Pharmaceutical Water purification Process

By -

Water Treatment Steps

 Raw water 

Under storage Tank


Over Head Tank


Dosing chemicals


Multi Grade Filter (MGF)


Activated Charcoal filter

Softener Filter

Ultra Filtration (UF)

CSRO ( Chemically Sanitization Reverse Osmosis)

Ozone sanitization

HSRO (Hot water sanitization Reverse Osmosis)


EDI (Electron De-Ionization)


Purified Water

WFI (Water For Injection) or Pure Steam 


Dosing Chemicals : 

10 % Sodium hypochlorite, Sodium hexa meta Phosphate, SMBS, Nacl and NaoH.

Chlorination:

To maintain minimum 2 ppm of chlorine dosing in to raw water.

De-chlorination:

To maintain 3 ppm of SMBS (Sodium Meta Bi sulfate)

Anti Scalent Dosing System :

To maintain the 2 ppm of sodium hexa meta phosphate 

Popular posts from this blog

Non-Viable particle count (NVPC)

By -
Image
Particle mater in room air limits are in particles of 0.5 μm and larger per cubic meter. ISO = cubic meter (m 3 ) FD Standard 209 E = cubic feet (ft 3 )   ISO class equal to federal standard 209 E class .  1m 3  = 35.31 ft 3 1m = 100 cm Adapted from former Federal Standard No. 209 E,                ISO = international organization for standard 14644 part -1, may -1999 p ublished. Maximum concentration limits (particles M3 of air) for particles equal to and larger than the considered sizes shown below: (a) ISO Classification Number(N) 0.1µm 0.2µm 0.3µm 0.5µm 1.0µm 5.0µm ISO 1 b                    10 d                 2 d d d e ISO 2 10...
Read more

Alert and Action Limits

By -
In pharmaceuticals alert and action limits are very important, because these limits are effective control to the process. alert and action limits are in house limits, these limits must be less than guideline limits or define limits. Alert and action limits defined based on trend analysis. alert and action limits are like a barrier before the guideline limits. Alert Limit: To be alert the microbial counts reach to this alert level. It is nor necessary to take any action. Possible deviation from normal process condition This is a trigger, that something is going wrong means microbial count increasing that area. Action Limits: When microbial count reach this action limits then action is mandatory. To control the  microbial count in the area. Signal an apparent deviation from normal process condition And require immediate action. If not controlled, we might get area failure. These alert and action limits must be less than final limits. Example : A...
Read more

TNTC vs TFTC

By -
Image
Too Numerous To Count (TNTC) or Too Many To Counts (TMTC) In samples with very high bacterial concentration, that is not suitable for counting (unable to get accurate counts) and reports the results as "to numerous to count" (TNTC). While the best solution is to collect another sample and dilute to get a more accurate counts, this might not always to be possible. Ideally one plate with 200 to 250 colonies are used. Counts above 250 are considered "to numerous to count" (TNTC), because it is impossible to count the colonies. plates countable range 25 to 250. Too Few To Count (TFTC): If there are less than 30 colonies on the plate, small errors in dilution technique or the presence of a few contaminants will have a drastic effect on the final count this count is called too few to count (TFTC).
Read more