Production Of An Injectable 2m Na2so4 Solution

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 Ð'ј", 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 CulliganÐ'® 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 Ð'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 Ð'oC. 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:

INTRODUCTION 4

THEORY/METHOD 5-10

FIGURE 1. PRELIMINARY DESIGN 5

APPARATUS 10-14

PROCEDURE 14-17

DESIGN OF EXPERIMENTS 17-18

TABLE 1. EXPERIMENTAL DESIGN 18

RESULTS AND DISCUSSION 19-21

TABLE 2. WATER ANALYSIS DATA 19

DESIGN CALCULATIONS 21-22

TABLE 3. SUMMARY OF PUMP HEAD REQUIREMENTS 21

TABLE 4. SUMMARY OF HEAT EXCHANGER DESIGN EQUATIONS 21

FINAL DESIGN 23-32

FIGURE 2. FINAL DESIGN 24

FIGURE 3. WFI STORAGE TANK 26

FIGURE 4. ALTERNATE DESIGN 28

TABLE 5. SUMMARY OF PUMP SPECIFICATIONS 30

FIGURE 5. TYPICAL LAYOUT OF A CLEAN ROOM 31

TABLE 6. BATCH SCHEDULING PARAMETERS 32

RECOMMENDATIONS/CONCLUSIONS 33

NOTATION 34

REFERENCES 35

EXPERIMENTAL SAMPLE CALCULATIONS 36-37

TABLE 7. PHYSICAL PROPERTIES OF SOLUTES 38

DESIGN SAMPLE CALCULATIONS 39-40

DERIVATIONS 41

APPENDIX I 42-50

APPENDIX II 51-52

DATA SHEETS 53-60

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 Ð'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 issues played a major role in almost every step of the design.

THEORY/METHOD:

We were able to use a fair amount of experimental data to configure our design, but most of the design was concieved from existing research and literature records. The water purification system, solute material, and heat exchanger were the only things in our design that were based on the experimental data we observed. The water storage unit, pump, piping, valves, sterilization recommendations and mixing vessels were among some of the things that were designed according to certain assumptions and research obtained from literature and other sources outside of the laboratory.

As seen in Figure 1, the first step in the design required that we implement a water purification system. This system was designed by considering purification units that could minimize the conductivity, total dissolved ions, and the total organic carbon content of the water. Another important factor that was considered was the daily production rate of the system. The system capacity had to be over-specified to more than 2000 gallons/day due to the 300 day/year working schedule of our plant. Once this purified water delivery system was in place, a storage system was designed to control the water delivered and provide an intermediate purity checkpoint before entering the mixers.

In order to transport the water

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