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Pharmaceutical | Freeze-drying and Vacuum Ovens

Posted by Jennifer Collins on May 4, 2020 9:00:00 AM

Pharmaceutical Freeze-drying and Vacuum Drying for Research and Manufacturing in the .01 Torr to 400 Torr Range Vacuum Pressure is used in Pharmaceutical Manufacturing to:  Help create bulk and active ingredients for FDA approved drug products Increase the shelf-life of a drug product Sterilize medical devices  Lyophilization, also known as freeze-drying, is a process used for preserving biological material by removing the water from the sample, which involves first freezing the sample and then drying it, under a vacuum, at very low temperatures. The low pressure environment helps minimize oxidation during drying. Lyophilized samples may be stored much longer than untreated samples. The resulting precipitate is a shelf-stable powder.  This powdered drug is later reconstituted at point of care for patient use. Vacuum Drying: Another way vacuum instrumentation is used in the pharmaceutical industry is in vacuum ovens. Vacuum devices are chosen based on the range required for a specific application and are used to measure and/or control vacuum pressure during the process.  Vacuum ovens applications include: removal of moisture or dehydration, out gassing, bake-out, and to prevent reactions. They are important tools in the medical field for sterilization of medical devices, as well as glassware for research purposes. Vacuum drying helps to maintain the integrity of the original item without damaging it with heat since drying can be accomplished at a lower temperature while under pressure. This is valuable for food and pharmaceutical processing since other drying processes can degrade the quality and/or make heat-sensitive drug products (Parikh, D, 2015).  Although all drying techniques share a common objective (i.e., dehydration), conceptually they are different and require modification/adaptation based on the properties of the compound being processed.  For high value products, like pharmaceuticals, the cost of the raw ingredient may be the primary driver for the selection of the processing method. The majority of pharmaceutical compounds are susceptible to stresses that develop during freezing and drying. Formulations undergoing freeze‐drying can be sensitive to deviations in temperature and chamber pressure, which may be exacerbated in a freeze dryer with poor temperature and chamber pressure control, thereby leading to additional losses in process efficiency as well as poor product appearance and quality attributes.  2 Drying Methods that Use Vacuum 1. Vacuum Ovens A vacuum drying oven is most often used for delicate drying processes, such as drying tiny parts or removing flammable solvents.    The low-pressure environment also minimizes oxidation during drying.  A standard vacuum oven can operate at temperatures as high as 200°C to 250°C.  Vacuum pressure is normally between 10 Torr to 100 Torr range. Applications: Vacuum drying has proven effectiveness in manufacturing probiotics, food and enzymes  Sources: Santivarangkna 2007, Foerst 2012, Bennett 2007, Palacio, 2012, Long 2007, Rossi 1997, Uritani 1995 2. Freeze-drying (or lyophilization) Freeze drying is a water removal process typically used to preserve perishable materials, to extend shelf life or make the material more convenient for transport. Freeze drying works by freezing the material, then reducing the pressure and adding heat to allow the frozen water in the material to sublimate. Sublimation means going  from its solid frozen state to its gaseous state without ever passing through its liquid phase.  Vacuum pressure is normally below 5 Torr. The freeze-drying process has important applications in the pharmaceutical and biotechnology industries. This process requires the use of vacuum for the drying of heat-sensitive drugs and biologics at a lower temperature. Freeze-drying is mainly used to improve the stability and storage of easily altered drugs. Commonly applied to the production of injectable dosage forms of drugs, pharmaceutical freeze–drying is also used to produce diagnostics Why Partner with DigiVac? DigiVac has been designing and manufacturing scientific measurement, control instruments and freeze dryer controllers since 1983.  We can also work with you on custom solutions with our team of software and hardware engineers. Our customers appreciate our attention to detail, predictable lead times and the ability to respond quickly to customer urgency. DigiVac Product Highlights for Freeze Drying and Vacuum Ovens | .01 Torr to 400 Torr Concerto | Vacuum & Pressure Controller Control Up to 4 Vacuum Ovens or Chambers at Once with 1 Vacuum Pump Simplify Your Lab & Control More With Less Maximize Throughput With a 17.5 mm vacuum path to each hose barb Precision Control & Intuitive Design Control Range: 2 Torr to 760 Torr Unique Vacuum Control: proportional throttle and proportional bleed control (vent to ATM) delivered from an integral dual valve module per channel   StrataVac Throttle Vacuum Control 775i Bundle The STRATAVAC  bundle with plunger-type vacuum control comes with a rugged industrial valve with a smaller .5″ orifice giving you a faster acting valve with tighter control on your process. Ideal for measuring and controlling vacuum ovens for vacuum drying applications Measurement Range: 1 Torr – 775 Torr range (medium vacuum range) for pharmaceutical and industrial applications Control Range: of 2 Torr to 770 Torr Extends life of pump by enabling pump to run closer to its base pressure   StrataVac Controller | Bleed Vacuum Control Bundle The StrataVac bundle with bleed vacuum control helps increase molecular flow and throughput Ideal for controlling vacuum level in freeze dryers Rich remote command line interface for integration with PLCs Bleed in inert gases like air, nitrogen, or argon to assist in vacuum drying Accuracy Range: .001 Torr to 6 Torr Control Range: 1 Micron to 6000 Microns (.001 Torr to 6 Torr)
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Topics: Medical/Pharma, Researcher topics, Vacuum Regulation, Vacuum system setup, vacuum system needs, Rough Vacuum, medical, laboratory, vacuum drying, freeze drying, vacuum oven

Medical Vacuum Applications | Vacuum Sterilization

Posted by Jennifer Collins on Apr 9, 2020 12:37:00 PM

Vacuum Instrumentation for Vacuum Drying and Sterilization of Medical Devices Sterilization of medical equipment is vitally important to render a product free from viable microorganisms (such as bacteria, fungi, and viruses).  Steam is used in the many sterilization processes. The steam is put under pressure that is higher than atmospheric pressure (> 1 bar). A sterilizer configured to run a vacuum cycle will be equipped with a vacuum system. A typical vacuum cycle will begin with a series of alternating steam and pressure injections. The use of a vacuum controller to lower the vacuum pressure this will remove air from the chamber. Why is Steam Sterilization Better? Pulling a vacuum to remove ambient air from the chamber allows the steam to be sucked into areas where it would otherwise have difficulty penetrating. The absence of air (or reduction in vacuum pressure) within the chamber allows “steam to penetrate the load more quickly and effectively” resulting in more reliable sterilization and shorter sterilization cycle times (Underwood and Perkins) compared to gravity-fed sterilization.1 As the temperature and pressure are increased, the time required to sterilize items can be greatly reduced. Compared with dry heat sterilization, steam sterilization is the more efficient method because the moisture in steam is a good conductor of heat and is superior at penetrating the viral load.2 Wrapped medical items must be dried before they can be aseptically removed from the sterilizer. During the sterilization phases condensation results, and vacuum drying is needed to effectively complete the process.2 Typical Vacuum Range for Efficient Vacuum Drying Consistent and reliable vacuum pressure is required to complete the vacuum drying process. A vacuum level of 1.0 to 2.0 psia (6.9 to 13.8 kPa; 51.7 Torr to 100 Torr) is recommended for efficient drying. Why Partner with DigiVac? DigiVac has been designing and manufacturing scientific measurement and control instruments since 1983.  We can also work with you on custom solutions with our team of software and hardware engineers. Our customers appreciate our attention to detail, predictable lead times and the ability to respond quickly to customer urgency. 1. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/flash.ht         2. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/steam.html   DigiVac Product Highlights for Medical Applications | 1 Torr to ATM   STRATAVAC 775i INDUSTRIAL VACUUM GAUGE Rugged: design for harsh applications StrataVac with an isolated piezoresistive sensor Measures: 1 Torr to 775 Torr: accuracy +/- 2 Torr) Ideal for rough vacuum processes     BULLSEYE PIEZO GAUGE | Vacuum & Pressure Portable, battery-operated, for measure vacuum and pressure The Bullseye Precision Gauge Piezo with isolated Vacuum to PSI sensor is highly accurate and reliable Total range: 20 Torr to 85 PSIG Most accurate range: 50 Torr to 85 PSIG Accuracy: +/- 15% Torr   +/- 0.5 PSI Measurement Units: micron, Torr, Inches of Hg, kPa, Inches of H20, millitorr, mbar, Pa, PSIA, mm of Hg, bar, and mm of H2O Also available in a Bluetooth version for remote monitoring.
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Topics: Medical/Pharma, Researcher topics, Vacuum Regulation, Vacuum system setup, vacuum system needs, Rough Vacuum, medical, laboratory

Vacuum Instruments For Lyophilizers | What You Need To Know

Posted by Eric Beardslee on Jan 7, 2015 12:13:43 PM

Accurate, reliable vacuum readings during freeze drying processes is one of the bigger challenges faced by users of older lyophilizers, and an even greater challenge faced by those designing new systems.
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Topics: Medical/Pharma, Food/Beverage

Industry Spotlight: Medical Application of Aspiration Vacuum Control

Posted by Tim Collins on Oct 21, 2014 8:00:00 AM

A surgical equipment manufacturer asked us to craft a product that would help physicians maintain consistent vacuum control during surgical procedures such as liposuction. Existing vacuum pressure controllers could not maintain consistent pressure, resulting in a build-up of vacuum pressure during a blockage of the cannula, resulting in a stall of vacuum, followed by an increase in vacuum pressure after the blockage was removed. 
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Topics: Medical/Pharma