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 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:
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
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:
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
References: 1. Darby, Ron, Chemical Engineering Fluid Mechanics, 2nd ed, Marcel Dekker, New York, 2001. 2. Incropera, Frank and DeWitt, David, Fundamentals of Heat and Mass Transfer, John Wiley & Sons, USA, 2002. 3. Zlokarnik, Marko, Stirring: Theory and Practice, Wiley-VCH, Germany, 2001. 7. Carleton, F. J., J. P. Agalloco, Validation of Aseptic Pharmaceutical Processes, Marcel Dekker, New York, 1986. 8. Kirk-Othmer Encyclopedia of Chemical Technology, Volume 22, 4th ed., Jacquelin I. Kroschwitz (ed.), J. Wiley & Sons, USA, 1997, pp. 403-411. 9. Conversation with R.N. Houze, Prof. Chemical Engineering, Purdue University, Centrifugal Pumps and Mixing, February 3, 2003. 10. Conversation with Rick McGlothlin, Lab Technician, Purdue University, Valve Placement, February 4, 2003. 13. McCabe, W. L., J. C. Smith, P. Harriott, Unit Operations of Chemical Engineering, Mc Graw Hill, New York, 2001. Density Calculations Anhydrous: Density = (vial + solution) – vial = (98.1261 – 38613) g Heat of Reaction for a 2000 gal Solution (7570.82356 L) Anhydrous 10554.1 J/ml * 1000 ml/L * 7570.8 L = 79902980 KJ Decahydrate -26097.4 J/ml * 1000 ml/L * 7570.8 L = -197578195 KJ Water for 2000 gal Solution (7570.82356 L)