Skip to main content

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

Popular posts from this blog

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...