Manufacturing tanks are various categories like Mixing tank, Holding tank,storage tank(WFI, Purified water).They are very sophisticated equipment having complex heating and cooling arrangement in jackets to maintain the temperature of vessel.Material of construction for tanks are SS316L and jackets are SS304. Water for Injection Storage tanks should be sterilized at regular intervals so as to avoid microbial contamination. Sterilization of tanks are required before and after batch preparations, can be performed through CIP and SIP(sterilization in place).
Mixing tank is very important equipment for manufacturing of parenteral preparation.In a layman we can say mixing tank is a container where we used to mix all the ingredient with utmost care. In household we can clean and utensils very easily by rotating under a tap water. But in large scale where we can not move the position of tank and is bit difficult to clean and charging of batches.
21 CFR 211.46(b) states that “Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.”
Manufacturing Tank Calibration:There are three methods for manufacturing tank calibration, depending on new or existing. In case of new tank installed it can be calibrated by physical or mathemetical.
“Take a standard 1 Liter capacity glass measuring cylinder & standardize it with 1 Liter volumetric flask using D.M. water.
- Standardize the 10 Liters flask by adding water by the standardized measuring cylinder. Mark the flask from outside for volume marking , lastly with 10 Liters marking.
- Standardize plastic bucket marking up to 40 Liters level , with the help of 10 Liters flask.
During all the transferring don’t spill out any water .Standardize the tank with the help of bucket , keep an accurate record of addition. Mark standard volume marking on the level glass from outside . 1000 , 1500 , 2000 , 3000 & 3500 ,4000,5000 Liters etc. for LVP.
Above the bottom dished area of manufacturing tank, distance between any two standard marking of same volume should have equal distance. Counter check the distance /volume by mathematical calculation between two volume level marking in cylindrical area using the formula : V = π r2 h where V is volume between two markings in cylindrical area of the tank , r is the internal radius of the tank , h is the distance between the two markings.
Chemical Method
Verify the volume marking as carried out by physical measurement method by using chemical method
Addition of Sodium chloride according to level marking (LVP)
| Sl. No. | Checking for level marking of | Quantity of NaCl added | Mixing Time |
| 1 | 1000 Lit | 9 Kg | 15 Min |
| 2 | 1500 Lit | +4.5 Kg | +10 Min |
| 3 | 2000 Lit | +4.5 Kg | +10 Min |
| 4 | 2500 Lit | +4.5 Kg | +10 Min |
| 5 | 3000 Lit | +4.5 Kg | +10 Min |
| 6 | 3500 Lit | +4.5 Kg | +10 Min |
Interconnected Lines And Accessories:
Different accessories are required for various functions, like transfer of different products in holding tank of desired batch sizes. Following table indicates the accessories available, their purpose and their details.
| Accessory | Purpose | Details |
| Filtration Housings | Filtration housings for 0.6 microns & 0.2 microns to filter the product solution to remove microbial contamination . | Filter size : Both are of 10 inches Pore size : 0.6 & 0.22 microns Make : Pall ( housing ) |
| S S pipe line. | SS pipe line is required to transfer solution from holding tank to Filling machine | One inch (SS 316) diameter pipe line at bottom with triclover fittings , sanitary diaphragm valves & temperature gauge . |
| Pressure gauges | Pressure gauges are required to check pressure differential at inlet & outlet points, pressure on the tank. | Position : On the tank & on SS line At the bottom Range : .0-4 kg/ cm2 |
| Spray ball | For proper flushing of entire internal surfaces of the tank with WFI | Position : On the top side of the tank Size : 1” diameter |
Utilities And Connections :
Following utilities are required for correct functioning of the manufacturing tank tank .
| Utility | Purpose |
| Compressed air / Nitrogen( 0.2 micron filtered). | For pressurising the bulk solution / water for transfer from the holding tank to the product line of the Filling machine. |
| Pure steam. | For sterilization of the tank. |
| Water for Injection | For flushing of the internal surfaces of the tank., so as to make it free from the traces of the previous product residues. |
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