03.05.2016 |

LOGFILE No. 17/2016 – Air cleanliness grades and associated process steps

Air cleanliness grades and associated process steps

Excerpt from the GMP Series pdf download Classes and Grades for Air Cleanliness

by Dr. Hans H. Schicht

Annex 1 to the EU GMP Guide: Manufacture of Sterile Medicinal Products (chapter C.6.1) also specifies the minimum air cleanliness requirements for the different process steps during the manufacture of sterile medicinal products.

Examples for assigning the appropriate air cleanliness grades to the different process steps during filling of terminally sterilized products are shown in Figure 1.

Figure 1 Assignment of air cleanliness grades to different operational steps during processing of terminally sterilized products
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Unusual risks are, for example:

high risks of microbiological contamination due to products

  • actively supporting microbial growth
  • requiring a long period between preparation and terminal sterilization
  • with, e.g., preparation of solutions not mainly in closed vessels

high risk of contamination from the environment due to

  • a slow filling operation
  • wide-necked containers
  • exposure to the environment for more than a few seconds before sealing

Examples for air cleanliness classification for different activities during production of aseptic preparations are given in Figure 2.

Figure 2 Assignment of air cleanliness grades to different operational steps during aseptic product manufacture
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Isolators for protecting, for example, the filling and closing area of an aseptic production line are less stringent in their environmental requirements. According to the EU GMP Guide, a grade D environment is considered to be sufficient as a rule. FDA, on the other hand, expects an ISO Class 8 environment (i.e. European grade C) for the occupancy state in operation.

In premises for manufacturing non-sterile active substances and medicinal products, the air cleanliness class appropriate for the different production steps should be determined based upon risk assessments – if they require room classification at all.

The text is an excerpt from GMP Series Classes and Grades for Air Cleanliness

 

You will learn all you need to know about:

  • GMP requirements for cleanroom premises
  • Air cleanliness grades
  • Design and construction of cleanrooms
  • Cleanliness zoning concepts
  • Implementing GMP requirements on cleanrooms

Don’t miss ordering your copy of Classes and Grades for Air Cleanliness

 

 
 
 

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