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.

GMP6 PW & WFI

PW:- Purified water is water that comes from any source, but has been purified to remove any chemicals or contaminants. Its has been mechanically filtered or processed to remove impurities and make it suitable for use. Types of purification include distillation, Capacities de-ionization, microfiltration, ultrafiltration reverse osmosis (RO), and carbon filtration. It's from an underground source and may or may not have been treated and purified . PW is used in Non-Parental drugs. WFI:- It is water that is intended for use in the manufacture of medicines for parenteral administration whose solvent is water (WFI in bulk), or water that is used to dissolve or dilute substances or preparations for parenteral administration (heat- sterilised WFI) PW is treat convert WFI is used in Parental Drugs. WFI is water of extra high quality without contamination. The United States Pharmacopeia (USP) defines as highly pu...

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.

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