Cleanroom

Introduction

Cleanroom (secondary engineering control) can be considered as an environment in which several parameters are controlled, monitored and maintained.

  • Contamination
  • Pressurization
  • Temperature and humidity
  • Personnel Access

It is typically used in industries such as pharmaceuticals, biotechnology, electronics and aerospace.



Compounding Sterile Preparations, 2018

ISO Classifcation of Particulate Matter
Secondary Engineering Control Requirements by USP 797



Guide to the Development of Sterile Pharmaceutical Preparation Facilities, 2010

Examples of Types of Construction Material for Clean Rooms

Cleanroom Classifications

NOTE: Best refer PIC/S for the updated info.



Manual for Sterile Preparations, 2021

Limits for Clean Room Control Parameters

NOTE: May refer PIC/S for more info.



External Links

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