to include the "worst case" scenarios

Who are the possible beneficiaries of the Aseptic Processing Course?

▪         Manufacturing professionals

▪         Project Management

▪         Process Chemistry

▪         Analytical Chemistry

▪         Quality Control professionals

▪         Aseptic Processing

▪         Regulatory Compliance

▪         Reformulation and Formulation Development

▪         Validation

▪         Microbiology

▪         Analytical Chemistry

▪         Quality Assurance

▪         Scale-up and Technology Transfer

Overview of Aseptic Processing Course

Aseptic Processing is identified as a process to manufacture Medicinal and Biotechnical products course impartial is to discover the character of aseptic filling to guarantee that industrial production will recall the bareness pledge level prescribed by GMPs

Disinfected products may be largely divided into two major divisions. These divisions depend on the mode of their production. The process includes pasteurization following the satisfying and closing of the ampule and those that are aseptically sterilized. Aseptic Dispensation plays a grave character with large particles that cannot be pasteurized. The confirmation of the procedure to harvest sterile products is gauged through the demo of numerous media fill process imitations. These simulations vary in both numbers and size of the containers and also on the volumes filled over a definite period.

Aseptic Processing contains jeopardy valuation in a continuous manner because of the characteristic risks due to penalties of organization and procedure disappointment and tests within the discovery, separation, control, and organization of creation pollution. Within sterile dispensation, the harshness of the penalties of a failure can be critical to the end user while uncovering barrenness challenges remains rather imperfect because of the trivial number of final products verified.

With sheath separation, it is vital to start satisfactory levels of bacteriological pollution to guarantee both produce security and acquiescence. Additionally, aseptic processes are related to endotoxin control, so it gets managed to satisfactory levels.

 A diversity of variable quantities can influence the barrenness pledge and the supplementary endotoxin level. These things always contain personnel, procedure, apparatus, mechanisms, cleansing, dehydrogenation along with facilitates that leave some impact on the organization and dispensation of the ultimate products. Issues that need to be careful include the monitoring of ecological areas and workers, water sources, media, media fills, growing, and cleansing.

Products that have been aseptically occupied have trusted the use of USP <71> Sterility Tests to prove barrenness. Nevertheless, since as many as 20 containers are tested per media (TSB and FTM) regardless of the manufacturer's lot size, the usage of barrenness tests does not deliver a high degree of sterility assurance (SAL). Therefore, media fills are used and applied to simulate the real fills and to prove at least a 10-3 sterility pledge level of no pollution. If the ability uses RABS or isolators to encounter their filling requirements, a SAL of 10-5 to 10-6 is likely since the connections with personnel and the environment decrease markedly.

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Faculty Barry A. Friedman

Faculty Barry A. Friedman Ph.D.

Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena 30 + years exp.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department of thirty one individuals involved in Client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity Dr Friedman enjoyed many client and regulatory interactions.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill ‘n Finish manufacturer located in Baltimore, MD. He was involved with the microbiology, environmental monitoring and analytical chemistry for Phase 1, 2, 3 and commercial products aseptically filled/lyophilized Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from The Ohio State University, his M.S. from Michigan State University in Microbial Genetics and his Ph.D. from The Ohio State University in Microbiology.

Dr. Friedman is a frequent seminar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, GBPR, PDA, PTi. He is a member of AAMI, ASM, and PDA. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.