The Preparation of Pharmaceutical Waters

Pharmaceutical Waters
While the public considers municipal water to be “pure”, the pharmaceutical market considers municipal water (feedwater) just the starting point in producing pure water. Water is the most widely used excipient in pharmaceutical manufacturing, and pharmaceutical water is a multi-functional resource, crossing all disciplines in the pharmaceutical industry. Water is used as a raw material, solvent, ingredient, reagent, and clean-ing agent, and is produced in a variety of “pure” forms.

Purified Water (PW), Highly Purified Water (HPW), and Water for Injection (WFI) used in pharmaceutical processes are produced on site from the local potable water, which has been produced by the treatment of the feedwater.

This best practice guide, titled "Pharmaceutical Waters Guide for Regulatory Compliance, Analysis and Real-Time Release" and produced by Mettler Toledo Thornton, provides insight on the following topics:

DOWNLOAD THE FULL GUIDE HERE.

Pharma Waters Overview


  • The Preparation of Pharmaceutical Waters
  • Pharmacopeia Overview
  • Industry Trends for Pharmaceutical Waters

Process Analytical Technology (PAT) and Intelligent Sensor Management (ISM)


  • Ensuring Pharmaceutical Water Compliance in a PAT Environment

Total Organic Carbon


  • Total Organic Carbon Measurement is a Key Control Point for Pharmaceutical Water Systems
  • Improving Water System Performance Continuous Real-Time TOC Measurements
  • Case Study: Real-Time TOC Analysis Safeguards Water Purity
  • Case Study: In-line TOC Monitoring: Reduces Production Downtime
  • Case Study: Leading Water Treatment Solution Provider Chooses METTLER TOLEDO Thornton
  • The Value of Measuring TOC in CIP and Cleaning Validation Applications

Conductivity/Resistivity


  • Ensuring the Absence of Ionic Impurities with Conductivity/Resistivity Measurements
  • Calibration Solutions for Pharmaceutical Waters
  • Case Study: Clean in Place Systems Manufacturer Relies on METTLER TOLEDO

Ozone


  • Reliable, Cost-effective Sanitization the Power of Ozone
  • Application and Control of Ozone Sanitization for Pharmaceutical Waters
  • Case Study: Critical Ozone Measurement in Purified Water Systems

Surface Heating for Analytical and Scientific Instrumentation

Cloth heater for Analytical and Scientific Instrumentation
Electric surface heating for
analytical and scientific
applications. (BriskHeat
In many research & development and laboratory applications, surface heat is required to successfully conduct experiments and tests. The heat may be required for a number of reasons:
  • Temperature Compensation - Varying results due to temperature fluctuation are eliminated when the temperature is constant over several repetitions or tests.
  • Vacuum Bake-out - Heat helps release moisture and impurities/particulates in a closed system to allow the test results to be more accurate and consistent.
  • Temperature Elevation - A higher temperature may be required to generate the desired results.
The document below, courtesy of BriskHeat, provides electric heating solutions for various laboratory applications where analytical and scientific apparatus require heat. You can also  download a PDF of "Surface Heating for Analytical and Scientific Instrumentation" here.

https://alliancetes.com
630-321-9646

UniCond Sensor Measures Conductivity of Water with Varying Purity Levels & Temperatures

Unicond Sensor
UniCond Sensor
As the video below will show you, Mettler Toledo Thornton's UniCond sensors provide three significant advantages over other conductivity sensors:

1) Unmatched Accuracy - a self-contained measuring circuit which produces a robust output digital signal that is reliable over very long cable and certified factory calibration and temperature compensation with ASTM traceability stored in the sensor's internal memory to ensure highest installed accuracy out of the box.

2) Widest Rangeability - A single 2-electrode UniCond sensor can measure from ultrapure water all the way up to sea water with high accuracy. This significantly simplifies the specification, installation and spare parts inventory for water treatment systems. 4-electrode UniCond sensors cover the higher conductivity ranges of acid and base ion exchange regeneration chemicals.

3) Maintenance-free Performance - Mettler Toledo Thornton conductivity sensors for pure water provide high accuracy measurements with widely spaced electrodes that do not trap ion exchange resin particles, corrosion particles or bubbles, and yield more reliable, maintenance-free operation than with other sensors.

https://alliancets.com
630-321-9646

Operating Principles of the Jogler Model ILT-6000 Magnetostrictive Level Transmitter

The Jogler ILT-6000 Direct Insertion Magnetostrictive Level Transmitter is a loop powered non-contact level measurement device that can be installed directly into a process vessel. Utilizing the magnetostrictive principle and time-of-flight calculations allow the ILT-6000 to provide a fast and accurate measurement of float position and, ultimately, liquid level in the gauge. The ILT-6000 is installed in an isolation well assembly allowing the transmitter to be removed, serviced, or replaced with no process interruption.

The video below briefly explains how it operates:


ILT-6000 FEATURES
  • 2 wire, loop powered (24VDC nominal)
  • LCD Display (4-20mA, %, in, and/or cm)
  • Generic HART communication
  • Quick-Cal function for simple recalibration
  • Isolated from process pressure
  • Long Measuring Lengths (up to 35ft)
  • Isolation Well assembly
  • Dual level outputs (total level and interface)
  • Epoxy-Coated Aluminum Enclosure
  • Class I, Division 1, Groups A, B, C, D
  • Class II and Class III, Division 1, Groups E, F, G
  • Class I, Division 2, Groups A, B, C, D
  • Class II and Class III, Division 2, Groups E, F, G
  • Intrinsically Safe Class I / II / III, Division 1, Groups A, B, C, D, E, F, G
  • NEMA 4X
630-321-9646

Process Refractometers Used in Industry

Process refractometer
Technician adjusts process refractometer in plant.
(Electron Machine)
Process refractometers provide the analysis to quickly, reliably, and very accurately identify a sample and determine it's concentration and purity levels. They measure the refractive index and temperature of flowing liquids, and apply mathematical functions to determine the concentration of dissolved solids.

Part physics, part material science and part chemistry, refractometry is the process which measures the composition of known substances by means of calculating their respective refractive indexes (RI).  Light bends and changes velocity as it travels from one media into another through the media interface. When light traveling through air enters liquid, the light rays change direction by an amount determined by the liquid's density. RIs are evaluated via a refractometer, a device which measures the curve, or refraction. The
unitless number given by the refractometer, usually between 1.3000 and 1.7000, is the RI. The composition of substances is then determined when the RI is compared to a standard curve specific to the material of the substance. Standard tables are available that correlate RI to a variety of materials. These same tables also correlate RI to varying concentrations of particular liquid media at a particular temperature. Take corn syrup for example. Different refractive indexes are observed for different corn syrup samples of different concentrations. Therefore, by using a process refractometer to observe the RI of a particular corn syrup sample, a determination of the concentration of that particular sample can be made. By referring to the table or scale that correlates the RI to concentration at a particular fixed temperature, liquid concentration can be determined.

Common industrial refractometer applications are:

Process refractometer
Process refractometer with flanged spool adapter.
(Electron Machine)
  • Calculating amount of sugar dissolved in juices and beverages.
  • In commercial food applications such as juice production or tomato processing, refractometers are used to measure degrees Brix (the Brix scale relates refractive index to sugar concentration, and is a key way to maintain consistency).
  • In the pharmaceutical industry, process refractometers are used to monitor and control concentration levels during supersaturation, a critical process in crystallization.
  • In pulp and paper production, process refractometers for measuring dissolved solids in black and green liquor during the chemical recovery process.

Equipment manufacturers have developed numerous refractometer configurations tailored to specific each use and application. Each has a set of features making it the advantageous choice for its intended application. Product specialists are invaluable sources of information and assistance to potential refractometer users seeking to match the best equipment to their application or process.

For more information on industrial refractometers, contact Alliance Technical Sales by visiting https://alliancets.com or by calling 630-321-9646.

Cloth Heating Jackets for Pipes, Tees, Valves, Fittings, and other Process Equipment

Cloth heating jacket
Cloth heating jacket (Briskheat)
Industrial heating applications are numerous and varied. Heating requirements can range from freeze protection to precise maintenance of process temperature in piping, equipment, or vessels. Two commonly employed heating sources are electric resistance heaters and plant steam. While each has certain advantages, steam may not always be available or practical. Electric heat offers a number of positive attributes.
  • Ease of design and installation
  • Precise control
  • Uniform heating across surfaces
  • Low maintenance requirement
  • Portability
  • Economical to purchase and install
  • Wide array of shapes, sizes, and configurations
  • Standard and custom products for every application
Cloth heating jackets are one of many electric heater variants. Formed to fit specific valves, fittings, or other items, these reusable heaters are comprised of an exterior of rugged fabric, a layer of thermal insulation, a heating blanket, and an electrical connection point or fitting. Hook and loop fasteners facilitate the unwrapping or opening of the jacket to allow for installation and removal. The surface remains cool to the touch for most applications. Control can be provided by any type of temperature controller, with prewired options available for inclusion with the heating jacket.

Construction of cloth heating jacket
Construction of cloth heating jacket (click for larger view).

Liner and Facing Material (Inside and Outside cloth material)
  • PTFE - Standard facing material. Exposure temperatures up to 500°F (260°C). Up to Class 10 environments. 
  • BriskClean - For cleanroom class 10. Exposure temperatures up to 600°F (315°C). 
  • Silicone Cloth Adds a degree of moisture and chemical resistance. Exposure temperatures up to 500°F (260°C).
  • Samox® -High temperature cloth. Exposure temperatures up to 1100°F (593°C). Up to Class 100 environments.
  • Aluminum- Facing material option. Exposure temperatures up to 450°F (232°C).
  • Fiberglass cloth - Liner material option. Exposure temperatures up to 900°F (482°C). Up to Class 100 environments.
Closure Options
  • Hook and loop fastener
  • Hook and lace
  • Grommets
Insulation (placed in between liner and facing)
  • Fits your application based upon process temperatures. BriskHeat's industry leading engineers will design your system with the correct amount of insulation. Insulation will make your system energy efficient and touch-safe.
Voltage Options
  • 120 - 600VAC
  • Single phase
  • 3 Phase (Wye)
  • 3 Phase (Delta)
  • 60 Hz.
  • 50 Hz.
  • DC
Power Plug / Connector Options
  • Mate-N-Lock
  • Twist lock
  • CPC connector
  • Bare wire
  • Other electrical connections available
Built-in Controlling / High-limit Safety Thermostat Options
  • 180°F (82°C)
  • 248°F (120°C)
  • 302°F (150°C)
  • 347°F (175°C)
  • 392°F (200°C)
  • 500°F (260°C)
  • Other temperatures available
Built-in Temperature Sensor Options
  • Platinum RTD
  • Type J thermocouple
  • Type K thermocouple
  • Thermistor
  • Other temperature sensors available
Built-in Low-Limit Alarm Thermostat Options
  • 180°F (82°C) with 30°F (17°C) differential
  • 248°F (120°C) with 50°F (28°C) differential
  • Other temperatures available

Happy Fourth of July from Alliance Technical Sales

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Ronald Reagan