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Chemingineering – Something Special

This month’s column examines the business of specialty chemicals, which are omnipresent in our daily routines. Specialty chemicals deliver significant values to the end product and command a premium price. Innovation and product differentiation are the hallmarks of specialty chemicals. These are being threatened by waves of commoditisation.

Specialty chemicals are omnipresent in our daily lives. They make the toothpaste foam and lend a pleasing fragrance to the chore of dishwashing. They help us groom ourselves and keep our homes and workplaces spick and span. They enhance the appeal of the food and beverages we consume. Smartphones that rule our lives would be unthinkable without them. The global market for specialty chemicals was valued at $630 billion in 2019.

Performance Chemicals
Specialty chemicals are often used to impart specific attributes, like flavour, fragrance, texture, lustre, or colour to the end product. They may also be used to modify the physical properties like porosity, surface tension, or structural stability of the end product. Specialty chemicals are used to alter the performance and perception of the end product. They are almost always directly present in the end product used by consumers. Though they form a miniscule constituent of the end product, the specialty chemicals add significant value and often contribute to the brand-building of consumer products. Specialty chemicals have even enabled products to foray into new applications and markets. They are thus able to command a premium price.

Processes
The processes in the specialty chemicals industry usually employ complex chemistries involving hazardous reactions like hydrogenation, nitration, halogenations, etc. Batch processing is the norm in the industry. The manufacturing operations are often challenging with multistep reactions. The purities required are often exceptionally high. More often than
not, these processes are developed in-house after considerable investments in R&D. The chemistries and recipes are zealously guarded. The precursors and raw materials for manufacturing are usually very expensive. As many of these chemicals end up in consumer products, such as fabrics, food, and beverages, cosmetics, electronic goods, etc., the quality requirements are very stringent and unforgiving of even trace impurities.

Innovation
The specialty chemicals industry is knowledge-driven and lays great emphasis on innovation and R&D. Product offerings are often customised to meet the requirements of individual customers. Unlike commodity chemicals, specialty chemicals from various suppliers are not interchangeable with one another. These chemicals are used in such small quantities in the final product that their cost is not of much concern to the endusers. Switching to a low priced competitor could be ruinous as it would sabotage the quality of the final product. Businesses take great pride in their chemistry and molecules, which are closely guarded and cherished like family heirlooms. The specialty chemicals businesses thrive on their reputation of supplying innovative, differentiated products and providing responsive customer service. They are thus able to carve out niches for themselves in a widely fragmented industry. The market for specialty chemicals is consumer-driven.

Bundling Services
Sometimes specialty chemicals are so unique and customised that the supplies come bundled with services. A very good example of this can be found in cooling water treatment. Suppliers of cooling water treatment chemicals are also awarded O&M contracts with personnel stationed at the customer’s site to monitor the performance on a daily basis. Similar examples of handholding can be seen in applications of construction and industrial cleaning, where formulation and dosages are situation-specific.

Fragmented Industry
The specialty chemicals industry is deeply fragmented with more than 350 segments. These include polymer additives, construction chemicals, water treatment chemicals, colourants, surfactants, textile chemicals, flavours and fragrances, cosmetics and personal
care products, etc. Specialty chemicals can be grouped either by functions or by markets. A good example of the functional classification is provided by the popularly known CASE segment made up of coatings, adhesives, sealants, and elastomers. The market classification would be construction, electronics, automotive, oil field, etc. Four end-user industries – Construction, Electronics, Food and Beverage and Personal care and Hygiene – account for a lion’s share of the global consumption of the specialty chemicals.

Construction
Many economists believe that the post-pandemic recovery would be fuelled by a construction boom. A suite of chemicals is employed by the construction industry. These include concrete curing compounds, mould releasing agents, floor hardeners, surface retarders, water repellents, waterproofing compounds, adhesives, rebar coatings, epoxy grouts, and protective and decorating coatings. Chemical admixtures are the smallest constituents of the concrete mix, but provide significant benefits by enhancing the compressive strength, durability and surface finish. Salts of lignosulphonic acids and hydroxycarboxylic acids are used as retarders in hot climates to slow down hydration of cement and lengthening the setting time. In colder climes, calcium formate and calcium chloride are used to accelerate cement hardening and reduce the setting time. Adhesives find myriad applications in construction for tile fixing, panel fixing, floor covering, etc. Adhesives based on polyurethane, acrylics, and silicones are commonly used.

Food and Beverage
Chemicals are used as additives in foods and beverages to improve their safety, freshness, flavour, texture, and appearance. The main types of additives are – thickeners and stabilisers, emulsifiers, colourants, sweeteners, enzymes, and preservatives. Additives ensure processed foods stay safe and fresh on their long journey from factories to homes. Thickeners and stabilisers, referred to as food hydrocolloids, are added to imbue food with stability, structure, and mouthfeel that customer’s desire. They are commonly used in bakery and confectionery, dairy products, and frozen desserts. Many of these are derived from natural sources like proteins and starches, but they are also produced synthetically at
lower costs.

Electronics
The electronics industry depends upon a broad spectrum of specialty chemicals to manufacture various components. Electronic Chemicals, as they are called, are used in the fabrication of semiconductors, integrated circuits, and printed circuit boards, and photovoltaic cells. Electronic Specialty Gases are used in various fabrication processes like film deposition, film etching, substrate doping, and chamber cleaning. These include various silanes, halocarbons, arsine, diborane, phosphine, germane, and various oxides of nitrogen.

Care and Hygiene
This segment of specialty chemicals addresses our physical and psychological well-being. Consisting of products for personal and home care and for home and workplace cleaning, this segment has come into the forefront following the COVID19 pandemic. Surfactants, pigments, fragrances, and solvents are some of the major chemicals that go into formulation of the care and hygiene products.

Commoditisation
The specialty chemicals industry has been fighting strong headwinds of commoditisation and consolidation for several years. Commoditisation will remove product differentiation, the USP of the specialty chemicals business. The increased standardisation and competition will depress margins, which in turn will hurt investments in innovation. The specialty chemicals industry needs to innovate continuously to keep pace with the rapidly changing demands of the new economic order that is bound to shape the postpandemic world. This will also help it stave off commoditisation.

Readers’ responses may be sent to:
k.sahasranaman@gmail.com or
chemindigest@gmail.com

Elemental Impurity Analysis in Pharmaceutical Products

Preface
It’s the duty and responsibility of a manufacturer to ensure that a pharmaceutical product consists of the right dose of lifesaving drug and is free from any form of unwanted and harmful contaminants. Health agencies like FDA regulate pharmaceutical market’s by issuing guidelines for identity, strength, quality and purity of drug products and their ingredients through USP.
Elemental impurities in Pharmaceutical products can be rooted from A. source of the ingredients used in preparation (e.g. Herbs), B. process of drug compound synthesis (e.g. Catalysts) or
C. manufacturing process (e.g. molding, packaging). Although there have been no known health related incidents from elemental contamination in pharma products, but it has been scientifically established that elements like Arsenic, Mercury, Cadmium, Lead are of potential toxic nature.

USP <231>
Prior to implementation of USP <232>, <233>& <2232> elemental impurity analysis is carried out by USP <231>, which is a calorimetric analysis based on element reaction with thioacetamide to produce a precipitate of metallic sulfide, which is then compared with a lead standard solution visually.
However, this approach of elemental determination has several drawbacks like loss of volatile elements (As, Hg) during sample preparation, Matrix & standard inconsistency, and variability in interpretation of results among analysts. Advancements in elemental scientific instrumentation have created a more simple and accurate measurement possible and so from Jan 2018, USP has implemented the new guidelines of USP <232>, <233>.

USP <232>, <233>, <2232> & ICH
USP <232> specifies limits for the amounts of elemental impurities in drug products, drug substances, active ingredients and excipients, USP <233> describes the analytical procedure (ICP-OES and ICP-MS) for the evaluation of the levels of the elemental impurities. USP <2232> describes elemental analysis in dietary supplements & ICH Q3D categorizes the elements in four classes for the risk assessment process and defines a more harmonized approach for drug assessment.
USP <232>
Toxicology limits in PDE (Permissible Daily Exposure) μg/day of Fifteen elements have been defined in this chapter based on their route of administration. These limits are as shown in the following table.

Table 1: Elemental Impurities for Drug Products

USP <233>
This chapter deals with analytical procedure for elemental impurity evaluation like sample preparation, Instrumental methods, protocol for method validation with instrumental procedures like ICP-OES & ICP-MS. It also specifies that an alternate procedure can also be used, provided that it meets the validation requirements.

Sample preparation states that “The selection of the appropriate sample preparation depends on the material under test and is the responsibility of the analyst. When a sample preparation is not indicated in the monograph, an analyst may use any of the following appropriately validated preparation procedures”. These procedures are Neat, Direct aqueous solution, Direct organic solution, Indirect solution (microwave digestion, leachate extraction).
Instrumental methodology states that “System standardization and suitability evaluation using applicable reference materials should be performed on the day of analysis”. This requires Matrix matched blank, Standard solution 1 (1.5J of target element), Standard solution 2 (0.5J of target element) and Sample solution diluted NMT 1.5J with an appropriate diluent.

“J value” is the concentration (PDE) of the element of interest, appropriately diluted to the working range of the instrument, after the sample preparation process. Calculation for “J value” is as follows.

J value= PDE (μg/day) / (Max daily dose x dilution factor)

System suitability is checked by running standard solution 1 (1.5J) before and after sample solution, and the drift should not be more than 20% for each target element. USP <233> doesn’t define any specific instrument conditions, instead states that the sample be analyzed according to the manufacture suggestions for program and wavelength, m/z.
Suitability of the technique and analytical procedure is to be established by validation/ verification protocols (USP <1225> <1224>) with various parameters like-
1. Detectability 2.Reputability, 3. Specificity 4. Accuracy, 5. Precision, 6. Limit of Quantification & 7. Linearity & range.

USP <2232>
This chapter defines the elemental contaminants in dietary supplements. It focuses on four elements As, Pb, Cd & Hg. Their limits are as defined in the following table.

Table 2: Elemental Impurities for Dietary Supplements

ICH Q3D
ICH Q3D defines the guidelines for elemental impurities in drug products. It has three parts in it.
1. Evaluation of the toxicity data for potential elemental impurities,
2. Establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern
3. Application of a risk-based approach to control elemental impurities in drug products. This guideline has classified elemental impurities into three classes based on their toxicity (PDE) and likelihood of occurrence in the drug product.

Table 3: PDE for Elemental Impurities as per ICH Q3D

How to comply with USP?
With these updates in Pharma guidelines there are lot of questions the minds of analysts, like:
Which technique is suitable for the analyst’s products?
What is the procedure for sample preparation?
How do the analyst interpret the data?

Let us look at these instrumentation and sample preparation approach for a better idea about how to treat samples and which instrumentation technique is suitable for specific analysis.

Sample PreparationSome of the pharmaceutical products are water soluble, so a simple dilution with a suitable solvent can do the job but for complex and insoluble products, different approaches like “Microwave digestion” has to be employed. This a simple technique where a sample is digested in acidic medium under high pressure and temperature environment is created inside the Microwave digestion vessel, whose parameters are controlled by dedicated pressure and temperature sensors. This approach gives a clear sample solution which can be analyzed by any of the two instrumentation techniques defined in the guidelines. For speciation and oxidation state analysis different approaches have to employed.

ICP-OES
Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES/ICP-AES) is a plasma spectroscopy technique where a liquid sample is aspirated into plasma through a suitable sample introduction system where specific element emits light. This emitted light consists of spectra of respective elements present in the sample which is further resolved by an optical system and then detected by a detector. This instrumentation technique generally has two viewing positions- Axial (for ppb to ppm rage) and Radial (for ppm to % range). This technique is suitable for high dynamic linearity range. Selection of elements is based on wavelengths and analytical interference are caused by spectral overlaps between elements.

ICP-MS
Inductively Coupled Plasma – Mass Spectroscopy (ICP-MS) is also a plasma spectroscopy technique which analyses elemental impurities in a sample based on the element’s mass to charge (m/z) ratio. It consists of a sample introduction system, which aspirates the sample into plasma, which then ionizes the elements present in samples. This ionized elements then travel through a collision or reaction cell which removes the interferences and then separated based on their m/z ratio by a quadrupole system and then detected by a detector. It has a single view position and analyses samples in the concentration range of ppt to ppm or sub % levels. Analytical interferences are caused by isotopic interferences of elements. Speciation analysis can be carried out by coupling with HPLC or IC units where the species separation is carried out by the chromatography technique and quantification of the species is done by ICP-MS.

Note: This document is intended for personal education use only and it is not a substituent to any guidelines or methods.

Analytica Jena’s Multi N/C Duo: One TOC Analyzer for Solid and Liquid Samples

With the multi N/C duo, Analytik Jena presents an analyzer that considerably simplifies TOC analysis (Total Organic Carbon). For the first time, it is possible to analyze solid and liquid samples using one single device – highly automated and without complex adjustments.
The new TOC analyzer of modular design can process up to 48 solid samples in less than four hours due to its high degree of automation. With up to 146 samples per sequence and parallel purge and analysis in NPOC operations, the analyzer adds to the highly automated and clean handling of liquid samples. Switching between the solid and liquid mode takes only a few mouse clicks. In order to measure solid matter, the multi N/C duo uses a robust, catalyst-free oxidation technique, which makes a considerable contribution towards reduced running costs. Furthermore, low-wear ceramic components make the combustion system of the analyzer particularly low-maintenance. Solid sample weights in the gram range compensate for the inhomogeneity of samples, thus increasing the reproducibility of the analysis results.

The multi N/C duo is designed particularly for labs in the environmental sector that see themselves confronted with an increasing number of solid and liquid samples. Automation and the high quality of analysis are brought together harmoniously by the device – with additional ease of use for the operator.

Multi N/C 2100S Duo

Multi N/C 2100S Duo – Whether Solid or Liquid – Robust Automation
The robust routine analyzer based on high-temperature combustion with septum-free injection technology is ideal for particle- or oil-containing water samples as well as very small sample volumes. It has a high degree of automation for both water and solids analysis.

Characteristics of the Multi N/C 2100S Duo:

  • Carry-over free direct injection technology
  • Suitable for very small sample volumes
  • Robust, catalyst-free solids TOC measurement
  • Fast switch-over from liquid to solid mode without system conversion
Multi N/C 3100 Duo

Multi N/C 3100 Duo – Whether Liquid or Solid – Highest Sample Throughput
The fast all-rounder for all samples thanks to a combination of catalytic high-temperature combustion and flow injection with intelligent rinsing and injection technology for particle-containing water samples. Highest sample throughput by parallel purge and analyzing in liquid mode and low sample preparation effort for solids.
Characteristics of the Multi N/C 3100 Duo:

  • Flow injection with intelligent rinsing and injection technology for samples containing particles
  • High sample throughput by parallel purge and analysis in NPOC mode
  • Robust, catalyst-free solids TOC measurement
  • Fast switch-over from liquid to solid mode without system conversion

Learn More about the Analytica Jena’s Multi N/C Series here-
https://www.analytik-jena.in/products/sum-parameter-analysis/toctnb-analysis/multi-nc-series/

Chemical Industry Digest – September 2020

Chemingineering – Green Hydrogen 
– K. Sahasranaman, Independent Consultant
Climate change, the imperative to replace fossil fuels & the drive towards energy efficiency are pushing the advent of the hydrogen economy faster. Our columnist covers the latest developments in hydrogen production & in particular the potential for green hydrogen using renewable energy.

Industry 4.0 Digital Technologies to Optimise Energy Use in Plants 
– Sunil Agrawal, Bharat Yadav– Tata Consulting Engineers Limited
Transformation, Business Unit, Emerson Automation Solutions, India The suite of industry 4.0 digital technologies are revolutionizing plant performance & maintenance & thus enabling optimizing energy use to levels not obtained earlier.

Back to Basics: Introduction to Pinch Technology 
– Shreyas Choudhari- Datta Meghe College of Engineering, Atul Choudhari– Tata Consulting Engineers Limited
As one of the major consumers of energy resources, the chemical industry should take steps in optimizing the energy requirements. Employing pinch technology can be one such way to efficiently utilize the available energy resources. Pinch analysis not only identifies the opportunities for energy savings but also provides a way to do so. The article refreshes the basics of pinch technology for the readers to enable them to utilize this technology to the fullest.

Sustaining Condensate Recovery Factor (CRF) 
– Vaibhav Pradhan – General Manager – Steam Systems Division, Forbes Marshall, Pune
The author explains CRF in detail & the challenges involved in sustaining a consistent CRF. Various factors that affect CRF are described including on how to sustain the highest possible CRF.

Steam Management and Case Study
– Arun Mote– Executive Director & CEO, Triveni Turbines
Managing energy efficiently in refineries, chemical, and petrochemical plants has become very crucial for reducing manufacturing costs. One of the ways to do so is by utilizing and managing steam in the plants. For which steam turbines – which are used in most process industries- need to be adapted to various levels of steam conditions. This article describes the role of steam turbines with case studies.

Process Integration for Energy Efficiency and Networking of Unit Operations
– C Sailaja– Tata Consulting Engineers Limited …
As energy is the major cost in petrochemical/chemical plants, process integration is the best solution to manage energy efficiently and thus improve overall competitivity. Our author describes in detail the parameters particularly for utilities on how energy can be optimized soas to reduce its consumption and thus the operational costs.

Out of the Box- Solutions to Industrial Problems
– Raghava Chari
The author has provided various solutions related to real-life industry problems he found in his 45 years of operational experience in process plants. In this feature, problems related to the elimination of arcing electrical insulators, flash failures due to electrical insulation, easy replacement of failed motors, and erratic radar level gauges are covered.

Chemingineering | Green Hydrogen

Dawn is breaking on the Hydrogen Economy and nations across the developed world are ramping up investments in technologies and infrastructure. This month, our columnist examines the various technologies to produce Green Hydrogen by splitting water using renewable power. The Hydrogen Economy is estimated to grow into a $12 trillion behemoth in the next three decades.

Green Hydrogen

Early during the present pandemic, on 20th April, the US oil benchmark West Texas Intermediate dropped below zero, hitting a jaw-dropping value of minus $37.63. But even more remarkable was the calmness with which the markets greeted this surreal information. Apparently, the world was expecting this sooner or later and was not prepared to shed tears for the impending demise of the fossil fuel. Though the fossil fuel may be around for some more decades, the bugle heralding the dawn of the Hydrogen Economy has been sounded loud and clear.

Hydrogen Economy
The idea of a Hydrogen Economy appears to have been first mooted 50 years ago in a concept paper – Towards a Liquid Hydrogen Fuel Economy – by Lawrence Jones in 1970. The environmental benefits of the Hydrogen Economy are only too obvious, yet high cost and lack of infrastructure has held back its adoption all these years. But with the climate change monster’s foot already in our door, there is scarcely a moment to waste, notwithstanding even the ongoing pandemic. If anything, the pandemic has only heightened the public awareness of health and environment. Politicians and policymakers can ill afford to be blind to this altered public perception.

Colours of Hydrogen
Three different kinds of Hydrogen are being recognised based on their environmental footprint. Grey Hydrogen is produced by steam reforming of fossil fuels, usually Natural Gas. Hydrogen derived from fossil fuels, but accompanied by CO2 capture, is dubbed as Blue Hydrogen. Green Hydrogen, the most sustainable variant is obtained by electrolysis of water using renewable energy. A deep synergy exists between Green Hydrogen and renewable energy. Cheaper renewable energy will drive down the cost of Green Hydrogen. Also Hydrogen may be a more sustainable alternative to metal-based batteries when it comes to storing and smoothening out the uneven production of power from renewables. The share of renewables in global electricity generation was 28% in Q1 2020 and is expected to grow to 45% by 2040.

Technology
Water splitting by electrolysis is more than 200 years old and was first demonstrated in 1800 by William Nicholson and Anthony Carlisle. The first industrial electrolyser was constructed in 1888 and by the turn of the century, few hundred electrolysers were in operation. Electrolysis of water for onsite generation of Hydrogen has been for very small volumes. This has to be scaled up by several orders of magnitude in a robust Hydrogen economy. Two matured technologies are available today for producing Hydrogen by electrolysis of water – Alkaline Electrolysis and Proton Exchange Membrane (PEM). Some more technologies are in advanced stage of development and are expected to break the existing duopoly.

Alkaline Electrolysis
Alkaline Electrolysis, the older of the 2 established technologies, typically uses 30% KOH solution as the electrolyte. The cathode and anode are separated by a porous diaphragm, which was historically asbestos based. Following the ban on asbestos, many other materials have been developed. The electrolyser is operated at a maximum temperature of 90 degrees C and the pressure is limited to 30 bar. The current density is typically between 2 and 4 KA/m2 and a representative power consumption is 4.5 KWH/Nm3 of Hydrogen. The largest Alkaline Electrolysis plant was started up in Japan, in March this year. It can produce 1200 Nm3/hr (900 tpa) of Hydrogen.

PEM
Proton Exchange Membrane (PEM) technology, also known as Polymer Electrolyte Membrane technology was first deployed in 1970s in space and military applications. The largest PEM facility for production of Hydrogen is expected to go on stream this year in Germany, befittingly at the site of the country’s largest refinery – Shell Rheinland Refinery near Cologne. The plant will consume 10 MW power to produce 1300 tonnes of Hydrogen per annum. Central to the PEM technology is a polymer membrane that electively transports protons from the anode to the cathode. The technology has several advantages over Alkaline Electrolysis. These include higher current densities, typically 5 times higher than the Alkaline Electrolyser. But a more significant advantage is its ability to respond to fluctuations in power, typically associated with renewables. The PEM cell is also safer because the membrane acts as an effective barrier between Hydrogen and Oxygen. PEM cells are expensive because the electrodes have materials like Platinum as catalysts.

AEM
Anion Exchange Membrane (AEM) technology seeks to build on the advantages of PEM and Alkaline Electrolysis. Operating at higher current densities and using less expensive materials it aims to lower the investment cost significantly. At the heart of the AEM technology is the membrane that will selectively transport hydroxyl ions from the cathode to the anode. The membrane is still under development and has received a funding of $ 2.4 million from European Union’s research programme. The membrane is expected to be in operation by 2022. The project sponsors are targeting to bring down the installed cost of AEM plants to $600-$700 per KW against $1200/ KW for PEM and $950/KW for Alkaline Electrolysis.

SOEC
A dark horse in the arena of Hydrogen Economy is the Solid Oxide Electrolysis Cell (SOEC). The cell operates at high temperatures in the range of 700 to 1000 degrees Celsius and reverses the process occurring in a fuel cell, converting electrical energy into chemical energy. Power required for SOEC is significantly lower, typically 3 KWH/Nm3 Hydrogen as against 4.5 KWH/Nm3 Hydrogen for Alkaline Electrolysis. The main advantage of SOEC lies in the possibility of co-electrolysis of steam with CO2 resulting in syngas, which can then be used as a building block for the production of various hydrocarbons. The high temperature operation however poses many material and engineering challenges including the structural stability of the electrodes. The technology is still in a nascent stage and much needs to be done before it can see the light of commercialisation.

Epilogue
Hydrogen is expensive today and accounts for only about 1% of the global production of Hydrogen. International Energy Agency (IEA) estimates the cost of Green Hydrogen at $3 – $7.5 per kg compared to $0.9 – $3.2 per kg for Grey Hydrogen. For Green Hydrogen to become competitive, two things need to happen – Electrolyser costs have to drop and renewable energy has to get cheaper. Big investments in these two areas are expected to drive down the costs in the next two decades.

Readers’ responses may be sent to:
k.sahasranaman@gmail.com or
chemindigest@gmail.com

Orix Plans to invest $980 Mln in Indian Renewable Firm Greenko

Japan’s Orix Corp would invest about $980 million in Indian renewable energy firm Greenko Energy Holdings as the company sees the fast-growing Asian market as a pillar of its overseas strategy. The move comes as Japanese companies including utilities, oil refineries, and trading houses are stepping up their investments in renewable energy assets at home and abroad as countries around the globe switch to cleaner energy to meet pledges to curb climate change. Orix will take a stake of more than 20 percent in Greenko within this year, according to a statement.
“Orix intends to expand its renewable energy business in and outside Japan, as well as business expansion in Asia,” the company said in a statement.

Chemical Industry Digest – August Issue -2020

Interview- Analytical Instrumentation: An Epitome of Digitalization in the Chemical Industry 
– Upendra Dixit, Managing Director- AJ Instruments India Pvt. Ltd.
The widen use of Analytical Instrumentation techniques in the chemical industry has accelerated and increased the efficiency of qualitative and quantitative analysis. Upendra Dixit in an interview to Chemical Industry Digest discusses the advances of Analytical Instrumentation and its deployment across industries.

Digital Transformation- A New Normal for Chemical Plant
– Khushbu Chaplot Chaudhary- Senior Manager – Digital Transformation, Business Unit, Emerson Automation Solutions, India
As the world is on its way recovering from the pandemic, the major change which has occurred is getting the work done digitally. Digital transformation has got the chemical industry on one platform to bring about a change in business and get work done more effectively. In this article, the author describes the importance of digital transformation and how it can impact the chemical industry in a positive way.

Revamp Projects- Instrumentation & Automation Perspective
– Milind Kulkarni- General Manager – Instrumentation at ThyssenKrupp Industrial Solutions (India)
Instruments are an important constituent of any plant and therefore for a project to undergo a revamp, it is important to completely evaluate various areas of instrumentation & automation systems. The success of the revamp itself depends on the instrumentation & automation systems that also need to undergo changes. The author addresses all these challenges required for addressing the problems in instrumentation & automation during a revamp.

Instrumentation: New Capabilities Boost Remote Monitoring
– Seán Ottewell- Editor, Chemical Processing
Wireless monitoring allows a plant to monitor anything, anywhere at a reasonable cost. The author describes in detail four such wireless technologies to provide an analytical solution to get results quicker than before, as difficult locations can be easily reached.

New-Age Technologies to Fight Substandard Medicines 
– Amit Chopra – Managing Director and Vice President, Thermo Fisher Scientific, India, South Asia & Middle East
The growing threat of counterfeit drugs has continually posed challenges in healthcare and particularly during COVID-19 crisis. It is therefore imperativeto ensure security through the  supply chain of these drugs to combat the threat. Employing new technologies with latest equipment is a way to overcome this situation which is discussed in this article.

Managing Cyber Security for data and Chemical plant protection in today’s scenario
– Ketan Karkhanis – Head of Information Technology, Clariant (India)
With most of the businesses going online, the numbers of cybercriminals have increased. Also, work from home due to the COVID-19 situation has provided opportunities for people to commit cybersecurity-related attacks. Therefore, it has become important to manage cybersecurity in chemical plants to protect the data.

Out of the Box- Solutions to Industrial Problems
– Raghava Chari
The author has provided various solutions related to real-life industry problems he found in his 45 years of operational experience in process plants. In this feature, problems related to the elimination of compressor wrecks, hot-spot repairs, and elimination of journal bearings failures are covered.

Chemingineering – Automation Culture
– K. Sahasramanan, Independent Consultant
Automation is an essential part of the chemical industry. It has made humans rely on digital systems more than actual eye-keeping of plants. It has also increased the efficiency of plant operations; however, it would not be correct to say that automation has brought about complete safety in the plants. Our columnistcites his own experiences and concludes that despite all the advances in automation & AI, it is not prudent to do do away with the human element.

Excellence in Pharmaceutical TOC Testing and Vaccine Quality Control

Excellence in Pharmaceutical TOC Testing and Vaccine Quality Control

  • Standard-compliant analysis according to international pharmacopoeias
  • Data integrity guaranteed
  • Extraordinary detection sensitivity and long-term stability

As a parameter for the quality and purity of water, the TOC content must be determined in international pharmacopoeias for various applications. It allows quick and reliable conclusions to be drawn about organic impurities and is, therefore, an integral part of the standards for ultrapure water control, cleaning validation, and testing of extractable components from packaging materials for pharmaceuticals.

The multi N/C pharma series offers tailor-made solutions for this pharma-specific TOC analysis. A special device for total protein analysis in aqueous pharmaceutical solutions also offers a simple method for the quality control of vaccines.

TOC ultrapure water testing and TOC/TN cleaning validation

The TOC ultrapure water test for water for injection (WFI) and Aqua purificata (purified water – AP) can be carried out per pharmacopoeias, e.g. USP <643> or EP 2.2.44, using high-temperature combustion or wet chemical UV digestion. In TOC cleaning validation, the same approach is used as a substance-independent method for the detection of organic residues, e.g. active pharmaceutical ingredients (API), additives and cleaning agents, on production equipment. multi N/C pharma offers solutions for both processes, whereby the devices for high-temperature combustion also allow the simultaneous determination of total nitrogen (TN) for cleaning validation.

Testing of extractable components from packaging materials
To ensure the suitability of polymer packaging systems for use in the pharmaceutical industry, USP <661.1> and <661.2> require the analysis of extractable components from the material or the packaging systems. For this purpose, ultrapure water eluates from the packaging materials or systems are tested for their TOC content according to USP <643>.

Quality control of vaccines
The total protein analysis in the production of vaccines by determination of the total nitrogen content according to e.g. USP <1057>, Method 7.2, enables the quantification of attenuated or devitalized viruses or bacteria as well as antigens. In the production of allergenic vaccines, this method can also be used to analyze raw materials such as pollen lyophilisates as well as different dosage forms such as desensitization vaccines, prick test solutions or sublingual drugs with the same TN test method.

Our models for the pharmaceutical industry

  multi N/C pharma UV multi N/C pharma HT multi N/C 3100 pharma multi N/C 2100S pharma
Sample digestion UV/Persulfate HTC HTC HTC
Sample injection principle Flow injection technique Flow injection technique Flow injection technique Direct injection technique
Measuring range [mg/l]
TC/TOC/NPOC/TIC
0 – 10,000 0 – 30,000 0 – 30,000 –
Measuring range TNb mg/l (CLD) – 0 – 200 0 – 200 0 – 200
Maximum injection volume 20,000 µl 3,000 µl 1,000 µl 500 µl
Highest precision in the TOC trace range x x (x)1 –
Highest automation comfort for NPOC (automatic acidification) x – X –
Additional flushing function x – X x
Self Check System/ VITA/ Easy Cal x x X x

1)  suitable as secondary application

If you are still not sure which model fits best to your requirements – use our finder.

multi N/C pharma UV – highly sensitive TOC trace analysis

The efficient TOC analyzer based on wet-chemical UV digestion for highly sensitive TOC trace analysis in ultrapure water analysis and cleaning validation allows injection volumes of up to 20.0 ml.

Characteristics of the multi N/C pharma UV:

  • TOC determination in direct NPOC mode without blank value influences for highest sensitivity and precision
  • TOC measurement <1 ppm without oxidation reagent
  • Lowest operating costs – no catalyst or combustion tube, no additional reagents required
  • Extension of the working range to up to 10,000 ppm using oxidation reagent that can be easily produced by the user

multi N/C pharma HT – the flexible TOC/TN analyzer

The versatile TOC/TN ultra-trace analyzer for ultrapure water and cleaning validation testing using high-temperature combustion. The optional direct swab combustion allows the determination of water-insoluble or sparingly soluble impurities in the TOC cleaning validation.

Characteristics of the multi N/C pharma HT:

  • TOC determination in direct NPOC mode for highest precision in the ultra-trace range
  • Injection volume up to 3.0 ml
  • Optional TN cleaning validation

multi N/C 3100 pharma – High throughput TOC/TN analysis

The system based on catalytic high-temperature combustion offers a large working range with effective rinsing function, a high degree of automation and parallel purge and analyzing for a high sample throughput.

Characteristics of the multi N/C 3100 pharma:

  • TOC determination in direct NPOC mode for high precision in the ultra-trace range
  • Injection volume up to 1.0 ml
  • Covering a TOC concentration range of 0 – 30,000 ppm
  • Automatic sample acidification and effective reverse rinse function to prevent sample carry-over in case of concentration changes

multi N/C 2100S pharma – the specialist for total protein analysis

The TN analyzer with catalytic high-temperature combustion and CLD detection for efficient protein analysis in vaccine production or TN cleaning validation with minimal sample consumption and a high degree of automation.

Characteristics of the multi N/C 2100S pharma:

  • No sample carry-over due to septum-free direct injection by means of microliter syringe and effective rinsing routines
  • Minimum sample consumption with a typical injection volume of 50 – 200 μl (max. 1.8 ml) Savings on costs for expensive products e.g. in vaccine quality control
  • Large working range from 0 – 200 ppm TN
  • High degree of automation for large sample sequences (up to 112 sample positions for HPLC vials)
  • Unattended 24/7 operation thanks to self-check system

Downloads

Brochure Pharmaceutical TOC Water Testing and Vaccine Quality control

multi N/C Series – Find the Right TOC Analyzer for Your Needs (English)

Analytik Jena Introduces New ICP-OES Series

Analytik Jena presents the evolution of its ICP-OES portfolio by introducing PlasmaQuant 9100 and the 9100 Elite. The new ICP-OES series offers more automation, greater adaptability, and shorter analysis times. The PlasmaQuant 9100 series is ideal for laboratories with difficult to analyze sample matrices and a steadily increasing number of samples. The target industries for the new solutions include the chemical industry, oil and gas industry as well as the mining and metal processing industry.

PlasmaQuant 9100 Elite

“Only our instruments achieve the lowest detection limits in the high matrix range, which reliably improves the product quality and process efficiency of our customers,” says Dr. Marc Diener, Director Product Management, Application & Marketing, whose team is leading the market launch of the new ICP-OES series.

The PlasmaQuant 9100 and the 9100 Elite can be used in the oil and gas industry to analyze the composition of naphtha, diesel, gasoline, and other fuels or to monitor heavy metals in oils. In the chemical industry, the PlasmaQuant 9100 can be utilized for routine tasks such as purity checks of salts, acids, polymers, or solvents. The systems are also suited for material analyses of ceramics, semiconductors, and complex chemical compounds.

PlasmaQuant 9100

PlasmaQuant 9100 and 9100 Elite are ICP-OES systems that can be tailored to a wide range of applications thanks to a comprehensive range of accessories. For example, Analytik Jena offers fully automated autosamplers for a large variety of sample types and applications, including solutions for oil sampling, water analysis, or for highly volatile samples. New switching valves optimize analysis times by reducing sample uptake and washout times. Laboratories thus save large quantities of consumables and also reduce instrument downtime. The PlasmaQuant 9100 series uses Analytik Jena’s patented plasma technology, which allows interference-free analyses and the lowest detection limits – especially the analysis of high matrix samples is easier and more sensitive than with comparable ICP-OES systems.

 

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