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HVAC Design for Pharmaceutical Facilities (GMP's)
In HVAC Design for Pharmaceutical Facilities (GMP's), you'll learn ...
- Be aware of the critical design issues related to pharmaceutical facilities
- Understand what GMP is and why it is important for safe guarding the end user
- Learn the current codes, standards and regulations that govern the GMP's
- State the requirements for proper pharmaceutical facility design including area classification, air change requirements and pressurization gradient
Overview
Preview a portion of this course before purchasing it.
Credit: 5 PDH
Length: 58 pages
Pharmaceutical manufacturing is generally conducted in environments that are cleaner and are carefully controlled at a required temperature, humidity and pressure. The HVAC system assumes a large part of the responsibility in maintaining these clean environments.
Design of pharmaceutical facilities is governed by Good Manufacturing Practices (GMP's), which require companies to document how they intend to design and operate their facility. These are intended to set forth engineering requirements deemed necessary for safe design and operation of pharmaceutical facilities. Failure to comply puts the owner at both regulatory and business risk and therefore it is important that the pharmaceutical facilities are constructed under a rigorous and well-defined quality-control system.
Learning Objectives
Upon completion of this course, participants will be able to:
- Identify critical design issues associated with pharmaceutical facilities.
- Explain what GMP is and why it is important for safeguarding the end user.
- Identify the current codes, standards, and regulations that govern GMP requirements.
- Describe pharmaceutical-facility design requirements, including area classification, air-change requirements, and pressurization gradients.
- Explain the importance of product, equipment, material, and personnel flow within the facility.
- Describe cleanliness requirements for sterile and nonsterile operations.
- Classify cleanroom air according to U.S. FDA and European Economic Community (EEC) classifications.
- Explain HEPA-filter theory, application, monitoring, testing, and repair.
- Describe the importance of pressurization and airflow patterns.
- Compare basic air-conditioning schemes, including constant-volume and variable-volume air-handling systems.
- Identify air-distribution ductwork materials and location requirements.
- Summarize commissioning, testing, validation, and documentation requirements.
Certificate of Completion
You will be able to immediately print a certificate of completion after passing a multiple-choice quiz consisting of 25 questions. PDH credits are not awarded until the course is completed and quiz is passed.
| This course is applicable to professional engineers in: | ||
| Alabama (P.E.) | Alaska (P.E.) | Arkansas (P.E.) |
| Delaware (P.E.) | District of Columbia (P.E.) | Florida (P.E. Area of Practice) |
| Georgia (P.E.) | Idaho (P.E.) | Illinois (P.E.) |
| Illinois (S.E.) | Indiana (P.E.) | Iowa (P.E.) |
| Kansas (P.E.) | Kentucky (P.E.) | Louisiana (P.E.) |
| Maine (P.E.) | Maryland (P.E.) | Michigan (P.E.) |
| Minnesota (P.E.) | Mississippi (P.E.) | Missouri (P.E.) |
| Montana (P.E.) | Nebraska (P.E.) | Nevada (P.E.) |
| New Hampshire (P.E.) | New Jersey (P.E.) | New Mexico (P.E.) |
| New York (P.E.) | North Carolina (P.E.) | North Dakota (P.E.) |
| Ohio (P.E. Self-Paced) | Oklahoma (P.E.) | Oregon (P.E.) |
| Pennsylvania (P.E.) | South Carolina (P.E.) | South Dakota (P.E.) |
| Tennessee (P.E.) | Texas (P.E.) | Utah (P.E.) |
| Vermont (P.E.) | Virginia (P.E.) | West Virginia (P.E.) |
| Wisconsin (P.E.) | Wyoming (P.E.) | |
Preview a portion of this course before purchasing it.
Credit: 5 PDH
Length: 58 pages
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