July 18, 2021: Pharmaceutical Interview Questions and Answers

#CleanRoomConditions, #AsBuiltAtRestInOperational, #TypesOfAirLocks, #DifferentialPressureBtweenCleanRoom, #ComparisonOfPascalsToMm, #OnlineCalculationPascalsToMm

1. What are the different clean room conditions? Explain it.

There are three conditions of clean rooms – as built, at rest and in-operation.

As built:

Condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present.

At rest:

Condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present.

In operational:

This condition relates to carrying out room  classification tests with the normal production process with equipment in operation, and the normal staff present in the room.

Reference: WHO Working document QAS/02.048/Rev.2

2. What are the different types of air locks? Explain it.

There are three types of air locks, Cascade airlock, Sink airlock and Bubble airlock.

Cascade airlock: high pressure on one side of the airlock and low pressure on the other side.

Bubble Airlock: high pressure inside the airlock and low pressure on both outer sides.

Sink Airlock: low pressure inside the airlock and high pressure on both outer sides.

Reference: WHO Working document QAS/02.048/Rev.2

3. What should be the differential pressure between two adjacent clean room zones?

The most widely accepted pressure differential to achieve containment between the two adjacent zones is 15 Pa, but pressure differentials of between 5 Pa and 20 Pa could be acceptable.

Where the design pressure differential is too low and tolerances are at opposite extremities, a flow reversal can take place. E.g. where a control tolerance of ±3 Pa is specified, the implications of the upper and lower tolerances on containment should be evaluated.

4. Comparison of pascals to mm of water?

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