Clariant MEVOPUR and REMAFIN-EP ingredients fully comply with new standard for pharmaceutical packaging

MOSCOW (MRC) -- Clariant, a world leader in specialty chemicals, has announced completion of testing on ingredients in its MEVOPUR and REMAFIN-EP product ranges in order to bring them into full compliance with USP <661.1>, said the producer in its press release.

The new standard for pharmaceutical packaging and drug delivery devices doesn’t take effect until May 2020, when it will impact all current and future drugs on the US market. Clariant is completing the testing process now to help customers "future-proof" packaging launched in the interim and, in addition, to offer data to support the ICH-Q3D guidelines for risk assessment of elemental impurities in drugs.

Experts from Clariant’s Healthcare Polymer Solutions are on hand on Stand E14 at Pharmapack 2018 to review the implications of the new regulation and consult with customers about packaging /drug delivery device design strategies. The Pharmapack 2018 even is being held in Hall 7.1 at Porte De Versailles, Paris, France, from Feb. 6-8.

"The ICH-Q3D guideline strengthens the risk assessment process by evaluating not only the pharmaceuticals themselves, but also the packaging to ensure it is not the source of elemental impurities in drugs," says Steve Duckworth, Global Head of Healthcare Polymer Solutions. "As part of Clariant’s commitment to the continued availability of ‘controlled, consistent, and compliant’ packaging ingredients through our MEVOPUR and REMAFIN-EP product ranges, we initiated the required testing in 2017 and completed it early this year."

During the transitional period, the US Food and Drug Administration (FDA) allows the industry to make new filings under the older <661> or the new <661.1> standard, but in 2020, all existing and new drug/package combinations will need to be tested and compliant to the new standard. By completing its testing early, Clariant is helping customers get out in front of these regulatory changes and avoid the potential for last-minute problems with <661.1> testing as the 2020 deadline approaches, Duckworth explains.

He adds that compliance to <661.1> represents a major change, involving not only a significant modernization of test methods, but also a more robust risk assessment process: "The major consequence of this change is that in 2020, the ‘food contact statements’ that have long supported the use of many materials in drug packaging will be deemed ‘insufficient’ to support their future use. Thereafter, packaging materials for any category of drugs, from solid oral dose to higher risk ophthalmic solutions, must be supported by data from in-vitro tests specified in USP<661.1> (e.g. for extractable metals) and USP<87> for cytotoxicity."

Though all manufacturers must prove the compliance of their finished pharmaceutical packages and drug delivery devices to the new standard, Duckworth says that customers who select MEVOPUR and REMAFIN-EP products for use in those packages or drug delivery devices can develop and test their products with an added measure of confidence and avoid the costs of testing and submission twice: "If our own tests have already indicated that there is a low risk of an ingredient in the packaging interacting with the drug, then the customer can proceed with additional tests, such as required leachable and shelf life stability testing, with a greater confidence that the package concept is going to get through these tougher regulations."

Longer term, Duckworth notes that the production controls in Clariant’s ISO:13485 medical manufacturing plants help to ensure that MEVOPUR and REMAFIN-EP materials and ingredients remain free of change and thus supporting continuous compliance worldwide.

We remind that, as MRC wrote previously, in March 2017, Clariant announced that it had been awarded a contract by Dongguan Grand Resource Science & Technology Co. Ltd. to develop a new propane dehydrogenation unit in cooperation with CB&I. The project includes the license and engineering design of the unit, which is to be built in Dongguan City, Guangdong Province, China.

Clariant AG is a Swiss chemical company and a world leader in the production of specialty chemicals for the textile, printing, mining and metallurgical industries. It is engaged in processing crude oil products in pigments, plastics and paints.
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MOSCOW (MRC) -- Austrian energy group OMV is ready to spend 10 billion euros to focus more on gas and value-added refined products and grow its business outside Europe, its CEO said on Tuesday, reported Reuters.

As other energy companies shift their portfolios towards natural gas as a less polluting alternative to oil, OMV said it too will beef up its gas exploration, refining and transport business, aiming to become one of Europe's top players in the market.

The partly state-owned group operates refineries in Austria, Germany and Romania and explores oil and gas fields in central and eastern Europe, the North Sea and the Middle East and Africa.

Half of the acquisition budget will be used to expand its refining business by investing in markets outside Europe, where it currently generates the lion's share of its sales.

"We are going to diversify it towards the growing markets, especially as we speak about downstream," Chief Executive Rainer Seele said at a presentation in London.

OMV said it will use part of the war chest to develop an upstream - or exploration and production - business in Australia and New Zealand.

The Vienna-based group aims to achieve clean current cost of supplies (CCS) earnings before interest and tax, which exclude special items and inventory gains or losses, of more than EUR5 billion (USD6.16 billion) by 2025, an increase of 70 percent to last year.

OMV said it targets a 10 percent share of the German gas market by 2025 from 2.5 percent at present and plans to feed additional gas from Norway and Romania into the European grid to increase sales to more than 20 billion cubic meters by 2025.

OMV is among five Western companies to have invested in Russian gas export pipeline Nord Stream 2, which the latest U.S. sanctions related to Russia's activities in Crimea and European Union opposition may make harder to realise.

It operates natural gas transmission pipelines in Austria, holds interests in the Central European Gas Hub, and operatesgas-fired power plants in Romania and Turkey.
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MOSCOW (MRC) -- Specialty chemicals company Lanxess will present an expanded offering of products and services for the paints and coatings industry at the 2018 American Coatings Show and Conference, which takes April 9-12 in Indianapolis, according to CoatingsWorld.

LANXESS Inorganic Pigments (IPG) is introducing its new product range of red iron oxide pigments. The new grades, Bayferrox 510, Bayferrox TP 5278 and Bayferrox TP 5279, satisfy demand for more yellow-shade red pigments. At the same time, they are produced by the Ningbo process, a uniquely sustainable manufacturing method based on patented technology, that meets the most stringent environmental standards.

Performance-wise, the new red grades meet the high standards of the well-known Bayferrox brand and provide unique benefits for paints and coatings producers. Some of those product characteristics include high chromaticity and tinting strength; good optical appearance with respect to gloss and haze; and optimized milling parameters for easy dispersability even at low shear energy input. Additionally, the Ningbo process significantly reduces the residual, water-soluble salt content of the pigments, making them suitable for corrosion-resistant coatings.

With the 2017 acquisition of Chemtura Corporation, Lanxess is now a leading global supplier of urethane systems for a range of applications. At the American Coatings Show, the new LANXESS Urethanes Systems (URE) business unit will be highlighting its portfolio of Witcobond polyurethane dispersions, Fomrez polyester polyols, and Trixene urethane prepolymers for the paints and coatings industry.

Water-based polyurethane dispersions from the Witcobond line provide a full range of polymer properties in terms of toughness, hardness, flexibility, weatherability and overall durability for industrial coatings, leather and textile coatings and finishes, and plastic coatings. Additionally, they enable formulators to comply with increasingly demanding regulations on VOC, effluents and other potentially harmful components.

Fomrez polyester polyols lend themselves to surface and substrate protection in coatings, and aid in pigment dispersion and durability in paints. Trixene (solvent-borne and water-borne) blocked isocyanates are used as crosslinkers designed for one-component factory applied heat-cured coatings.

Lanxess is a leading specialty chemicals company with about 16,600 employees in 29 countries. The company is currently represented at 52 production sites worldwide. The core business of Lanxess is the development, manufacturing and marketing of plastics, rubber, intermediates and specialty chemicals.
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MOSCOW (MRC) -- Shell EP Middle East Holdings B.V. has completed the sale of the entire share capital of Shell Iraq B.V (SIBV), which held its 19.6% stake in the West Qurna 1 oil field, for $406 million, to a subsidiary of ITOCHU Corporation, as per Euro-petrole.

The purchaser has also assumed debt of USD144 million as part of the transaction. The West Qurna 1 venture will continue to be operated by ExxonMobil. Shell’s other businesses in the country are not affected by this divestment.

The divestment scope covers Shell Iraq BV, which is 100% owned by Shell EP Middle East Holdings B.V. (“SEPMEH”) and holds a 19.6% working interest in West Qurna 1 (“WQ1”) Technical Service Contract (“TSC”) in Iraq. Other partners in the TSC are ExxonMobil (32.7%), PetroChina (32.7%), Pertamina (10%) and Oil Exploration Company (5% state partner).

On completion of the sale of SIBV, Shell will have no participating interest in the TSC and will have completely divested its interest in West Qurna 1.

On 14 September 2017, Shell Iraq Petroleum Development B.V. (SIPD) announced that the Ministry of Oil of Iraq has endorsed its recent proposal to pursue an amicable and mutually acceptable handover of the Shell interest in Majnoon, with timings to be agreed in due course.

Royal Dutch Shell plc is incorporated in England and Wales, has its headquarters in The Hague and is listed on the London, Amsterdam, and New York stock exchanges. Shell companies have operations in more than 70 countries and territories with businesses including oil and gas exploration and production; production and marketing of liquefied natural gas and gas to liquids; manufacturing, marketing and shipping of oil products and chemicals and renewable energy projects.
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MOSCOW (MRC) -- KBR, Inc. has announced that it has been awarded an ammonia plant contract by Toyo Engineering Corporation (TOYO) for the Hindustan Urvarak and Rasayan Ltd (HURL) greenfield urea project in Gorakhpur, India, as per Hydrocarbonprocessing.

Under the terms of the contract, KBR will provide licensing and basic engineering design (LBED) services for the project.

HURL is a joint venture of three of the most prestigious Indian public sector companies - Coal India Limited (CIL), NTPC Limited (NTPC) and Indian Oil Corporation Limited (IOCL) - in cooperation with Fertilizer Corporation of India Limited (FCIL) and Hindustan Fertilizer Corporation Limited (HFCL) HURL's Gorakhpur plant is an important milestone for the Government of India towards making India self-sufficient in urea production and is the first initiative of its kind by the Indian Government since the last set of plants were built over 10 years ago. The foundation stone of the project was laid by the Indian Prime Minister Narendra Modi in July 2016.

"We are pleased that KBR's ammonia technology has been selected for the first greenfield urea plant being set-up by HURL as part of this initiative by the Government of India," said John Derbyshire, President, KBR Technology & Consulting. "This project will be an important milestone for India to meet its urea demand and KBR is honored and proud to be a part of this project."

"HURL project at Gorakhpur shows the commitment and support of Government of India, Niti Aayog, Department of Fertilizer under Indian Ministry of Chemicals and Fertilizers and promoter companies, towards the Indian Fertilizer sector," said Mr. Arun Kumar Gupta, Managing Director, HURL. "We believe that with best technologies and project management practices, this project will fulfill our vision of growth, efficiency and building national self-sufficiency."

As MRC wrote before, in January 2018, KBR, Inc. announced that it had been awarded a contract from Indorama Eleme Fertilizer & Chemicals Limited (Indorama) and Toyo Engineering Corporation (Toyo) for the Train 2 ammonia plant at Indorama's Port Harcourt site in Nigeria.

KBR is a leader in ammonia technology and has been involved in the licensing, design, engineering, and/or construction of more than 230 grassroots ammonia plants and over 100 revamp ammonia projects globally.
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