GMP2 Difference between (316L & 304) Stainless steel in Pharma Company

Stainless steel 316 is more resistant than 304 against the acid and base attach because addition of molybdenum. Weak acid and base have no effect on the stainless steel. both of these are non - Magnetic the stainless steel grades with L (304 & 316L) has the low amount of carbon(0.03%).

➤ Chromium is help to improve mechanical properties, steel’s strength, hardness, and ability to be heat treated.

➤ 2% manganese (Mn) improve working strength of the stainless steel at high temperature while above 2% also increase the tensile strength.Manganese is used in steels to help the heat treating process. When steels are heated and quenched to increase hardness and strength, the quench must be done a fast rate. The faster this rate, the more unstable the process becomes. This helps to reduce the risk of defects forming during the heating and quenching process.

➤Silicon (Si) help to strength & resistance to Strong acid as sulphuric acid.

➤Nickel (Ni) help and improves the resistance to the hot and humid environmental conditions.

These properties makes the stainless steel strong & durable.
➤Molybdenum is used to prevent the highly reactive acid such as nitric acid.

Stainless Steel 316L chemical composition
Carbon (C) :- 0.03%
Manganese (Mn) :- 2% Max
Silicon (Si) :- 0.75% Max
Sulfur (S) :- 0.03%
Phosphorus (P) :- 0.045%
Chromium (Cr) :- 16 - 18 %
Molybdenum (Mo) :- 2 - 3 %
Nickle (Ni) :- 10 - 12 %

Stainless Steel 304L chemical composition
Carbon (C) :- 0.08%
Manganese (Mn) :- 2% Max
Silicon (Si) :- 0.75% Max
Sulfur (S) :- 0.03%
Phosphorus (P) :- 0.045%
Chromium (Cr) :- 18 - 20 %
Molybdenum (Mo) :- 0.02 - 0.04 %
Nickle (Ni) :- 8 - 10 %

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.

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...

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.

Pharma Help

Search This Blog