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You searched for "Pharmaceutical Manufacture".

Products

Ulvac Mechanica Booster Pumps

Ulvac Rotary Piston Pumps

The PKS series models are extremely durable, large oil rotary vacuum pumps with very stable pumping characteristics. They are used in many applications, in areas ranging from the metal and automotive industries, to the chemical, pharmaceutical and food industries. Pumping Speed  [96 to 420m3/h(1600 to 7000L/min)]     Contact us now > Or call us now on 0161 442 9963 to speak to a Product Specialist. You can also visit the ULVAC website for more product details by clicking on their logo below:  

PlasmaPURE acids

PlasmaPURE Plus Acids

PlasmaPURE Plus acids are manufactured with trace metal levels less than 10 ppt (0.01ppb). Commonly used in semiconductor, nuclear, clinical, pharmaceutical and geochemical analysis. Used for sample and standards preparation for ICP-AES, ICP-MS, Flame AA and Graphite Furnace AA spectroscopy. Supplied with a Certificate of Analysis containing lot number expiry date maximum specification for over 60 analytes Complete documentation for audit purposes Packaged in Class 10 clean room conditions –  Supplied in preleached Teflon® bottles for optimum quality Available in sizes from 250 ml to 2 litres Acetic acid Ammonia solution Hydrochloric acid Hydrofluoric acid Nitric acid Sulfuric acid Hydrogen…

UniPol 2020

The UniPol 2020 is fully automatic digital polarimeter designed for pharmaceutical and chemical applications. The entire measuring range of ± 360° is divided into several measuring ranges which can be easily selected. The standard model is equipped with the 589 nm wavelength, other wavelengths are available on request. High-performance circle polarimeter Compatible with various polarimeter tubes inc. microtubes Plug in connector for temperature sensor Energy saving LED light source 21 CFR part 11 ready Complies to international standards e.g EP and USP Calibration with Quartz control plates Main specifications Measurement scale °Optical Rotation / °Specific Rotation / °Z International Sugar…

Polartronic H532

The Polartronic H532 is a high performance circle polarimeter with up to 5 wavelengths. The system has the highest precision and resolution, ideal for applications dealing with different substances and requiring extreme accuracy; e.g. in pharmaceutical, medical and chemical laboratories. Spectral lamps make the system calibration free. Highest measuring precision over the entire measuring range by direct measurement of the angle Short measuring times, no mechanical wear Determination of the optical rotatory dispersion (ORD), measurement at several wavelengths Calibration free because of spectral lamps 21 CFR part 11 software available Main specifications Measurement scales °Optical rotation, °Specific rotation, °Z International…

VariPol

Application Determines the concentration of the optical active substance dissolved in an optically inactive liquid. The VariPol polarimeter is especially designed for pharmaceutical applications. The system is compact, includes peltier temperature control and is 21 CFR part 11 ready. Especially designed for pharmaceutical applications Peltier system for automatic temperature control 21 CFR part 11 ready Energy saving durable LED’s Control via touchscreen, PC, tablet or Smartphone Detailed specification for the Varipol are listed below Measurement scales ° Optical rotation, ° Specific rotation, °Z International Sugar Scale, % Concentration (g/mL, g/100mL, g/L), further scales freely definable Measuring range ± 89.9° Resolution…

Schmidt & Haensch Density Meter EDM 5000

Application Continuous density measurement of liquids. Suitability cosmetics food and beverage medicines paints and lacquers petroleum Markets brewing chemical cosmetics food and beverage lubricants neutraceutical petrochemical pharmaceutical Specification Integrated reference oscillator High-precision temperature measurement Automatic detection of gas bubbles High precision and reproducibility of 0.0005 g/cm³ Touch screen interface Optional moisture and air pressure sensor Contact us now > Or call us now on 0161 442 9963 to speak to a Product Specialist. You can also visit the Schmidt & Haensch website for more product details by clicking on their logo below:

Schmidt & Haensch Density Meter EDM 4000

Application Determines the density of liquids. Suitability cosmetics food and beverage medicines paints and lacquers petroleum Markets brewing chemical cosmetics food and beverage lubricants neutraceutical petrochemical pharmaceutical Specification Integrated reference oscillator High-precision temperature measurement Automatic detection of gas bubbles High precision and reproducibility of 0.0001 g/cm³ Touch screen interface Optional moisture and air pressure sensor For more details on Schmidt & Haensch density meters, please visit www.schmidt-haensch.com Contact us now > Or call us now on 0161 442 9963 to speak to a Product Specialist. You can also visit the Schmidt & Haensch website for more product details by clicking…

RIGAKU Nano3DX

The NANO 3DX is an X-ray microscope (XRM) wich offer 3D computed tomography (CT) images with high contrast and at high resolution. This is accomplished by using a high powered rotating anode X-ray source and a high-resolution CCD detector. The rotating anode provides for fast data acquisition and the ability to switch anode materials easily to optimize contrast for specific sample types. High-resolution, high-contrast X-ray microscope The new nano3DX allows you see into many types of samples, including those that have low absorption contrast, for example CFRP, or denser materials like ceramic composites. The nano3DX allows you to achieve this…

Multi N/C® Total Organic Carbon and Nitrogen Analyzers

The Multi N/C® range of TOC and TNb analyzers from Analytik Jena deliver robust, high performance results on an easy to use, low maintenance platform. Technology Highlights • Industry leading, high performance TOC for all applications. • No kits required for difficult high saline samples making the system easy to use. • Direct injection variable volume autosampler injects only the amount of sample required. Inject small volumes for concentrated samples or complex matrices or large volumes for enhanced sensitivity. • 10 year NDIR detector warranty • Sensitivity down to 2ppb, upper range of 30,000ppm without dilution. • Automatic sample preparation,…

Gamry Instruments for Electrochemistry & Corrosion

Gamry Instruments Inc. design and manufacture a wide range of electrochemical instrumentation. Products include potentiostats and electrochemical software for electrochemical research, battery testing, fuel cell development and corrosion science. Gamry electrochemical instruments perform physical electrochemistry, pulse voltammetry, cyclic voltammetry (CV), electrochemical impedance spectroscopy (EIS), dc corrosion measurements, and electrochemical noise. Gamry offer the following solutions: • potentiostats and multiplexer • eQCM • electrochemistry software • electrochemical cells and special systems • spectroelectrochemistry Contact us now > Or call us now on 0161 442 9963 to speak to a Product Specialist. You can also visit the Gamry website for more product…

Potentiostats

Gamry Instruments Inc. design and manufacture the Reference™ 600, Reference 3000, Interface 1000 Potentiostats. The choice of potentiostat is usually based on the maximum and/or minimum level of current expected in the experiments. Gamry Potentiostats can function as a potentiostat, a galvanostat, or a Zero Resistance Ammeter (ZRA). All Gamry Potentiostats include (as standard) hardware capable of performing electrochemical impedance spectroscopy (EIS). Gamry Potentiostats electrically fully float, allowing electrochemical experiments with grounded samples such as pressure vessels. Gamry’s eQCM 10M is a rapid, impedance-scanning electrochemical quartz crystal microbalance (EQCM). The EQCM adds a valuable tool in the analytical toolbox of…

Ring Shear Tester-XS

The Ring Shear Tester RST-XS.s is compact and bench-mounted. It is designed for applications with powders of up to particle size 1.5 mm. This RST is particularly well-suited for small sample volumes. The RST-XS is an easy-to-operate, computer-controlled tester for the precise determination of the flow properties of fine-grained powders and bulk solids. It is appropriate for those industries and research institutions which deal with either fine-grained materials or have only limited amounts of powders for testing (e.g. pharmaceutical, food, chemical industries and others). The tester measures the flowability and other physical quantities like the internal friction of a powder,…

VIAVI MicroNIR Onsite

The MicroNIR Onsite from VIAVI (ex JDSU) is the world’s smallest NIR spectrometer. The ‘fit for purpose’ design allows the user to apply NIR in a way never seen before. The MicroNIR family of spectrometers is the next generation of ultra-compact near-infrared spectrometer sensors and analysers, solving customer needs across multiple industries. The pharmaceutical, agriculture and chemical industries have deployed the MicroNIR spectrometer for real-time, non-intrusive chemical and physical analysis of materials and monitoring of processes. This has resulted in improved quality control, reduced costs and faster decision-making. The MicroNIR spectrometer’s small form factor, its cost-effectiveness, exceptional performance and ease…

MicroNIR PAT and MicroNIR PAT Wireless

The MicroNIR PAT is an ultra-compact, near-infrared (NIR) wireless spectrometer covering 950 – 1650 nm for on-line process monitoring applications in the pharmaceutical, food, and chemical industries. It is suitable for batch processes. The MicroNIR PAT also allows continuous manufacturing processes that use multiple NIR sensors across an entire process flow. Pharma applications includes monitoring blend uniformity, drying conditions, and API concentrations in blenders, fluid bed dryers, and tableting. The MicroNIR PAT is available as a wired or wireless device. The MicroNIR PAT WIFI: • non-destructive, non-invasive, and real-time near-infrared analysis • user-selectable WiFi or Ethernet for system control and…

Custom designed systems

hello As all of our equipment is used by researchers and all research is different, at SciMed, we take the view that there is no ‘one-size-fits-all’ solution. In partnership with Parr Instrument Company, we are able to tailor the equipment to your needs using catalogue items as a starting point. The tailored change may be something as small as the addition of an extra valve, through to the construction of a full interrogated pressure system with numerous vessels, ancillaries and full DCS control. This can be achieved in the following way: What does the customer need? In the initial consultation…

4500 Series Stirred Pressure Vessels

Parr supply a family of stirred pressure vessels ranging from 25ml to 5 USG (18.75L). These are split into 7 series which all follow the same design principles and use Parr’s extensive design and manufacture capabilities to ensure that the systems are as user-friendly as possible without compromising the pressure vessel safety.                                   All of these vessels come complete with a stand comprising heater and motor and a Parr 4848 controller. Material of Construction All standard Parr pressure vessels are made from 316 stainless…

Model 410 Industrial Flame Photometer

Flame Photometry is the technique of choice for the measurement of sodium, potassium and calcium in all sample types for: • mineral extraction • oil industry • paper industry • pharmaceuticals • soil analysis • utilities • food and beverage • chemical manufacture • fertilisers Sherwood Scientific’s Model 410 Industrial Flame Photometer with digital output (for printer or PC connection), also offers sodium linearization capability to allow higher concentrations of Sodium (<40 ppm) to be directly measured using a single point calibration. This facility can be switched on or off according to the operator’s preference or protocol for sodium determinations….

Sherwood 926 Chloride Analyser

The Sherwood Model 926 Chloride Analyser is used for the determination of Chloride Ions (Cl-)  in both human and animal food products, agriculture, cement, gypsum and the pharmaceutical and water industries. Sample preparation is minimal for most products with running costs of approximately £0.20/test. The Sherwood Model 926S is used in clinical laboratories, generally for sweat test analysis on infants. It is calibrated at 100mmol/L. Sample size for this application is user selectable at 20ul or 100ul. Contact us now > Or call us now on 0161 442 9963 to speak to a Product Specialist. You can also visit the…

Applications

Pharmacetical applications of thermal analysis

Thermal analysis is widely used in the pharmaceutical industry to measure properties such as polymorphism, excipient compatibility, purity, melting points and humidity studies.

Quantitative analysis of polymorph impurities of tablets by transmission X-ray diffraction

In the tableting process for pharmaceuticals, it sometimes happens that the active pharmaceutical ingredient reacts with materials used as excipients, such as sugar or starch, and dehydration reactions, polymorph transitions and other processes may occur due to the pressure during tableting. In recent years, a need has arisen to check, in the shortest possible time, whether or not the active pharmaceutical ingredient maintains its original crystal system, and whether or not there are polymorph impurities. Furthermore, this must be done in the tableting process, while maintaining the tablet form. Therefore, we used a powder X-ray diffractometer to non-destructively measure the…

Measurement of Bulk Samples, Brake pad of a motorcycle

Bulk samples such as metal blocks, ceramic sintered bodies, or pharmaceutical tablets are aggregates of microcrystals that can be measured by powder X-ray diffraction. In conventional powder diffraction measurements, samples need to be filled into a sample holder the size of a typical coin and placed in the center of the diffractometer. Hence, to perform measurements of bulk samples, it has been necessary to cut or pulverize samples according to the sample holder, or to use an attachment with an electrically driven adjustment axis in the thickness direction of the sample. With Rigaku’s bulk sample holder, thick bulk samples can…

LOQ of Trace Impurities in active pharmaceutical ingredients via the DD Method

Quantification of a trace amount of polymorphic impurities is critical especially in the quality control of Active Pharmaceutical Ingredients (APIs). Conventional quantitative analysis by X-ray diffraction (XRD) requires calibration curve preparation, reference intensity ratio (RIR) or crystal structure (Crystallographic Information File, CIF). However, the materials of APIs are often missing from the database. Therefore, their quantification is not straightforward. Rigaku have developed a novel quantitative analysis method called “Direct Derivation (DD)” that requires only XRD data and chemical formula(1)- (3). Here, quantitative analysis of trace amounts of the hydrate phase of API is performed using the DD method and the…

Identification of the crystal form of the active pharmaceutical ingredient in a tablet

Many active pharmaceutical ingredients have multiple crystal forms, and it is known that solubility and bioavailability vary depending on the crystal form. In the drug manufacturing process, active ingredients may sometimes undergo a crystalline phase transition to another crystal form, due to factors such as heat, light, humidity or pressure, and there is a need to check what crystal form the ingredient is in, in its final product state. With optical systems employing the Bragg-Brentano focusing method, of the type generally used with powder X-ray diffractometry, measurement of the powdered sample is done with a reflection arrangement, but if a…

Analysis of silicone coating on paper, clay coated paper and plastic

Paper and plastic are coated with a thin layer of silicone as a release coating in the manufacture of labels, tape or other adhesives, or as a barrier coating for protection against air in the packaging of food, medical products and other materials. In a clay coated paper the clay coating adds weight and adjusts various physical properties, such as paper glossiness and ink retention. During the coating process the amount of silicone coating, usually expressed as coat weight in g/m2 or lbs/ream, must be periodically measured in order to ensure the proper physical properties of the product. When coating…

F in solid geological samples by HR-CS AA and solid-sampling accessory

Fluorine is a common element in the earth’s crust formed in minerals and rocks as fluorides. The abundance of fluorine in the crust averages about 650 ppm (parts per million) and is commonly found in basalts, gabbros, andesites, granodiorites, rhyolites and granites. Marine phosphorites contain significantly higher concentrations of fluorine, averaging more than 30,000 ppm. Fluorite (CaF2), also known as fluorspar in industry, also has important uses in metallurgy including steel production, in the manufacture of ceramics and for the production of hydrofluoric acid as a precursor for other manufactured products. Optical grade fluorite with exceptional clarity is used for lenses in…

Analysis of metallic Tungsten by high-resolution ICP-OES

Analysis of metallic Tungsten by high-resolution ICP-OES The rapid analysis of traces impurities in refractory metals and alloys is an important part of the quality-control process in the manufacture of these materials. All classical atomic spectrometry techniques, however, have major disadvantages with respect to trace detectability in these matrices, which for example arise from the high atomization temperatures (AAS), the wealth of emission lines (ICP-OES) and adverse metal oxide formation (ICP-MS) of refractory elements like W, Mo, Ta and Nb. The novel high-resolution array technology of the PlasmaQuant® PQ 9000 eliminates almost all spectral interferences of classical ICP-OES providing increased…

Detection of trace elements in Urea by high-resolution ICP-OES

Urea is an organic compound that plays an important role in biological metabolism processes. Besides its physiological properties, synthetically synthesized urea has become a very meaningful compound in the clinical, pharmaceutical, and chemical industries. It is a starting material for the synthesis of a large number of chemicals including hydrazine and melamine that are further used for the production of resins eventually used as building materials. In agriculture, urea is a preferred compound to be used as fertilizer because of its high nitrogen content. Another application with constantly rising importance is it use as an active ingredient in exhaust gas…

Elemental Impurities in Pharmaceutical materials according to ICH and USP Chapters <232> and <233>

Chapter and ICH Q3D specify maximum limits for the amount of elemental impurities permitted in drug products, drug substances, active ingredients and excipients. These impurities may be present naturally, derived from the production catalysts or introduced inadvertently through the manufacturing process, or they could be environmental contaminants in the pharmaceutical raw materials. When elemental impurities have the potential to be present, compliance to the specified levels is a requirement. Here we present a simple and effective method for routine preparation and analysis of pharmaceutical material according to ICH and USP 232 and 233.

TOC System Suitability Test – Redefined According to New USP Regulations

The USP represents the general method for TOC testing in pharmaceutical applications and provides guidance on how to qualify the analytical technique for use as well as guidance on how to interpret instrument results for use as a limit test. A wider concentration range has to be covered by the TOC method applied and an SST test at 8 ppm must be passed.

Total Protein Determination in Pharmaceutical Products (Vaccines)

In pharmaceutical vaccine production, starting, intermediate and end products need to be controlled for the level of antigens. They are tested for the quantity of attenuated or devitalized viruses or bacteria. Since these antigens typically consist of proteins, the analytical quantification of total protein is a method of choice. Pharmacopoeia regulations list a number of relevant methods, among them are several UV/Vis assays (e.g. Lowry, Bradford, BCA assay) and two total nitrogen methods, which is the Kjeldahl and the catalytic combustion method. This application note focuses on the catalytic combustion method which is described in Pharm. Eur. Monograph 2.5.33, Method…

Calorific value determination of Refuse Derived Fuel (RDF) & Solid Recovered Fuel (SRD)

Calorimeters are a crucial tool in the manufacture and burning of RDF and SRF fuel. The total energy content of the fuel is key to its value and power generation abilities when burned and the Parr range of calorimeters can determine this CV waste

Manufacturing Scale Implementation of MicroNIRTM PAT for Blend Monitoring of Solid Dose Formulations

For many years now, the pharmaceutical industry has adopted Near Infrared Spectroscopy (NIRS) for various applications, particularly raw material identification and qualification. When the US FDA released its PAT Framework document in 2004, many of the larger innovator companies dedicated much time and effort into the development of NIRS for real time monitoring and control applications in solid dose manufacturing. One of the key processes targeted was Fluid Bed Drying (FBD) because of the static nature of the process and its criticality to downstream manufacturing operations. Many of these companies also used dynamic blenders for their blending operations, however, during…

Techniques for Developing Raw Material Libraries

For many years, pharmaceutical and related industries have used near-infrared spectroscopy (NIRS) as a means to identify raw materials as they are received by a manufacturing facility. The NIRS technique is highly specific for many of the organic compounds used in the formulation of tablets, capsules, crèmes, and suspensions. The development of portable and smaller instrumentation has helped many organizations become much more mobile with the use of the method, whereby point-of-receival/storage analysis is possible. This technical note is the first of a two-part series that discusses the critical issues behind material sampling. In particular, it addresses collecting the most…

Combining a Compact Process Analytical Technology (PAT) Analyzer, Analytics, and Applications in a Quality by Design (QbD) Environment

Technological advances in analytical instrumentation and computing systems have allowed many industries to better monitor and control business critical processes. This has enabled proactive, not reactive approaches to real-time quality assurance and product release. Until the advent of QbD and subsequent PAT initiatives, pharmaceutical and related industries were not fully equipped with the right guidance and supporting architecture to gain the benefits of modern, state-of-the-art quality control and assurance systems.

The Effects of Sample Presentation in Near-Infrared (NIR) Spectroscopy

NIR spectroscopy is a desirable methodology due to its unique ability to measure a wide range of different material types such as powders, liquids, solids, and slurries—often with little or no sample preparation. Users can measure these materials in their current states, saving analysis time and increasing sample analysis throughput. However, when developing a method for NIR spectroscopy, care should be taken to ensure that the sample presentation is both repeatable from user to user and is reproducible over time.

Method Transfer across Multiple MicroNIR™ Spectrometers for Raw Material Identification

Raw material identification or verification (of the packaging label) is a common quality-control practice. In the pharmaceutical industry, the increasing global footprint of the supply chain and public health concerns1 resulting from contaminated materials (or mislabeling) have driven many regulatory bodies to require inspection of every barrel in every shipment of materials used in the manufacture of pharmaceutical drugs. Handheld analytical instruments are becoming more common for rapid and non-destructive testing of incoming raw materials directly in warehouses, reducing the cost and time needed for taking samples to the laboratory and quarantining incoming shipments until lab testing is complete.

Polarimetry Fundamentals

Polarimetry is a sensitive, non‐destructive technique for measuring the optical activity exhibited by inorganic and organic compounds. A compound is considered to be optically active if linearly polarised light is rotated when passing through it. The amount of optical rotation is determined by the molecular structure and concentration of chiral molecules in the substance. Each optically active substance has its own specific rotation.  The polarimetric method is a simple and accurate means for determination and investigation of structure in macro, semi‐micro and micro analysis of expensive and non‐duplicable samples. Polarimetry is employed in quality control, process control and research in the…

Saybolt and Mineral Oil Automated Colorimeter

ASTM Colour: For the visual determination of the colour of a wide variety of petroleum products, such as lubricating oils, heating oils, diesel fuel oils, and petroleum waxes. Saybolt Colour: Determines the colour of refined oils such as undyed motor and aviation gasoline, jet propulsion fuels, naphthas and kerosine, and, in addition, petroleum waxes and pharmaceutical white oils.

Method Transfer across Multiple MicroNIR™ Spectrometers for Raw Material Identification

“Raw material identification or verification (of the packaging label) is a common quality-control practice. In the pharmaceutical industry, the increasing global footprint of the supply chain and public health concerns1 resulting from contaminated materials (or mislabeling) have driven many regulatory bodies to require inspection of every barrel in every shipment of materials used in the manufacture of pharmaceutical drugs. Handheld analytical instruments are becoming more common for rapid and non-destructive testing of incoming raw materials directly in warehouses, reducing the cost and time needed for taking samples to the laboratory and quarantining incoming shipments until lab testing is complete.”

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