Difference Between Classified & Unclassified Area

All the drug products in pharmaceutical industries are manufactured in classified or cleanrooms & you will be amazed to read that non classified areas also exist in pharmaceutical industries.

So did you ever think about which activities are performed in non classified areas of pharmaceutical industries or which are the non classified areas in pharmaceutical industries.

In this article we will discuss the examples of classified & non classified areas along with the key difference between classified & non classified areas.

Classified VS unclassified area

What Is Classified Area

In pharmaceutical industries the classified area is the area where our drug products have direct contact with the air & we have a control number of airborne particles.

  • The classified area is also known as cleanroom.
  • In classified areas we have controlled temperature.
  • In classified areas we controlled humidity level.
  • Classified areas come under the ISO classification system.
  • HEPA filters are used in classified areas.

Examples Of Classified Area

Here are few examples of classified areas in pharmaceutical industries,

  • Sampling Area 
  • Dispensing Area
  • Manufacturing areas like

Granulation, compression, Coating, encapsulation, filling, sealing, blistering area etc.

  • Microbiological lab

What Is Non Classified Area

Non classified area in pharmaceutical industries is the area where our products have no direct contact with the air & we don’t have controlled airborne particles.

  • Non classified areas are also known as un classified areas.
  • In non classified areas the temperature & humidity is controlled for human comfort.
  • In classified areas there is no ISO classification system.
  • In non classified areas HEPA filters are not used.

Examples Of Non Classified Area

There are many non classified areas in pharmaceutical industries & some are given as below,

  • Change rooms
  • Packaging Hall
  • Raw material Store
  • Packaging Material Store
  • Finish Good Store
  • Quality Control Lab

All above are the areas where our products are not directly in contact with the air so these are non classified.

Also Read 

  1. Why is a Separate Manufacturing Facility Required For Penicillin And Non Penicillin Products
  2. Types of airlocks in pharmaceutical industries.
  3. Why Three Batches For Validation
  4. Types and functions of HEPA filters.
  5. Cleanroom classification in pharmaceutical industries.
  6. HVAC or Heating Ventilation & Airconditioning System.