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...

GMP1 Difference between Static Pass Box AND Dynamic Pass Box

Pass Box is used to pharma sectors.It is used to transfer or pass material between two areas. The area must be same class or different class. Their are different room classification like ISO1 to ISO9 and WHO A, B, C, D. The box transfer lower level cleanliness to high level cleanliness or vice-versa. It is made of 304 Stainless steel (Pass box). Two type of pass box give 1) Static Pass Box, 2) Dynamic Pass Box Static Pass Box 1) Static Pass Box is transfer material which is equally clean. 2) High possibility, there are pressure is Equal. (Both Room) 3) Electromagnet interlock system arrange both side of the door. It is help to only indicate, door are open or close with the help of LED light. 4) Its both doors are open at a time. Their no feature to interlock both doors. 5) Static Pass B...

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