Microbioz India : July 2018 Lab Edition

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The edition brings for you a cover story titled ‘Are you working safe: Rethinking Laboratory Safety, A working understanding of the prevention of laboratory accidents is integral to any scientific discipline, has legal ramifications, and is a skill that employers expect scientists to have.

Story covered by Microbioz Editorial team

Featured article

Over 2.36 lakh bottles of Atorvastatin Calcium tablets which were used for lowering the cholesterol has been recall from US as per the report by the US health regulator.

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Added to this, the current edition has a special featured article titled, covering upcoming leading trade shows and exhibition of Bio-Pharma and Laboratory named Thailand lab 2018 and PharmaLytica 2018 based in Thailand and Hyderabad.

Product Launches

Cholesterol lowering tables recalls from 24 US by Dr. Reddy’s Laboratories.

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Lupin collaborating with Mylan to commercialise Enbrel

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The drug major Lupin has collaborated with the Mylan for commercialising Enbrel for the treatment of Arthritis.

Basically, Embrel is an autoimmune disorder drug.

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

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elcome to the July 2018 edition of Microbioz India magazine, edition is designed especially for laboratory and analytical professionals. This is for readers who want to know the basic steps and rules need to follow while working in the laboratory.

It is a “Laboratory Edition” supported by the cover story titled ‘Are you working safe? Rethinking Laboratory Safety, by Microbioz India editorial team, The best way to prevent lab accidents is to be prepared and knowledgeable about what you are working with, be it equipment, chemicals or biological materials. Having a range of knowledge for each type or chemical/biological class of hazard you will work with, in advance, is what I call a “working understanding” of your environment in the lab. A working understanding for prevention of lab accidents and incidents is developed by learning how to recognize and evaluate hazards, evaluate risks of those hazards, elimination / minimization of identified risks, and by attention to tasks being performed.

In the event page, a complete list of Upcoming Mega Trade Fairs of Laboratory, Pharma & Hospital 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

Are you working safe?

Rethinking Laboratory Safety working understanding of the prevention of laboratory accidents is integral to any scientific discipline, has legal ramifications, and is a skill that employers expect scientists to have. Four topics can be considered the foundation of this working knowledge. They include hazard recognition and evaluation, risk evaluation, elimination / minimization of identified risks, and attention to tasks being performed.

The best way to prevent lab accidents is to be prepared and knowledgeable about what you are working with, be

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it equipment, chemicals or biological materials. Having a range of knowledge for each type or chemical/biological class of hazard you will work with, in advance, is what I call a “working understanding� of your environment in the lab.

A working understanding for prevention of lab accidents and incidents is developed by learning how to recognize and evaluate hazards, evaluate risks of those hazards, elimination / minimization of identified risks, and by attention to tasks being performed.

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Cover Story Work in a laboratory, if not properly controlled, can present a significant risk to staff and students. No department could afford a major laboratory accident, which would have a devastating impact on the individuals involved and their department. In order to minimize the risk of laboratory operations, the following should be considered seriously and rigorously implemented Safety should be factored into laboratory design and the installation of laboratory facilities and equipment before commencing work; Personnel working in laboratories should have adequate safety training and supervision; All activities in a laboratory should be in accordance with relevant safety guidelines and, if available, specific local safety rules such as Standard Operating Procedures (SOP); Regular laboratory safety inspections should be conducted by departments to identify and control any unacceptable risk.

Here I am sharing few precious laboratory safety rules.

General lab safety rules:

General Lab Safety Roles The hypothetical question “What would happen if…?” should always be posed before an experiment or procedure is attempted.

Do not conduct the procedure unless you can answer all “What if” questions.

Never underestimate the risk and hazards involved in working in laboratories.

Plan ahead. Review thoroughly all proposed laboratory procedures to determine the potential health and safety hazards before you begin work.

Assume that substances of unknown toxicity are hazardous.

Assume that a mixture will be more toxic than its most toxic component.

Be alert to unsafe conditions and ensure that they are corrected as soon as they are detected.

Be prepared for accidents or unexpected events.

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Before beginning an experiment, know what specific action to take in the event of an accidental release of a hazardous substance or an injury. b) Always know the location of safety equipment in your area, and the emergency safety procedures and contact numbers for your area. c) If a test result is different than the predicted, a review of how the new result impacts safety practices must be made.

Housekeeping safety rules Effective housekeeping can help control or eliminate workplace hazards. Poor housekeeping practices frequently contribute to incidents. If the sight of paper, debris, clutter and spills is accepted as normal, then other more serious hazards may be taken for granted.

Housekeeping is not just cleanliness.

It includes keeping work areas neat and orderly, maintaining halls and floors free of slip and trip hazards, and removing of waste materials (e.g., paper, cardboard) and other fire hazards from work areas. It also requires paying attention to important details such as the layout of the whole workplace, aisle marking, the adequacy of storage facilities, and maintenance. Good housekeeping is also a basic part of incident and fire prevention.

Effective housekeeping is an ongoing operation: it is not a one-time or hit-and-miss cleanup done occasionally.

Periodic "panic" cleanups are costly and ineffective in reducing incidents.

A good housekeeping program plans and manages the orderly storage and movement of materials from point of entry to exit. It includes a material flow plan to ensure minimal handling. The plan also makes sure that work areas are not used as storage areas by having workers move materials to and from work areas as needed. Part of the plan could include investing in extra bins and more frequent disposal.

The costs of this investment could be offset by the elimination of repeated handling of the same material and more effective use of the workers' time. Often, ineffective or insufficient storage planning results in materials being handled many times and being stored in hazardous ways. Knowing the workplace layout and the movement of materials throughout it will help when planning work procedures.

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Cover Story Worker training is an essential part of any good housekeeping program. Workers need to know how to work safely with the products they use. They also need to know how to protect other workers such as by posting signs (e.g., "Wet - Slippery Floor") and reporting any unusual conditions.

Housekeeping order is "maintained" not "achieved."

Cleaning and organization must be done regularly, not just at the end of the shift. Integrating housekeeping into jobs can help ensure this is done. A good housekeeping program identifies and assigns responsibilities for the following: Clean up during the shift Day-to-day cleanup Waste disposal Removal of unused materials inspection to ensure cleanup is complete Do not forget out-of-the-way places such as shelves, basements, sheds, and boiler rooms that would otherwise be overlooked.

Dress safety rules Laboratory housekeeping rules also apply to most facilities and deal with the basic upkeep, tidiness, and maintenance of a safe laboratory.

Always keep your work area(s) tidy and clean.

Make sure that all eye wash stations, emergency showers, fire extinguishers, and exits are always unobstructed and accessible.

Only materials you require for your work should be kept in your work area. Everything else should be stored safely out of the way.

Only lightweight items should be stored on top of cabinets; heavier items should always be kept at the bottom.

What can be done to ensure proper use of personal protective equipment?

All personal protective equipment should be safely designed and constructed, and should be maintained in a clean and reliable fashion. It should fit comfortably, encouraging worker use. If the personal protective equipment does not fit properly, it can make the difference between being safely covered or dangerously exposed. When engineering, work practice, and administrative controls are not feasible or do not provide sufficient protection, employers must provide personal protective equipment to their workers and ensure its proper use. Employers are also required to train each worker required to use personal protective equipment to know: When it is necessary What kind is necessary How to properly put it on, adjust, wear and take it off The limitations of the equipment Proper care, maintenance, useful life, and disposal of the equipment If PPE is to be used, a PPE program should be implemented. This program should address the hazards present; the selection, maintenance, and use of PPE; the training of employees; and monitoring of the program to ensure its ongoing effectiveness.

Solids should always be kept out of the laboratory sink.

Any equipment that requires air flow or ventilation to prevent overheating should always be kept clear.

Personal protection safety rules What is personal protective equipment?

Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses. These injuries and illnesses may result from contact with chemical, radiological, physical, electrical, mechanical, or other workplace hazards.

Personal protective equipment may include items such as gloves, safety glasses and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests and full body suits.

Chemical safety Rules Regardless of where you work with chemicals or products containing chemicals, it is important to remember that these types of products have the potential of being extremely harmful and dangerous if they are used incorrectly or incorrectly mixed with one another. Being aware of the following safety tips regarding chemicals, and products containing chemicals, will help protect you from a possible accident and injury.

Keep the telephone number of the Poison Control Center near every telephone.

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Cover Story

The telephone number of poison control is 800-222-1222 in the United States Visit Poison Control Centers in Canada for the telephone number for each province The telephone number for United States animal poison control of the ASPCA is 888-426-4435.

However, there is a consultation fee for this service

General Safety Tips for Chemicals Never combine any products that contain ammonia and chlorine bleach.

“When these common household substances are combined, they form a gas that is highly toxic and can result in serious breathing difficulties or death�

Always take the time to read the warning label on any chemical product you use.

The label provides safe guidelines for using that specific product. In addition to the information on safe usage, the label also generally provides information on safe storage and gives instructions on how to protect you properly when using the product such as the need for of tevonews.com protective gloves, eyewear or Courtesy ventilation.

The label also includes the contact information for the manufacturer of the product.

Always follow the manufacturer's safety recommendations when using any chemicals, products that contain them or any other substances that are hazardous.

References 1.

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https://safety.lovetoknow.com/Chemical_Safe ty_Tips http://www.wellness.uci.edu/toolkit/april/10 ChemSafeRules.pdf https://www.uib.no/en/hmsportalen/80013/safety-rules-work-laboratory https://www.ccohs.ca/oshanswers/hsprogram s/house.html https://www.deviantart.com/cringe27/art/Lab oratory-Safety-164664576

Guest Post

Veer-O-Metals Pvt Ltd Leading manufacturers and exporters of precision sheet metal fabrication parts & preferred supplier to OEM’S and OEM’s products

About Our Company Veer-O-Metals Pvt. Ltd. established during 1965, is one of the leading manufacturers and exporters of precision sheet metal fabrication parts & preferred supplier to OEM’s and OEM products. The group has its manufacturing locations based in India and Philippines.

We have strong capabilities in designing products and manufacturing of stamping and precision metal fabrication parts including mechanical and electromechanical assemblies and machining. We cater to various sectors like Energy Management, Solar Inverter, Oil & Gas, Rail & transportation, Automotive, Aerospace and Defence, Healthcare, Fire protection and Security, and Telecommunication.

Veero introduces OEM products like Monitor arm, Production Monitoring system, Hi Purity Lab Water Purification system Type I, II, III and Sheet metal honey comb / PUF filled doors & panels for housing, clean room, pharmaceutical labs, security and emergency doors.

Veero Monitor Arm: Veero has designed and developed adjustable Monitorarm which allows to easily adjust height and angle of the computer monitor to required positon. It can be used with sit-stand desk and regular office desk and easily attached to work space or wall.

This will help workers avoid the development of musculoskeletal disorders as recommended by ergonomists.

Hi- purity Lab Water Purification system: Veero designed and developed very economical and user-friendly table top placing system, which is producing Type I & III Hi-purity water as per IP standard.

Managing Director: Mr. Sham Sunder Directors: Mr. Praneet Kumar and Mr. Vaneet Sham Sunder

For more details, please contact

Applications TYPE I: Chromatography: HPLC, UPLC, LC-MS & GC and various critical pharma lab requirements.

TYPE III: Instrument feed water, glassware washing, rinsing, autoclaves and water bath.

Renuprasad.H General Manager OE-Product Design & Development Ph +91-80-2345 1945/2345 2497,Fax;+91-80-2345 0654 Mob : 9739045588 Email ID ; info.marketing @veerometals.com Veer-O-Metals pvt Ltd. A-02, BEL Industrial Estate, Jalahalli, Bengaluru- 560013, INDIA. Website : www.veerometals.com

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Market Research

China to give swift regulatory approval to Indian pharmacy

The Indian pharmaceutical companies are looking ahead to fill the blank spaces which are currently present in the Chinese demands for the generic drugs, software, variety of rice etc. The China is preparing to give swift regulatory approvals India- manufactured drugs, the head of an Indian export promotion group said.

We do feel that China is receptive at this time and it's all about making prices competitive," said by a government official involved in the effort to promote trade in China.

India is becoming huge in the Pharmaceutical market, India is dominating the generic drug market by exporting 17.3 billion worth of drugs in year 2017-18 (AprilMarch) year, including to the US & EU, but only 1 percent to China which is the second- largest market for the pharmaceuticals.

Currently many of the India drug-makers are already doing business with the European Union. As the EU is already the one of the key export market for medicines for India.

The swift regulatory approvals in China will allow the Indian companies to boost the revenue during the pricing scrutiny and regulatory troubles have hurt the US sales.

Currently many of the India drug-makers are already doing business with the European Union. As the EU is already the one of the key export market for medicines for India. The swift regulatory approvals in China will allow the Indian companies to boost the revenue during the pricing scrutiny and regulatory troubles have hurt the US sales.

For more information: Reuters.com

Cholesterol lowering tables recalls from US by Dr. Reddy’s Laboratories.

Over 2.36 lakh bottles of Atorvastatin Calcium tablets which were used for lowering the cholesterol has been recall from US as per the report by the US health regulator.

Dr. Reddy’s Lab Inc is recalling the 2.30 lakh bottles due to “failed impurities/degradation specifications,” regulator USFDA said in their Enforcement Report.

The drugs are in 10mg, 20mg & 40mg so out of the total bottles which has been recalled there were 55,126 are of 10mg, 44,894 bottles were of 20 mg & highest quantity was of 40 mg around 1,30,081 bottles.

The 80 mg bottles have been also recalling on account of “presence of the foreign substance: A product complaint was received for the defective tablets with an embedded foreign object observed in a bottle”, the total 80mg bottles are estimating to be 6,397, the reported said.

These tablets were manufactured by the Dr. Reddy’s laboratories Srikakulam facility.

For more information: PTI

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Market Research

Government focusing on developing small pharma firms A big news for the small pharma firms who are looking forward to expand their business, the Union government is ready to provide an interest subvention scheme for the small pharma companies to expand their infrastructure and technologies for a better development. In this scheme the government will tolerate the interest burden of 6% on loan of up to 4 crores for a period of 3 years.

According to the sources the DoP (Department of Pharmaceuticals), who has proposed the scheme, has the budget of around 144 crores for the year 2018-20, with an aim to help around 250 SME pharma companies.

The main aim of this scheme is to provide interest subvention to SME pharma companies having GMP, compliant manufacturing facilities both for the bulk drugs and formulations.

Indian Drug Manufacturers’ Association (IDMA) president Deepnath Roy Chowdhury welcomed the move. “It’s a welcome step. We have been pursuing the government for something like this,” he said..

The launching of the product will be in September, 2018 and it’s the generic equivalent Pfizer's Advil Liqui-Gels Capsules.

"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Ibuprofen capsules OTC, 200 mg," Aurobindo Pharma said in a BSE filing. .

"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Ibuprofen capsules OTC, 200 mg," Aurobindo Pharma said in a BSE filing.

The estimated market size of ibuprofen capsules OTC is USD 164 million for the twelve months ending March 2018. The company has said that it has total of 373 ANDA (Abbreviated New Drug Application) approvals.

For more information: PTI

Lupin collaborating with Mylan to commercialise Enbrel

“This has been intended to improve the manufacturing practices and, therefore, quality of the medicines,” said Navdeep Rinwa, joint secretary in the DoP. Indian Drug Manufacturers’ Association (IDMA) president Deepnath Roy Chowdhury welcomed the move. “It’s a welcome step. We have been pursuing the government for something like this,” he said.

For more information: Microbioz India

Ibuprofen will be now manufactured by Aurobindo pharmaceuticals

The final approval has been received from US health regulators to manufacture the Ibuprofen capsules, which is used as a pain reliever and fever reducer. Now the Aurobindo pharma will manufacture and do the marketing of Ibuprofen.

The drug major Lupin has collaborated with the Mylan for commercialising Enbrel for the treatment of Arthritis. Basically, Embrel is an autoimmune disorder drug. The Mylan will make Lupin’s proposed Embrel biosimilar in countries like Europe, Australia, New Zealand, Latin America, Africa and in the markets in Asia. Embrel (etanercept) biosimilar is the identical copy of a branded drug, which is currently becoming the one of the largest selling drugs in the world with global sales of approximately $11.6 billion in December month ending 31, 2017 as per the IQVIA.

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Market Research The first biologic treatment to get approval for the moderate to serve the RA (Rheumatoid Arthritis) in 1998, & it is used for treating 5 long-term inflammatory conditions which are- rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis (JIA).

The Lupin has also teamed up with the Japanese company Nichi-Iko for selling etanercept in Japan, the product will be launched after receiving the approval from the Japanese drug regulator Pharmaceuticals and Medical Devices Agency (PMDA)

"The introduction of biosimilars is an important mechanism to help increase access to more affordable biologics treatments and our industry-leading portfolio of 20 biosimilar products," said Mylan President Rajiv Malik.

Mylan is well-positioned to commercialise our Etanercept biosimilar given their significant expertise and global infrastructure. This partnership enables us to accelerate our Etanercept market plans across multiple regions globally as we continue to advance our pipeline of biosimilar candidates," said Vinita Gupta, CEO, Lupin Limited.

"The introduction of biosimilars is an important mechanism to help increase access to more affordable biologics treatments and our industry-leading portfolio of 20 biosimilar products," said Mylan President Rajiv Malik.

For more information: Microbioz India

All set to collaborate with Chinese Pharma market As per the report which has not been public that encouraged the Indian pharma industry to work with the Chinese but is careful with their intellectual properties.

While looking at the Chinese market it’s the second largest pharmaceutical industry so for India it will be beneficial in order to gain market access to the market.

It has been projected that the Chinese Healthcare sector will hit $1 Trillion by 2020, so the Indian Pharmaceutical companies should be more engaged with the Chinese market.

In today’s time China is the largest supplier of the API , while India is the largest supplier of the finished pharmaceutical product , so the Chinese market is looking to go from the manufacturing of the basic ingredients for drugs ,(also termed as APIs) to start manufacturing the finished drugs in which India is leading.

They should have a proper understanding of the Chinese market to the Indian industry to make them self strategized for penetrating the Chinese market with their Indian generic drugs.

As the finished products have high margin and this is the thing which is attracting the Chinese market a lot.

Therefore the Indian Pharmaceutical industry has to be prepared and strategized which shaking hands with the China’s giant healthcare market.

For more information: Microbioz India

High Performance Fingerprinting Lens Compact in design, Resolve Optics Model 228 is a full featured, high performance RUVIS lens proven in the world of fingerprinting and forensic investigation.

optical products on time to strict quality and target price guidelines.

For more information: Resolve Optics Ltd

Nightingale Health and UK Biobank Announce Major Initiative to Analyse Half a Million Blood Samples to Facilitate Global Medical Research Comprehensive metabolic biomarker profiles of the world's largest health database to be analysed in 30 months.

The Model 228 lens offers a true high-resolution macro viewing capability by imaging onto a RUVIS scope with a 1:1 lens magnification whilst exactly matching the optical resolution of both lens and image intensifier.

Providing unmatched high performance in both the UV and visible wavebands, the Model 228 lens enables investigators to identify and focus on a target in the visible and then quickly slide the UV filter across to take images in the UV without having to refocus.

Offering a wide field of view the lens offers unmatched high-resolution macro images for fingerprinting and human skin damage applications in particular. Because of its wide field of view and the high transmission qualities of the lens coatings used the Model 228 lens is considerably more light-efficient than other longer focal length lenses offering an identical view.

Drawing upon approaching 30 years experience Resolve Optics has built a strong reputation for specialist lens design and manufacture of smaller production quantities of high performance lenses and

Nightingale Health, the Finnish innovator of an internationally recognized blood biomarker technology for studying chronic diseases, will analyse the biomarker profiles of 500,000 blood samples from UK Biobank.

The ground-breaking research initiative was announced at the UK Biobank Scientific Conference 2018 in London.

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Microbioz India July 2018

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Product Launches Nightingale’s biomarker profiling technology will be used to analyse UK Biobank blood samples by measuring metabolic biomarkers that recent studies have found are predictive of future risk for heart disease, type 2 diabetes and many other common chronic diseases.

Until recently, technological constraints and prohibitive costs have prevented the analysis of comprehensive metabolic data from large-scale biobank collections, but this process has been made viable by Nightingale’s technology, which measures over 200 metabolic biomarkers in a single blood test.

This initiative will further enrich the world’s most detailed public health database provided by the UK Biobank.

Professor Sir Rory Collins, UK Biobank’s Principal Investigator, said the commitment by Nightingale to perform these assays would allow researchers around the world to advance health research more quickly. He expects the combination of these biomarker data with the detailed health information that participants have already provided to generate many new insights. “We are delighted to see these novel blood sample analyses being done in UK Biobank,” said Professor Collins. “We already have an enormous amount of information about the lifestyles and genetic make-up of the participants in UK Biobank, as well as about their health, and are currently conducting imaging studies of their brains, hearts and bodies. Providing the medical research community with these additional high quality metabolic biomarker data on such a large scale will enhance discovery science and population science, providing opportunities to benefit patient care and public health.”

“Analysing 500,000 blood samples from a single study with Nightingale’s comprehensive biomarker profiling technology allows us to uncover metabolic signatures that reflect a risk for future disease onset, as well as their underlying risk factors. We anticipate this detailed molecular readout of the health state, combining both lifestyle and genetic makeup, will result in a wealth of scientific applications from the research community.

This will be relevant not only to the British population but also yield ground-breaking science and enhanced drug development opportunities with a global public health impact,” said Dr. Peter Würtz, Scientific Director and Founder, Nightingale Health.

Nightingale Health’s technology has been previously used to analyse more than 500,000 blood samples from over 200 cohort studies and clinical trials around the globe, with more than 150 peer-reviewed publications showcasing how the detailed metabolic biomarker data provide novel insights into health and disease.

“Nightingale’s mission is strongly linked to scientific evidence generation. This means working with worldleading institutions and biosample collections to continuously improve the understanding of health and disease. Our aim is to translate this understanding into improved early prediction of diabetes and cardiovascular diseases, achieving better healthcare for everyone. Our

initiative with the UK Biobank demonstrates Nightingale’s unwavering commitment towards supporting innovative medical science carried out by researchers from across the world,” said TeemuSuna, CEO and Founder, Nightingale Health.

The initiative corresponds to over 10 million EUR investment in UK Biobank and will be funded by Nightingale Health, with analyses of UK Biobank samples being performed at Nightingale’s laboratory in Finland. In line with the founding principles of the UK Biobank, this metabolomic data will be incorporated back into the UK Biobank's resource following a 9 months exclusivity period for Nightingale Health and made openly available to the scientific community.

For more information:Nightingale Health

Optimized Screw Cap for Automated Handling Micronic, leader in innovative sample storage and automation solutions, launches the new the Screw Cap Ultra.

The Screw Cap Ultra is the latest addition to the range of caps for tubes with an internal thread that Micronic offers to seal tubes. The design of the cap is optimized for automated and manual handling. The high-quality silicon O-ring of the cap fits inside the sample storage tube, creating a ‘‘hard’’ stop between the cap and the tube. This unique closure also enhances the sealing performance for tubes with an internal thread.

The Screw Cap Ultra is available in 4 different premium ‘‘pearl’’ colors: blue, light green, yellow and red. The different cap colors enrich the tube identification process. The color provides a visual clue that works faster than text alone. By adding cap color coding next to 1D and 2D barcodes, users can speed up sample storage and retrieval time, eliminate human errors, and reduce the risk of lost samples.

The Screw Cap Ultra is designed to be compatible with the Micronic Screw Cap Recappers and other automated systems. Hence, the cap is particularly suitable to be used in the process of standardizing the workflow in a laboratory.

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Product Launches The improved sealing performance of the cap leads to a reduction of sample loss and an enhanced sample integrity. The working range of the Screw Cap Ultra is between: Vapor phase LN² and +100°C. This makes it possible to use the cap for short-term and long-term sample storage in extreme temperatures.

The Micronic caps are produced in certified class-7 clean rooms at facilities in both the Netherlands and the United States. The caps are made from the highest purity polypropylene (CE-IVD) and are RNase/DNase and pyrogen free. The caps are available in bulk and precapped on Micronic Tubes with Internal Thread.

For more information: Micronic B.V

New Sterility Test Isolator Fulfills User Dreams Tailored to the requirements of the user – the STISO from Metall+Plastic is modular, ergonomic and fast

Product safety is the focal point during the filling of pharmaceutical products. Sterility test isolators are used to inspect cleanliness and sterility of filled batches and to increase safety. Metall+Plastic offers an appropriate solution with the new sterility test isolator – or short STISO. The STISO was designed as a plug&play isolator for aseptic (STISO), and toxic (STISOtox) applications.

It has a variety of new features and was one of the highlights of the Achema 2018.

The sterility test isolators from Metall+Plastic are easy to adjust to customer requirements due to their modular design. The standard version includes four glove ports in the isolator chamber. Isolator chambers with two or three glove ports are also available. The MTC (Material Transfer Chamber) can be installed to the left or the right of the chamber or on both sides. The MTC can also be retrofitted later. It comes in two different sizes in the standard version. The STISO can be operated from one side and therefore, is suitable for space saving installation against the wall, allowing the STISO to be used for small batches.

A fatigue free workspace: operators benefit from the ergonomic design To minimize physical stress for the operators, the designers for the STISO placed an emphasis on its ergonomic design. An ergonomic study was performed in cooperation with the company “Scala Design” and the results of the study were incorporated into the design of the sterility test isolator.

Therefore, the operator panel is at an optimal height, it is pivotable and angle adjustable. In addition, the machine allows for sufficient legroom. The insertion heights can be adjusted to match the operator’s height. It is also possible to work in a sitting position with an ergonomically designed pivoting chair. Operators also benefit from the loading cart and trolley. Additional options are: particle monitoring, air sampler, sterility test pumps and scales.

Highly active agents like Cytotoxic for live vaccines, viruses and bacteria are becoming more and more vital.

It is critical to guarantee the operator’s and the product’s safety while processing toxic substances. This is accommodated by utilizing HPT filters from Metall+Plastic. The filters separate the airborne particles from the product. The HPT filters are able to handle a volume flow of approximately 1300 cubic meters per hour in H13 or optional in H14 quality. The filters are lightweight and easy to change. They also offer the opportunity to perform an integrated filter integrity test and the plastic paneling can be burned without any residue.

The requirements of the user were also considered during the design of the glove testing units; they are integrated on the side of the panel to make the operation easy. Inspection covers are integrated on the side of the system, are ready-for-use in a short amount of time and stowed-away fast. The software for the testing unit is integrated into the HMI. Reduced ventilation and cycle times Another benefit for the operator, besides the ergonomic design of the STISTO, is the shortened cycle times that are the result of catalytic ventilation. This ventilation ensures that the H2O2 used for the isolator decontamination is removed quickly. The evaporation system RGx enriches the pre-conditioned carrier air with H2O2 and blows it into the STISO. Due to the catalytic ventilation, the Metall+Plastic system obtains timesavings of several hours, depending on the expected remaining H2O2 concentration. This is achieved by a constant air circulation with a catalytic converter that absorbs H2O2 and removes it continuously during the operation.

The STISO creates a maintenance friendly so-called flash evaporation. With the patented DECOjet process from Metall+Plastic, the liquid H2O2 will be transformed into a gaseous state. The advantage: hardly any maintenance work is needed in the evaporator area. Still no residues were determined within half a year during the recommended maintenance interval.

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Product Launches Manufacturer of highly active substances are able to design their sterility tests efficiently and extremely secure. The modular design permits the adjustment to the particular room conditions and the requirements of the staff. This offers an efficient workspace without fatiguing your operation personnel, and eventually benefiting your sterility tests and quality control.

The STISO celebrated its world premiere on the Interphex in New York and was presented on the Achema 2018 in Frankfurt.

For more information: OPTIMA packaging group GmbH

collector, much more sophisticated reaction automation (such as automated sample loop filling), the ability to program multiple experiments and, critically, integration with the Flow-UV™ inline UV-vis spectrophotometer to monitor steady state conditions in real time.

Highly Upgradeable Modular Flow Chemistry System

Advanced Autosampler and Liquid Handling System Improves Lab Productivity

Uniqsis introduces the FlowLab Plus™ for process research chemists looking for a flow chemistry system combining top performance with true operational flexibility.

FlowLab Plus™ is a versatile flow chemistry system built around the Uniqsis Binary Pump™ dual channel reagent delivery system. The system is configured to run both manual and automated flow chemistry reactions. It is the modular equivalent of Uniqsis’ renowned FlowSyn™ integrated flow reactor and may be configured with any combination of up to 4 individual reactor modules.

The computer, pumps and modules are connected over a LAN using an Ethernet hub. In this way, the system can be controlled remotely by Wi-Fi, allowing the control computer to be conveniently operated outside your fume hood.

A wide variety of configurations are possible. By selecting from the HotCoil™ and HotChip™ heated reactor modules, and the Polar Bear Plus Flow™ and new Polar Bear Plus GSM™ cryogenic modules, an operating range from -40°C to 300°C is possible.

Adding Uniqsis’ powerful FlowControl II software permits integration of the FlowLab Plus with a fraction

Uniqsis specialises in the design of meso-scale continuous flow chemistry systems for a wide range of applications in chemical and pharmaceutical research.

The company’s aim is to make flow chemistry easily accessible to both novices and experienced users.

For more information:Uniqsis Ltd

Multistep, automated workflows designed to be versatile, fast and offer high throughput

Laboratories can now automate manual steps and achieve high sample throughput and high productivity with a new autosampler and liquid handling system intended for use in pharmaceutical, contract research, food safety, environmental, clinical research and forensic workflows.

The Thermo Scientific TriPlus RSH AutoSampler and Liquid Handling System with Robotic Tool Change is designed to provide the versatility of multistep workflows in a single, cost-effective solution that is customizable to accommodate a wide range of sample processing and application needs. Thermo Fisher Scientific showcased the new instrument during the 66th American Society for Mass Spectrometry (ASMS) Conference, held June 3-7, in the Sapphire Ballroom ABEF at the Hilton San Diego Bayfront, San Diego.

"Engineered as a flexible and customizable solution, the TriPlus RSH AutoSampler and Liquid Handling System

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Product Launches with Robotic Tool Change is expected to let customers in applied markets maximize productivity and automate manual steps in complex workflows, including laboratories using triple quadrupole technology and high resolution systems such as the Q Exactive Focus Hybrid Quadrupole Mass Spectrometer," said EvettKruka, vice president and general manager, life science mass spectrometry, Thermo Fisher.

"We anticipate the new solution will reduce opportunities for human error with the Thermo Scientific Transcend family of liquid chromatography (LC)/MS systems and help enable laboratories that perform contract testing with dedicated applications on an improved cost-per-test basis."

For more information: Thermo Fisher Scientific

Mass Spectrometer System Offers Solution for Small Molecule Identification and Characterization New, easy-to-use analytical detection system extracts meaningful data quickly from acquisition to analysis Scientists can now use a powerful new system to automatically capture as much spectral information about small molecules as possible and efficiently translate this into confident identification of chemical compounds. It will now be possible to collect much more structure-informative data to increase the depth of small molecule compound analysis and boost confidence in IDs, to improve the structural characterization of extractables and leachables, metabolites, and other compound classes and to advance the study of metabolomic, lipidomic and natural product samples.

The Thermo Scientific Orbitrap ID-X Tribrid Mass Spectrometry system combines quadrupole, Orbitrap and linear ion trap mass analyzer technology, novel automated data acquisition strategies, and powerful structural analysis software to significantly improve small molecule compound identification. Thermo Fisher Scientific showcased the new system during the 66th

"Interpreting an unknown compound’s mass spectra continues to be a considerable challenge and a bottleneck to progress in many important fields of study," said EvettKruka, vice president and general manager, life sciences mass spectrometry, Thermo Fisher.

"With the launch of the Orbitrap ID-X Tribrid Mass Spectrometry system, and its associated data acquisition and analysis software tools, customers now have access to a complete, intelligent and automated solution that can accelerate and transform small molecule identification and characterization."

"The Orbitrap ID-X Tribrid mass spectrometer delivers complementary information with multiple dissociation techniques and robust MSndata required to deduce structural information and increase confidence in metabolite annotation," said Warwick Dunn, PhD, professor, Analytical and Clinical Metabolomics at the Phenome Centre Birmingham, School of Biosciences and Institute of Metabolism and Systems Research, University of Birmingham, UK. "With AcquireX built-in intelligent data acquisition, we now collect more informative data and, not just more data, we can maximize metabolome coverage and increase confidence in the identification on unknowns applying intelligentDDA approaches."

Designed as a complete solution from data acquisition to data analysis, the Orbitrap ID-X Tribrid Mass Spectrometry system offers the following benefits:

Proven and trusted Tribrid architecture combined with fit-for-purpose user interface designed to efficiently acquire high-quality data using ready-to-use experimental parameters AcquireX, a fully automated acquisition workflow allowing for comprehensive sample interrogation capturing critical data MSn librarygenerating tool allows users to create their own spectral library for subsequent data analysis m/z Logic, an automated MSn data processing routine designed for improved coverage with increased confidence.

American Society for Mass Spectrometry (ASMS) Conference, held June 3-7, in the Sapphire Ballroom ABEF at the Hilton San Diego Bayfront, San Diego.

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Product Launches The seamless combination of the Orbitrap ID-X Tribrid Mass Spectrometer with software acquisition and analysis solutions, including Thermo Scientific Mass Frontier 8.0 spectral interpretation software and Thermo Scientific Compound Discover 3.0, facilitates the characterization of small molecules, the elucidation of their structures, the identification of metabolites and the detection of extractables/leachables by users with a range of experience and expertise.

For more information: Thermo Fisher Scientific

The chamber door opens down to the front, and columns, valves and fittings are mounted on the inside of the door for exceptional, unobstructed ease of access.

The EchoTherm Model CO30 also features RS232 I/O port for programming, and data collection, timer with user settable Auto-Off, Peltier technology with no CFC’s, separate chamber and valve drains, and twelve month warranty. The unit comes with valve mounting hole, 3-wire AC line cord, fused high and neutral lines, and instruction manual.

NEW HPLC Column Chiller/Heater with Largest Chamber Available

The Model CO30 is available in models that operate on 100, 115, or 230 VAC, 50/60 Hz. UL, CSA, and CE approvals.

For more information: Torrey Pines Scientific Inc

Torrey Pines Scientific announces its new EchoTherm™ HPLC Column Chiller/Heater Model CO30 with the largest, easiest to access chamber available.

Small Versatile Benchtop Autoclave Whether you are planning a start-up laboratory, an established lab with low sterilising throughputs, creating a Cat 3 laboratory or a lab manager wanting a more affordable, simple to operate and easy to install steam steriliser, the selfcontained Priorclave C40 bench top laboratory autoclave is the perfect choice.

This new column chiller/heater has a temperature range from 4.0°C to 70.0°C readable and settable to 0.1°C. The PID temperature control software regulates temperatures to ±0.2°C, even at ambient. The chamber is large . . . 15.625" tall x 6.385" wide x 5.125" deep, and is capable of holding four 30 cm x 1 inch columns, plus a valve, tubing and fittings.

It is a compact, featured-packed and competitively priced autoclave offering truly exceptional value and requires simply plugging directly into a 230V supply to get it fully operational.

The chamber temperature is kept constant throughout by an internal fan.

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Product Launches Every sterilising process is easily programmed through the proven TACTROL® controller - just set temperature and time, select any options needed and press start, operation is fully automatic once the cycle has started.

There are a number of options available in the C40 benchtop range. In addition to the standard format this benchtop range of laboratory autoclaves and research sterilisers is available with stand-off legs providing significant advantages to designated CAT 3 application areas, allowing much easier access beneath the autoclave for cleaning and disinfection of the laboratory work surface. This helps prevent spread of virus and eliminate potential cross contamination.

Adding to the versatility of this C40 autoclave range from Priorclave is an option to be fitted with a highly efficient vacuum system. This is ideal for those research laboratories carrying out low-volume sterilisation of items such as bagged mixed plastic waste, tubing and narrow bore glass ware.

Each model in the C40 laboratory autoclave range has a 40 litre, 350mm diameter chamber which is accessed through a wide aperture door for easy loading and removal and one that incorporates a high level of personnel safety with interlock preventing opening at elevated temperatures and pressures.

Designed and manufactured by one of Britain’s top laboratory autoclave producer, it has an extremely small footprint, ensuring that even the smallest laboratory could consider this highly efficient and reliable front loading benchtop autoclave. Investing in the Priorclave brand gives access to an exceptional level of customer pre and after-sales support through a dedicated team always on-hand to provide expert advice, ensuring each and every laboratory maximises the use of these robust autoclaves.

The C40 benchtop autoclave is part of an extensive Priorclave laboratory autoclave range that includes compact top loading machines, large format frontloading and powerdoor autoclaves as well as double-door autoclaves, pass-through and stackable units. Priorclave has also developed a large range of addons that can be fitted during manufacture, tailoring each autoclave purchase, ensuring it delivers the ultimate sterilising performance matched to the application.

With all Priorclave products, at the end of the normal warranty period, this dedicated autoclave manufacturer is able to ensures that their autoclave’s offer exceptional operational longevity. Planned Maintenance Programmes help maintain full functionality, reliability and sterilising performance which reduces very significantly the overall cost of ownership.

For more information: Priorclave Ltd

Refractive Index Detector for Challenging GPC/SEC Applications The Differential Refractive Index (DRI) Detector from Testa Analytical Solutions is a next-generation instrument for challenging GPC/SEC applications.

The DRI Detector has been designed to fit seamlessly with all commercially available MALS and SLS detectors resulting in more accurate and reliable results. Its high sensitivity makes the Testa Analytical DRI Detector the perfect companion for characterization of natural and synthetic polymers as well as protein investigations that demand leading edge performance.

The instrument operates at the same wavelength as MALS and SLS detectors thereby enabling determination of both absolute concentration and also total mass balance. Operating from room temperature up to 80 °C underlines the unmatched operational flexibility of this instrument. Designed to operate in both horizontal and vertical orientations, the compact DRI offers the versatility to fit your available benchspace.

While developed for use with GPC/SEC multi detector systems, the DRI detector also provides unbeatable performance in more classical HPLC application such as detection of sugars and is available optimised for low flow rates down to 300 µL/min.

Testa Analytical Solutions e.K. is a company dedicated to supplying the best possible instrumental solutions for characterization of polymers, particles, nanomaterials and proteins. Drawing upon over 30 years experience of technologies serving these markets, the staff at Testa

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Product Launches Analytical are happy to share their knowledge with researchers worldwide to help provide them with a working solution for even the most demanding applications.

For more information: ESTA Analytical Solutions

New Ocean MZ5 ATR-MIR Spectrometer Delivers Rapid, Accurate Analysis

Ocean MZ5 is a self-contained system that does not require any external equipment such as light sources or fibers. Ocean Mirror, the dedicated software platform that comes with the system, is designed for measuring absorbance and transmittance of liquids placed on the instrument’s crystal surface. A rotating cover protects the crystal when not in use.

Now available from Ocean Optics is the Ocean MZ5, a compact, fully integrated ATR-MIR spectrometer that measures liquid samples from 1818–909 cm-1 (5.511 μm).

Ocean MZ5 comprises a sample interface, light source, detector and software, and provides a fast, convenient alternative to traditional FTIR spectroscopy for lab research.

Applications range from chemical discrimination and food and flavorings authentication, to biofuels analysis and environmental testing.

Ocean Optics has extensive applications and solutions development experience across the UV, Visible and NIR wavelength ranges. With Ocean MZ5, the company has partnered with Pyreos Limited (Edinburgh, Scotland) to expand its capabilities into new mid-IR solutions.

For more information: Ocean Optics

Pre event Coverage

Hyderabad to witness latest innovations and trends in the pharmaceutical sector with PharmaLytica 2018 India’s most comprehensive Analytical, Lab, Pharma Machinery & Contract Services Event by UBM India UBM India, organizers of CPhI / P-MEC India, the leading global pharma trade show and conference, today announced the 5th edition of PharmaLytica 2018. two-day event will be held at Hyderabad, the Bulk Drug capital of India, at the HITEX Exhibition Center on 10th & 11thAugust 2018.

The most important pharma related expo in South India, PharmaLytica 2018 will enable the pharmaceutical community pick up on the latest industry trends, innovations and conduct business with Analytical, Laboratory, Machinery, Packaging and other allied Industries. The expo is well supported by associations including Pharmexcil, Confederation of Indian Pharmaceutical Industry (CiPi) and Indian Drug Manufacturers’ Association ( IDMA ).

In the current edition, PharmaLytica will witness the participation of over 150 exhibitors from across the country including notable industry players such as Kirloskar, Standard Group of Companies, Bry-Air Asia, Allyone Industries, Rotomark Innovations, Gandhi Automation, Mack Pharmatech, Autocal Solutions, Helios Concrew, S.K. Pharma Machinery, NPM Machinery, GMM Pfaudler, ELGI Equipments, First Source Lab, Apex Chromatography, Valfit Engineers, Integrated Cleanroom Technology, Dumra Machines, Sigma Scientific Glass, among many others.

The event also comprises the PharmaLytica Seminar, covering a number of insightful sessions and discussions on the latest industry trends. Some of these include subjects such as ‘A Smart Pharma Manufacturing for Operational Excellence; Latest in Pharmaceutical, Analytical & Lab’ ; ‘Technology Edge’ that will talk about the Importance of information in the pharmaceutical industry; ‘Cost-Quality Efficiency’; ‘Setting Quality Culture Parameters’ that will talk about challenges pertaining to quality culture articulation; ‘A distant view of Indian Pricing & Regulatory: US Perspective’; ‘Presentation of Case study on Pharmacoeconomics’; ‘Is Regulatory Compliance much more than good manufacturing Practices (GMP) ?’and ‘Regulatory, Pricing & Patients – Equilibrium.

To enhance the touch-and-feel aspect of the expo, one of the much-anticipated highlights will be the inclusion of an

Innovation Gallery, where visitors get to view first-hand, the eye-catching innovations and technology offered by the exhibitors.

The expo plans to spread out its wings in 2019 by venturing into the Western region with its strong pharma market by hosting PharmaLytica for the first time in Mumbai. 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 preeminence in this region. This will enhance the exhibition profile as a one stop shop for all end-to-end Pharma solutions under one roof.

Speaking on the announcement of the 5th edition of PharmaLytica, Mr. Yogesh Mudras, Managing Director, UBM India said, “Over the years, PharmaLytica has evolved as the leading marketplace for products and services along the entire value chain in niche segments within the Pharma industry. The expo and especially the conference within it, seeks to deepen understanding of the changing landscape in the sector to enable responses to marketplace trends. It will also play a key role in establishing a unique drug safety ecosystem in India”.

“By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and 6th largest market globally in absolute size. The pharma companies are making tremendous efforts to discover new drugs, increasing R&D expenditure, implementing technology and introducing new methodologies to improve quality of manufacturing. Our

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Pre event Coverage

focus at PharmaLytica, would be to keep the companies abreast with innovations in the growing businesses of India’s pharma industry. Given our growing and unrivalled offering in the pharma domain, and the fact that the expo has been growing in tandem with the growth of the sector including in the ancillary side, we are pleased to move PharmaLytica to Mumbai in 2019. Side by side, we are also increasing our offerings and this will no doubt, add immense value to the strong Western market in addition to the Southern one.” he further added.

Renowned as the pharmacy of the world, the Indian pharma economy has been lauded for its rapid growth in recent decades. The pharmaceutical sector was valued at US$ 33 billion in 2017. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at US$ 17.27 billion in 2017-18 and are expected to reach US$ 20 billion by 2020.

The various economic drivers and government policies like pharma parks, boosting the biosimilars and biologics sector, along with ancillary sectors, and reducing manufacturing costs are the key driving factors for the growth of the sector in the country. The ‘Pharma Vision 2020', introduced to make India a

global leader in end-to-end drug manufacturing, has also boosted investments. __________________ To know more about the event and register for a free entry to the event, visit - www.ubmindia.in/pharmalytica 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 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 www.ubm.com/india for more information about our presence in India.

For any media queries please contact: MSL India Suhasini Kona: 9505038290 / suhasini.kona@mslgroup.com Azam Khan: 9848037367/ azam.khan@mslgroup.com

Thailand LAB INTERNATIONAL Open its New Booming Market: Medical Laboratory & Pharmaceutical ‘MEDLAB’ Asia Pacific is expected to register the highest growth rate during the forecast period owing to the increasing penetration of cutting-edge clinical laboratory technologies in Asia Pacific countries, and a significant rise in disposable income among the middle-class population. The clinical laboratory services market is segmented into North America, Europe, Asia Pacific, and the Rest of the World and is projected to grow at a CAGR of 5.2% to reach USD 146.14 billion by 2022 from USD 113.44 billion in 2017, at a CAGR of 5.2%. The increasing global burden of target diseases, advancements in clinical diagnostic techniques, and government initiatives to improve the quality and affordability of clinical diagnostic testing procedures are the major drivers of demand in this market.

Thailand's business environment will continue to offer opportunities for multinational drug makers. The Thai government forecasts sales to rise from THB160bn (USD4.5bn) in 2016 to THB275bn (USD8.3bn) by 2026, at a compound annual growth rate of 5% in local currency terms and 6.2% in US dollar terms. The factors supporting market expansion include improvements in healthcare access and rising demand for medical treatments as Thailand's elderly population continues to grow.

The 8th International Trade Exhibition and Conference on Analytical Laboratory Equipment & Technology, Biotechnology & Life Sciences and Chemical & Safety will return during 12th – 14th September 2018 at EH102-103, BITEC, Thailand.

This year, Thailand LAB INTERNATIONAL will launch a new segment--‘MEDLAB’.

We will focus on the medical & clinical laboratory,

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Pre event Coverage biotechnology and pharmaceutical industries by inviting leading companies to showcase their latest innovative products such as hematology and histology analyzers, clinical chemistry and laboratory equipment, in vitro diagnostics and lab automation & equipment supplies etc. Moreover, seminars on clinical laboratory, precision medicine and quality assurance will be organized and promoted.

Visitor information revealed that 23% of visitors work in the medical laboratory industry. Most are hospital directors, healthcare facility owners, healthcare management consultants, hospital owners, investors, microbiologists, virologists, chief med-tech officers, lab supervisors, medical technologists and more.

Visit and explore the exhibition with the ‘Hosted Buyer Program’ If you are a key local or international buyer, investor or decision maker, you will be eligible for our “Hosted Buyer Program” (HBP). HBP will provide an opportunity to meet leading manufacturers/ suppliers as well as offering complimentary air tickets or accommodation.

Other benefits include: Fast track registration at the Buyer Counter, Access to the buyer lounge with refreshments and snacks throughout the day, Complimentary accommodation for two nights at the official hotel, an invitation to join networking functions: the opening ceremony, the networking reception and more, online & offline business matching services.

Apply this program, please contact chanunrat.kon@vnuexhibitionsap.com or www.thailandlab.com to get more information.

RNI NUMBER: UPENG/2017/73675