Understanding and Remediating Corrosion Problems during Parenterals Manufacturing


Instructor: Barrett Rabinow
Product ID: 704983

  • Duration: 2 hrs
In this two-hour webinar you will learn how to recognize problems related to corrosion, how to diagnose their specific causes, and how to remediate them. This webinar surveys the range of corrosion-mediated failure modes of parenteral solution manufacture. The roles of physical factors such as temperature, humidity, oxygen as well as formulation variables such as chloride level, pH, and inorganic metals will be discussed in this session.
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Why Should You Attend:

Corrosion of manufacturing tanks, solution transmission lines, valves, impellers, etc. causes many different kinds of problems that frequently are not even recognized as being related to corrosion. Steel pitting and outright rust leading to solution leakage are the most obvious manifestations. Subtler are rouging and ring around the inside of the mix tank. Subtler still are formation of color and particulate matter in your product or on the inside of your process filter or container. Additionally, new elemental impurity guidelines, ICH Q3D, regulate the levels of trace metals that can be present in your finished product. Steel related impurities such as iron, chromium, and especially nickel are of concern and must be assessed by a risk analysis called out by the new regulations.

To prevent corrosion, various ways of passivation, pickling, and electroplating are discussed and compared with regard to effectiveness, cost, and difficulty. The webinar reviews what kinds of improvements to these procedures should be undertaken to address different problems.

Solving corrosion problems involves evaluating the interactions among numerous variables, to determine which is important and what must be rectified. Fortunately, the problems can be rapidly and accurately modeled by much smaller, laboratory-scale simulations. There are several models available, each with its own advantages and disadvantages, which convey specific kinds of information. The webinar will survey these models and provide considerations for selection among them to solve different problems.

Areas Covered in the Webinar:

If you have responsibility for building, installing, maintaining, or qualifying manufacturing equipment, you need to understand the diversity of problems caused by corrosion, ranging from gross leakage to color and particulate formation and elevated trace metal levels.

  • Understand the impact of corrosion upon compliance with new Elemental Impurities Regulations ICH Q3D
  • Understand the causes of corrosion involving your solution formulation and environmental factors
  • Understand how to model corrosion to simulate reality
  • Understand how to select corrective actions and test them for efficacy
  • Learn how to diagnose plant problems and differences among plants related to corrosion
  • Understand the role of various metallurgical tests

Who Will Benefit:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production managers
  • Manufacturing engineers
  • Production engineers
  • Design engineers and managers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
Instructor Profile:
Barrett Rabinow

Barrett Rabinow
Baxter Distinguished Scientist, Baxter Healthcare

Barrett Rabinow was previously a Baxter Distinguished Scientist at Baxter Healthcare Corporation where he worked for over 39 years. He received his A.B. from Cornell University in 1968 and a Ph.D. in Chemistry in 1974 from the University of Chicago. From 1975-1976, he completed postdoctoral fellowships in electrochemistry, and in clinical chemistry at Michael Reese Hospital, Chicago. From 1976-1977, he served as Director, Clinical Chemistry Laboratory, Norwegian-American Hospital in Chicago. He then joined Baxter Healthcare Corporation in 1977. His positions of increasing responsibility led to the position of Director, Chemistry, where he oversaw chemistry, particle science, material science, polymer technology, and manufacturing troubleshooting for the parenterals solutions business. Dr. Rabinow has been active in industry task forces, organized by the Parenteral Drug Association, AdvaMed, Association for the Advancement of Medical Instrumentation, and the International Standards Organization as well as collaborative studies with USP, FDA, and NIH. For six years, he identified and evaluated new business opportunities, leading to Baxter acquisitions. He has developed lifecycle reformulations of drugs with new pharmacological characteristics in the area of nanosuspensions and stereoisomers. He led a team developing innovative lean stability testing protocols for parenteral solutions. Dr. Rabinow has numerous patents to his credit in the area of pharmaceutical formulations, nanoformulations, and biomaterials. He has authored four book chapters and over 40 articles, in the areas of physical-organic chemistry, clinical and analytical chemistry, trace metals, biomaterials, packaging, pharmaceutical science, drug delivery, pharmacokinetics, pharmacology and drug targeting.

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