Overview
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.
This 5-hour course provides an introduction to “Good Manufacturing Practices” with focus on the HVAC system design.
The reader must take a multiple-choice quiz consisting of twenty-five (25) questions at the end of this course to obtain PDH credits.
Specific Knowledge or Skill Obtained
This course teaches the following specific knowledge and skills:
- 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
- Explain the importance of product, equipment, material and people flow in the facility
- Describe the cleanliness requirements for sterile and non-sterile operations
- Learn the cleanroom air classifications as defined by US FDA and European Economic Community (EEC)
- Describe HEPA filter theory, application, monitoring, testing, and repair
- Learn the importance of pressurization and air flow pattern
- Understand the basic air-conditioning schemes including types of air-handling systems (constant volume v/s variable volume)
- Learn about the air distribution ductwork materials, and location requirements
- Understand the commissioning, testing, validation and documentation requirements
Course
Click on the following link to the PDF document to review the course material before taking the quiz for credit.
HVAC Design for Pharmaceutical Facilities
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