Understanding Cleanrooms

From microelectronics to biotechnology and pharmaceuticals, advanced manufacturing demands controlled environments where airborne particulates are strictly limited. In Bangladesh, industrial growth has led to a major increase in the demand for certified cleanrooms designed under international standards.

The ISO 14644-1 Cleanroom Standard

Cleanrooms are classified by the cleanliness of their air, defined by the maximum concentration of particles per cubic meter of air. ISO 14644-1 ranges from Class 1 (cleanest) to Class 9 (standard room air):

  • ISO Class 5 (Grade A): Demanded for aseptic filling zones where raw drugs are exposed to the environment. Requires laminar airflow and absolute HEPA coverage.
  • ISO Class 7 (Grade C): Common for preparing pharmaceutical solutions and staging active ingredients.
  • ISO Class 8 (Grade D): Suitable for primary packaging and less critical pharmaceutical production steps.

Three States of Cleanroom Testing

When auditing a cleanroom in Bangladesh, certification is performed in three distinct states:

  1. As-Built: The physical cleanroom structure and HVAC are complete, but no machinery or personnel are inside.
  2. At-Rest: The production equipment is installed and running, but no workers are present.
  3. Operational: The cleanroom is fully staffed and active, running at peak production.

The Aircons Ltd. provides turn-key cleanroom design, testing, validation, and engineering support, ensuring your facility passes international audits with absolute confidence.