Cleaning Validation Risks: Front-Line Strategies for an Effective and Compliant Program

Held May 27, 2009

The FDA is cracking down hard on drug and device manufacturers for violating their cleaning validation processes and protocols.

For example, in a recent warning letter, one company received five paragraphs of cleaning validation violations — from failure to have cleaning validation studies to a lack of documentation describing the preparation of the cleaning/sanitizing agent.

But you don’t have to fear Form 483s, warning letters, lawsuits, recalls or bad publicity — if you have front-line strategies in place for implementing an effective and compliant cleaning validation program.

Maintaining or cleaning equipment at appropriate intervals or lack of indication of final rinse verification may seem like small issues on the surface but can easily lead to serious cleaning validation violations. Do you know the best strategies you can implement to avoid these — and other — disasters through every step of the process? For example, are you aware:

  • Equipment must be located and configured to allow for proper cleaning and all cleaning procedures must be documented and logged?
  • Every contact point during every step along the processing path creates a contamination risk and must be dealt with?
  • Cross contamination can occur if more than one product, or its components, are in the same space or come in contact with the same equipment or utensil?
  • The chemicals and solvents used to clean equipment are crucial — the wrong one can fail to accomplish the cleaning task or could leave a residue?
  • Equipment that is porous, such as filters, can break down over time or can be damaged by solvents and create adulterating substances?

Equipment and utensils that have not been validated for cleanliness can cause thousands of drug doses or devices to be adulterated — a further GMP violation. Plus, contaminated products that make it to market can cause patient injury resulting in recalls, bad publicity, fines and lawsuits.

So, where can you go to find the best techniques for cleaning validation?

Rich Yeaton, an expert in cleaning, validation and disinfection of all product contact surfaces, will provide front-line strategies for implementing an effective and compliant cleaning validation program. In this 90-minute audio CD/Transcript he'll demonstrate, through real-life case studies, how to identify potential problems in equipment and utensil cleaning, and how to resolve problems already in effect. He'll also describe how to ensure the best techniques for cleaning validation are being used.

Order now for your entire team to listen in and discover:

  • Three steps to take before cleaning validation on equipment can begin
  • The best analytical methods and sampling to determine the cleanliness of equipment
  • The importance of a cleaning validation master plan and the five most important components of one
  • What documentation and SOPs companies need for cleaning agents and testing equipment
  • Equipment and utensils that create special challenges and how to validate their cleanliness
This audio CD/Transcript is a must for professionals in drug, device, biotech, biologic and diagnostic companies, including:
  • Compliance officers
  • Consultants/service providers
  • Engineering and design control teams
  • Executive management
  • General/corporate counsel
  • Investigators
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management professionals
  • Training personnel
  • Validation specialists/ scientists/engineers
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Rich Yeaton, president of East Coast Validation Services, LLC, has more than twenty years of experience working in FDA-regulated industries. He was initially introduced to GMP operations on the devices side as a development engineer in DuPont’s Medical Products Division. There, he developed and improved new process equipment and was told to validate what he had designed. He moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharmaceutical industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist MedImmune to obtain its first two commercial licenses. He has since worked with small start-up companies and larger operating companies such as Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and start-ups. Rich recently assisted Avecia Biologics, a microbial fermentation contract manufacturer, to successfully prepare for its first preapproval inspection held in January 2009. His is a member of the ASME, the ISPE and the PDA and has degrees in electrical engineering and mechanical engineering from Lehigh University.

Order now!