Good Design Practices For Pharmaceutical Water Systems

Duration: 60 Minutes
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Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, an out-of-control water system can cause harm to the patient or adulterate pharmaceutical products. Purification of water is required to prevent interaction with drug substances or other ingredients in the product formulation. Water must also be microbiologically controlled and monitored. This webinar will assesses some of the requirements for good design, together with the control measures necessary to maintain effective microbiological control in pharmaceutical facility water systems.
Pharmaceutical Water Systems
Instructor: Tim Sandle
Product ID: 509151
Objectives of the Presentation
  • Water system design, including sanitization, dead-legs, system maintenance
  • Different expectations from different types of water systems
  • The risk of biofilms
  • The risk of bacterial Endotoxin
  • Remedial actions to return a water system to use
  • Controlled changes to water systems
  • Qualification of water systems
Why Should you Attend
Compendial water is a critical utility at any facility. An excursion in system operation may affect product water quality and facility operation potentially resulting in significant effects on patient and product. Attend this webinar to learn about the microbial and chemical contamination risks from an improperly designed or maintained water system; to consider good design principles; to review the steps for water system qualification.

Areas Covered
  • Pharmaceutical water types and the main differences (including recent revision to European WFI production)
  • Water system design
  • Water system qualification
  • Microbial risks
  • Microbial profiles, including ‘marker’ organisms
  • Endotoxin risks
  • Remedial actions to take when a system becomes contaminated
  • Water system qualification requirements
Who will Benefit
  • Quality Assurance
  • Logistics
  • Manufacturing
  • Quality system auditors
  • QA directors and managers
  • Microbiology analysts and technicians
  • Consultants
  • Regulatory and Compliance Management
  • Compliance lab personnel
  • R&D, and engineering
$375
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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