HEPA (High-Efficiency Particulate Air) and ULPA (Ultra-Low Penetration Air) filters are both advanced filtration systems designed to remove particulate matter from the air, but they differ in efficiency, applications, and cost. Filtration Efficiency: HEPA filters capture 99.97% of particles as small as 0.3 microns, making them highly effective for general use in cleanrooms, medical facilities,…
In the fast-paced world of tablet manufacturing, maintaining a comfortable and healthy work environment is crucial for productivity and employee well-being. A well-designed Heating, Ventilation, and Air Conditioning (HVAC) system plays a vital role in achieving this goal. In this guide, we’ll delve into the essential HVAC requirements, system design and installation, and safety measures…
High efficiency particulate air filters are used to maintain the area cleanliness in classified area. Pore size of these filters is always 0.3 microns. HEPA filters use a four-step process to purify air: The smaller the micron, the harder it is to filter out of the air.To understand, the human eye detects particles around 10…
In pharmaceutical HVAC systems, filters are crucial for maintaining clean air quality and ensuring compliance with Good Manufacturing Practices (GMP) and other regulations. The filters used in these systems can be categorized based on their efficiency and application in different cleanroom environments. Here’s a detailed breakdown of the common filter types, their integrity tests, and…
Airflow Visualization (Smoke Studies) Purpose: Confirms airflow patterns, particularly in cleanrooms and critical areas where contamination control is crucial. Process: Smoke or fog is introduced to visualize the airflow direction, ensuring it moves as intended (e.g., from high to low classification areas) and does not lead to recirculation or contamination risks. Focus Areas: Laminar flow…
Design Qualification (DQ) The DQ phase involves verifying that the HVAC system is designed according to the requirements of the facility, production process, and regulatory guidelines (e.g., WHO, EU GMP, FDA). It should ensure that: Room classification: Cleanrooms and controlled environments are designed to meet the required cleanliness level, such as ISO 7 or ISO…
Clean Room Pressure Cascades When considering pressures cascades, consider a design concept to have a “clean corridor” or a “dirty corridor” design ,typically, low moisture drugs such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential were positive to the corridor,…
