Pharma Sterilization
Benefits of Precision Continuous Flow Thermal Processing-Drugs, Pharmaceuticals, and Active Pharmaceutical Ingredients
Less Heat With The Same Sterility
Continuous flow thermal processors expose your product to less heat while providing the same overall reduction of bacteria as batch thermal processes (i.e. autoclaves or reactors). Thus, many products that are incapable of being thermally processed using a batch method can be processed on a continuous thermal processor.
The following graph shows the difference in heat exposure provided by a batch process and continuous thermal process that yield the same reduction of bacteria as indicated by the Fo. The area under each curve represents the total impact of the process. Notice that the batch method is many times larger than the equivalent continuous process. Thus, many thermally sensitive products that cannot withstand a batch process, can be sterilized with a continuous process with less destructive impact.
Our precision, continuous flow thermal processors deliver specific, optimized, heating that is more uniform, and less destructive than autoclaving, batch heating and traditional continuous flow methods. Additionally, since they do not utilize filtration, they can be used as kill systems to sterilize or pasteurize pharmaceuticals that are formulated as suspensions.
Our precision processors:
Produce the highest quality products due to minimized uniform, precisely controlled heat exposure
Retain peak functionality of active pharmaceutical ingredients (API's)
Can be used to sterilize suspensions or other non-filterable products
Eliminate the risk of perforated sterilization filters
Minimize lost product by matching process flow rate to filling operation
Are “Green”-their regenerative heating minimizes energy consumption
Maximize profits because of energy efficiencies, yield increases, reliability, & ease of use
Pharmaceutical Applications
Our precision continuous flow thermal processors produce sterile or pasteurized:
Oral Pharmaceuticals and Drugs
Injectable drugs
Active pharmaceutical ingredients (API)
Suspensions
WFI (water for injection)
Concept of a Continuous Flow Thermal Process
In a completely closed system, product is pumped through one or more heat exchangers to rapidly raise it to the “process temperature”. It then flows through a hold tube (an insulated tube to hold it at its process temperature for a specified time period). It is within this “hold tube” that the exposure of the product to the process temperature reduces or eliminates any bacteria, viruses, etc., depending on the specific pasteurization or sterilization process.) Next, it flows through one or more heat exchangers to cool it to the filling temperature. Finally, the product exits the system to your next unit operation or to a collection vessel.
Our optimized processors heat, hold, and cool your product at extremely precise conditions to maximize its lethality and safety assurance. Our touchscreen PLC/PC makes them extremely easy to use. Finally, the energy efficiencies of or equipment makes it very “GREEN” and can greatly reduce your operational costs.
• Click here to view a sample flow diagram •
Production Pharmaceutical Sterilizer, Pasteurizer, and Kill Systems
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Model
PreheaterTemperature
Final Heater Temperature
Viscosity Range
Hold Times (sec.)*
• S-1S
to 300° F (150°C)
NA
Low to medium
15 and 30
• S-2S
to 250° F (121°C)
170°-305°F (76°-152°C)
Low to medium
15 and 30
*other times available. Flow rates from 1-4.5 (or higher) Liters/minute (15-71 GPH) available
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FEATURES
• Simple Operation
• Automated PLC Control & Data Acquisition
• Rapid Sterilize in Place (SIP) (SPO)
• Clean-in Place (CIP)
• Dual Product Inlet
• Vari-Speed Product Pump
• Two Hold Tubes
• Product Cooler
• Back Pressure Valve
• Component By-passes
• Spare Parts & Tool Kit
• Compact Design
• cGMP compliance
PLC Automation of Pharmaceutical Sterilizers, Pasteurizers, and Kill Systems
Our integral touchscreen PLC/PC package:
-Automates, centralizes and simplifies operation of the equipment
-Provides precise control of the process variables
-Records data
-Provides process alarms
-Provides communication to the processor for troubleshooting over the Web by MicroThermics technicians
• Click here to view sample automation controls•
OPTIONS
• Added Hold Tubes & Coolers
• Added Temperature/Pressure Sensors
• Automatic Filling Control
• CE marking
• Clean-Fill Hood/Sterile Product Outlet
• Flow Meters
• Inlet Funnel System & Tanks
• Water Chillers
DIMENSIONS
• Length: 54" or 70" (1.47-1.8M)
• Height: 73" (1.9 M)
• Depth front to back 32" (.8 M)
