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Description

The TAK x500 series of courses are focused on Facility Operations in biopharmaceutical manufacturing.  The first module, X501 is required to take any of the other three modules.  TAK X502 is the second in the Facilities Operations series, and explores differences between and maintenance of open and closed systems involved in manufacturing. There is one synchronous meeting for three hours, with required work to be completed after the meeting and submitted to the course site within one week. (Section 5 will have only a 1 hour meeting but additional work before meetings.  See that section's description for further details.)

TAK X501 must be completed before registering for this course.

Courses offered from 9a-12p must meet a minimum of 10 registered participants. Courses offered from 5-8p must meet a minimum of 5 registered participants. Courses that do not meet the minimum will not be offered. Individuals signed up for sessions that are cancelled during under enrollment may switch other sessions.

Outline

Topics Covered

  • What does it mean to be an open or closed system?
  • Where do we have open or closed systems, how do we control?
  • CIP/SIP/Chemical sanitization of the columns
  • Higher room classifications
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