Express Pharma

‘Our products meet the statutory and regulatory requirements of the EU’

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What are Remi’s major milestones?

Sunil Saraf

Remi is a well-known brand with the scientific and healthcare professionals in India for more than 50 years. REMI is a pioneer in supplying innovative products that are import substitutes thereby helping the nation save precious foreign exchange. We were the first in India to manufacture table top centrifuges, laboratory and magnetic stirrers, high speed (20000 RPM) centrifuges, refrigerated centrifuges, blood bank centrifuge for component separation, CE marking for table top centrifuges, mixers and shakers and biggest top entry agitator in India for fluid mixing.

The company is a global manufacturer and exporter of laboratory and blood bank instruments. How far has the company been able to spread its business?

Remi has been exporting its products to more than 50 countries globally. Our products are used extensively in our neighbouring countries and in African sub-continent. We have around 50 per cent market share in Italy for bench top centrifuges and are now looking at other countries in Europe to increase our penetration. Our products meet the statutory and regulatory requirements of the European Union. We also participate in international exhibitions and trade shows to increase our presence and keep ourselves abreast with the changing technology and customer requirements, new product introductions etc.

Tell us about your certifications obtained from global authorities?

Being a global exporter of laboratory and blood bank instruments, it is imperative for REMI to get its products and processes certified by international bodies. All REMI products have certifications recognised by international organisations such as ISO-13485 : 2003: Quality management system for medical devices, ISO-9001-2008: certification for design, manufacturing and supply of laboratory and blood banking instruments, CE Marking: important conformity standards in EU, all REMI products carry a CE mark as adhering to conformity. WHO-GMP certificate: manufacturing facilities adhere to WHO – GMP guidelines as laid down by World Health organisation time to time.

Has the company conducted any research work recently? How rewarding and successful was it?

Research forms an integral part for survival of a company. Though we don’t have to involve in path breaking research like the pharma majors and CRMS, but often focus on incorporating products with new versions. Our research is based on developing user-interface and integrating maximum functions on microprocessors to eliminate human errors. Since all the products are manufactured in-house it offers us maximum flexibility to validate the products along with testing prior to launch. Lately, we launched a new product for our healthcare division ‘PRP Centrifuge’ the evolution of product was need-based to harvest platelet-rich-plasma (PRP). Been a leader in blood bank instrument industry, our sales and service team felt need to develop specific product to address this issue faced by physicians and surgeons (Used to harvest platelet-rich-plasma in pain, wound and cosmetic treatments). Presently Remi PRP Centrifuge is the only product specially focused for harvesting PRP in India.

Indian pharma companies are facing a lot of flak from global regulators like the US FDA. Does your products meet all these regulatory compliances? Do you think your products will help Indian pharma companies resolve issues faced on the regulatory front?

Our products meet the requirements of global regulators like US FDA. Instruments like incubators, stability chambers, freezers, walk in stability chambers, cold rooms etc. are supplied with proprietary “REMI Datasoft” software which comply with the requirements of 21 CFR Part 11.

Remi Elektrotechnik’s upcoming new manufacturing facility

Where are your manufacturing facilities located?

Starting way back in 1960 in a small shed, today our manufacturing facility is located at Vasai. The facility is spread across an area of 65,000 sq ft which houses all different departments’ like design and development, fabrication, pre-treatment, powder coating, assembly lines, quality assurance, packaging and dispatch. The installed capacity is more than 5000 units per month. We also have a dedicated test room to simulate different environment conditions to do type testing of our products internally. The manufactured products include FHP motors, laboratory and magnetic stirrers, bench top and floor standing centrifuges in refrigerated and non refrigerated versions, shakers and mixers, incubators, stability chambers, cold cabinets, deep freezers, etc. We also manufacture blood bank instruments like blood bank refrigerators, blood collection monitors, plasma freezers, platelet incubators/agitators and ultra low temperature freezers. Recently, we have introduced Clevofuge and PRP centrifuges in the Indian market. The manufacturing facility is ISO-9001:2008 certified and ISO-13485 certified for medical devices and possesses a documentary quality management system in place. All products prior to dispatch are calibrated internally with the use of calibrators which are tested in NABL accredited test laboratories. We provide all documents and test reports as per customer requirements.

Do you plan to set up new facilities or expand the existing ones?

Our existing facility has sufficient space to fulfil our expansion plans in the coming years. Up-gradation of facility and investment in new technologies, machinery etc. would be done in keeping with our expansion plans to cater to our customers, both in India and abroad.

Who are your major clients?

Our major clients include leading hospitals, path labs and diagnostic centres, medical colleges, educational and research institutions, pharma/ biotech/ chemical/ cement/ paint industries and CSIR labs etc. We take pride in the fact that every twenty minutes; someone in India is buying a Remi laboratory/ blood banking product for their use.

How much revenue did the company generate during the last fiscal? What are your expectations from the current year?

Due to a wide customer base using our basket of products, we have not been affected by any slowdown. In fact, Remi has been significantly growing year-on-year. Last year we grew by more than 15 per cent. Considering the feel good factor that is slowly creeping in the Indian economy, we expect to increase our growth rate substantially and double our existing turnover in a short span.

Tell us about the company’s plans for the next 25 years’?

Our historic and successful past has helped to gather profound insights on customer needs in the segments that we operate in. We introduce new products or upgrade our existing products based on our customers’ feedback. We see a lot of business opportunities in healthcare and medical devices market. In future, we will launch new products for this segment. We have already chalked out exciting plans to venture into this segment with the launch of ‘Remi Healthcare Division’ this year. You will hear more about this division in the coming years.

At the moment, Remi is also helping blood banks in upgrading themselves from a storage centre to a component preparation blood bank. We see ourselves in facilitating this changeover in a big way, in the years to come. We will also look at consultancy opportunities in the field of upgrading or establishing new blood banks, path labs and diagnostic centres.

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Question & Answer with Schott Glass India
Harish Kapoor, General Manager – International Business Development, ACG Worldwide: What is a Type I glass?

Schott Glass India: Type I is a special designation used in the ISO standards and pharmacopeia to describe the quality of glass used for pharmaceutical primary packaging. Type I describes the highest quality and is generally recommended to be used for parenteral packaging whereas Type III describes the lower quality and is recommended to be used rather for orally applied and solid drugs (except for lyophilisation products).

According to the definition in the current Pharmacopeia Type I glasses are borosilicate glasses containing significant amounts of boric oxide, aluminum oxide and alkali and/or alkaline earth oxides. With this composition they offer a high hydrolytic resistance and a high thermal shock resistance.

Whether glasses belong to the group of Type I glasses is determined with both the glass grain test and the container surface test. Both tests evaluate the resistance of the glass against water attack at 121°C. The higher the resistance of the glass is the higher is its quality and the more it is a preferable packaging material.


Abhay Bagesar, Manager Regulatory Affairs, USV: What are extractables and leachables (E & L)?

Schott Glass India: Extractables are components of the container closure system (all packaging materials) that are released during a certain stress test procedure (e.g. aggressive solvents, exaggerated conditions of time and temperature).

Leachables are components of the container closure system that migrate into the drug formulation during usual production process and storage.

The amount of E & L coming from the material is dependant on many different factors like the material itself (glass or plastic; Type I or Type III glass), the converting process, pH value of the drug formulation, ionic strength of the formulation, closure system, sterilisation methods, temperatures during processing and storage, secondary packaging, and many more. Due to this high amount of diverse parameters only the owner of the finished product (the pharma company) is able and obliged to perform E & L studies on their products. These studies are done as stability studies (extractables studies, accelerated aging studies, durability studies) to evaluate the quality and the compatibility of the packaging material.

(To feature in this column, email your queries to Dr Bettine Boltres ,SCHOTT AG: [email protected])

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