What is a clean room and their requirements.

Clean room is a enclosed space in which particulates and contaminate are kept within strict limits.

1. Temperature

2. Relative humidity

3. Differential pressure dp

4. Sound.

5. vibration

6. Air flow pattern.

7. Particle contamination

8. Microbial contamination.

9. Process specific.

Comments

GMP5 Dead Leg calculation

Shown picture, if D=25mm & distance X is greater than 50mm, we have a dead leg that is too long. Long dead leg is helpful to growth microorganisms. Long dead leg means to store excess water (WFI, PW etc). Long Dead leg does not circulate the water, hence it always short. Dead leg is not more than 1.5D of the pipe line. A Dead leg system can obtain than this type of problem created Fluid pooling, Reduced Cleasnability, Difficult sterilization. Hence dead leg always short.

GMP4 Pharmaceutical company used 2 type of Diffuser in clean room.

Pharmaceutical company used 2 type of Diffuser in clean room. 1) Perforated Plate Diffuser. 2) Swirl Diffuser. 1) Perforated Plate Diffuser.:- WHO permit or recommended diffuser used to pharma company. This type of diffuser use to air pass laminar flow. Diffuser pass Air through perpendicular and parallel. 2) Swirl Diffuser.:- WHO permit or recommended diffuser used to pharma company. This type of diffuser use to air pass rotation flow. Diffuser pass Air through swirl rotary.

GMP3 HVAC (Heat Ventilation Air Condition) system checklist

Checklist before HVAC installation. 1) Manual J Calculation is used to calculate actual load requirement of the room area. 2) Windows, pass box area, doors, lamps, machines, human should be included in the calculation of rooms. 3) Check all the equipment are calibration and energy efficient. 4) Check all construction of civil work, mechanical work, structure. Checklist during HVAC system. 1) All joints of ducts should be insulated, sealed properly to avoid the air leakage and temperature loses. 2) Thermostats, Temperature sensor, Valve, magnehalic gauge, DP should be checked and calibrated. Checklist after HVAC installation . 1) Get the Operation manual, Warranty Card, Drawings, installation procedure manual, maintenance agreement from the manufacturer. 2) Validate the area for temperature and relative humidity, HVAC system tests. 6) Area should be validated for non viable and viable particle count. 7) Check integrity for all HEPA (High efficient particulate air) filte

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