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46 Cover Story 14 The edition brings for you a cover story titled Process Analytical Technology for High Shear Wet Granulation; High shear wet granulation (HSWG) transforms fine powder blends into free-flowing granules with improved compression properties during the tabletting process. Story authored by Tim Freeman, Managing Director, Freeman Technology Ltd

Aurobindo Pharma Q1 profit slips 12% to Rs 455 crore

New Delhi: Drug firm Aurobindo Pharma NSE 3.24 % today reported a 12.10 per cent decline in its consolidated net profit to Rs 455.59 crore for the first quarter ended June 30, mainly on account of rise in expenses.

Featured article 42 Added to this, the current edition has a special featured article titled, Perform Thermal Validation for Peace of Mind not in Pieces, covering Thermal validation system is being widely used by End Customers, OEMâ&#x20AC;&#x2122;s, Third Party Service Providers (TPSPs) for validating the Thermal Processes.

Product Launches

The edition also covers recent Healthcare news articles and product launches collected from worldwide sources to update the readers with the current trends in the industry

Teva wins FDA nod for its generic of Mylan's EpiPen after 2-year delay

After a delay of more than two years, Teva has won approval of its generic version of Mylanâ&#x20AC;&#x2122;s highly successful EpiPens.

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ear friends and readers, I hope you would have enjoyed reading our previous issue. Once again, I am delighted to bring for you the new edition of your favourite magazine Microbioz India. It is a “Laboratory Edition” supported by the cover story titled ‘Process Analytical Technology for High Shear Wet Granulation’ by Tim Freeman, Managing Director, Freeman Technology Ltd High shear wet granulation (HSWG) transforms fine powder blends into free-flowing granules with improved compression properties during the tabletting process. Granulation also enhances the uniformity of a blend, increases density and reduces dust levels, an important health and safety benefit. The pharmaceutical industry is one of several which rely heavily on HSWG processes, most especially in the manufacture of oral solid dosage forms. A Quality-by-Design (QbD) approach in drug development and manufacture relies on data collection at relevant points in the process to control the critical quality attributes (CQAs) of the product. The current edition has also brought for you a featured article on “Perform Thermal Validation for Peace of Mind not in Pieces...” authored by Mr. Ramesh Sahu from Skytech India. We have the latest market research news and insightful product launches inside collected from worldwide sources to keep you updated with what is going on in the industry. In the event page, a complete list of Upcoming Mega Trade Fairs of Laboratory, Pharma & Biotech Industry has been provided where our presence is there. I hope you have a good read. Dear friends and readers, I hope you find some value in the magazine. Also, I would like to thanks you for being together in the beautiful journey so far. We will wait for your valuable feedback and suggestions as they help us come with better content each time. For any further value addition, please write to us at editor@microbiozindia.com.

Cover Story

Process Analytical Technology for High Shear Wet Granulation Authored by: Tim Freeman, Managing Director, Freeman Technology Ltd High shear wet granulation (HSWG) transforms fine powder blends into free-flowing granules with improved compression properties during the tabletting process. Granulation also enhances the uniformity of a blend, increases density and reduces dust levels, an important health and safety benefit. The pharmaceutical industry is one of several which rely heavily on HSWG processes, most especially in the manufacture of oral solid dosage forms. A Quality-by-Design (QbD) approach in drug development and manufacture relies on data collection at relevant points in the process to control the critical quality attributes (CQAs) of the product. Granules are typically an intermediate, rather than the end product, making it more difficult to identify the critical process parameters (CPPs) that impact the CQAs of the finished product. Research has shown that HSWG processes can be successfully optimised using at-line techniques such as dynamic powder testing, but continuous, real-time analysis has the ability to provide further information by measuring the wet granulated mass, in-process, without interrupting the granulation operation. The Lenterra Flow Sensor (LFS) System (Lenterra Inc. USA) is a Process Analytical Technology (PAT) that provides high frequency, high resolution in-line flow force measurement. In this article we look at how it work and examine its potential application in HSWG monitoring and control. Research using FT4 Powder RheometerÂŽ (Freeman Technology, UK) suggest that both can be used at different stages of development and manufacturing to optimize HSWG processes.

Figure 1: FT4 Powder Rheometer (left), Lenterra Drag Force Flow Sensor (right)

The challenge of HSWG During HSWG a blend of active ingredients and excipients are energetically combined with liquid, often water, to form relatively large, homogeneous granules. These undergo further processing to produce an optimal feed for downstream tablet manufacture. A typical objective for tableting would be to produce homogeneous granules that enable high throughput on the press and result in tablets with target CQAs.

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Cover Story The properties of granules are controlled through manipulation of a number of processing parameters, including: ➢

Quantity of water added

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Water addition rate

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Impeller/hopper speed

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Granulation time

Altering these variables enables the optimisation of granule properties and is usually a lengthy empirical process that relies on the implementation of statistical design-ofexperiment (DoE) studies to correlate CPPs with the critical quality attributes of the manufactured granules. The resulting correlations tend to be scale-dependent, and process scale-up is a widely recognised challenge. Producing granules with properties that are wellmatched to the requirements of subsequent processes relies on being able to measure relevant properties during the course of the granulation. Dynamic powder testing, an at-line technique that measures bulk powder/granule flowability, has been shown to be valuable [1]. Its application enables characterisation of the developing granules, wet or dry, in terms of parameters that directly correlate with, for example, the CQAs of finished tablets [2].

The development of equally successful techniques for in-line measurement has the potential to deliver more responsive HSWG control and process scale-up.

In-line HSWG monitoring A number of the PAT options proposed for granulation monitoring are based on the measurement of specific properties of the developing granules, for example, particle size. However, rather than focusing on individual particle parameters, which may or may not be relevant, measuring bulk properties, such as flowability, can have potential benefits. The LFS system incorporates a drag force flow (DFF) sensor for in-line measurement of flow and an optical sensor interrogator for data processing and analysis. The sensor is a thin hollow cylindrical needle, in the order of 1-4 mm diameter, that can be mounted inside processing equipment such as a mixer, granulator or feeder, to provide real-time local measurement of the flow forces within the in- process material. Material flow causes a deflection of the pin, the magnitude of which is measured using two optical strain gauges, fixed to the inner surfaces of the sensor.

Cover Story The resulting measurements correlate directly with fundamental parameters of the material, such as density and shear viscosity, and can therefore be used to track the progression of a process, such as HSWG, that changes these attributes. Complementary temperature measurements enable the automatic correction of any temperature-related drift in measurement baseline.

Figure 2: Drag Force Flow Sensor in a High Shear Wet Granulator It is increasingly recognised that the quality of granules is not easily defined in terms of a single granule property but rather is a function of a number of parameters including density, porosity, surface adhesion, and size. Techniques that focus on bulk properties, as a function of water content, formulation or process changes, therefore have considerable potential. Research has provided evidence of the value of dynamic powder testing and in-line flow force measurement for monitoring HSWG processes. While dynamic powder testing is an at-line technique, flow force measurement has been successfully implemented as an in-line sensor, via the LFS system. This PAT tool for real-time continuous measurement offers robust technology for routine HSWG monitoring and control during scale-up and into manufacture.

Key advantages of this type of sensor are minimal intrusion into the flow, and relative insensitivity to the adherence of material on the sensor surface; an important attribute for robust continuous operation within a granulator. Furthermore, the probe has no moving parts, enhancing its inherent reliability, and measures at a sufficiently high frequency, up to 500 samples per second, to provide a high-resolution datastream that is able to successfully detect the evolving properties of the in-process materials. In a mixer or granulator it is typically installed through a standard port in the lid of the vessel, above the impeller and, like all in-line technologies, offers the opportunity to monitor the process without stopping and sampling. This is an important gain for process optimisation studies, and process control. A DFF sensor reports data in the form of the Force Pulse Magnitude (FPM) which characterises the flow force associated with the passing of inprocess material, and associated deflection of the pin. Changes in FPM therefore correlate directly with bulk properties of the process material - wet mass consistency and/or densification in the case of an HSWG process. FPM is a differential Measurement and therefore not subject to baseline drift - an important additional benefit for process monitoring.

Cover Story

Case study â&#x20AC;&#x201C; monitoring HSWG A study was carried out to investigate whether in-line drag force flow measurements can be used to track a granulation process by comparing the DFF data with off-line dynamic measurements of basic flowability energy (BFE), an established parameter for assessing granule development. Six batches of three pharmaceutical formulations with different levels of Hydroxypropyl Cellulose were produced (1% w/w HPC, 3% w/w HPC and 5% w/w HPC). Two kilogram batches of dry powder were made up according to pre-determined compositions and granulated with 800g of water in a 10 L high shear wet granulator (Pharma-ConnectÂŽ, GEA). Processing conditions were set in accordance with previous optimization studies. In-line data was gathered during the granulation step using a DFF sensor (measurement range +/- 3N) mounted in the granulator lid, 2.5 cm above the blade and 8.2 cm off the blade rotation axis. Samples of the granulate were taken after fixed time periods and BFE was measured using an FT4 Powder Rheometer. A comparison was then made between the in-line FPM data and the BFE measured using the powder Rheometer (Figure 3).

In-line DFF measurements showed excellent repeatability with the derived FPM reflecting the change in consistency of the granulating mass throughout the process. The three formulations generate similar profiles. The initial work (shear) to mix the dry powders does not result in significant changes in FPM, however, FPM rises rapidly as water is added, indicating the development of larger, denser, less compressible and more adhesive granules. A peak FPM is observed shortly after the end of water addition, after which FPM declines as the continued mixing generates smaller granules. It was also observed that FPM increases with respect to HPC percentage, suggesting that higher binder concentration results in stronger, denser and larger granules. The BFE profiles support the FPM data, showing a rising profile during water addition and subsequent decay as water addition ends, as well as the increase with respect to binder content. The sensitivity of DFF measurement is illustrated by the magnitude of the increase in signal associated with water addition compared to the corresponding increase in BFE. For these formulations, FPM values peak shortly after water addition is complete, while the BFE values peak towards the end of the water addition phase. However, the data demonstrate how both techniques can be used to track granule development.

Looking ahead Wet granulation is a much-valued process in the pharmaceutical industry, but is notoriously difficult to control and scale-up. There is considerable value in developing analytical techniques that can reliably monitor HSWG processes. It is increasingly recognised that the quality of granules is not easily defined in terms of a single granule property but rather is a function of a number of parameters including density, porosity, surface adhesion, and size. Techniques that focus on bulk properties, as a function of water content, formulation or process changes, therefore have considerable potential. Research has provided evidence of the value of dynamic powder testing and in-line flow force measurement for monitoring HSWG processes.

Figure 3: Comparing in-line with at-line data for three formulations

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Cover Story

While dynamic powder testing is an atline technique, flow force measurement has been successfully implemented as an in-line sensor, via the LFS system. This PAT tool for real-time continuous measurement offers robust technology for routine HSWG monitoring and control during scale-up and into manufacture.

References 1.

Freeman, T. (2014) Choosing a Powder Tester. Freeman Technology.

Freeman, T. (2014) In Pursuit of Wet Granulation Optimization. Pharmaceutical Manufacturing.

Narang, AS. (2016) Process Analytical Technology for High Shear Wet Granulation: Wet Mass Consistency Reported by In-Line Drag Flow Force Sensor Is Consistent With Powder Rheology Measured by At-Line FT4 Powder RheometerÂŽ. Journal of Pharmaceutical Sciences. 105:185-187

Event Coverage

New supporting programs at analytica Anacon India and India Lab Expo this year in Hyderabad ➢

Launching new conference ‘Smart Lab Summit’

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Buyer Seller Forum continues to offer business matchmaking service to exhibitors and visitors

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Seminar on ‘Analytical Solutions for Life Sciences Research to be jointly organized with Indian Analytical Instruments Association

More than 300 companies will be exhibiting at India’s leading trade fair for laboratory technology, analysis, Biotechnology and diagnostics industry displaying the best of the technologies. It comprehensively covers the entire value chain for pharma, food, chemical, industrial and research laboratories. The trade fair is accompanied by compelling supporting programs to further enhance the visitor experience.

Co-Location brings benefits For the second time in a row, the co-location with PHARMA Pro &Pack Expo brings a pool of manufacturers and suppliers of pharmaceutical machinery, laboratory and analytical equipment to analytica Anacon India and India Lab Expo. Buyers and trade visitors of analytica Anacon India and India Lab Expo will benefit from attending product segments of PHARMA Pro & Pack Expo and vice-versa. This cross-display of technology will allow visitors to witness a wider range of exhibits and thus, will position the three trade fairs as the most important gathering for the pharmaceutical machinery, analysis and laboratory industry.

New: Smart Lab Summit Visitors to analytica Anacon India and India Lab Expo have the opportunity to engage themselves in a knowledge based forum – Smart Lab Summit, which will be a talking point with respect to latest products, technologies and innovations concerning the laboratory and research & development sector.

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Event Coverage

This will be a top notch forum with a gathering of scientists and key industry experts sharing deep insights about their industry enabling a strong interactive and engaging platform with the audience.

Growing interest for Buyer-Seller Forum: 1,000 meetings expected The buyer seller forum has been an integral supporting program at the trade fair as it involves focused business discussions between the buyers and sellers of the technology. The one-to-one meetings facilitate direct contact between exhibitors and buyers from domestic and international markets through prescheduled meetings. This tailored match-making platform allows exhibitors to connect with possible business partners filtered by branch, position or companies. In return, it allows visitors to search for specific applications or brands. In this edition, more than 1,000 meetings are expected to take place during the show days.

Seminar: Analytical Solutions for Life Sciences Research Attendees will also benefit from an additional supporting program at the analytica Anacon India and India Lab Expo. The seminar on Analytical Solutions for Life Sciences Research will lead to informative sessions and discussions pertaining to key analytical solutions compatible with life sciences and research. The attendees to the seminar will take away important insights about the latest technologies and the best of their applications. “Year on year, we have been receiving an overwhelming response for our supporting programs. This year, we are delighted to launch a new conference, ‘Smart Lab Summit’ keeping in view the feedback of the industry. We are confident that our attendees will witness a balanced mix of latest technologies and knowledge-rich supporting programs, making the most of their visit to the trade fairs.”, Bhupinder Singh, CEO, Messe Muenchen India, summing up the event.

About analytica Anacon India and India Lab Expo Analytica Anacon India addresses the rapidly growing Indian market with exhibition sectors for analysis, laboratory technology, biotechnology and diagnostics. It is being held in conjunction with India Lab Expo, one of India’s leading trade fairs for analysis, laboratory technology and biotechnology. The next events take place from September 6 to 8, 2018 in Hyderabad.

About analytica worldwide Messe München is the world’s leading trade fair organizer for laboratory technology, analysis and biotechnology: Part of the analytica network are the trade fairs analytica China, analytica Anacon India and India Lab Expo in Mumbai and Hyderabad, analytica Vietnam and analytica Lab Africa.

Messe München Messe München is one of the leading exhibition organizers worldwide with more than 50 of its own trade shows for capital goods, consumer goods and new technologies. Every year, a total of over 50,000 exhibitors and around three million visitors take part in more than 200 events at the exhibition center in Munich, at the ICM – Internationales Congress Center München and the MOC Veranstaltungscenter München as well as abroad. Together with its subsidiary companies, Messe München organizes trade shows in China, India, Brazil, Russia, Turkey, South Africa, Nigeria, Vietnam and Iran. With a network of associated companies in Europe, Asia, Africa and South America as well as around 70 representations abroad for over 100 countries, Messe München has a global presence.

For more information: Siddhartha Jain Deputy Head, Marcom Tel: +91-9971600-355 Email: siddhartha.narain@mm-india.in Messe Muenchen India “INIZIO” 507 & 508, 5th floor, Cardinal Gracias Road, Opp. P&G building, Chakala, Andheri (E), Mumbai – 400 099, INDIA www.mm-india.in

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Event Coverage

Connecting with Stalwarts of Pharma & Machinery Industry Intro – PharmaTech Expo & LabTech Expo 2018 is all geared up to bring together the best of the best at one place, where one can network, exhibit, participate, interact with foreign and domestic buyers and share information on Pharma Machinery and Pharma Industry. PharmaTech Expo & LabTech Expo 2018 is premier event dedicated to Pharmaceutical innovation, Technology and knowledge. It has emerged as a crucial platform for showcasing the latest innovation and technologies throughout all phases of the product lifecycle, focusing Pharma manufacturing and processing technology, Pharmaceutical systems and services. This year the focus will be on Pharma Machinery, Formulations, Nutraceutical, Lab, Analytical and Packaging Equipments. Late Mr. Kantilal N Shah, founder of M/s. Kantilal N. Shah has been handling the media and publicity agency of the group since 1971 for national as well as international technical journals, periodicals directories for various industries. His son Ramesh Shah followed the footprints of his father. Ramesh Shah formed KNS MEDIA in the year 1998. Mr. Ramesh Shah is the Chairman of KNS Group of Companies. Mr. Shah took the family business to newer heights. He directed a part of their business to the Pharmaceutical market with the formation of KNS Media. A huge breakthrough for him was getting the opportunity to showcase their abilities in 1998 at the Golden Jubilee celebration of L. M. College of Pharmacy.

After the grand success at their maiden trade show, new avenues opened for them. His Son Mr. Aarjav Shah (MBA, Certified in Exhibition Management (CEM) joined family business and implemented new techniques & technology. Gujarat, one of the most sought after destination in the pharma landscape of India, with its strong and well-established engineering sector plays a dominant role in the pharmaceutical machinery manufacturing sector in India. The coastal state which is all geared to become a global pharmaceutical giant, is also India’s Pharma Machinery hub, producing 40 percent of the country’s machinery. At present Gujarat accounts for about 4500 licensed manufacturing in pharmaceutical industry with share about 32 percent in India Pharma Market. According to industry estimates, approximately 35 to 40 percent of India’s Pharmaceutical machinery is produced in Gujarat. As per FDCA Gujarat estimates, 155 new pharmaceutical manufacturing units have approved in last one year, envisaging investment of Rs. 3800 Corers. These proposed manufacturing facilities are under various stages of implementation. Since these new plants will require pharmaceutical machinery in near future which augment well for pharma machinery industry in Gujarat. PharmaTech Expo 2018 & LabTech Expo 2018 international exhibition on pharma machinery, lab, analytical, Pharma formulations, nutraceuticals & packaging equipment being held from August 22nd to 24th 2018 at Ahmedabad is of special significance

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Event Coverage for the machinery manufactures of the region in view of, the strong growth prospects of the pharmaceutical exports segment and growth in the pharmaceutical machinery sector. PharmaTech Expo 2018 is being organised at a time when the potential of the pharmaceutical industry in India is attracting global attention. It is for sure this initiative will go a long way in creating a strong global brand proposition. In this the 8th edition of PharmaTech Expo, the focus will be on Pharmaceutical formulations, nutraceuticals, API’s cosmetic and Ayurveda. Drawing more than 7000 visitors, more than 250 exhibitors, it is western India Largest Pharma Exhibition, incorporating exhibitors from Pharma machinery, lab equipment packaging equipment, formulation & nutraceutical sector of industry. The exhibition has been planned in about 7500 square meters. The exhibitors will be displaying their latest technology and live demonstration of machinery and equipment for producing drugs and pharmaceutical products. The Expo gives opportunity top suppliers, manufactures, industrialist, entrepreneurs, buyers and consultants to assemble at a common platform. This is a unique platform for displaying the latest technology in pharma manufacturing, testing equipment and formulations. Our event Partner is Drug Marketing & Manufacturing Association (DMMA). The event is being organized in Association with Indo-African Chamber of Commerce & Industry (IACCI), with International Support from The Council of EU Chambers of Commerce in India (Mumbai) & Exclusively Supported By Food and Drug Control

Administration, Gujarat (FDCA) and Federation of Indian Export Organisations (FIEO). Indo Africans Chamber of commerce and Industry (IACCI) is organising reverse Buyer-Seller Meet. IACCI has invited buyers from Botswana, South

Africa, Sudan, Tanzania, Zimbabwe. We are also organising Buyer-Seller Meet with domestic Buyers with potential investment in pharmaceutical industry. The following seminars are concurrently organised: “INDIAN PHARMA INDUSTRY GEARING FOR GLOBAL GIANT” organised by FDCA, Gujarat on 23rd August 2018. “CURRENT TRENDS IN COMPLIANCE – ROLE OF HUMAN RESOURCES” supported by Pharma Knowledge Centre on 24th August 2018. There are few companies who are displaying their highly technical machines with the ultra-modern technology & facilities for the first time in India at PharmaTech Expo and LabTech Expo 2018 at Ahmedabad. The visitors will be privileged to see this high technology machinery at one place & platform. PharmaTech Expo welcomes all the visitors, delegates, exhibitors, supporters and sponsors and wishes them a great business during 22nd to 24th August 2018 at Gujarat University Convention & Exhibition Centre, Ahmedabad. Be a part of the show that will have everything in one place, the best product, business information and services that all industry is looking for.

For more information: Thanks & Regards, Lalitha Gururaj KNS Group 702, Corporate House, Opp. Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 Ph : 079 - 27540493 / 27541142 E-mail : kns_98@yahoo.com Website: http://www.PharmaTechologyindex.com,

www.PharmaTechExpo.com, www.KnsMedia.com,

Event Coverage

PharmaLytica 2018 closes on a high note Witnessed 24% increase in visitor footfall in its 5th edition in Hyderabad ➢

A premier industry event from the organisers of CPhI and P-MEC India

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Showcased the latest in Quality Assurance, Technology, Quality Culture and Regulatory & Compliance Standards for the Pharmaceutical Sector

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Witnessed participation from over 150 exhibitors

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Set to further expand its reach into the Western region by hosting in Mumbai from 2019

Hyderabad, 21st August 2018: The fifth edition of PharmaLytica, hosted by UBM India, successfully concluded at the Hitex Exhibition Centre recently. This year, PharmaLytica witnessed a massive turnout from exhibitors of the Pharma industry with a whooping increase of 24% in visitor footfalls. Positioned as India’s most Comprehensive Analytical, Bio-technology, Lab equipments, Pharma Machinery and Pharma Packaging event, PharmaLytica 2018, brought the pharmaceutical fraternity under one roof to witness the latest industry trends, innovations and conduct business. A series of insightful sessions and panel discussions convened by industry experts were organized to discuss the trending subjects in Quality Assurance, Technology, Quality Culture and Regulatory & Compliance Standards in the Pharmaceutical Sector. The conference focused on the growth phase, challenges and how the industry can again truly distinguish itself in the global pharma industry in the years to come. The expo is set to get bigger by further expanding its reach into the Western region with its strong pharma market by hosting PharmaLytica for the first time in Mumbai from 10 – 12 June, 2019. While targeting the South-West market with sectors such as Lab & Analytical, Pharma Machinery & Packaging, PharmaLytica will also launch API and Excipients zone to continue its pre-eminence in this region.

Speaking on the conclusion of the fifth edition of PharmaLytica in Hyderabad 2018, Mr. Yogesh Mudras, Managing Director, UBM India said,

“We are thrilled that PharmaLytica 2018 witnessed such a great participation from Indian and global firms. At UBM India, we are committed to encouraging novelty in products and an exchange of ideas within the framework of our exhibitions. We are looking forward to taking this prestigious platform to the next level in the coming years. Given our growing and unique offering in the Pharma domain, we are pleased to announce PharmaLytica's move to Mumbai in 2019, aiming to add substantial value to the strong Western market in addition to the Southern one.” Microbioz India

Event Coverage

Speaking at the event, Mr. Uday Bhaskar, Director General, Pharmexcil said,

“I’m happy to be associated with PharmaLytica which has been helping the industry and visitors to understand the latest equipment and trends. It is the one place where they witness an entire range of the industry and get to know about new developments. After all, machinery plays an important role as per FDA guidelines, and this expo has been facilitating machinery manufacturers and product manufacturers. I’m happy that UBM India did a meticulous job in this domain.”

About UBM Asia: UBM Asia recently became part of Informa PLC, a leading B2B information services group and the largest B2B Events organiser in the world. Please visit http://www.ubm.com/asia For more information about our presence in Asia.

About PharmaLytica: PharmaLytica is organised by UBM, which in June 2018 combined with Informa PLC to become a leading B2B information services group and the largest B2B Events organiser in the world. Please visit http://www.ubm.com/india for more information about our presence in India.

For any media queries please contact: UBM India Roshni Mitra / roshni.mitra@ubm.com Mili Lalwani / mili.lalwani@ubm.com

Featured Article

Perform Thermal Validation for Peace of Mind not in Pieces... Thermal validation system is being widely used by End Customers, OEM’s, Third Party Service Providers (TPSPs) for validating the Thermal Processes with respect to Thermal Variants like Temperature, Pressure, and Relative Humidity. In Pharmaceutical Manufacturing Validation plays a major role, being a critical product where Patient safety is the ultimate goal we always strive to achieve the Quality by itself and not by accident. This calls for sub-processes of the manufacturing need to be performing to its Optimum Efficiency and Accuracy. Validation of a process is a critical need. By performing validation of the process generally we ensure the process will perform to its predetermined specification consistently. As highlighted above 3 concepts/parameters are needed to be taken care of in depth with Understanding and consideration. “Will Perform” this is a futuristic and ultimately predicting about the system process performance. So applying a 6 sigma concept the qualifying parameters should not be the same as operation parameters. “Predetermined specification” is another parameter to be understood well. Many times we take the specification of the process or equipment as our specification. However it should be the other way round i.e. the process or equipment should be designed to meet the specification. This specification should be derived to suit all the application that we have with us where the equipment or Process is going to be used. Take out the worst case scenario so the rest of the cases is ultimately taken care of. “Consistency” this is very important aspect to be implemented as it indicates the steadiness of the output from the process or equipment. It ensures that the prediction is better by quality not by chance but surety. There are Regulations and Guidelines like ISO, CFR, EU, HTM , cGMP and many more available which help us to do it right. Some guidelines have the Process Specific Chapters as well where they define in detail about the Procedures, Parameters, Different tools to be used etc. similarly organization like PDA, ISPE also share some practical guides which help you do it right.

Mr. Ramesh Sahu, Skytech India A Right Tool for the validation plays a major role as it is a crucial indicator for the process and the result from this TOOL “Pass or Fail” the Process/Equipment. So the major Question arises-Is the data authenticate enough to certify? Does the Measurement chain not deteriorate its attributes? Regulatory guidelines have very scientifically addressed these points by adding 2 basic steps in the validation process i.e.Pre-calibration and Postverification of the Test instrument. These two steps ensures you to use right specification tool for the validation and also ensures that nothing has gone wrong to the test instrument during the validation process and it is in the acceptable state after performing the Validation. So a validation system should also include a calibration setup so that it becomes a complete set. The same also can be found in regulatory guidelines e.g. FDA GMP guidelines for Steam autoclave. These guidelines defines and talks about the total system Accuracy which is defined as “Total System Accuracy includes the accuracy of data logging device, sensors, calibration reference and calibration standards.” Calibration of any system need expertise in performing it as it takes in to account the behaviour of the sensors, data logger, reference and master components used. There are many other critical points to be considered like point of calibration, external and internal interferences, stability requirement etc. so a calibration engineer is preferred to do this activity to ensure the calibration is done right.

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Featured Article At the end documentation is the key aspect which is needed to be taken into account as this is the final output of the validation activity and the same is available for the auditor. The report should be able to explain all the activities done during validation and also how we ensure the process or equipment performing to meet all quality and the regulatory requirement. There are software available which convert your regular data to a well-defined report with all required information in it. So along with Data logger, sensor, Calibration reference and Calibration Master we also need a reporting tool to make it complete.

With automation we can still increase the reliability of the system by eliminating the human operation error like automatic sensor detection methodology, ensuring the system should not be used uncalibrated, fully automatic calibration with fixed calibration parameters and adhering to the same etc. so ultimately automation makes our life more easier and compliant. There are always options available for any customer to choose the best in class component from different sources to make the solution economically. However this creates more complication to meet the quality and lot of additional precautions and variables have to be taken care of.

The Electronic Data Management Drive of various regulatory bodies (21 CFR Part 11) also demand to preserve the raw data file which should be coded files and in human unreadable format and should be available for ready to use software to cross check the integrity of the reports all the time. Marching towards lean management some time we prefer to outsource full or part of the process of validation. However the responsibility lies with us and the outsourced company canâ&#x20AC;&#x2122;t be the excuse for the non-complaints. Here also we need to ensure the TSP is using right tool and take the job of entire validation including the Pre-calibration and Postverification of the instrument used for the validation. On hiring multiple vendors to perform parts of the process like Validation and Calibration always call for the added risk. One stop solution support more automation and less human intensive, as many sub-procedure has been atomised so errors are being eliminated. Even a uniform Reporting structure for every process provides the reviewer ease, confidence and reliability. Hence the user of the process or Equipment and the people who performed the Validation gets the Peace of Mind and confidence. Authored By: Ramesh Kumar Sahu Email ID: rsahu@skytechindia.com

Market Research

Aurobindo Pharma Q1 profit slips 12% to Rs 455 crore New Delhi: Drug firm Aurobindo Pharma NSE 3.24 % today reported a 12.10 per cent decline in its consolidated net profit to Rs 455.59 crore for the first quarter ended June 30, mainly on account of rise in expenses. The company had posted a net profit of Rs 518.33 crore in the corresponding period previous fiscal, Aurobindo Pharma said in a BSE filing. The company's revenue from operations stood at Rs 4,250.27 crore for the quarter under consideration. It was Rs 3,678.75 crore for the year-ago period. Total expenses of the company for the first quarter were Rs 3,723.28 crore, compared to Rs 2,992.86 crore in the same period last fiscal. "We have achieved 16 per cent growth in revenues led by a healthy growth across key geographies and segments," Aurobindo Pharma MD N Govindarajan said. However, profitability was impacted largely due to certain one-off product related provisions, he added. "With consistent focus on execution and enhancement of capabilities, we have started filing dermatology ANDAs (abbreviated new drug applications) and is on track in other speciality segments," Govindarajan said. Story source / Credit: PTI

Pharma companies bag 40% of US generics The volume share of Indian pharma companies in the US generic market has grown to nearly 40% in August despite regulatory woes and pricing pressures. A steady increase in drug approvals and portfolio rationalisation by MNCs resulted in India’s volume share rising by 5% over the last few months, though value is still impacted due to price erosion. The US, the most lucrative generics market valued at around $60 billion, accounts for 40-60% of revenues of most domestic companies — including Sun Pharma NSE 0.61 %, CiplaNSE -0.22 %, Lupin NSE 3.71 % and Aurobindo — with an overall share of around $10 billion.

Over the last couple of years, channel consolidation and deep pricing pressure has hit generic companies, leading to biggies like Teva, Mylan and Sandoz recently rationalising their portfolio.

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Market Research This has given ground for Indian companies to increase their hold in the US market and it can continue to rise as the portfolio rationalisation is far from over since new (domestic ) companies are still awaiting approvals in base products, according to an analyst from DSP Merrill Lynch India. Planned portfolio exits from large MNC firms have taken India’s volume share up 4 percentage points in the last six months. Around 100 generic drug discontinuations have already been registered with the American regulator USFDA till now, largely from these MNCs, with their share in the US market plummeting to all-time lows — dropping to the level of Indian generic makers. For example, Mylan’s latest rolling four-week market share at 6.1% is already neck and neck with Lupin and Aurobindo, while market leader Teva is at 12.6% share — down 140 basis points y-o-y (100bps = 1 percentage point).

GlaxoSmithKline whacks 165 jobs as it closes skincare products plant in Ireland The future of GlaxoSmithKline’s Sligo plant in Ireland has been uncertain for many years. Now it’s settled: The U.K. company will close the plant and lay off its 165 workers over the next three years. In an announcement to employees on Thursday that was shared by the company, it said the plant had improved its cost efficiency over the years but that sales of its skincare products have not met projected demand. GSK called the “current business model unsustainable.”

The volume-led upside in certain companies is not well reflected as yet, but will soon drive growth in the near and mid-term, and drive earnings 5-7% higher in FY19-20, the analyst adds. Not only have drug approvals of ‘plain-vanilla’ generics surged in the US, but an increasing number of domestic companies are manufacturing ‘complex first generic’ products.

AT Kearney partner (healthcare and pharma) Abhishek Malhotra says, “The first stage of growth was based on leveraging India’s high-quality and lowcost manufacturing base, and primarily focused on generic drugs. Given the pressure on pricing, increased competition and higher regulatory scrutiny, many leading Indian companies have embarked on the second leg of the growth journey. This includes moving up the value chain and developing more complex and specialty drugs and acquiring US companies to have manufacturing and R&D assets in the US.” PwC India leader (pharmaceutical & life sciences) Sujay Shetty says complex generics and speciality products, which are difficult to manufacture, and niche drugs could add value for domestic companies in the near to mid-term as they are more resilient to pricing pressure. Story source and Credit: (This article was originally published in The Times of India)

Glaxo considered alternative uses for the plant but said they were unworkable “without significant further investment.” “We informed employees at our skincare manufacturing site in Sligo of a proposal to close the site. Under this proposal, which affects 165 employees, we would phase down production over three years, before decommissioning the site in the latter part of 2021,” Glaxo said in its announcement. GSK considered shuttering the plant after getting it in a 2009 deal to buy dermatology specialist Stiefel Labs. Instead of closing it then, GSK in 2012 committed to investing about $12.9 million in upgrades. GSK has been making cuts to its manufacturing network for several years as it trims businesses to save costs. Last year, it said it would unload some marginal businesses and make other cuts that would cost about 320 manufacturing jobs in its home country over the next three years. In addition, the company canceled plans to build a new biologics plant there that would have resulted in about 500 new jobs. It cut an unspecified number of jobs at its Barnard Castle manufacturing site in the U.K. earlier this year. Source/Credit: The article originally published in fiercepharma by Eric Palmer

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Trump urges Justice Department to target opioid makers with a ‘major lawsuit’ Months ago, the Department of Justice backed the hundreds of lawsuits that accuse drugmakers and distributors of their alleged contribution to the nation’s opioid epidemic. Now, President Donald Trump is asking Attorney General Jeff Sessions to take another step, to bring “a major lawsuit” of its own. During a cabinet meeting on Thursday,

Trump asked Sessions to bring “a major lawsuit” against opioid makers “that are really sending opioids at a level that it shouldn’t be happening,” according to a conference transcript from the White House. Trump said that instead of joining existing litigation brought against the companies, he wanted the attorney general to bring a separate federal lawsuit, and that he’d be “very, very firm on that.” Sessions, appearing to concur with the president, said his department is “looking at various, different legal avenues to go after abusive companies.” In a statement sent to Fierce Pharma, Purdue Pharma, which is under scrutiny for its marketing of OxyContin, said it “shares the president’s concern about the opioid crisis,” and that it “is committed to working collaboratively with those affected by this public health crisis on meaningful solutions to help stem the tide of opioid-related overdose deaths.”

The request coincided with a new proposal the Justice Department and the Drug Enforcement Administration jointly unveiled to fight opioid abuse. The agencies propose to cut production quotas for the six most frequently misused opioids by an average 10% next year. Those six opioids are oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl. It also came a week after the DOJ reached an agreement in principle to settle a federal probe into Insys Therapeutics’ sales practices of Subsys, an under-the-tongue spray version of fentanyl. The company is paying $150 million to wrap up charges that it engaged in off-label marketing and paid kickbacks to doctors for prescriptions. After filing a “statement of interest,” the DOJ in April decided to participate in settlement talks of lawsuits brought by hundreds of cities and counties now consolidated in a federal court in Cleveland. Plaintiffs in that multidistrict litigation accuse opioid makers of aggressive marketing of their drugs, and claim that distributors failed to properly monitor suspicious orders. Drugmakers targeted in the litigation include Purdue Pharma, Johnson & Johnson, Teva, Allergan and Endo, along with the Big Three drug distributors, AmerisourceBergen, Cardinal Health and McKesson. The companies have denied the allegations. U.S. Judge Dan Polster, who is presiding over the litigation, has been championing for a settlement in the case as soon as possible and immediately moved the parties in that direction. However, in a March filing, the judge indicated the efforts had hit a snag earlier after the parties “identified various barriers to a global resolution.” He set a trial date for September 2019. New York state this week became the latest entity to bring a lawsuit. In its complaint filed to the New York Supreme Court against Purdue, the state alleged that the OxyContin maker intentionally misrepresented the risk of opioids in its marketing while exaggerating the drugs’ benefits.

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Market Research President Donald Trump declared the opioid crisis a national health emergency back in October. And in March, the administration rolled out a new basket of policies aimed at tackling the opioid crisis. The plan includes using tougher law enforcement to crack down on drug dealing, as well as ideas to cut nationwide opioid prescriptions by one-third over three years. The DOJ and DEA said their new proposal is consistent with that goal. At the cabinet meeting, Trump also blasted China and Mexico for sending fentanyl to the U.S., calling it “a form of warfare.” “In China, you have some pretty big companies sending that garbage and killing our people,” said Trump. “I’d like to do whatever you can do legally to stop it from China and from Mexico.” In response, Sessions said the DOJ has returned indictments against distributors from China. Source/Credit: The article originally published in fiercepharma by Angus Liu

Teva wins FDA nod for its generic of Mylan's EpiPen after 2-year delay After a delay of more than two years, Teva has won approval of its generic version of Mylan’s highly successful EpiPens. The approval comes at an

opportune time given that manufacturing issues have made supplies of Mylan’s epinephrine injectors spotty, leaving some parents of children with lifethreatening allergies frantic. The FDA Thursday said it had approved Teva’s copies of the EpiPen and EpiPen Jr epinephrine auto-injector in two doses, 0.3 mg and 0.15 mg strengths.

They are approved for emergency treatment of allergic reactions, including life-threatening anaphylaxis, in adults and children who weigh more than 33 pounds. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” FDA Commissioner Scott Gottlieb, M.D., said in the announcement.” In an emailed statement, a Teva spokesperson said: "We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market. Once launched, Teva’s product will be the only generic, AB-rated/therapeutically equivalent version of EpiPen." The FDA first considered the Teva copy in 2016 but rejected it because of "certain major deficiencies," which Teva at the time said would mean a significant delay. While Mylan’s branded EpiPen once had the market pretty much too itself, other epinephrine autoinjectors are now on the market, including a generic EpiPen from Mylan, which it introduced at the time amidst criticism over its near monopoly position and the high prices of its EpiPens. Impax Laboratories, now part of Amneal Pharmaceuticals, and Kaleo also have approved products. The approval of Teva’s products comes as parents of children who need the pens in the event of a severe allergic reaction have been scrambling to find replacements in some markets. Spot shortages of Mylan’s EpiPens developed last year when a Pfizer subsidiary that makes them for Mylan had manufacturing delays. The FDA this May added it and the injectors from Impax Laboratories to its drug shortages list. In a note to clients, Wells Fargo analyst David Maris said the approval may surprise investors who were thinking it would not happen before 2019. He agreed that given reports of "widespread shortages at back-to-school time", the approval comes at an opportune moment for Teva. He pointed out that Mylan currently has about 73.5% of the epinephrine market, with its branded EpiPen at approximately 24.7% and its own generic at 48.7%. He said the latest data shows that Impax's generic has a 24.9% share and Auvi-Q approximately 2%.

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Market Research Other analysts agreed that the supply issues Mylan and Impax face presents Teva with an opportunity, they point out that the value of the market has declined since Teva first missed approval, with pricing pressure from other products. They see the Teva upside at about $300 million annually from its copy. Source/Credit: The article originally published in fiercepharma by by Eric Palmer

Ex-lawyer of pharma exec Shkreli gets 18 months prison for fraud scheme NEW YORK, Aug 17 (Reuters) - A New York lawyer was sentenced to 18 months prison on Friday for helping Martin Shkreli, currently serving a seven year prison sentence after being convicted of related charges, defraud a drug company that Shkreli had founded.

"I will regret, every day of my life, the day I met Martin Shkreli," Greebel said. Reed Brodsky, Greebel's lawyer, said he planned to appeal. Greebel was found guilty by a jury in December. A different jury in August 2017 found Shkreli guilty of defrauding hedge fund investors, but not guilty of conspiring with Greebel to steal from Retrophin. Greebel, 45, was a partner at the law firm Katten Muchin Rosenman when he was working for Retrophin. He later joined the firm Kaye Scholer, but resigned after his arrest. Shkreli, 35, became notorious in 2015 when he raised the price of anti-parasitic drug Daraprim to $750 a pill, from $13.50, as chief executive of Turing Pharmaceuticals. The price hike is unrelated to the criminal case. The charges he and Greebel faced related to Shkreli's management of his previous drug company, Retrophin, and of two hedge funds, MSMB Capital and MSMB Healthcare, from 2009 to 2014. Prosecutors said Shkreli lied about the funds' finances to lure investors and concealed devastating trading losses. They said he paid investors back with money and shares stolen from Retrophin, which he founded in 2011. Prosecutors said Greebel assisted Shkreli in defrauding Retrophin through a series of settlement and sham consulting agreements. Greebel was also convicted of conspiring with Shkreli to exercise secret control over Retrophin shares belonging to several other shareholders. Shkreli was found guilty of that charge during his trial. (Reporting by Brendan Pierson in New York Editing by Chris Reese) Source/Credit: The article originally published in Reuters

ÂŠReuters. FILE PHOTO: Former drug company executive Martin Shkreli exits U.S. District Court following the fourth day of jury deliberations in his securities fraud trial in the Brooklyn borough of New York City

Evan Greebel, who was outside counsel to Shkreli's former company Retrophin Inc, was sentenced by U.S. District Judge Kiyo Matsumoto in Brooklyn. His lawyers had asked that he be given no jail time, while prosecutors had asked for five years. The judge also ordered Greebel to pay about $10.4 million in restitution to Retrophin. Matsumoto said she had considered that the sentence would be a hardship for Greebel's three children and for his wife, who recently lost her brother. However, she said a prison sentence was necessary to punish Greebel's "extremely serious" conduct and deter other lawyers from aiding clients in committing crimes. Before being sentenced, Greebel apologized to his family and said he felt "shame and sense of loss" since his arrest in December 2015.

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BioTek Granted Autofocus Patent The US Patent and Trademark Office has issued a

patent to BioTek Instruments Inc, Winooski, Vt, for the company’s user-trained autofocus feature in the Gen5 Microplate Reader and Imager Software integrated with its advanced cell imaging systems. The autofocus method enables users to overcome imaging challenges arising from debris or dead cells, thick biology, overexposure, or fluorescent dye bleaching. It works by capturing a user-defined reference scan and applying it to automatically determine comparable focal locations in subsequent images.

Patented user-trained autofocus is available for fluorescence and brightfield image capture, montage, and z-stacking processes in BioTek’s Cytation cell imaging multimode readers and Lionheart automated cell imagers, including existing systems via a software upgrade. Along with user-trained autofocus, the Gen5 software also offers BioTek’s patented laser autofocus and other image-based autofocus methods to provide users with several unique options to address a wide variety of biological sample types and imaging workflows. For more information: visit BioTek.

Waters’ Empower Software integrates Metrohm ion chromatography systems Waters™ leading chromatography data software (CDS), Empower™, increases versatility with the introduction of control for Metrohm ion chromatographs. Laboratories can now perform all their chromatographic applications (including ion chromatography) on one universal software platform. This provides the opportunity to increase efficiency, lower costs, and benefit from faster sample turnaround.

The integration of the Metrohm IC instruments is based on a dedicated driver developed by Metrohm. This enables Empower users to program, control, and monitor all components of their Metrohm system in a familiar software environment. Empower software enables laboratories to appropriately manage data and ensure the traceability of all electronic records, meta data, and analytical results consistent with FDA 21 CFR Part 11 requirements.

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Product Launches Leveraging a single Enterprise CDS, like Empower, minimizes the need for staff to learn multiple applications, and simplifies and reduces validation costs. Over the last twenty-five years, Waters’ Empower Software has provided the gold standard for CDS, defining clear standards for laboratories across the globe. Empower Software has a global reach, with over 475,000 users worldwide on over 4,000 networks. With the recent introduction of Empower Cloud, Waters’ customers can also leverage the power of the internet to procure technology and further drive operational efficiency. For more information: Metrohm AG

Clarity Chromatography Software Version 8.0 with Major Changes We are excited to introduce a Clarity version 8.0 that brings a graphically enhanced user interface. Great attention options where

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enhancements were added. Theportfolio of controlled instruments has grown again, it results in more than 700 supported instruments in Clarity 8.0 software platform. Existing users of Clarity Chromatography Software can update to the new version free of charge.

Detailed information on the new version features can be found at our webpages. Clarity Chromatography Software has a strong position in the chromatography data systems market. Clarity is highly regarded for its intuitive approach, excellent performance, cost-effectiveness and proficient technical support. DataApex is solely focused on chromatography software development. A strong emphasis is placed on technological innovation, visionary adoption of new laboratory standards, best practices and extensive customer support. DataApex products are sold in over 100 countries around the world. 15 chromatography instrument manufacturers resell privately labelled versions (OEMs) of DataApex’s software. For more information : DataApex

Avacta Group plc and Tufts University School of Medicine Collaborate to Develop Novel Class of Drug Conjugate Drug conjugate combines Avacta’s Affimer technology with drug conjugates developed at Tufts Avacta Group plc (AIM: AVCT), the developer of Affimer® biothera peutics and reagents, is pleased to announce that it has agreed a codevelopment partnership with Bach BioSciences, a company commercialising the research of William Bachovchin, Professor of Developmental, Chemical and Molecular Biology at Tufts University School of Medicine, Boston.

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Product Launches The collaboration will develop a new class of Affimer drug conjugate therapies with a novel mode of action that combines Avacta’s Affimer technology with drug conjugates developed at Tufts.

In a ground-breaking co-invention with Tufts, the Company has devised a new class of drug conjugate. This selectively releases a potent drug in the tumour microenvironment (TME) without requiring cellular internalisation of the conjugate as is otherwise the case with traditional antibody-drug conjugates. Some of the novel and differentiating features of Avacta’s Affimer-drug conjugate (“AfDC”) platform include: Affimers that target immune checkpoints such as PD-L1, which serves the dual purpose of localising the drug conjugate to the tumour, while also being immuno-oncologically active and functioning as immune checkpoint inhibitors; and Incorporating a novel linker chemistry designed by Tufts to release, only in the tumour, the active forms of highly potent small molecule drugs that are activators of innate immunity. This thereby creates a highly localised inflammatory event that is synergistic with the Affimer checkpoint inhibitor. Avacta and Tufts have jointly filed for broad patent protection for this inventive concept. The patent covers Affimers, and a wide range of other binders, against oncology, viral and inflammatory targets that are not internalised rapidly enough to be useful in traditional antibody-drug conjugates. It also covers a wide range of drugs to which the binders can be conjugated. The drug development partnership that the Company is now initiating with Professor Bachovchin will develop the first example of this new class of drug conjugate based on the combination of Affimer PDL1 inhibitors and an I-DASH small molecule inhibitor, for which considerable clinical data has already been generated by the laboratory at Tufts. Avacta has exclusive rights to commercialise these novel drug conjugates. Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “We are very excited indeed by this highly novel Affimer drug conjugate concept, the first example of which builds on our own PD-L1 programme and the world-class research of Professor Bachovchin at Tufts University School of Medicine, one of the top US medical schools and research institutes. We believe that this new drug conjugate platform is transformational for the business.

From our initial discussions with several large pharmaceutical companies, it is clear that there is significant interest and there is certainly the potential for partnering at an early stage once we have the appropriate supporting data from the collaboration with Professor Bachovchin. Broad patent protection for this dual mode of action therapy would be extremely valuable because it could be applied to a wide range of cancers for which patient response to checkpoint inhibitors alone is not high. The initial embodiment of the concept, which uses a PD-L1 Affimer, becomes Avacta’s second major drug development programme alongside the PDL1/LAG-3 bispecific blockade. This will maximise the value we deliver to shareholders from the investment in the PD-L1 programme since 2015 and we very much look forward to updating the market on the progress made in the coming months.” Dr Amrik Basran, Chief Scientific Officer of Avacta Group, added: “Cancer immunotherapy can be an effective treatment strategy, but pharmaceutical companies’ early enthusiasm has given way to the reality of limited patient responses that the industry is now trying to address. In particular, while patients that do respond to current checkpoint inhibitors do so with significant and durable benefits, the unfortunate reality is that for most major tumours only about 20-30 percent of patients actually respond to the use of checkpoint inhibitors, leaving a substantial number of patients unable to realize the full therapeutic benefit. Development of bispecifics, such as our PDL1/LAG-3 programme, is one way to address this, but inducers of innate immune responses have also garnered considerable attention. In this new class of drug conjugate that we are developing with Professor Bachovchin, this innate immune response will be combined with check-point inhibition and we expect to see significant improvements in efficacy and safety. The Affimer-drug conjugate circulates as a single molecule, in which the conjugated drug is inert, until it encounters enzymes selectively expressed in tumours, where the drug is released, and through its mechanism of action is designed to turn immunologically “cold” tumours “hot” and receptive to immunotherapy. It is our expectation that this will increase the percentage of responsive patients dramatically and, in doing so, it will make a meaningful difference to the lives of a great many cancer patients.” For more information: Avacta

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Peak Scientific Underlines its Position as the Leader in Nitrogen Systems for Single Quad LC-MS

This compact nitrogen generator, which can easily fit under most standard lab benches, delivers analytical grade nitrogen

Peak Scientific, the global leader in gas generation for analytical laboratories, has introduced a new nitrogen gas solution to the market, Genius SQ 24. A standalone plug & play nitrogen generator, Genius SQ 24 is a cost-effective solution specifically designed for single quad mass-spectrometers which require up to 24L/min of analytical grade nitrogen gas. Genius SQ 24 is an ideal solution for these less demanding LC-MS applications, offering a perfect balance of performance and value, with trusted Peak reliability and on-site service coming as standard.

gas, with a variable flow rate of between 3 and 24L/min, at up to 116 psi. Described by Peak Scientific as â&#x20AC;&#x2DC;The best value nitrogen generator on the marketâ&#x20AC;&#x2122; the Genius SQ 24 comes with a 12-month comprehensive warranty and has been designed with optimized performance in mind. For more information: Peak Scientific Instruments Ltd

RNI NUMBER: UPENG/2017/73675