METS1015 Controlled Environment and Aseptic Techniques (On Hold)
This course introduces the student to controlled environment and aseptic work areas. Procedures for human, product, and equipment entry and exit from controlled environments are introduced and practiced. Basic requirements for working with blood borne pathogens and pyrogens, creating sterile fields, and biohazard handling are reviewed. Students will gain an understanding of the ISO 14644 and Federal 209-E standards.
Prerequisite
None
Course Requirements and Evaluation
Refer to Course Syllabus for detailed information regarding the requirements and evaluation standards for this course. The Course Syllabus will be distributed the first week of the course.
Learning Outcomes
The following outcomes will be addressed in the course:
Identify aseptic concerns in medical device manufacturing
Construct an aseptic work area in a controlled environment
Explain the business reasons for manufacturing in controlled environments
Demonstrate knowledge of ISO 14644
Differentiate between product contamination and product sterilization
Text and References
A list of textbooks required for this course is available at the bookstore.
Course Scheduling
The scheduled hours of instruction include sixteen hours for each lecture credit, thirty two hours for each lab credit and forty hours for each credit of supervised occupational experience (SOE). Lecture credit may include formal or impromptu lectures, demonstrations or discussions with the entire class or with small groups or individuals. Refer to the Credit Details section of this course outline for the credit breakdown.
Accommodations Statement
Access Services - Reasonable accommodations are available to qualified students with documented disabilities. Upon attending an intake meeting with Access Services, qualified students will receive a letter listing the approved accommodations that they may provide to their instructors. If you have a documented disability that may require accommodations, contact HTC Access Services at
AccessServices@hennepintech.edu or
https://hennepintech.edu/current-students/access-services/index.html.
Campus
Eden Prairie Campus: 952-995-1300
Credit Details