Production of an Injectable 2m Na2So4 Solution

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Production of an Injectable 2M Na2SO4 Solution

JOHN SMITH

ABSTRACT:

As we head into the 21st century, the pharmaceutical industry requires more efficient processes for the production of excipients used in commercial injections. The following design attempts to maximize the production rate of a 2M sodium sulfate solution to 2000 gallons/day without compromising the purity required by the FDA of the solution. The design minimizes the quantity of moving parts using a single Mark III (Rev. Vane) 1K3*2-62, 4 ¼", 1150 RPM pump to deliver the ultra pure water to the mixer and serve as an agitator when a specified amount of sodium sulfate decahydrate is inserted. The water purification system consists of a Culligan® Reverse Osmosis apparatus and an UltraPure SMEF Multiple-Effect Distiller. This system has a maximum capacity of 4,000 gallons/day and can maintain a water conductivity level of ≤ 5 µS/cm. The design consists of 40 feet of piping, 6 elbows, 2 T's, 6 two-way plug valves, and 5 three-way plug valves, 2 storage tanks, and 2 mixing vessels. This equipment is all made from passivated 316L SS to increase corrosion resistivity. This system also has a double-tube-shell, shell and tube heat exchanger with a length of 0.5 meters and an area of 0.0822 m2 that is used to keep the dissolution temperature at a pyrogen inhibiting 80 °C. Dissolving the decahydrate at this temperature also reduces the mixing time significantly. The mixing tanks will be located in a clean room atmosphere generated by using HEPA filters. According to certain assumptions about scheduling, the entire supply of 2000 gallons of solution can be prepared in 17.5 hrs.

TABLE OF CONTENTS:
INTRODUCTION4

THEORY/METHOD5-10
FIGURE 1. PRELIMINARY DESIGN5

APPARATUS10-14

PROCEDURE14-17

DESIGN OF EXPERIMENTS17-18
TABLE 1. EXPERIMENTAL DESIGN18

RESULTS AND DISCUSSION19-21
TABLE 2. WATER ANALYSIS DATA19

DESIGN CALCULATIONS21-22
TABLE 3. SUMMARY OF PUMP HEAD REQUIREMENTS21
TABLE 4. SUMMARY OF HEAT EXCHANGER DESIGN EQUATIONS21

FINAL DESIGN23-32
FIGURE 2. FINAL DESIGN24
FIGURE 3. WFI STORAGE TANK26
FIGURE 4. ALTERNATE DESIGN28
TABLE 5. SUMMARY OF PUMP SPECIFICATIONS30
FIGURE 5. TYPICAL LAYOUT OF A CLEAN ROOM31
TABLE 6. BATCH SCHEDULING PARAMETERS32

RECOMMENDATIONS/CONCLUSIONS33

NOTATION34

REFERENCES35

EXPERIMENTAL SAMPLE CALCULATIONS36-37
TABLE 7. PHYSICAL PROPERTIES OF SOLUTES38

DESIGN SAMPLE CALCULATIONS39-40

DERIVATIONS41

APPENDIX I42-50
APPENDIX II51-52
DATA SHEETS53-60
INTRODUCTION:
The purpose of our project was to create a plant design capable of delivering 2000 gallons/day of an FDA approved 2M sodium sulfate solution in 200 gallon, 316L stainless steel totes to Eli Lilly. This goal was subdivided into three core objectives that will be seen as recurring themes throughout our design. The first of these objectives dealt with the purity of the water in our solution. Since we assumed that the solute delivered to us by the manufacturer would be completely pure, our only concern rested on producing the biologically pure water. We designed a water purification system capable of delivering water with a conductivity reading under 5 µS/cm at an adequate flowrate. The second objective dealt with the capacity requirements of our system. Eli Lilly requires 2000 gallons/day every single day of the year, but our plant had to be designed with a 300 day/year operability limit. This objective encompassed all the time, scheduling, and rate issues of our design. The third and final recurring theme in our design was really something that stemmed from the first objective. Not only did we worry about producing a biologically pure solution, but we also needed to design a plant that could maintain this purity as well. From the materials in pipes, fittings, and storage vessels to the transportation of the solution to the 200 gallon totes, sterilization...
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