Pharma Help

Five terms of vessel manufacturing 1) Mechanical Characteristics 2) Automation 3) Operation Characteristics 4) Testing 5) Qualification. 1) Mechanical Characteristics:- A) Volumes Ranging from 0.5 L to 80 KL working capacity.  Calculate volume (Litres) Ex. Cylinder vessel:  B) Space Conserving design. Before manufacturing vessel, we know the how much space availability for vessel assemble like height, diameter calculation. C) Materials SS316L & SS304. (GMP2) D) Surface Finished. As per client requirement Matt finished (0.8 um) or Mirror finished (0.4 um). E) Pressure Range As per client requirement.Client give as working pressure of material or solvent, solution. Ex:- if working pressure is 3 kg/cm2.        than Design pressure is 1.5 X working pressure = 1.5 X 3= 4.5  kg/cm2.        and hydrotest pressure is 1.3 X Design pressure = 1.3 X 4.5 = 5.85  kg/cm2. F) Temperature As per Client requirement.  Client give as temperature of material or solvent, s

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 purified water containing less than 10 CFU/100 ml of

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.

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.

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

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

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 Box is 8 watts. 6) Fluorescent lamp is 40 watts. 7) The Static Pass Box do not have filters. 8) No required gauge by same classifica