Pharma Help

1. Tell me about HVAC, why we used in pharma 2. Draw flow drawing of ahu 3. Filter details, used in HVAC 4. MOC of filters 5. Validation process of ahu 6. PM process (monthly, quarter, half yearly, etc) 7. RC AND OT TYPE. 8. Delta pressure type . Bubble, cascade, sink 9. Iso 14644 10. Chiller principal, working, cycle. 11. Humidifier, dehumidifier. 12. Classification of room iso 1 to 9 13. Calculation of acph 14. Validation instruments details 15. LAF AND RLAF SO ON 

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