General Course Description:

During this two-day in person seminar, day one will focus on Application of Sanitizers, Disinfectants Use and Sterilants in a GMP Controlled and Classified Environment, and on the second day, the speaker will address Revision of the FDA Endotoxin Test for Human Parentaeral Drugs, Biological Products and Medical Devices. While the first part of the instruction will describe how to clean, sanitize and disinfect within a controlled and classified environment, the second day will focus on the need for assurance that your facilities and products are devoid of endotoxin. These two courses may be taken together in sequence or individually.

Day 1


Day 2

Course Description:

Microbiology plays a role throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process which may include raw materials, in-process operations and the final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential.

Maintaining this controlled environment also requires knowledge of the microorganisms present and their susceptibility to various sanitizers, disinfectants and sterilants. Whether the final product is non-sterile or sterile, bioburden exists throughout the process and/or within the product's environment. This seminar will illustrate best practices for a critical review of the overall microbiological process, which will determine whether the critical in-process points permit the final product to meet its acceptance criteria.

Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. This seminar will instruct attendees on the importance of being aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the SOPs, internal validations as well as government and other regulatory body documents are being maintained to control the bioburden and permit the final product to enter the marketplace as microbiologically safe.

The objective of day one of this interactive seminar is to:

  • Explore the use of various sanitizers, disinfectants and sterilants within a controlled environment
  • Learn which materials may be appropriate for your facilities’ operations
  • Ensure that you are complying with your own SOPs, governmental and regulatory guidances and regulations

USP<1072> Disinfectants and Antiseptics will be used as a reference throughout the course.

Learning Objectives:

  • Determining the implementation aspects of a cleaning and disinfection program
  • Determining the vendor qualification requirements
  • How to develop an application schedule
  • Determination of how application schedules apply to commissioning of a facility and after a shutdown
  • Learn the impact of sanitizers, disinfectants and sporicides on various common microorganisms found within a pharmaceutical facility
  • Impact of product expiration dating and regulatory implications
  • Understand the use of coupons and liquid suspensions – their advantages and disadvantages
  • Understand the regulatory expectations of sanitizers, disinfectants and sporicides
  • Monitoring and interpretation of the results of the cleaning and disinfection program
  • Understand resistance and rotation of disinfectants and its meaning to facilities

Course Description:

On Tuesday, July 12, 2011, the FDA posted a notice on their website that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices. They advised that the 1987 Guideline is considered obsolete and does not reflect the agency's current thinking on the topic.

In lieu of this document, the FDA advised that they would be issuing a Guidance for Industry on Pyrogen and Endotoxins Testing: Questions and Answers during the November/ December 2011 timeframe. After much delay, this new guidance was released in June 2012.

The FDA referenced, however, three documents that they believe have more than offset the previous FDA guidance that was withdrawn. They advise that these documents be referenced for the fundamental principles of the gel clot, photometric and kinetic test methods.

This new, revised guidance supplements the above three documents and addresses those issues that may be subject to misinterpretation, not covered in compendial procedures or in the previously available guidance document.

The objective of day two of this interactive seminar is to:

  • Explore the new Guidance for Industry on Pyrogen and Endotoxins Testing which addresses those issues that may be subject to misinterpretation and are not covered in compendial procedures or in the currently available guidance documents
  • Understand how they impact testing within the typical quality control laboratory

Examples of FDA Warning Letters which illustrate problems associated with endotoxin will also be provided.

Learning Objectives:

  • Review of the current testing requirements
  • Understanding what happened to the old 87/91 LAL Guidance for Industry document
  • Learn what has replaced it and why
  • Learn of common issue misunderstandings and misinterpretations
  • Determine who comprised the agency guidance team involved with this new proposed guidance
  • Reviewing documents supporting this new guidance
  • Understand sampling, storage, handling and pooling
  • How does one transition from one bacterial endotoxin test to another?
  • Understand the Rabbit Pyrogen Test (RPT)
  • Learn about the Monocyte Activation Test (MAT)
  • Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
  • Understand the FDA's expectation for screening of therapeutic products

Who Will Benefit:

  • Manufacturing
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Regulatory Compliance
  • Validation

Topic Background - Day 1:

The determination of which disinfectant to use is largely dependent upon the site of application and the type of microorganism present. For example, gram-positive cocci are very easy to kill, while spore forming rods and fungi are more resistant. Other elements that need to be considered include the biocidal activity and its contact time, surface of application, concentration of microorganisms, and secondary issues to include water hardness and organic materials. In addition, surface films may also interfere with the direct contact of the microorganism and the disinfecting agent. Any objectionable or specified microorganisms that may be encountered during the procurement of raw materials and its processing must also be considered.

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Course Title: Use and Application of Sanitizers, Disinfectants and Sterilants in a GMP Controlled and Classified Environment

  1. Regulatory Expectations of Sanitizers, Disinfectants and Sporicides
  2. Application of USP<1072> Disinfectants and Antiseptics
  3. Determining the Vendor Qualification Requirements
  4. Facility Requirements – Coupon and Suspension Studies
  5. The Impact of Sanitizers, Disinfectants and Sporicides on Various Common Microorganisms
  6. Developing an Application Schedule within Newly Commissioned, After Renovations, and Following Shutdown Facilities
  7. Monitoring and Interpretation of Results of the Cleaning and Disinfection Program
  8. A Review of Warning Letters

Course Title: Revision of the FDA Endotoxin Test for Human Parentaeral Drugs, Biological Products and Medical Devices

  1. Learn about Current Testing Requirements
  2. What Happened to the 87/91 LAL Guidance for Industry Document
  3. Gain an Understanding of the FDA’s Recent Questions and Answers Document
  4. Learn More about Typical Issues Confronting the End User of LAL Testing
  5. How Does One Transition from One Bacterial Endotoxin Test (BET) to Another
  6. Understand the Rabbit Pyrogen Test (RPT) and When It Will Be Discontinued
  7. Understand the Regulatory Expectations for Screening of Therapeutic Products
  8. A Review of Warning Letters

Meet Your Instructor

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. 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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