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Setup of Clean Rooms (ISO 14644, D&C Act 1940)

Setup of Clean Room as per ISO Clause requirement (ISO 14644 & Drug and Cosmetics Act 1940)

Setting up a cleanroom in India requires a dual approach: meeting the international technical standards of ISO 14644 and the legal mandate of the Drugs and Cosmetics Act (1940).

Desing –

The design phase is governed by ISO 14644-4 (Design & Construction) and Schedule M (Premises).

A. Architectural Requirements (Schedule M)

  • Surface Finishes: Walls, floors, and ceilings must be smooth, impervious, and non shedding. All joints must be coved (curved) to prevent dust accumulation.
  • Zoning: A “logical flow” must exist for personnel and materials. This involves Airlocks (PAL for personnel, MAL for materials) to maintain pressure gradients.
  • Aseptic Setup: For sterile products, Grade A (critical zone) must be surrounded by a Grade B background.

B. Engineering (HVAC & ISO 14644-1)

  • You need to select an ISO Class between 1 and 9 based on your Grade which ranges from A to D.
  • The Grade A (ISO 5) standard requires unidirectional airflow to maintain a velocity range between 0.36 m/s and 0.54 m/s.
  • The Grade B/C/D (ISO 5/7/8) standard requires non-unidirectional airflow to maintain specific Air Change Rates (ACR) which usually exceed 20 changes per hour and reach up to 60 changes per hour.
  • Pressure Differentials: Air must flow from “Clean” to “Less Clean” areas. Typical requirement is a 10–15 Pascal difference between adjacent rooms of different grades.

Validation-

validation proves the cleanroom works as designed.

A. Design Qualification (DQ)

The “on-paper” verification. You ensure the blueprints and equipment specs (like HEPA
filter ratings) meet the user requirements (URS) and ISO/GMP laws.

B. Installation Qualification (IQ)

Physical verification

  • Checking if the AHU (Air Handling Unit) and ductwork are installed as per the DQ.
  • Verifying HEPA filters are correctly seated.
  • Ensuring all sensors (Pressure/Temp/RH) are calibrated.

C. Operational Qualification (OQ) – “At Rest”

Testing the room while it is running but with no staff or production.

D. Performance Qualification (PQ) – “In Operation”

Testing the room during actual production (with people and machines).

  • Viable Monitoring: Testing for bacteria/fungi using settle plates and air samplers.
  • Non-Viable Monitoring: Continuous particle counting to ensure the Grade limit
    isn’t exceeded during work.

Monitoring-

Once validated, the cleanroom must be monitored to ensure it stays in a “state of control” as per ISO 14644-2.

A. Environmental Monitoring (EM)

  • Non-Viable Particles: For Grade A and B, continuous monitoring is required. For C and D, periodic sampling is enough.
  • The system requires daily monitoring of differential pressure which usually achieves automatic logging when alarms are triggered. .

B. Microbiological Monitoring

  • The procedure requires agar plates to be placed in the testing area for a maximum period of 4 hours.
  • Active Air Sampling: Using a machine to pull a specific volume of air ($1\text{ m}^3$) through a filter or plate.
  • Surface Monitoring: Using “Contact Plates” (Rodac) on walls, tables, and equipment.
  • Personnel Monitoring: Testing the gloves and gowns of operators after they exit the cleanroom.

C. Re-Validation Frequency

  • Every 6 Months: For Grade A and B (critical zones).
  • Every 12 Months: For Grade C and D.
  • Immediate: After any major repair to the HVAC system or HEPA filter replacement.
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