COMPANY REPORT
SPOTLIGHT
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Dec’s Powder Handling Leads to Compliance Success From the chemical sector to the pharmaceutical industry, Powder Transfer Systems guarantee compliance with the highest sanitary standards of raw material manipulation throughout the manufacturing processes of final products for both human use and consumption. To that end, Switzerland-based Dec offers innovative solutions worldwide for industries where powder processing is submitted under strict and controlled conditions. From accurately transferring and dosing powder from milligrams to tons, grinding materials from microns to millimeters, or mastering high-mixing requirements, Dec provides trendsetting solutions for contained, sterile and safe manufacturing conditions to a number of industries, from chemicals and pharmaceuticals to cosmetics and those that apply special materials in areas such as battery manufacturing processes or in the nuclear industry. As a specialist in powder handling, Dec’s registered technology, PTS Powder Transfer System®, provides innovative solutions for automated transfer, dosing and packaging of powders by means of vacuum and pressure. With its unique filtration concept, PTS is the only vacuum dense-phase system that functions at optimum levels when handling ultra-fine, sticky and adhesive powders. Dec’s PTS technology enables active powder Read the complete article More about this company
management for safe reactor loading and efficient powder handling. It is also considered a dust-free system that is easy to clean and safe
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SPOTLIGHT when handling toxic, explosive or very low MIE dust. As such, it can also transfer large varieties of powders, from a few kilos to tons, while maintaining a containment level of <1 µg/m3. This system can be used during any stage of production throughout the plant to handle raw materials, intermediates or final products. Moreover, powder can be transferred over long distances, allowing greater flexibility in plant design. This process simplifies powder handling logistics because raw materials can be kept on the ground floor and transferred directly to the equipment, meaning elevators are no longer necessary. One of the major advantages of PTS technology is that it separates air from powder, keeping the receiving vessel inert during the charging operation. Therefore, it is possible to safely charge powder into a reactor that contains solvents or that is pressurized without the risk of explosions. Other notable benefits are its dust-free filling and discharging, packaging and dosing. In addition, there is neither product retention nor particle damage, it is easy to clean (CIP device) and it has a mobile unit available. The Cleaning in Place (CIP) device allows for a complete cleaning of the powder line and PTS through a speed cleaning time of up to two minutes. It also has automatic drying of between 15 and 20 minutes with the possibility of sterilization. The system is fitted with a liquid separator component installed in the upper part of the PTS body. The liquid separator sucks liquids into the system and a float located in the main cover prevents the liquid from entering the vacuum line. The PTS body and the powder transfer hose are cleaned at the same time, which is a considerable advantage compared to using a spray nozzle. Dec also offers the Mobile PTS, including all the features of the static system but with the additional benefit of being portable. The system can be dismantled and relocated anywhere in the production unit. The control panel and vacuum pump remain permanently mounted on the trolley while the PTS can be installed on the process equipment to be charged. Application Examples Dec’s PTS offers full processing flexibility, tailored to customer needs. At the core of Dec’s Powder Handling Excellence, the PTS encompasses a broad range of applications: + Standard and high containment filling and discharging In combination with Dec’s Drum Containment System, the PTS provides a safe solution for filling or emptying big bags and drums. + Small quantity dosing Accurate and repetitive volumetric dosing of small quantities of powder ranging from 1mg to 100g. + Single and multiple reactor charging Safe and reliable vessel charging; the oxygen is removed from the powder before entering into the process.
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SPOTLIGHT + Blending PTS Batchmixer for fully contained homogeneous powder blending. + Filling and packaging facilities Continuous Liner System for optimized GMP compliant packaging solutions enabling high containment levels (< 1μg/ m3). In combination with the PTS and the Dosivalve, this system allows for any equipment discharging and precise dosing into drums/containers. MC Jetmill To correctly achieve powder system management, Dec supports its PTS with the MC Jetmill® system, Dec’s fourthgeneration jet mills, which have been re-designed from the ground up using “Smoothflow Jet Technology” to develop and build new micronizing equipment that can deal with the most difficult products, from sticky to hard and from brittle to soft, while minimizing blowback and product build-up, which includes the use of alternative materials. This range is supplied in accordance with the cosmetic Good Manufacturing Practices (GMP) guidelines based on ISO 22716:2007. Dec’s jet mills can be fabricated with different materials depending on the physical properties of the product to be micronized (stickiness, hardness, Mohs scale > 6, etc.) The MC Jetmill micronization allows for a Narrow Particle Size Distribution (PSD), has simple and rapid assembly/ disassembly, a limited number of components and high yields with a low energy consumption and sterile manufacturing. To improve ergonomics and flexibility, the DEC MC Jetmill® series can be operated both vertically and horizontally with full SIP and CIP options for sterile production. It also has green credentials as it has an optimized gas flow, providing less gas consumption compared to current systems. It can be supplied contained for HPAPIs or non-contained for nontoxic products.
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leaning is defined as the removal of unwanted soils from the surface of a part. Mechanical components must be cleaned as part of the manufacturing process or during maintenance and overhaul operations.
Proper cleaning during remanufacturing and overhaul is also critical. Cleaning mechanical parts will reveal defects, which may lead to a decision to scrap some of them. Cleaning also contributes to worker safety, as much of the contamination will be removed from components before they are dismantled and overhauled. There are four factors that affect the cleaning process: chemistry; temperature; mechanical action; and time. These factors are generally synergistic. For example, in most cases, adding a little heat (temperature) makes the cleaning solution (chemistry) more effective.
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Chemistry
Basic Principles of Aqueous Cleaning Rubén Hernandez
Most chemical agents used in aqueous cleaning fit into one of three categories according to pH. Neutral cleaners, the kindest of cleaners, are preferred for light soils. Generally, they are environmentally friendly. Depending on local codes and the composition of the soils that become part of the mix during use, spent cleaning solutions can sometimes be disposed of without further treatment.
Commercial Projects Adviser | T5DC Alkaline cleaners are the most used for removing oils, grease and general soils. There are numerous chemical substances available depending on the type and degree of contamination, the material to be cleaned, the type of cleaning equipment used and the subsequent use of the cleaned material. Acidic cleaners are primarily used to remove tarnish and oxides and to brighten non-ferrous metals. Although some limited cleaning of organic soils (such as oils) is possible with some acidic chemicals, they are rarely used for general cleaning. It is not unusual, however, to use an acidic chemical substance to brighten work previously processed with an alkaline cleaner and a final rinse. Temperature Temperature has a significant effect on cleaning efficiency in most applications. Generally, the hotter the cleaning solution is, the faster cleaning occurs. One application that illustrates the effect of temperature is the removal of buffing compounds. Most buffing compound formulations contain a significant portion of fats. Try to remove it at 48°C and you are in for a long day. At about 65°C cleaning becomes possible. At 82°C cleaning is much easier. This is because the higher temperature softens, or preconditions, the contamination and allows the chemistry to work more efficiently. There are other considerations concerning temperature. In a buffing compound removal application with brass parts, using 82°C could cause the parts to tarnish as soon as they are removed from the cleaning solution. For this application, there is more than one right answer. You can back off on the temperature and accept a longer cleaning cycle. Alternatively, you can add another wash step (and rinse) using an acidic chemical step to remove the tarnish. This trade-off is typical of many cleaning applications,
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where the advantages and disadvantages of various alternatives need to be balanced. Mechanical Action Mechanical action is sometimes described in more technical articles as “impingement,” which refers to the application of mechanical force. A simple method of applying mechanical action is agitation. The most common type of part agitation machine uses vertical agitation. The repeated up and down motion is effective in cleaning simple parts, such as parts without blind holes and/ or deep grooves. Another type of part agitation machine uses a rotating basket, typically for small parts that tumble through the cleaning solution as the basket rotates. There is also part-onpart contact with a rotating basket that adds some mechanical scrubbing into the process. For industrial parts cleaning, there is practical equipment that uses liquid agitation. Methods for moving the liquid include impellers, eductors and air agitators. Liquid agitation can also be an effective way of cleaning simple parts without blind holes and deep grooves. It’s not unusual to add liquid agitation to other types of equipment to increase effectiveness. For example, it is not unusual to combine a rotating basket with liquid agitation. Ultrasonic cleaning depends on a phenomenon called “cavitation.” In ultrasonic cleaning, a sound wave is created in water in a manner similar to the way an audio speaker creates sound in air, by vibrating a diaphragm. As the sound wave passes through the water, alternating areas of high and low pressure are created. As the frequency of the sound becomes higher, the sound waves are closer together. When the frequency approaches the limit of human hearing and beyond, the alternating high- and low-pressure areas occur fast enough that cavitation can occur on a microscopic scale if the intensity (amplitude) of the sound wave is high enough. The mechanical energy in ultrasonic cleaning occurs when the cavitation bubble implodes (collapses rapidly). Water rushes in at high velocity, although not exactly evenly, to fill the space formerly occupied by the vapor bubble. The result is “micro-jetting” that provides the mechanical energy for cleaning. Cavitation occurs everywhere throughout the liquid, including deep grooves and blind holes, or any area that the liquid can reach. Ultrasonic cleaning is effective on parts that are not cleanable by other methods.A quick note about ultrasonic cleaning and chemistry is needed here. Not all cleaning chemical agents are suitable for use in ultrasonic cleaning equipment. For good cavitation, the cleaning solution should have high surface tension, low vapor pressure and low viscosity. Time The fourth factor, time, is an important consideration in cleaning applications. For a given set of process conditions, longer exposure generally results in cleaner parts. No discussion of aqueous cleaning is complete without mention of the importance of adequate rinsing. Depending on the material being cleaned, the chemical agents used, and the cleanliness specifications, anything from a simple immersion or spray rinse
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to multiple rinses, including an ultrasonic rinse, may be required. Rinsing can be especially important with parts made from more than one metal. Chemical residue between the different metals can act like a battery and promote long-term corrosion. How Clean Is Clean? Before beginning to develop a cleaning process, it’s best that you are able to answer an often-overlooked question: How clean is clean? The answer can vary widely. For example, a machined aluminum bracket for a farm tractor accessory may need to be only clean enough for the assembler to handle and attach it without making a mess. On the other hand, an aluminum valve body for an ABS brake system may need to be 100 percent free of any particles greater than 10 microns. Nowadays, the residue-free cleaning of surfaces plays a vital role in virtually every industrial manufacturing process. Perfect cleaning enhances the quality of your products. The introduction of quality management systems and increasingly stringent environmental legislation has led to more and more attention being focused on aqueous cleaning techniques. This technology is now firmly established in many fields. Precision parts cleaning and ultrasonic parts cleaning in the metal-processing industry meet the highest demands. In the precision metal industry, the requirements that have to be met for the aqueous cleaning of parts are enormous. Besides factors such as material compatibility and the contaminants themselves, the success of aqueous cleaning processes depends above all on taking the customer’s existing cleaning system fully into account in the cleaning proposal. Decoating is the process of removing the old coating on the workpiece before the coating. The workpiece can be repaired after the initial coating is used and the coating can be used again. It can also be repaired and repeated several times. However, the continuous accumulation of multiple coatings will have a negative impact on the service life of the workpiece and the accuracy of the workpiece, so there is a need for repainting. The decoating process is mainly divided into chemical decoating and electrolytic decoating. Both decoating processes utilize the chemical reaction between the decoating solution and the coating to oxidize and decompose the coating. During the decoating process, regardless of the methods, the decoating solution may also damage the substrate while oxidizing and dissolving the coating because some steel contains the same alloy components as the coating, such as Ti, W and Al, especially P-type hard alloy, which contains about 15 percent TiC and is more sensitive to the corrosion solution. In addition, cobalt is used as a bonding agent in cemented carbide and cobalt is easily lost in a chemical solution. After cobalt loss, the cemented carbide composition around it loses its binding force, making it easy to fall off, and the surface of the workpiece is destroyed. Therefore, for the workpiece that needs to be decoated, be fully prepared before decoating and understand the characteristics of the workpiece substrate material. In addition, after the Read the complete article More about this company
workpiece is decoated, apply some necessary post-treatment, such as sandblasting or polishing, to reprocess and repair the workpiece surface.
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Q: How does Sievers Analytical Instruments promote sustainability and how do you share the potential of your business model with clients? DK: Sustainability is in the company’s DNA. Our mission and vision as a business group revolves around the circular economy. Rather than a linear economy and production to waste, a circular economy creates sustainable processes and products. For our business, this concept comes into play mostly in the industrial and semiconductor world, but we also play an important role in the pharmaceutical world, which uses water for cleaning and for the sustainable production of its products. Sometimes water is an ingredient in the final product, and sometimes water is used
Geert Verstraeten
for cleaning. Either way, monitoring it can lead to more efficient processes and can impact how much water is used. Wastewater is another application. When you look at wastewater treatment
General Manager | SUEZ - Water Technologies & Solutions
in oil and gas and semiconductor industries, they are looking to reclaim and reuse water, and also to monitor discharge and ensure they are complying with regulations. We are ensuring that water is safe and healthy to use for whatever application our clients are implementing. This is true for water used for production, process monitoring or cleaning. Soon after, the water is discharged back into rivers. The company ensures the water’s cleanliness and that it is compliant with all regulations so that it is safe to be discharged again into the rivers to be reused by someone else. It’s the ‘river to river’ philosophy that fits in with our overall business mission and vision. Q: What role does the Mexican market play within Sievers Analytical Instruments’ international strategy?
Dave Kremer Global Commercial Leader | SUEZ Water Technologies & Solutions
DK: The Mexican market is very important, and we have had a phenomenal partner, T5DC, here for the past 26 years. The country is part of our Latin America market, which comprises Central America, South America and Puerto Rico. Mexico is a large pharmaceutical market in Latin America due to its pharmaceutical production, development and infrastructure. In South America, there is not a great deal of production. Brazil, for
Water Monitoring and Reuse Through Safe and Trustworthy Processes
example, imports many prescription drugs and has not invested in enough infrastructure to produce pharmaceutical products. For that reason, Mexico is very important because it is a large producer like Puerto Rico. In the 1980s, ‘90s and early 2000s, many multinational companies moved to Mexico for tax benefits and for the availability of professional workers. Moreover, there are controls on water, which is required for pharmaceutical feed water used in production processes and ensures appropriate quality of the drugs being produced. There have been some challenges in the past, specifically those concerning governmental regulation on the pharmaceutical market. Nevertheless, we still see Mexico as a great opportunity for our business and that is why we support our Mexican partners and help them drive value to their customers. GV: In addition, when looking at the company’s analytical instruments, partners such as T5DC can help educate our customers. It is important for us as market leaders to follow regulations. Typically, when you see instrument providers with a catalog of many products, they tend to have a different approach. Sievers Analytical Instruments takes a focused
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approach with our instruments and parameters we test, as we are technical experts that provide our customers with the tools they need to help them understand their processes and water quality. The company’s instruments, services and innovations help customers to be more efficient, obtain higher quality, quicker results and to be able to define if a batch is compliant or not compliant. These are all very innovative traits and we have grown together with our partners in knowledge so that we can provide a satisfactory customer service to customers by providing them with the right technology to measure and control processes. Q: What industries does the company participate in? DK: Sievers Analytical Instruments is involved in every industry where water plays a major role, which is basically every industry. Water is used as a raw material, as a cleaning agent and as a cooling agent. It is used in many different ways. We have our Life Sciences market and our Industrial & Environmental markets. The Life Sciences market focuses on pharmaceuticals, personal care, nutraceutical, cosmetics, medical devices and biopharmaceuticals. In the Industrial & Environmental industries, we are looking at the semiconductor and microelectronics segments, where high purity water is used to produce microchips and advanced instrumentation is needed. We also support industries such as chemical, food and beverage, wastewater, power, and drinking water. As part of the company’s mission and vision, we call water our most sacred resource. It is not replenishable and we need to make sure that we are creating new processes that can sustain water for the long term. Water is used in almost every step of most major manufacturing processes and if we did not have water, we would not be able to produce fossil fuels, pharmaceutical, or microelectronic products. GV: In regard to drinking water, especially in areas where there are many droughts, the reuse of water will become fundamental and we can play an important role in measuring and controlling the quality of reused water. Q: What are Sievers Analytical Instruments’ latest solutions implemented in Mexico for water monitoring? DK: In Mexico, the company focuses mainly on our Life Sciences vertical and less on Industrial & Environmental. Today, water in pharmaceuticals is about efficiency, so companies in that sector are looking at process analytical technology (PAT), Pharma 4.0 and lean manufacturing. Pharmaceuticals are always looking to decrease costs and increase profitability. To do that, you need to look at all areas to increase efficiency and quality. We work with our analytical instruments on water systems to ensure they meet quality specifications before the water is used for any production requirements. Ensuring that companies have a more efficient process will decrease costs and create overall higher quality pharmaceuticals and at a lower cost to customers. This is where we provide our
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instrumentation to meet four compendial requirements for the production of water for pharmaceutical purposes: TOC, conductivity, endotoxin and bioburden. Our analyzers display any contamination in water systems and in cleaned bioreactors used for production. This is what the company is focusing on from an instrumentation standpoint. On the software side, pharmaceutical companies want data that is accurate and actionable and they want it immediately, so Sievers’ biggest commitment has been the release of a new software product data aimed at obtaining information from all of our worldwide systems in one location so that pharmaceutical manufacturers can see real-time pharmaceutical water quality across parameters we measure, making data immediately accessible and actionable. If there is an issue with the water system, our customers will know immediately, ensuring the issue is solved promptly and that the impact on that batch is minimal, helping to decrease costs. Q: How can water treatment and reuse become more economically viable and attractive for companies? DK: Once technology development progresses, water use and reclamation will become cheaper. For example, desalination has not been popular because of its extreme cost, yet as technology continually improves, there is more and more innovation. For instance, we are witnessing that desalination is now affordable in large implementations, not only in California but in Singapore as well. At Sievers Analytical Instruments, we are continually innovating. We consider ourselves a high-tech company that invests in innovation, research and development. For instance, our first TOC unit was built for the international space station. One cannot pipe water into space, so it is self-contained at the international space station, meaning all water is reused. What one flushes down the toilet is what one eventually drinks because that is the only water available, and that can be done safely by having very clean and direct purification methods. Our instruments provide accuracy and expertise for testing and verifying the cleanliness of water. In regard to pharmaceutical water reuse, the key is having attached wastewater treatment plants that will reuse water over time, instead of just dumping it back into the river. The pharmaceutical industry is generally more conservative and very slow to change, so we are going to start seeing more reuse in the next 10 years. The key today is to measure water quality and minimize waste. GV: We help our clients find a simple solution so they can obtain an accurate analytical result and obtain higher quality and faster throughput. Q: What are Sievers Analytical Instruments’ key projects and objectives in Mexico for 2022? DK: The company’s main efforts are going to be based around driving new product launches. For the pharmaceutical industry, as of December of last year, we offer instrumentation for the four parameters for continual water testing for the pharmaceutical industry. We look forward to driving more adoption of online and real-time release time testing in Mexico with our new M500
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TOC Analyzer that was launched recently, alongside our Data Share Elite Software. Moreover, we are looking at improving endotoxin analysis at the major pharmaceutical manufacturers in the country with our new automated platform for endotoxin detection, the Sievers Eclipse. We also just purchased technology for bioburden detection, which will be released shortly. It is a big initiative for the Mexican pharmaceutical production marketplace. All of these systems are simple and easy to use, and incorporate elements of sustainability wherever possible. For instance, our endotoxin testing system uses up to 90 percent less of the Limulus amebocyte lysate (LAL) reagent, derived from horseshoe crabs, that is required today. This is a big win in terms of the use of natural resources. Sievers Analytical Instruments aims to introduce these sustainable products into the industry and contribute to improving water sustainability and production goals. This is what we are planning to focus on this year. In addition to hardware, our objective is to look at software and integrate all data into a strong data management platform called Sievers Data Share Elite.
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Horseshoe Crabs and Pharma: How Tech Is Saving Natural Resources It may be surprising to many who are not familiar with drug or medical device manufacturing, but there is a link between horseshoe crabs and the biomedical industry. The animal’s blood contains factors that are used to manufacture limulus amebocyte lysate (LAL), a reagent that can test whether medical products have been contaminated with bacterial endotoxin. This testing is critical to detect dangerous – and potentially deadly – contaminants but it puts pressure on horseshoe crabs and their blood. Bacterial endotoxin testing (BET) is an important part of continuous quality control testing in pharmaceutical, biopharmaceutical, medical device, and other related industries to ensure safe medical products, such as insulin, intravenous devices, and COVID vaccines for patients. However, the industry is motivated to find ways to use less LAL reagent in these tests and reduce the reliance on horseshoe crabs. In addition to numerous sustainability initiatives led by the biomedical industry to protect the long-term vitality of the species, the industry has sought advances in technology to reduce and optimize the use of this resource. This has been achieved with the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform, which reduces LAL use by up to 90 percent while remaining compliant with all global pharmaceutical regulations. This is a significant improvement compared to traditional LAL methods, such as the 96-well plate and gel clot. The Sievers Eclipse is able to achieve this by leveraging microfluidics, technology known for enabling accurate and sensitive chemical analyses and diagnostic tests using smaller volumes of reagents and samples to carry out reactions. New lab-on-a-disc and lab-on-a-chip microfluidic applications have emerged that have changed laboratory practices and diagnostics, offering advantages like cost efficiency, improved ergonomics,
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reduced reagent consumption, faster diagnostic speed, and sensitivity. For the Sievers Eclipse BET platform, a novel microplate was designed that facilitates accurate and rapid dispersion of LAL and samples using centripetal force, metering chambers, and microfluidic channels. The microfluidic system enables users to carry out the same biochemistry that is performed in traditional endotoxin assays but with minimal hands-on effort, greater consistency, and drastically reduced LAL consumption. By decreasing horseshoe crab lysate use by up to 90 percent, the Eclipse platform reduces the demand on the most sensitive and unmatched natural endotoxin detection reagent on the planet. In addition, because the system is automated and reduces the number of steps required of technicians, it results in not only greater efficiency but also fewer retests. To further improve sustainability efforts, modern endotoxin testing technologies can also minimize cold storage and eliminate storage needs for reference standard endotoxin (RSE) or control standard endotoxin (CSE). This reduces costs and simplifies the supply chain beyond minimizing the amount of LAL consumed per run. Besides reagents and storage, there is another important aspect of sustainability in endotoxin testing to consider: the sustainability of workers. Traditional endotoxin testing is labor-intensive, requiring over 200 pipetting steps to prepare the assay. By using technology like microfluidics, labs today can minimize unnecessary repetitive actions for personnel and decrease the risk of repetitive stress injury. Improving ergonomics is a high priority and automated technologies, such as the Sievers Eclipse, can be implemented to protect employee health and wellness. With a critical focus on conserving resources in the biomedical industry, endotoxin testing is a prime example where technology can drive improvements. Using the Sievers Eclipse, automation can improve employee sustainability by significantly reducing handsRead the complete article More about this topic
on time, and centripetal microfluidics can reduce LAL usage up to 90 percent delivering a fully compliant BET assay that the global horseshoe crab population can sustain.
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Sievers Software Designed to Exceed Data Integrity Rules Today, pharmaceutical manufacturers rely on Sievers’ DataShare Elite software to make quicker, more informed and prompt decisions to carry out their elaborate data processes, while monitoring one or multiple locations around the world. This intuitive centralized software program provides a convenient way to manage and store Sievers TOC instrument data in a single repository from multiple sites and instruments. In addition, it supports data integrity compliance and efficiency while reviewing and managing Sievers total organic carbon (TOC) and conductivity data in one location from any place in the world. “DataShare Elite software eliminates the reliance on removable media devices, such as USBs, to transfer data and strengthens the chain of custody of data and records. The software allows users to import the full history of an instrument (newer Sievers instruments as well as legacy instruments), including calibrations, verifications and validations along with data, meta data and audit trails,” Tony Saavedra, Life Sciences Associate Product Manager for Sievers Analytical Instruments, told American Pharmaceutical Review in an interview. Distinguishing Features Among DataShare Elite’s unique features are that the software is intuitive, it is easy to use and compatible with Active Directory (AD). Therefore, users can log into the software using the same login as their work computer. In addition, with simplified data storage for life sciences customers, DataShare Elite software provides a single, central location to manage all Sievers’ TOC and conductivity data – pulling from multiple instruments, whether in the same location or across the globe. “The software also provides simplified management to review audit trails and allows the import of instrument audit trails and software audit trails, as well as maintains its own audit trail to show full chain of custody for all data, metadata, calibrations, verifications, and validation protocols,” said Saavedra. Data Integrity In today’s world, data integrity poses a major data management challenge that should be taken very seriously by all companies in the life sciences manufacturing environment. As a result, DataShare Elite software was designed to meet and exceed data integrity rules and regulations, and guidance issued by government agencies and professional user groups. According to Sievers’ website, facilities must not only assure data integrity for compliance and its role in patient safety but they must also strive to achieve the efficiency and productivity gains necessary to keep up with today’s production demands. “The software eliminates the reliance on weaknesses such as printing or using USBs in the chain of custody of data and records. Data may easily and securely be passed from a remote instrument, such as the Sievers M500 Analyzer, to a secure server without exposing those records to unsecure USB
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media devices, open file types that could be edited without traceability, accidental loss or deletion, or any other human interaction that could call into question the completeness, consistency, or accuracy of those data and records,” said Saavedra. In addition, Sievers’ DataShare Elite software meets 21 CFR Part 11 compliance and follows ALCOA+ principles to ensure users maintain data integrity. Whether in the lab, or even remotely off-site, DataShare Elite gives the user access to data and the ability to view and electronically sign-off on reports, according to the company’s website. DataShare Elite is available to complement current Sievers M9, DataPro2, M500, and CheckPoint product lines as well as legacy 900, DataPro900, and 500 RL products. The software facilitates audit reviews throughout the data life cycle and improves data management. When it comes to available configurations for DataShare Elite, it can be used for both enterprise and standalone installations. According to Saavedra, it can be configured in client-server, client, or standalone configurations. The software is compatible with Active Directory (AD). “The software easily integrates with current and legacy Sievers TOC instruments, and Sievers support is available to ensure fast, easy, and successful implementation,” said Saavedra. Sievers website states that DataShare Elite provides a highly customizable enterprise solution with ALCOA+ data integrity compliance features and influence to cGMP guidelines using new data transfer, data security and data management features. Data Transfer + • Remotely connect or import data over a secure network Data Security + • Customizable Password protection + • Unique User ID requirements + • Data encryption + • Electronic signatures
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+ • Easy import and review of audit trails + • Customizable access, roles, and permissions + Network-Based Data Management + • Closed system architecture + • Compatible with Active Directory (AD) + • Use with local server or an existing enterprise Microsoft SQL server + • Customizable data transfer and export Enhanced Data Features Remote Data Management • Review instrument data remotely and electronically sign-off on: • Calibrations • Verifications & System Suitability Tests • Validations • Conductivity (if applicable) + • TOC Sample Results + • Audit Trail + • Easily search, filter, parse out data and save protocol results + • Manage and transfer data from the production environment and back for faster release of water systems + • Manage real-time data and audit trails as events happen Data Visualization + • Qualitative and quantitative data + • Graphing and export capability Secure Data Integration + • Easy to integrate into LIMS and MES systems. Available Configurations + • Standalone: Single computer being used to access instruments, includes up to 5 instruments. Uses Microsoft Express SQL Server. Users can purchase and add additional instruments up to 15 in total. Read the complete article More about this topic
+ • Enterprise: Uses your existing SQL 2019 Enterprise, access to instruments remotely. Includes up to 10 instruments. Users can purchase and add additional instruments up to 50 in total.
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Borer Chemie Lays a New Foundation in Fight Against Corrosion In an effort to remove iron from the surface of corrosionresistant steel parts in medical instruments and implants, Swiss company Borer Chemie AG has introduced the deconex® MT 19 and deconex® MT 41 spray chemical to improve the cleaning passivation process. Chemical passivation is the process that allows metals to resist corrosive agents. By applying this treatment, a thin, but dense and uniform film is produced, guaranteeing that metals are not harmed by oxidizing agents that can cause corrosion, said the company. The main objective of this process is to enhance corrosion resistance, in addition to ensuring the longevity and safety of the instruments. Today, the medical industry greatly benefits from chemical passivation, since safe and aseptic environments are necessary requirements in the healthcare industry. To contribute to this objective in an economical and eco-friendly way, deconex® MT 41 product lines are designed to facilitate the passivation process of medical instruments and implants while abiding to the strict ASTM A967 passivation standard, which offers various options for passivating medical products. To achieve a successful passivation, the ASTM standard A967 provides common methods such as Nitric 2, Nitric 4, Nitric 5 and Citric 4. These differ from each other in terms of duration,
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temperature, concentration, chemistry and application as well as in relation to the materials used. For instance, “the Nitric 5 process, where the process deconex® MT 19 and deconex® MT 41 from Borer Chemie AG is classified, offers completely unique possibilities. With this application, individual process parameters (time, temperature, chemistry) can be selected and categorized under Nitric 5. At the end of each process, its functionality must be confirmed by validation. Before the actual passivation step is prompted, the surface must be completely free of residues, such as machining oils, fingerprints, dust, salts, polishing paste, etc,” said the company. Borer reports that the deconex® MT 19 cleaner removes unwanted residues, provides optimal wetting and rinses off superbly. A thorough cleaning process lays the foundation for an excellent passivation with deconex® MT 41. This coordinated combination of products is ideal for passivating instruments and implants. In addition, complete assembled products featuring a combination of metals, silicone, carbon fiber and color markings, which is often the case with medical instruments, can be passivated without any major issues. Application In stainless steel, the passivation process uses nitric acid or citric acid to remove free iron from the surface. The chemical treatment leads to a protective oxide layer, or passivation film, that is less likely to chemically react with air and cause corrosion. Passivated stainless steel resists rust. According to Borer, chemical passivation significantly increases the presence of CrOx on the surface of the metal, although this effect depends on the nature of the material and the surface treatment. To solve this issue, Borer Chemie AG has developed a spray and immersion passivation process that is considered more effective than the traditional process. This chemical process consists of treating the metal with acids aimed at removing iron from the surface while an oxide anticorrosion is applied. Chemical Biodegradable Components Borer Industry´s products are environmentally friendly as well as cost-effective. In addition, the company is aware that most manufacturing processes in the industry have a considerable impact on the passive layer of stainless-steel surfaces. Chromium is the important element to build a passive and stable filling. The corrosion resistance of stainless steel is obtained by cation enrichment of chromium in the passive oxide with a threshold value 12% alloy. “This amount is needed to achieve significant enrichment in the passive layer in acid medium. Other elements include phosphoric acid (15-30%), nitric acid (< 5 %) and non-ionic surfactants,” said the company. Borer’s products are biodegradable and do not require treatment of precipitates (heavy metals). The company says its bio spray does not contain anti-corrosives, perfumes, dyes, chlorine nor silicates, which may lead to complications in patients. The company says that resistance to localized
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corrosion in the presence of chlorides (Epit > Erev,O2) is difficult to obtain by passive film technology and is enhanced by the addition of slowly dissolving elements, such as molybdenum. Testing To make sure all products abide by the strictest production processes, Borer Chemie AG has tested this newly developed process in cooperation with health institutions, including German-based NMI Natural and Medical Sciences Institute and accredited laboratories like Switzerland-based Niutec AG. “Well-known materials, such as 1.4112, 1.4057, 1.4021, 1.4034, 1.4301 and 1.4404, which are used in medical technology, were tested for their corrosion resistance using a wide range of process parameters and passivated using immersion and spray processes,” said Borer. The test results gathered are based on Free-Iron and ICPMS measurements and on comparisons with conventional methods (Nitric and Citric) via XPS analyses, according to the company. Free-Iron and ICPMS testing confirmed resistance through passivation with deconex® MT 41. It was also reported via XPS testing that the Cr and Fe ratio, as well as the ratio of Cr oxide and Fe oxide, performed better by at least a factor of 2 compared to conventional methods. Advantages Borer´s new passivation process provides completely new working methods for the evaluation of cleaning and passivation systems. This passivation solution offers new opportunities when considering zone concepts in production, for instance in a cell production. Borer reports that the application in a closed system, such as spraying systems, can now also be used in a sluice function. “This greatly reduces the effort required in the process, such as adhering to the zone concept, achieving short transport distances and eliminating additional handling, for example, moving the products into a new transport container or new Read the complete article More about this topic
product holders. The liquid passivation concentrate can also simply be added to the deionized water before starting the process,” said the company.