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USP - Crosslinking agents - Addivant
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Kunststoffe international, Maintaining Clarity Long-Term
...y profiles. They differ in melt viscosity, mechanical performance, and resistance to lipids and chemical agents. They have very high transparency for an impact-modified plastic. Furthermore, these products are bisphenol (BPA)-free and compliant with USP class VI and ISO 10993 requirements. They are resistant to disinfectants and lipids and are recommended for components requiring gamma ray, electron beam, or ethylene oxide (EtO) sterilization. Effect of Solvents and DisinfectantsHealthcare-assoc...
Kunststoffe international, 2005-11-21, "Medical Grade" Plastics
...y able to pass the ISO tests), and - to provide the product manufacturer with data which can help him reduce the number of tests required on the end-product. By far the best known document available in connection with medical-grade plastics is the USP Class VI certificate [6]. USP (U.S. Pharmacopoeia) Class tests contain a series of tests to demonstrate that the plastic in question is suitable for pharmaceutical containers (Table 2). A comparison between USP class tests and the requirements of I...
Kunststoffe international, 2005-11-21, Functionality is the Key Factor
...ltrafast cycling times without any problem. Other major advantages are its intensive black colouring, which enhances the quality of the fluorescence measurements involved in the processes, its physiological inertness, its conformity to FDA/BGA and USP Class VI, its chemical resistance and its NMR compatibility [12]. Because of their specific application advantages, polyurethanes (grades: Baydur and Bayflex, manufacturer: Bayer) are used for a wide variety of medical products, in particular for h...
Kunststoffe international, 2005-11-21, Materials: Housings and Catheters
...clear, UV-resistant material with a high resistance to chemicals and stress cracking. At the same time, it offers the advantages of amorphous moulding compounds, such as a low tendency to warp and good creep behaviour. The material is licensed to USP, Class VI, which is the highest rating for the United States Pharmacopoeia. It is suitable for the production of parts that come into direct contact with active ingredients or body fluids. These include housing parts as well as infusion and transfus...
Kunststoffe international, 2005-11-21, Micro-Injection Moulding: Microfluidic Systems with Integrated Semiconductor Chips
...ated into the system (Fig.18). The entire spectrum of integrated that can be manufactured by means of appropriate semiconductor technologies and/or microsystem processes are available. Using biocompatible polymers according to ISO 10993-1 and USP Class VI, such as POM or LCP, it is conceivable to integrate the entire system into the body if the appropriate transmitter and receivers can also be integrated into the semiconductor chip. With the use of MID-compatible polymers, the injection moulded...
Kunststoffe international, 2005-11-21, Sulfone Polymers: Sound Properties
...d enfluran). It was also possible to confirm this property in laboratory experiments. Finally, Radel R PPSU is available in various colours and degrees of transparency. In addition, the selected PPSU grades were tested in accordance with USP VI and are thus suitable for medical applications requiring biocompatibility (in direct or indirect contact with bodily fluids). It is this combination of properties that qualifies PPSU in a special way for repeated-use products in the field of medicine: fir...
Kunststoffe international, 2005-11-21, Sulphone Polymers: Clear Vision
...nts, e.g., for the automotive, aerospace, electrical or electronic industry. Multitalented: Stable and Resistant Medical applications focus on the sulphone polymers Udel PSU and Radel R PPSU. They meet the approval regulations according to USP VI, and meet requirements for sterilisability, are not known to be toxic, and are biocompatible. They maintain their excellent impact resistance, even when disinfectants are used. Polyphenylsulphone withstands the highest number of steam-sterilisation cycl...
Kunststoffe international, 2005-11-21, The Newly Discovered Charm of Parts
... a car. Customers first choose whether they want a BMW, Mercedes or Audi and only then do they decide whether to go for the 3-Series, the C-class or the A4. And, what is more, brands do not just grow on trees – they need what is called USP, or the unique selling proposition. Without innovations, brands lose their appeal. But it is the suppliers more than ever who have the innovations, no matter whether it be the electro-hydraulic brake, pump nozzle, parktronic, telematic or automatic distance co...
Kunststoffe international, 2005-11-21, Trend Report: Colour Management for Global Production
...stic preforms in reflected and transmitted light (Fig. 7). Hunterlab offers a reference-grade spectrophotometer called UltraScan PRO (Fig. 8). It measures in both reflection and transmission mode, and complies with CIE, ASTM and USP guidelines. With a resolution of 5nm, it achieves maximum measurement accuracy. For the first time, the light source has been standardised in both the UV and the visible range. This has substantially extended the measuring range to allow accurate measurements of flu...
Kunststoffe international, 2005-11-21, Wide Range of Applications: Styrene Copolymers
...rs. Each of these applications is subject to numerous national approval procedures, including, among others, the Drug Master Files (DMF), the US Food and Drug Administration (FDA) as well as the European and American Pharmacopeia (EP and USP). BASF sees additional opportunities in the market for health care and diagnostic devices with the introduction of the new grade Terlux 2802 HD. Just as with other materials for health care and diagnostics, the challenge here is to provide customer- and sec...
Kunststoffe international, 2006-01-30, Plastics for Medical Technology: Long Life Ensured
...ceutical and medical applications. Detailed tests on the granules show, for example, that Terlux 2802 HD fully complies with the requirements of the European and the US Pharmacopoeia (EP 5.2, chapter 3.2.2 and USP Biological Test Classification VI). Formulation Consistency Guaranteed over the Long Term. One invisible but nevertheless significant advantage of the new transparent ABS grade is the commitment made by BASF to keep the formulation of Terlux 2802 HD completely constant unless changes ...
Kunststoffe international, 2006-01-31, Multiple Stopcocks: Permanently Lipid-resistant
...wed the best resistance in comparison with currently used polycarbonate grades (PC) and polymethyl methacrylate (PMMA: Table2). Of course, the material described above also meets the relevant requirements for medical technology products. It has a USP Class VI rating and is therefore approved for direct contact with pharmaceuticals and body fluids – and for infusions and transfusions. The Author Dipl.-Ing. Dirk Heinrich, born in 1970, is employed by Degussa AG, Marl in the Market Development Dep...
Kunststoffe international, 2008-01-15, Bringing Measurement to Optical Effects
Bringing Measurement to Optical Effects Color Measurement (Trade Fair Report K 2007) The range of requirements is expanding. Automobile manufacturers and their suppliers have to reliably determine both color and surface effects. Capturing light dependent effects, gloss as well as the colormetric behavior of translucent objects is becoming more important. In some extrusion applications color measurement is already part of the quality control and is starting to be used as part of the production ...
Kunststoffe international, 2008-04-14, Safety Has Priority
...n this sector. Testing of formulations and/or tests performed on the pellets ensure conformance to, for instance, the EU Pharmacopeia (EP 5.2, Chapter 3.2.2 "Plastic Containers and Closures for Pharmaceuticals" and the US Pharmacopeia ("USP Biological Test Classification VI"). Additional biocompatibility tests of the resins in accordance with international standards (such as cytotoxicity as specified in ISO 10993) along with creation of a drug master file (DMF) simplify the appli...
Kunststoffe international, 2008-10-17, Low-Density Polyethylene (PE-LD, PE-LLD)
...ducts with a good transparency and good draw-down properties as well as to injection molded products with a low tendency to warp. Contrary to the case for PE-LD, PE-LLD is produced by a low-pressure process in a gas phase fluidized bed, solution or suspension. To achieve the low density, use is made of nonpolar comonomers, such as butene-1, hexene-1 or higher α-olefins, whereby the latter offer technical advantages on account of the better mechanical properties that can be achieved in the...
Kunststoffe international, 2009-02-17, Optimized Silicones for Medical Applications
...ely important across the entire medical field. This applies to cytotoxicity, systematic and intracutaneous toxicities, and pyrogenicity. All Silpuran products have been tested in accordance with selected ISO 10993 and USP (United States Pharmacopeia) class VI tests.
Kunststoffe international, 2011-05-12, Surfaces that Help Healing
... microparticles during use under frictional loading. Even if a coating is biocompatible, the release of a large number of such particles in the body involves certain risks. Directive 788 of the United States Pharmacopeia (USP), for example, therefore stipulates maximum values for the number of particles above 10 or 25 μm in size contained in injection solutions. The critical (“worst case”) use of coated catheters was therefore simulated in a tubing system containing numerous curves and filled wi...
Kunststoffe international, 2011-08-24, High Transparency for Challenging Applications
... nor absorbs odors. Grilamid TR meets the criterion for neutral taste towards a wide variety of aromas and substances. In addition, Grilamid TR 55 and Grilamid TR 90 natural meet the medical requirements of the United States Pharmacopoeia (USP) Class VI and both products are certified to 3-A Sanitary Standard Certification. High Surface Hardness A new product from the company’s ongoing R&D activities is Grilamid TR 30, which was developed to achieve a combination of high strength and good im...
Kunststoffe international, 2011-09-23, Trouble-Free Sterilization
... changes in mechanical properties at radiation doses up to 50 kGy remain moderate (Fig. 4). Like all products of the Silpuran range, the vulcanizates of the new liquid silicone rubber grade are biocompatible according to selected ISO 10993 and USP Class VI tests. In the ISO 10993 test, the post-cured vulcanizate was examined for cytotoxicity and pyrogenicity, as well as for its sensitizing properties. The USP Class VI testing included tests relating to acute systemic toxicity, intracutaneous tox...
Kunststoffe international, 2011-10-17, Polyoxymethylene (POM)
... to offer Hostaform MT grades oriented to the needs of medical technology – POM grades specifically modified to meet the stringent demands of medical technology. They comply, for example, with the directives of USP Class VI and are outstandingly suitable for powder inhalation devices, insulin pens and other medical technology products. Furthermore, all Hostaform products are available in a large number of different colors which are naturally free from heavy metals such as Cd, Hg, Pb and Cr(VI). ...
Kunststoffe international, 2012-02-24, Portable Medical Devices
...atory compliance. This policy ensures the consistency and biocompatibility of healthcare grades. This healthcare product policy provides device manufacturers with the following: Pre-assessment of biocompatibility according to ISO 10993 or USP Class VI standards; U.S. Food & Drug Administration (FDA) or Device Master File listing, with letter of authorization provided if needed; healthcare product nomenclature for easy identification; and products subject to formula lock and change management...
Kunststoffe international, 2014-01-23, Fluorinated Oils: Going Smoothly
...olecular weights and are mostly used as processing aids. The main purpose of PCA and SG types is to improve the usage properties of plastics. The SG additive is a cleaned type. It was specially optimized to comply with the regulations of the USP United States Pharmacopeia authority for applications that require class IV classification. In addition, the NAMSA (North American Science associates) contract research organization tested the SG type, approved it for application in medical devices and h...
Kunststoffe international, 2014-06-17, Beam Splitting Generates Periodic Patterns
...plitting of the beam. In addition, users can use the integrated measurement sensors for tool calibration and parametrization before the process, and for quality control after the process. Over the past few years, the use of ultrashort pulsed lasers (USP lasers) in material processing has been riding a wave of success. Reasons include the laser’s outstanding properties as well as the opportunity to process nearly any type of material with the highest degree of precision. Because the range of poss...
Kunststoffe international, 2014-08-19, New Ideas and Political Markets
...obased housing should in no way be underestimated. Thanks to close cooperation with a company specializing in bioplastics, the global Uhu brand could succeed at this as a mid-size company. Now they have a USP with which they hope to stand out amidst their competitors.Improved environmental performance in important respects through the use of renewable raw materials and demonstrably reduced greenhouse gas emissions together with unchallenged USPs – these are the essential driving forces behind th...
Kunststoffe international, 2014-10-10, Polyoxymethylene (Polyacetal, POM)
...facturing Practice) and usually meet the requirements of the European Authority for Food Safety (EFSA) and FDA for food contact and, depending on the product, United States Pharmacopoeia, ISO 10993-5 and ISO 10993-11, and USP Class VI. Two variants of these specialty grades are available in the DuPont range of engineering polymers, both of which are aimed at a large number of medical articles that are not intended for implantation. The SC grades (SC = Special Control) are made to very high produ...
Kunststoffe international, 2015-11-23, Tailor-Made for Special Cases
...erm and in some cases global delivery of products of invariable composition – this can be ensured, for example, by a second, independent manufacturing base.The resins on offer must also fully meet regulatory requirements on biocompatibility (USP Class VI/ISO 10993) and food contact (EU and FDA) and preferably be deposited in a DMF (Drug Master File). WPropertyNormISOMBSZylar 650MBSZylar 960SBCStyrolux 3G46SBCStyroflexMVR 220/10[cm3/10 min]1,1334565120140Tensile modulus[MPa]5272,1001,6001,550120E...
Kunststoffe international, 2016-10-17, Clean or Uncontaminated Packaging?
...ng for pharmaceutical products), DIN 15593 (hygiene management in the production of food packaging), the ISO 14644 series of standards for cleanrooms and, with regards to product quality, the European Pharmacopoeia / U.S. Pharmacopeial Convention (USP) as well as volume 19, part 1 and 2 on technical cleanliness published by the VDA.Plastic Packaging in the Cleanroom Process ChainThe products manufactured in these industries require end-to-end quality monitoring. This applies to pharmaceutical a...
Kunststoffe international, 2017-07-19, The Properties’ Champions League
...inue to become more so. The introduction of a quality management according to EN ISO13485:2016 illustrates that patient safety and consequently product security are being emphasized by medical product manufacturers. The necessary approvals, such as USP Class VI in combination with requirements regarding specific functions, severely limit the selection of materials for sensitive applications. They consist mostly of only high-performance plastics such as polytetrafluorethylene (PTFE), perfluoroalk...
Kunststoffe international, 2018-02-21, Faster than the Heat Can Flow
...er, depending on the material to be processed. This is due to thermal processes, in which the residual material is mechanically damaged, for example by stresses, cracks, chips, melting and burrs. Such damage does not occur with ultrashort pulse (USP) lasers, due to the significantly shorter pulse duration.The disadvantage of conventional lasers is also that they can only process material that meets their specific wavelength, i. e. have sufficiently high absorption at the radiated wavelength. Thi...
Kunststoffe international, 2020-04-08, New Kinematics for Increased Efficiency and Availability
... the market. Trodat, an international manufacturer of sophisticated stamp products based in Wels, Austria, has a great deal of experience with handling equipment from Engel. The injection-molding machines in its factory are equipped with type ER-USP sprue pickers. Last fall, it purchased its first sprue picker of the new pic A type (Fig. 1). “The very compact construction with the innovative kinematics gives us a clear advantage,” reports Thomas Dobritzhofer, Head of Maintenance and Facility at ...
Kunststoffe international, 2020-08-11, Uniting Glass and Plastic
..., it must be noted that, during the structuring process, the glass sample heats up. If the structural density is too high, thermally induced stresses can cause cracking in the part. These disadvantages can be avoided by using ultrashort pulsed (USP) laser sources. The strong focusing of the laser beam and its short pulse times of 15 ps (15 * 10–12 s) generate locally high intensity peaks > 1013 W/cm², which instantaneously ablate the material. Because of the short pulse duration and the sublima...
...y profiles. They differ in melt viscosity, mechanical performance, and resistance to lipids and chemical agents. They have very high transparency for an impact-modified plastic. Furthermore, these products are bisphenol (BPA)-free and compliant with USP class VI and ISO 10993 requirements. They are resistant to disinfectants and lipids and are recommended for components requiring gamma ray, electron beam, or ethylene oxide (EtO) sterilization. Effect of Solvents and DisinfectantsHealthcare-assoc...
Kunststoffe international, 2005-11-21, "Medical Grade" Plastics
...y able to pass the ISO tests), and - to provide the product manufacturer with data which can help him reduce the number of tests required on the end-product. By far the best known document available in connection with medical-grade plastics is the USP Class VI certificate [6]. USP (U.S. Pharmacopoeia) Class tests contain a series of tests to demonstrate that the plastic in question is suitable for pharmaceutical containers (Table 2). A comparison between USP class tests and the requirements of I...
Kunststoffe international, 2005-11-21, Functionality is the Key Factor
...ltrafast cycling times without any problem. Other major advantages are its intensive black colouring, which enhances the quality of the fluorescence measurements involved in the processes, its physiological inertness, its conformity to FDA/BGA and USP Class VI, its chemical resistance and its NMR compatibility [12]. Because of their specific application advantages, polyurethanes (grades: Baydur and Bayflex, manufacturer: Bayer) are used for a wide variety of medical products, in particular for h...
Kunststoffe international, 2005-11-21, Materials: Housings and Catheters
...clear, UV-resistant material with a high resistance to chemicals and stress cracking. At the same time, it offers the advantages of amorphous moulding compounds, such as a low tendency to warp and good creep behaviour. The material is licensed to USP, Class VI, which is the highest rating for the United States Pharmacopoeia. It is suitable for the production of parts that come into direct contact with active ingredients or body fluids. These include housing parts as well as infusion and transfus...
Kunststoffe international, 2005-11-21, Micro-Injection Moulding: Microfluidic Systems with Integrated Semiconductor Chips
...ated into the system (Fig.18). The entire spectrum of integrated that can be manufactured by means of appropriate semiconductor technologies and/or microsystem processes are available. Using biocompatible polymers according to ISO 10993-1 and USP Class VI, such as POM or LCP, it is conceivable to integrate the entire system into the body if the appropriate transmitter and receivers can also be integrated into the semiconductor chip. With the use of MID-compatible polymers, the injection moulded...
Kunststoffe international, 2005-11-21, Sulfone Polymers: Sound Properties
...d enfluran). It was also possible to confirm this property in laboratory experiments. Finally, Radel R PPSU is available in various colours and degrees of transparency. In addition, the selected PPSU grades were tested in accordance with USP VI and are thus suitable for medical applications requiring biocompatibility (in direct or indirect contact with bodily fluids). It is this combination of properties that qualifies PPSU in a special way for repeated-use products in the field of medicine: fir...
Kunststoffe international, 2005-11-21, Sulphone Polymers: Clear Vision
...nts, e.g., for the automotive, aerospace, electrical or electronic industry. Multitalented: Stable and Resistant Medical applications focus on the sulphone polymers Udel PSU and Radel R PPSU. They meet the approval regulations according to USP VI, and meet requirements for sterilisability, are not known to be toxic, and are biocompatible. They maintain their excellent impact resistance, even when disinfectants are used. Polyphenylsulphone withstands the highest number of steam-sterilisation cycl...
Kunststoffe international, 2005-11-21, The Newly Discovered Charm of Parts
... a car. Customers first choose whether they want a BMW, Mercedes or Audi and only then do they decide whether to go for the 3-Series, the C-class or the A4. And, what is more, brands do not just grow on trees – they need what is called USP, or the unique selling proposition. Without innovations, brands lose their appeal. But it is the suppliers more than ever who have the innovations, no matter whether it be the electro-hydraulic brake, pump nozzle, parktronic, telematic or automatic distance co...
Kunststoffe international, 2005-11-21, Trend Report: Colour Management for Global Production
...stic preforms in reflected and transmitted light (Fig. 7). Hunterlab offers a reference-grade spectrophotometer called UltraScan PRO (Fig. 8). It measures in both reflection and transmission mode, and complies with CIE, ASTM and USP guidelines. With a resolution of 5nm, it achieves maximum measurement accuracy. For the first time, the light source has been standardised in both the UV and the visible range. This has substantially extended the measuring range to allow accurate measurements of flu...
Kunststoffe international, 2005-11-21, Wide Range of Applications: Styrene Copolymers
...rs. Each of these applications is subject to numerous national approval procedures, including, among others, the Drug Master Files (DMF), the US Food and Drug Administration (FDA) as well as the European and American Pharmacopeia (EP and USP). BASF sees additional opportunities in the market for health care and diagnostic devices with the introduction of the new grade Terlux 2802 HD. Just as with other materials for health care and diagnostics, the challenge here is to provide customer- and sec...
Kunststoffe international, 2006-01-30, Plastics for Medical Technology: Long Life Ensured
...ceutical and medical applications. Detailed tests on the granules show, for example, that Terlux 2802 HD fully complies with the requirements of the European and the US Pharmacopoeia (EP 5.2, chapter 3.2.2 and USP Biological Test Classification VI). Formulation Consistency Guaranteed over the Long Term. One invisible but nevertheless significant advantage of the new transparent ABS grade is the commitment made by BASF to keep the formulation of Terlux 2802 HD completely constant unless changes ...
Kunststoffe international, 2006-01-31, Multiple Stopcocks: Permanently Lipid-resistant
...wed the best resistance in comparison with currently used polycarbonate grades (PC) and polymethyl methacrylate (PMMA: Table2). Of course, the material described above also meets the relevant requirements for medical technology products. It has a USP Class VI rating and is therefore approved for direct contact with pharmaceuticals and body fluids – and for infusions and transfusions. The Author Dipl.-Ing. Dirk Heinrich, born in 1970, is employed by Degussa AG, Marl in the Market Development Dep...
Kunststoffe international, 2008-01-15, Bringing Measurement to Optical Effects
Bringing Measurement to Optical Effects Color Measurement (Trade Fair Report K 2007) The range of requirements is expanding. Automobile manufacturers and their suppliers have to reliably determine both color and surface effects. Capturing light dependent effects, gloss as well as the colormetric behavior of translucent objects is becoming more important. In some extrusion applications color measurement is already part of the quality control and is starting to be used as part of the production ...
Kunststoffe international, 2008-04-14, Safety Has Priority
...n this sector. Testing of formulations and/or tests performed on the pellets ensure conformance to, for instance, the EU Pharmacopeia (EP 5.2, Chapter 3.2.2 "Plastic Containers and Closures for Pharmaceuticals" and the US Pharmacopeia ("USP Biological Test Classification VI"). Additional biocompatibility tests of the resins in accordance with international standards (such as cytotoxicity as specified in ISO 10993) along with creation of a drug master file (DMF) simplify the appli...
Kunststoffe international, 2008-10-17, Low-Density Polyethylene (PE-LD, PE-LLD)
...ducts with a good transparency and good draw-down properties as well as to injection molded products with a low tendency to warp. Contrary to the case for PE-LD, PE-LLD is produced by a low-pressure process in a gas phase fluidized bed, solution or suspension. To achieve the low density, use is made of nonpolar comonomers, such as butene-1, hexene-1 or higher α-olefins, whereby the latter offer technical advantages on account of the better mechanical properties that can be achieved in the...
Kunststoffe international, 2009-02-17, Optimized Silicones for Medical Applications
...ely important across the entire medical field. This applies to cytotoxicity, systematic and intracutaneous toxicities, and pyrogenicity. All Silpuran products have been tested in accordance with selected ISO 10993 and USP (United States Pharmacopeia) class VI tests.
Kunststoffe international, 2011-05-12, Surfaces that Help Healing
... microparticles during use under frictional loading. Even if a coating is biocompatible, the release of a large number of such particles in the body involves certain risks. Directive 788 of the United States Pharmacopeia (USP), for example, therefore stipulates maximum values for the number of particles above 10 or 25 μm in size contained in injection solutions. The critical (“worst case”) use of coated catheters was therefore simulated in a tubing system containing numerous curves and filled wi...
Kunststoffe international, 2011-08-24, High Transparency for Challenging Applications
... nor absorbs odors. Grilamid TR meets the criterion for neutral taste towards a wide variety of aromas and substances. In addition, Grilamid TR 55 and Grilamid TR 90 natural meet the medical requirements of the United States Pharmacopoeia (USP) Class VI and both products are certified to 3-A Sanitary Standard Certification. High Surface Hardness A new product from the company’s ongoing R&D activities is Grilamid TR 30, which was developed to achieve a combination of high strength and good im...
Kunststoffe international, 2011-09-23, Trouble-Free Sterilization
... changes in mechanical properties at radiation doses up to 50 kGy remain moderate (Fig. 4). Like all products of the Silpuran range, the vulcanizates of the new liquid silicone rubber grade are biocompatible according to selected ISO 10993 and USP Class VI tests. In the ISO 10993 test, the post-cured vulcanizate was examined for cytotoxicity and pyrogenicity, as well as for its sensitizing properties. The USP Class VI testing included tests relating to acute systemic toxicity, intracutaneous tox...
Kunststoffe international, 2011-10-17, Polyoxymethylene (POM)
... to offer Hostaform MT grades oriented to the needs of medical technology – POM grades specifically modified to meet the stringent demands of medical technology. They comply, for example, with the directives of USP Class VI and are outstandingly suitable for powder inhalation devices, insulin pens and other medical technology products. Furthermore, all Hostaform products are available in a large number of different colors which are naturally free from heavy metals such as Cd, Hg, Pb and Cr(VI). ...
Kunststoffe international, 2012-02-24, Portable Medical Devices
...atory compliance. This policy ensures the consistency and biocompatibility of healthcare grades. This healthcare product policy provides device manufacturers with the following: Pre-assessment of biocompatibility according to ISO 10993 or USP Class VI standards; U.S. Food & Drug Administration (FDA) or Device Master File listing, with letter of authorization provided if needed; healthcare product nomenclature for easy identification; and products subject to formula lock and change management...
Kunststoffe international, 2014-01-23, Fluorinated Oils: Going Smoothly
...olecular weights and are mostly used as processing aids. The main purpose of PCA and SG types is to improve the usage properties of plastics. The SG additive is a cleaned type. It was specially optimized to comply with the regulations of the USP United States Pharmacopeia authority for applications that require class IV classification. In addition, the NAMSA (North American Science associates) contract research organization tested the SG type, approved it for application in medical devices and h...
Kunststoffe international, 2014-06-17, Beam Splitting Generates Periodic Patterns
...plitting of the beam. In addition, users can use the integrated measurement sensors for tool calibration and parametrization before the process, and for quality control after the process. Over the past few years, the use of ultrashort pulsed lasers (USP lasers) in material processing has been riding a wave of success. Reasons include the laser’s outstanding properties as well as the opportunity to process nearly any type of material with the highest degree of precision. Because the range of poss...
Kunststoffe international, 2014-08-19, New Ideas and Political Markets
...obased housing should in no way be underestimated. Thanks to close cooperation with a company specializing in bioplastics, the global Uhu brand could succeed at this as a mid-size company. Now they have a USP with which they hope to stand out amidst their competitors.Improved environmental performance in important respects through the use of renewable raw materials and demonstrably reduced greenhouse gas emissions together with unchallenged USPs – these are the essential driving forces behind th...
Kunststoffe international, 2014-10-10, Polyoxymethylene (Polyacetal, POM)
...facturing Practice) and usually meet the requirements of the European Authority for Food Safety (EFSA) and FDA for food contact and, depending on the product, United States Pharmacopoeia, ISO 10993-5 and ISO 10993-11, and USP Class VI. Two variants of these specialty grades are available in the DuPont range of engineering polymers, both of which are aimed at a large number of medical articles that are not intended for implantation. The SC grades (SC = Special Control) are made to very high produ...
Kunststoffe international, 2015-11-23, Tailor-Made for Special Cases
...erm and in some cases global delivery of products of invariable composition – this can be ensured, for example, by a second, independent manufacturing base.The resins on offer must also fully meet regulatory requirements on biocompatibility (USP Class VI/ISO 10993) and food contact (EU and FDA) and preferably be deposited in a DMF (Drug Master File). WPropertyNormISOMBSZylar 650MBSZylar 960SBCStyrolux 3G46SBCStyroflexMVR 220/10[cm3/10 min]1,1334565120140Tensile modulus[MPa]5272,1001,6001,550120E...
Kunststoffe international, 2016-10-17, Clean or Uncontaminated Packaging?
...ng for pharmaceutical products), DIN 15593 (hygiene management in the production of food packaging), the ISO 14644 series of standards for cleanrooms and, with regards to product quality, the European Pharmacopoeia / U.S. Pharmacopeial Convention (USP) as well as volume 19, part 1 and 2 on technical cleanliness published by the VDA.Plastic Packaging in the Cleanroom Process ChainThe products manufactured in these industries require end-to-end quality monitoring. This applies to pharmaceutical a...
Kunststoffe international, 2017-07-19, The Properties’ Champions League
...inue to become more so. The introduction of a quality management according to EN ISO13485:2016 illustrates that patient safety and consequently product security are being emphasized by medical product manufacturers. The necessary approvals, such as USP Class VI in combination with requirements regarding specific functions, severely limit the selection of materials for sensitive applications. They consist mostly of only high-performance plastics such as polytetrafluorethylene (PTFE), perfluoroalk...
Kunststoffe international, 2018-02-21, Faster than the Heat Can Flow
...er, depending on the material to be processed. This is due to thermal processes, in which the residual material is mechanically damaged, for example by stresses, cracks, chips, melting and burrs. Such damage does not occur with ultrashort pulse (USP) lasers, due to the significantly shorter pulse duration.The disadvantage of conventional lasers is also that they can only process material that meets their specific wavelength, i. e. have sufficiently high absorption at the radiated wavelength. Thi...
Kunststoffe international, 2020-04-08, New Kinematics for Increased Efficiency and Availability
... the market. Trodat, an international manufacturer of sophisticated stamp products based in Wels, Austria, has a great deal of experience with handling equipment from Engel. The injection-molding machines in its factory are equipped with type ER-USP sprue pickers. Last fall, it purchased its first sprue picker of the new pic A type (Fig. 1). “The very compact construction with the innovative kinematics gives us a clear advantage,” reports Thomas Dobritzhofer, Head of Maintenance and Facility at ...
Kunststoffe international, 2020-08-11, Uniting Glass and Plastic
..., it must be noted that, during the structuring process, the glass sample heats up. If the structural density is too high, thermally induced stresses can cause cracking in the part. These disadvantages can be avoided by using ultrashort pulsed (USP) laser sources. The strong focusing of the laser beam and its short pulse times of 15 ps (15 * 10–12 s) generate locally high intensity peaks > 1013 W/cm², which instantaneously ablate the material. Because of the short pulse duration and the sublima...
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