GMP Compliance Adviser Update No. 3/2018

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

3.I Air Handling Technology

GMP in Practice

Chapter 3 Premises

3.I Air Handling Technology

The term air handing technology is subdivided into the two categories “air handling technology for rooms” and “process air technology”.

In the field of pharmaceuticals manufacturing the basic types of air handling units used are:

  • 100 % fresh air units
  • Central re-circulating air or mixed air units
  • De-central re-circulating or mixed air units with central fresh air conditioning
  • 100 % re-circulation units

Ambient air is interspersed with different substances of various particle sizes and various types. This mixture of substances is to be removed using air filters to a degree that the specified cleanliness standards in a production are upheld.

When developing the design concept of an air handling system for a pharmaceutical manufacturing facility, the external conditions and situation of the site, the requirements placed on the rooms, the climate factors influencing the production process and the requirements associated with the layout must all be known.

During detailed design of the ventilation system the following criteria must be reflected:

  • Air flow patterns in rooms
  • Filter classes and filter stages
  • Room environmental conditions
  • Pressure differential stages

The reliable, effective and economic operation of an air handling unit is dependent upon an effective maintenance program.

The maintenance program includes various activities: inspections serve to identify and assess the current state of the equipment, planned maintenance serves to maintain the desired target conditions and overhauling is necessary to re-instate target conditions. (Harald Flechl)