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.
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 Should Attend:
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
Key Topics Covered:
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.
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
Form FDA 483s
Equipment set up
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
Key Topics Covered:
Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences
Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.
Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of 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, both domestic and international.
Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history 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 Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.
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