De Lama: interview for the Indian Cutting Edge magazine. History & prospectives of the 1st italian sterilizer manifacturer and world leader

Dr. Marco Bianchi, Marketing and Sales manager, third generation of the De Lama family, gave a long interview to Cutting Edge a magazine published by Spinco Biotech and distributed in 30,000 copies to over 600 pharmaceutical companies in India and in the hands of the best professionals of the sector, together with the digital format, received via mail and read by thousands of other readers.

The interview traces the history of the company, the milestones that have characterized it, but above all highlight the strengths and uniqueness of De Lama, which characterize it as a leader in the industrial sterilization machinery and for industrial washing in the pharmaceutical sector.

Marco Bianchi also highlighted the many and important innovations launched on the market recently, which put De Lama as one of the most proactive and technologically advanced companies in the sector and today ready for a structured and coordinated launch of the brand in India.

Among the most innovative equipment there is certainly to report_

  • the new high-vacuum vacuum hydrogen peroxide sterilizer Link DLVHP/ST
  • the new hydrogen peroxide pass-box for vacuum decontamination:  Link a DLVHP/DE
  • the new cGMP Washer for the pharmaceutical: a revolution for a 100% repeatable process: the 100% custom washing machine for the pharmaceutical industry.  Link a DLWD
  • the new MagnetoDoor ® (registered trademark and patent pending, the first magnetic driven door that allows a direct coupling of all De Lama equipment with the isolator of other brands, with the advantage of creating a single aseptic environment together with the isolator and leading to the elimination at the root of all transfer problems such as the risk of cross-contamination.
  • Link a Magnetodoor® Link Integration with isolator

 

Here is the link to the number in digital format, find the interview from page 40 to 45: https://www.spincotech.com/ebook/april2019/

Below is the complete and original text of the interview in English:

De Lama Interview for April’19 CuttingEdge

De Lama, Italy are the world leaders, in design and manufacturing of Process and Sterilization equipment since 1949. With more than 5000 installations mostly in pharma companies across the world, the company provides fully integrated solutions for sterilization, drying, pass boxes for decontamination, washing etc. Mr. Marco Bianchi, who belongs to the third generation of the De Lama family and responsible for marketing and business development, recently visited Spinco Towers, Chennai along with Mr.Andrea Muggiasca, Technical Director, to sign a partnership contract with Spinco Biotech followed by visits to a few of pharmaceutical customers in India. During the visit Mr.Marco Bianchi shared the long and successful history of the De Lama and how many of their ‘first in the industry’ products such as ‘magnetic-door based autoclaves’, ‘combo washing + sterilization unit’ ‘ hydrogen peroxide pass-box for decontamination etc,. have carved a niche for themselves.
Excerpts from the full discussion with Mr.Mohan who was in De Lama facility recently.

Thank you for visiting India. Please share with us about your 70-year long successful journey in sterilization technology

De Lama, founded in 1949, by engineer Franco De Lama was the first company in Italy to produce autoclaves. The founder saw the importance of sterilization in post-war reconstruction after the Second World War and soon laid the foundation for a strong base in Italy, further expanding in Europe and starting from the 60s, began establishing leadership position all over the world as a manufacturer of high quality autoclaves and sterilizers for the pharmaceutical industry.

The pharmaceutical sector has been the field which De Lama took as a reference point to create equipment in compliance to stringent requirements and offering high performance. Backed by highly skilled and capable teams, we were in the forefront of introducing many novel technologies right from the beginning and have many firsts to our credit – 1st Dryer under vacuum in 1958, 1st saturated steam sterilizer with liquid sealed containers cycle in 1964, 1st ethylene oxide sterilizer in 1968, 1st Superheated water autoclave in 1980, 1st micro-processor based system in 1984, 1st Air Mix Sterilization Sterilizer in 1986, 1st autoclave for pathogenic treatment in 1994, 1st line of industrial washing machines for the pharma sector in 1997, 1st combo washing+sterilization unit in 2005, 1st autoclave coupled with an isolator in 2008, 1st magnetically driven door for autoclave in 2016 and 1st Hydrogen Peroxide passbox for decontamination under vacuum. As we further expand our market reach, we are more than ever committed to bring out more innovative products for the benefit of our customers.

Please outline the range of advanced Sterilization solutions provided by De Lama for the Indian pharmaceutical industry which is poised to grow rapidly in the coming years.

De Lama has mastered not alone sterilization and decontamination but also the production of industrial cGmp washers for the pharmaceutical industry and also hot air static dryers and vacuum dryers. Talking about sterilization, De Lama offers a very wide range. It starts naturally from saturated steam sterilization, a technique that has been our strength for 70 years, air-steam mixture sterilization, dry heat sterilization, ETO sterilization and sterilization with superheated water.

In 2018 we introduced hydrogen peroxide sterilization under deep vacuum (not to be confused with surface decontamination), creating an innovative low-temperature sterilization technique, suitable for thermo sensitive products, which also makes it possible to sterilize pre-filled syringe packaging, avoiding the use of clean rooms for final packaging. Our innovative pass-boxes for decontamination under vacuum, allow an extremely fast cycle (one hour of process against the classic 3-4 hours) that do not involve any connection to the company HVAC (with no impact on the ventilation systems); these units can reach dimensions of even several cubic meters, unlike any machine of this type on the market. With the vast array of unique solutions, we believe we are fully equipped to meet the growing needs of the Indian pharmaceutical industry.

 

What are the differentiating features that are unique to De Lama Sterilization equipment in comparison to the other sources in the market?

From a technological point of view, De Lama is at levels of excellence that only a few manufacturers in the sterilization world can reach. The excellence and the uniqueness of De Lama equipment compared to other companies can be immediately seen in the range offered by us that very few other companies, sometimes nobody, in the world can offer: an example is the Hydrogen peroxide (H202) sterilization units under deep vacuum and equipped with a magnetic door that allows total cleanability of both door sides (unlike any other door on the market), and makes it possible for direct coupling with isolator of other manufacturers.

From a product point of view, thanks to their quality, De Lama’s equipment have a life cycle that exceeds 20 years and often reaches 30 years.

Another important point that makes the difference is the usage of components and spare parts for our equipment (such as valves, etc) from established, well-known and high quality manufacturers: this means that a customer can request spare parts from De Lama, but can also find them directly in the market thus providing an effective way to procure standardized components from the market directly and freeing them from the burden of always having to buy from the equipment maker. This helps in faster turnaround times during servicing of equipment and adds to the productivity of our systems at our customer’s shopfloor.

Can you delineate how Italy became the ‘most sought-after hub’ for Sterilization Equipment since ages?

Italy has important districts that produce machinery for the pharmaceutical industry. It is a tradition. De Lama is proud, as the first Italian manufacturer of autoclaves, to have paved the way and contributed to the evolution and know-how in this sector. In fact, De Lama was the first company to present many solutions or equipment that are now adopted by the entire world-market in sterilization: we talk, at the process level, of the concept of counter-pressure for sealed liquids, of air-steam mix units. As regards automation which began to take shape in the eighties, De Lama was the first company to introduce micro-processor system (1984) and later, in 1988 the first PC+ PLC control system architecture- (SCADA). Over the years, De Lama improved its ability to combine different equipment and processes in one single unit, offering in 2005 the 1st mixed washing and sterilization unit in the world. The deep committment to research and innovation continues even today with many of our product offerings ‘being industry’s first’ and bearing testimony to our unique capabilities.

What are the various strengths in product design, manufacturing etc. that have been leveraged at De Lama to offer the best solutions to customers?

De Lama, in addition to superior quality and a wide range of solutions, has total customization as its strong point. Each machine is 100% produced within the De Lama factory in Italy and is not part of any serial production. Each machine is designed from scratch on white paper and built according to the needs of design, size, shape, type of product to be treated, loading, production need, with particular attention to all customer needs. Manufacturing is marked by versatility in design and production, high construction quality, absolute safety in operation, easy maintenance and maximum life time. Our wide attention addressed to customer’s quality requirements is amply demonstrated by the extensive list of certifications received over the years.

Please explain the salient features of De Lama’s recently launched ‘magnetic door and isolator integration concept’ in sterilizers, which happen to be the first in the world

The magnetic door represents a revolution in the sector. This door can now be requested as a feature for every De Lama’s equipment. The advantage of using the magetic driven door for a stand-alone equipment is to give life, unlike the classic sliding door, to a 100% door that can be cleaned on both sides. This total cleanability, a unique feature, meets the increasingly stringent standards of cleaning-validation. This door has a construction without belts and with simplified mechanisms that also minimizes components that in future will need to be replaced (such as the belts). Since this door is 100% compatible with hydrogen peroxide it has also become a must-have to create a direct coupling with isolators of other brands. Having a direct connection with an isolator eliminates the problems of transferring products into or out of the autoclave and the risk of cross-contamination while transferring products to the isolator and vice-versa.

Within De Lema equipment coupled to an isolator, a product can be, for example, washed, then sterilized (inside the same combined unit, with hydrogen peroxide, saturated steam or dry heat) and immediately unloaded inside the isolator, just after opening the magnetic door.

Please illustrate on De Lama’s capabilities and strengths for the compliance-driven pharmaceutical industry.

70 years of excellence coupled with continued interactions and business with the best pharma companies, has given the unique position De Lama enjoys today. We have been working with the most demanding pharmaceutical industry in the world for many years, finding new or better solutions in order to preserve client’s investment. Continuous improvement and comparison, aimed at ever better performance and a constant initiative to stay updated with the newest regulations, keeps us always tuned to needs of the industry and our valued customers.

De Lama’s customers include groups such as GSK, Eli Lilly, MSD, Sanofi, Grifols, Novartis, Novo Nordisk, Sanofi, Menarini, Bracco, ACS Dobfar, Baxter, Teva, Pliva, Fresenius, HTL just to give some names.

How do you address the needs on providing sterilization equipment offering robust performance coupled with lower costs of ownership?

As we have already pointed out, the De Lama equipment is extremely robust and durable. They allow the costs to be amortized over many years of use by the client. Finally, all the components are available directly on the market: there are no extra costs associated with De Lama for replacing the components (eg valves, filters, etc.) because they can be purchased immediately from the market without necessarily having to pass through De Lama. A lot of simplicity has been brought in through measures such as using windows based software, custom designing to address layout constraints, Vacuum Hydrogen Peroxide design for terminal sterilization of syringes in non-classified area etc., for cost effective yet, the reliable solutions for our customers.

Please share with us your experience while travelling with Spincoites in India and meeting a few of the scientific personnel at pharma companies.

We were greatly impressed by the organization of Spinco, by the professionalism and their extensive reach in the market. A crucial point we understood from the Indian context is on the level of preparations that makes it possible to create a local technical support team, highly qualified and ready to intervene quickly to resolve problems at customer facilities.

 

Marco Bianchi

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