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21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11 applies to pharmaceutical companies, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. The regulative code 21 CFR Part 11 requires that respective companies implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

A

Used in optics and lens production, the Abbe number is a dimensionless parameter named after German physicist Ernst Abbe. Also known as the V-number or constringence of a transparent material, it indicates material dispersion and shows how much the refractive index changes with the wavelength of the light. The higher the dispersion, the smaller the Abbe number. The number is given by a function of the refractive index of the material at 486.1 nm, 587.6 nm, and 656.3 nm. The Abbe number or V-number is mainly used to characterize and monitor the quality of glasses and polymers used in lens production. The Abbe or V-number can be reliably measured with the SCHMIDT + HAENSCH multi-wavelength refractometer ATR-L.

Absorption of electromagnetic radiation is the process in which matter takes up photon’s energy and transforms the radiation into internal energy. When light is absorbed, the energy from the photon typically manifests itself as thermal energy: the temperature of the matter increases. The absorption of light makes an object dark or opaque to the wavelengths or colors of the incoming wave. Transmittance in this case, refers to energy loss by absorption, whereas total transmittance is due to absorption or reflection.

In food and beverage industries, for some products it is crucial to determine their color by measuring their absorption or light transmittance. This is especially important for crystalized sugar (ICUMSA) or for beer (EBC) and wine to ensure their quality. EBC and ICUMSA as well as the color of wine can be reliably determined with the SCHMIDT + HAENSCH Coloromat 100.

Alkalinity is the capacity of a liquid substance or solution to resist acidification. It should not be confused with basicity which is an absolute measurement on the pH scale.

Alkalinity is the strength of a buffer solution composed of weak acids and their conjugate bases. Alkalinity can be controlled or monitored automatically by the SCHMIDT + HAENSCH on-line titration system, fitting in seamlessly into your production process. Alkalinity is expressed in units of concentration, such as meq/L, μeq/kg or mg/L CaCO3. Each of these measurements corresponds to an amount of acid added as a titrant. Measure alkalinity within the production process with the SCHMIDT + HAENSCH automation analyzers for sugar production. The purpose of this device is to reduce the amount of lime during the purification of first expressed sugar beet juice. The SCHMIDT + HAENSCH online titrator is suitable for those purposes.

The AOAC is a non-profit scientific association headquartered in Maryland, USA. It publishes standardized, chemical analysis methods designed to increase trust in the results of chemical and microbiological substance analysis. Government agencies and civil organizations often require that laboratories use official AOAC methods. To comply with AOAC standards, SCHMIDT + HAENSCH tests those methods on all laboratory instruments. To see all products by AOAC standards, click here.

ASTM International (originally American Society for Testing and Materials) is an international standards organization based in West Conshohocken, Pennsylvania, USA. It publishes technical standards for goods and services. SCHMIDT + HAENSCH instruments comply with a multitude of ASTM standards: eg. ASTM D4052, ASTM D5002, ASTM D5931, ASTM D6448, ASTM D1218 and many more. To find out about products by standards, click here

SCHMIDT + HAENSCH offers a variety of automation technologies. Automation is the robotic aid during production or laboratory processes which replaces human effort – and often human error. Through automation, production as well as laboratory processes can be optimized. We at SCHMIDT + HAENSCH offer laboratory automation such as automatic filtration (AutoFilt), automatic dosage (AutoDosage), and automatic sampling (Samplify), as well as factory automation for on-line measurements in sugar production.

B

Polarimetry is the measurement and interpretation of the polarization of light. Typically, polarimetric analysis of a specific material is accomplished using electromagnetic waves that travel through the material or have been reflected, refracted, or diffracted by it. Plane polarized light consists of electromagnetic waves whose spatial oscillations are transverse to the direction of propagation.

If natural light passes through a so-called polarizing filter, most of its other vibrating directions will be filtered out, leaving only one specific direction. If this light oscillates in only one direction, it is called linearly polarized or plane polarized light. Optical rotation in general means that the polarization of the direction of light will be rotated by a certain angle when passing through an optically active substance. Many organic and inorganic substances are optically active in their crystalline, liquid, or dissolved state. Polarized light that shines on these substances is rotated around an angle specific to the substance. The principle of the polarimeter is accomplished if a dissolved optically active substance is introduced between two polarizing filters, crossed at 90°. The intensity of the light on the detector behind the second polarizing filter varies as a function of the angular position of these two filters. A polarimeter is a scientific instrument used to measure the angle of rotation caused by passing polarized light through an optically active substance.

Refractometry is an analytical method to control and determine the quality, concentration, and composition of substances. Often used in laboratories or process monitoring, refractometers are suitable for liquids, gases, and solids such as glass and gemstones. The determination of the density of samples can also be done with refractometry. As a basic rule in optical measurement, density and dry substance correspond to each other. Refractometers can express the measured refractive indices in concentration or density. SCHMIDT + HAENSCH develops and produces refractometers since the company’s founding in 1864. Refractometry presents one of the long-standing core competences of the optoeletronic manufacturing company. All laboratory and process refractometers by SCHMIDT + HAENSCH are characterized by their unparalleled precision, reliability, and longevity.

Degrees Brix (°Bx) describes the sugar content of a liquid substance or solution. One degree Brix is one gram of sucrose in 100 grams of solution and represents the strength of the solution as percentage by mass. If the substance contains dissolved solids other than pure sucrose, then the °Bx only approximates the dissolved solid content. For example, if equal amounts of salt and sugar are added to equal amounts of water, the degrees of refraction (Brix) of the salt solution increases faster than the sugar amount. The °Bx is traditionally used in the wine, sugar, carbonated beverage, fruit juices, syrups, and honey industries. All SCHMIDT + HAENSCH refractometers, such as the Vari Ref and process refractometers apply for brix measurement in the sugar, food and beverage industry, chemical industry and many more.

The Braunschweig Method is a method developed by the International Commission for Uniform Sugar Analysis (ICUMSA GS3-1). It is a method to determine the polarization of white sugar using a polarimeter or a way to determine sugar reflectance using a spectrophotometer such as the SCHMIDT + HAENSCH Saccharoflex.

C

In chemistry, concentration is the amount of a substance divided by the total volume of a mixture. It is usually used for solutions. There are several types of concentrations: mass concentration (g/l), molar concentration (mol/l), volume concentration (ml/l), etc. Due to thermal expansion, a concentration measurement always depends on the temperature of the solution.

Knowing this dependency, SCHMIDT + HAENSCH’s instruments measure the temperature at any time during analysis with highest precision to retrieve the most reliable measuring results. Liquid concentration measurement is made simple with all SCHMIDT + HAENSCH laboratory refractometers like the ATR-BR, the Variref series, the in-line process refractometers, e.g. iPR FR2, and our polarimeters in case the substance is optically active.

The electrical conductivity or specific conductance of a substance defines its capability to conduct an electric current. It is commonly signified by the Greek letter σ (sigma). The SI-unit is S/m (Siemens per meter). The reciprocal of the conductivity is the electrical resistance (Ω). Both conductivity and resistance can be easily measured with the SCHMIDT + HAENSCH Ash color turbidity analyzer. This analysis enables a fast and automated quality control of sugar as well as determination of the turbidity analysis of liquids.

D

Degree Z is a physical parameter, or measuring scale, which is primarily used in the sugar industry. The basis of the 100 °Z point of the scale is the optical rotation of a standard sugar solution containing pure sucrose at a wavelength of 546.23 nm at 20 °C in a 200 mm tube. The standard sugar solution is defined as 26.016 g of sucrose dissolved in water at 20 °C to a final volume of 100 ml. Similar to the Brix scale for sugar level, Degree Z is sensitive to temperature. Temperature control is important and is included in all SCHMIDT + HAENSCH polarimeters.

Density or more precisely the volumetric mass density ρ (rho) of a substance is its mass per unit volume. The units most often used for density are kg/m³ or g/cm³, or ρ. The volume of a sample depends on its temperature. Because of thermal expansion, the density of a substance highly depends on its temperature. The SCHMIDT + HAENSCH density meter VariDens allows a precise measurement of density by adjusting the temperature of the sample. Additionally, the relative or specific density as well as the true or apparent density can be determined by the VariDens. The SCHMIDT + HAENSCH density meter VariDens allows a consistent manufacturing process and tighter tolerances on the results, while reducing costs and increasing product quality at the same time. For high performance and quality choose the SCHMIDT + HAENSCH VariDens.

The VariDens can be used for the dairy industry, petrochemicals, polymer density measurements, beverages, cosmetics like pharmaceutical creams, and many more.

The relative or specific density is the ratio of the density of a substance to the density of a given reference material. It is nearly always measured with respect to water at its densest (4°C).

The true density is the density of a substance in vacuum. It is independent of external conditions, such as buoyancy in air or gravity. The apparent density of a sample is weight in air per volume. All Schmidt & Haensch VariDens density meters measure the real density. The VariDens can be used for the dairy industry, petrochemicals, polymer density measurements, beverages, cosmetics like pharmaceutical creams and many more.

E

The European Brewery Convention is an organization representing the technical and scientific interests of the brewing sector in Europe. The EBC measures beer and wort color, as well as quantifying turbidity (also known as haze) in beer. The color is an important parameter to monitor the quality of beer and wort during the brewing procedure. EBC and beer color can be tested easily and reliably with the SCHMIDT + HAENSCH Coloromat 100. For physical color determination of beer samples, the light absorption is detected at 430 nm by a photometer. The EBC number represents a single point in the absorption spectrum of beer. The hue of a beer can be described as a gradient of yellow and brown tones ranging from golden yellow and light yellow to red, copper, and dark brown to black. The measurement of beer color, wort color and wine color with the SCHMIDT + HAENSCH Coloromat 100 is simple and gives reliable results to ensure a consistent quality.

The International Honey Commission (IHC) was formed in 1990 to create a new world honey standard.  All modern routine honey analysis methods were collaboratively tested and compiled as “Harmonised methods of the European Honey Commission”, published in Apidologie, extra issue, 1-59, 1997. Based on these methods the Codex Alimentarius Standard and the EU Honey Directive were revised. The EHC standard for sugar determination of specific rotation can be best measured with the SCHMIDT + HAENSCH Saccharomat V.

F

We at SCHMIDT + HAENSCH are passionate about creating automation technologies to make factory processes smoother and more efficient. Our on-line automation systems such as the ash on-line analyzer to the fully integrated on-line purity analyzer are stand-alone fully automatic measuring systems for sugar factories which control processes, optimize processes, and reduce manpower and human error to a tremendous extent.

G

Good Manufacturing Practice and Good Laboratory Practice (GLP) are formal frameworks for conducting safety testing on chemicals, pharmaceuticals, pesticides, food additives and explosives. In many countries, GMP/ GLP are required by law.

GLP and GMP regulations pertaining to testing serve two different purposes. The GLPs are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. In contrast, the GMPs are intended to demonstrate to the FDA whether individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.

In general, “lot release” or “lot conformance” testing of regulated products produced for sale, like finished pharmaceuticals, should be done under GMP.

Safety testing and efficiency testing should be done under the GLP testing regulations. It is a matter of debate whether validation studies should be done under GLP or GMP. It may depend on what is being validated; in some cases, either GLP or GMP may be appropriate.

For more information on our validation services, please see our service section.

I

The International Commission for Uniform Methods of Sugar Analysis (ICUMSA) is an international standards body, founded in 1897, that publishes detailed laboratory procedures for the analysis of sugar. The ICUMSA Methods Book contains detailed instructions for analyzing raw, cane, white, beet, molasses, plantation white and specialty sugars. Among these are methods for determination of dry solids content by polarimetry, densimetry, refractometry and color (extinction coefficient at 420 nm). The value of the absorbency index multiplied by 1000 is reported as ICUMSA Color (method GS2/3-9 and -10). The resulting values are referred to as ICUMSA Units (IU). The color of a sugar solution is directly related to the degree of refining and is used to measure its quality. Besides the Coloromat 100 SCHMIDT + HAENSCH offers a variety of instruments to maintain a consistent product quality like Polartronic, Saccharomat, ATR-P, ATR-BR, VariRef B, VariDens and the Saccharoflex 2020.

The word in-line or inline (both spellings are common) refers to the line of a production. Hence, “in” a production line means the integration of instruments within the process of production without interruption or divergency of that process. The term is usually used in engineering and production or manufacturing. With regards to measuring techniques, the word refers to instruments which measure data in real-time during a production process. SCHMIDT + HAENSCH in-line process refractometers and sensors are world leading in-line instruments for the most precise and reliable control of your production process, measuring liquid concentration, brix value and other physical parameters.

Degree Z is a physical parameter, or measuring scale, which is primarily used in the sugar industry. The basis of the 100 °Z point of the scale is the optical rotation of a standard sugar solution containing pure sucrose at a wavelength of 546.23 nm at 20 °C in a 200 mm tube. The standard sugar solution is defined as 26.016 g of sucrose dissolved in water at 20 °C to a final volume of 100 ml. Similar to the Brix scale for sugar level, Degree Z is sensitive to temperature. Temperature control is included in all SCHMIDT + HAENSCH polarimeters.

Validation is one of the fundamental building blocks of quality management in medical technology. SCHMIDT + HAENSCH has been supplying laboratory equipment to its customers for more than 150 years and has excellent specialist know-how in process validation.

IQ Installation Qualification
IQ stands for “Installation Qualification” Installation Qualification (IQ) involves documenting and proving that a device has been supplied with the requirements in the Design Qualification and has been installed correctly. This also includes verifying that the appropriate working environment has been selected.

OQ Operational Qualification
OQ stands for “Operational Qualification”. During Operational Qualification (OQ), the correct functioning of the device in the selected working environment is checked. It is documented that the system functions properly according to the specifications, including all individual settings.

PQ Performance Qualification
PQ stands for “Performance Qualification”. During performance qualification (PQ), the use of the machine within the entire production process is tested. Proof is provided that a machine consistently achieves the defined performance parameters under real operating conditions and delivers repeatable, reliable results in regular use.

L

Automation can be a helpful asset for laboratories: especially when it comes to sample preparation or dosing, human errors can be eliminated and handlings that are usually time intensive. With the SCHMIDT + HAENSCH laboratory automation, namely Samplify P, AutoDosage and AutoFilt products, sample preparation for production or research laboratories can be optimized. 

O

The International Organization of Legal Metrology (French: Organisation Internationale de Métrologie Légale – OIML), is an intergovernmental organization, created in 1955 to promote the global harmonization of the legal metrology procedures that underpin and facilitate international trade. Such harmonization ensures that certification of measuring devices in one country is compatible with certification in another, thereby facilitating trade in the measuring devices and in products that rely on the measuring devices. Such products also include measuring devices by SCHMIDT + HAENSCH for various applications. 

SCHMIDT + HAENSCH instruments stand in compliance with most relevant OIML requirements and documentation allows for a verified instrument qualification. 

The OIML works closely with other international organizations such as the International Bureau of Weights and Measures (BIPM) and International Organization for Standardization (ISO). 

Some well-known optical substances are tartaric acid, lactic acid, benzoic acid and derivatives, amino acids, proteins and of course sugars. If an optically active substance is dissolved in an optically inactive liquid (as water for instance), the degree of angle rotation depends – amongst others – on the concentration of the solution. This angle of rotation is absolutely determined by the SCHMIDT + HAENSCH polarimeters with highest precision. This allows the user to easily determine the concentration or the purity of solutions containing optically active substances. Concentration and purity measurements are especially important to determine product or ingredient quality in the food and beverage, and pharmaceutical industries. Suitable for this purpose are the VariPol Series polarimeters, the Polartronic H532, the Polartronic V and the Unipol 2020.

Optical rotation in general means that the polarization of the direction of light will be rotated within a certain angle when passing through an optically active substance. Many organic and inorganic substances are optically active in their crystalline, liquid, or dissolved state. These substances can rotate the direction of oscillation of polarized light around a determined angle. The principle of the polarimeter is accomplished if a dissolved optically active substance is introduced between two polarizing filters, crossed at 90°. The intensity of the light on the detector behind the second polarizing filter varies as a function of the angular position of these two filters.

Optical rotatory dispersion is the variation in the optical rotation of a substance in dependency of the wavelength of light. A polarimeter can be used to measure the rotation and to calculate the concentration of an optical active solution. This usage makes a polarimeter a tool of great importance to those dealing with, e.g. raw sugar, crystal sugars or first expressed raw sugar juices. Optical rotary dispersion can be measured using the SCHMIDT + HAENSCH Polartronic H532 and VariPol.

P

A pharmacopoeia generally refers to “medical compendia of comprehensive indication, composed of prescriptions or Pharmacopoeia” called Pharmacopoeia (as in Latin Pharmacopoea from Greek pharmakopoieĩn ‘to prepare medicines’). It is a collection of recognized or previously recognized pharmaceutical rules on the quality, testing, storage and designation of medicines and the substances, materials and methods used in their manufacture and testing.

Official pharmacopoeias or modern pharmacopoeias are standard works or books of regulations applicable to pharmacy operations and industrial drug production. They are based on a legislative act and are bindingly valid.
This also includes pharmacopoeias for veterinary medicines. 

Continents or countries establish legally binding pharmacopoeias to secure quality and efficiency of the locally produced or imported pharmaceuticals. When it comes to quality testing such as chirality testing or content analysis of pharmaceuticals, measuring techniques such as polarimetry or refractometry are crucial factors to comply or fulfill those standards defined by the pharmacopeia. 

SCHMIDT + HAENSCH is proud to deliver pharmacopoeia compliancy with all our pharma-ready laboratory instruments such as VariRef, VariPol or Polartronic H532.

In chemistry, pH is a scale used to specify the acidity or basicity of an aqueous solution. Acidic solutions are measured to have lower pH values than basic or alkaline solutions. At 25 °C, solutions with a pH less than 7 are acidic, and solutions with a pH greater than 7 are basic. With the SCHMIDT + HAENSCH on-line process titrator the continuous analysis of the pH value and alkalinity during the purification of the raw sugar juices is made simple and reliable. Your process will be optimized, saving resources and auxiliary materials while all important process parameters are being controlled.

Optical rotation in general means that the polarization of the direction of light will be rotated within a certain angle when passing through an optically active substance. There is a great number of organic and inorganic substances being optically active in their crystalline, liquid or dissolved state. That means these substances are able to rotate the direction of oscillation of polarized light around a determined angle. The principle of the polarimeter is accomplished if a dissolved optically active substance is introduced between two polarizing filters, crossed at 90°. The intensity of the light on the detector behind the second polarizing filter varies as a function of the angular position of these two filters.

Q

Refractometry is the quantitative measurement of the refractive index (RI). However, when the composition of a substance is known, the quality of the substance may also be determined. For mixtures such as olive oil or orange juice, the measuring value within a specific range corresponds with the quality of the product. Hence, the refractive index determination is also used in evaporation, dilution, or purification processes. A qualitative analysis using refractometry is suitable for any multi-compound solution. A good example for such an analysis is a solution of sucrose in water, which has been studied thoroughly. One degree Brix equals 1 gram of sucrose dissolved in 100 grams of water. If the solution contains dissolved substances other than sucrose, the °Bx value will only approximate the sucrose content. All SCHMIDT + HAENSCH refractometers, such as the Vari Ref and the process refractometers are applicable for Brix measurement.

R

In optics, the refractive index (also known as refraction index or index of refraction) of a material is a dimensionless number that describes how fast light travels through a material. It is defined as n=c/v, where c is the speed of light in vacuum and v is the phase velocity of light in the medium. The refractive index varies with wavelength, this causes white light to split into constituent colors when refracted. This phenomenon is referred to as dispersion. It can be observed in prisms and rainbows, and as chromatic aberration in lenses. The refractive index is an important property of the components of any optical instrument. It determines the focusing power of lenses, the dispersive power of prisms, the reflectivity of lens coatings, and the light-guiding nature of optical fiber. Since the refractive index is a fundamental physical property of a substance, it is often used to identify a particular substance, confirm its purity, or measure its concentration. The refractive index is used to measure solids, liquids, and gases. Most commonly it is used to measure the concentration of a solute in an aqueous solution.

SCHMIDT + HAENSCH’s optoelectronic measuring instruments simplify the determination of the refractive index and dispersion in laboratories and industrial manufacturing processes. SCHMIDT + HAENSCH inline process refractometers can measure the real time concentration. SCHMIDT + HAENSCH laboratory refractometers such as VariRef and ATR-L can determine dispersion and multiple wavelengths if desired. The following instruments are suggested for those applications: ATR-L, iPR B3, iPR FR2, iPR HR2 and the Vari Ref.

A refractometer is used to determine a concentration of a particular substance within a given solution. This substance or solution always has a specific refractive index that depends on the solution’s temperature. A refractometric scale is hence a reference value of the refractive index of a specific solved substance at a specific temperature. Those absolute scales are used to determine concentration and more physical properties of a substance and to help characterize liquids.

S

A scale (from Latin scalae ‘ladder, staircase’) is a succession of a number of graduation lines on a display surface. The graduation can be even or, if necessary, uneven. It is used to indicate a value with the aid of a reading mark. Many physical measurands and units are related to each other and can be converted into each other. In measurement technology and specifically refractometry, we speak of scales when, for example, the refractive index is converted into a suitable substance-specific unit.
Among the more than 100 scales in use, the most common is the BRIX scale. It is used to determine the sugar concentration in aqueous solutions and is often pre-installed on refractometers. This scale (1 % BRIX corresponds to a 1 % sucrose/water solution) is widely used, e.g. for content determination in the chemical or automotive industry.

If standard scales are no longer sufficient, our digital refractometers can help. It can convert individualized mathematical relationships between concentration and nD value into conversion formulas. A list of more refractometric scales can be found here.

Specific rotation is defined as the angle of rotation in degrees of the plane of polarization of monochromatic light passing through a 100 mm tube containing a solution of an optical active substance with a concentration of 1 g/ml. Some materials like quartz, sucrose solutions or organic compounds, can rotate the direction of oscillation of polarized light around a determined angle. They are called optically active materials and can be dextrorotatory or levorotatory. The specific rotation is a substance-specific physical parameter, which can be determined by all the SCHMIDT + HAENSCH polarimeters. Depending on the temperature and wavelength of the light, the measuring instruments indicate the specific rotation. For some samples this value depends on the concentration as well, which is why SCHMIDT + HAENSCH’s customization of measuring methods considers all parameters related to the specific rotation.

The specific rotation is an important parameter to check the purity of optically active substances like raw materials for the production of pharmaceutical and cosmetic products, or active pharmaceutical ingredients (API’s).

T

Turbidity is the cloudiness or haziness of a fluid caused by large numbers of individual particles that are generally invisible to the naked eye, similar to smoke in air. It is caused by small undissolved particles which scatter the light passing through the suspension. Depending on the particles’ shape and surface quality, the light is scattered with different intensity in all directions. With a measuring instrument such as the SCHMIDT + HAENSCH colorimeter Coloromat 100, the turbidity of any liquid substance can be easily determined. This kind of instrument is commonly used in the sugar and beverage production. Turbidity can also be analyzed automatically using the SCHMIDT + HAENSCH Ash color turbidity analyser to control the quality of sugar within the production process. SCHMIDT + HAENSCH also offers a range of fast automatic filtration instruments for turbidity-free solutions.

V

An essential element of validation processes is the qualification of equipment and systems. As a manufacturer of laboratory equipment, we at SCHMIDT + HAENSCH meet the enormous demand for qualification services with a holistic  concept. Find out about our validation services in our service section.

W

In physics, the wavelength is the spatial period of a periodic wave—the distance over which the wave’s shape repeats. It is the distance between consecutive corresponding points of the same phase on the wave, such as two adjacent crests, troughs, or zero crossings. The wavelength is a characteristic of both traveling waves and standing waves, as well as other spatial wave patterns. Wavelength is commonly designated by the Greek letter lambda (λ). The SCHMIDT + HAENSCH multi-wavelength refractometer measures the refractive index at multiple wavelengths.

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