Genzyme monitors 50,000 SCADA
points with the Anybus Communicator

Genzyme,  a world leader in biotechnology, is creating a new polyclonal antibody production site. This is an innovative production facility: the process has been automated as far as possible, to reduce human error in the many stages of the process (separation, purification, filtration, ultrafiltration, haemadsorption etc.). This involves being able to interface with a battery of very mixed laboratory equipment, which was not initially designed to communicate with fieldbuses. Genzyme has used about thirty HMS Anybus Communicator gateways, to enable consistent SCADA management across all the devices in use. Benefits are as much in terms of quality as in production costs.

Bioproduction: a series of complex processes
Unlike traditional chemistry, production based on living cells involves many different complex and expensive stages. The production cycle for a recombinant protein requires an industrial infrastructure which is suited to large-scale production involving several stages staggered over several months. Each stage is subject to numerous quality controls. Tests to ensure the absence of viruses and contaminants are performed throughout the production cycle. At the end of the line, the purity and action of the protein are also checked.

The production of this drug involves many complex stages, punctuated by a succession of technical and quality assurance tests. The production process can be broken down into four main stages: 1) The collection of the immunoglobulins, which is done by injecting human tissue into rabbits. 2) The purification of the immunoglobulins to remove undesirable proteins (particularly anti-erythrocyte antibodies), by haemadsorption. 3) The chromatography stage consists of anion exchange through the use of an ion exchange resin. Impurities are captured by the resin, whilst the immunoglobulins, which are not negatively charged, are eluted. This stage is checked using spectrophotometry and electrophoresis. 4) The precipitation stage is intended to eliminate the last remaining impurities. The purified immunoglobulins are pasteurised (60°C for 10 hours). This solution is freeze-dried before being sealed into vials.?

Genzyme´s new site for the production of polyclonal antibodies for transplants and haematology covers22,000 m². It has involved investment worth 115 million euros.

The Anybus Communicator series of gateways for connection to industrial Ethernet/Fieldbus makes it possible to network devices which were developed for use in a serial network. The 30 Anybus Communicators on site send the data back over the Ethernet or Profibus to the central SCADA.

"In this process we can, for example, program in the settings for the centrifuges (speed, temperature, working time etc.). These values can be changed in the SCADA to take the specific requirements of the current production batch into account. Readings are taken at every stage and sent back to the SCADA. This enables us to put a very precise traceability process in place. In particular, this means that the workload for the quality assurance teams is significantly reduced, which is an advantage in cost terms," adds Alexis Ducancel.

The Lyon site, like the Marcy site, will receive FDA and AFFAPS approval. "Naturally, we chose HMS, because we felt that no other company has standard solutions available to return data from a very mixed set of equipment which has not necessarily been designed for connection to fieldbuses. We have 28 centrifuges, pH-meters, balances and so on. The interface protocols vary: serial or ASCII for example. The 30 Anybus Communicators on site send the data back over the Ethernet or Profibus to the central SCADA."

Anybus Communicator: the solution for integrating Serial equipment into an industrial communication network
The Anybus Communicator series of gateways for connection to industrial Ethernet/Fieldbus makes it possible to network devices which were developed for use in a serial network. The Anybus Communicator can connect most products with an RS-232/422/485 serial interface to an industrial Ethernet or fieldbus. It performs an intelligent conversion between the serial protocol and destination network. This conversion is configured using the "ABC Config Tool" software. The network configuration, once completed, can be re-used for all networks supported by the Communicator.

"Quite apart from the quality of the product, we found that technical support was there whenever we needed it," concludes Alexis Ducancel.

Around fifty employees are now in place at the Genzyme production site, where initial production batches are being run to validate the production process. Full production should start in late 2011, once the AFSSAPS certifications have been obtained. The total number of staff should then rise to 270.

Genzyme in profile
Genzyme originated in Cambridge, Massachusetts (United States), in 1981, when its founders took the gamble of providing solutions for patients affected by serious illnesses for which no treatment existed at the time. A personalised approach to health, coupled with a duty to innovate, make it a cutting-edge biotechnology company which is recognised throughout the world. Whilst help for patients affected by rare genetic diseases remains its prime calling, Genzyme also provides innovative treatments to help patients with kidney disease, cancer and arthritis, or those requiring a transplant or surgery, in addition to its work in fields such as diagnostic testing. Genzyme, a pioneering biotechnology company, is now a diverse internationally-based company, employing 11,000 people around the world. For further information, contact  Michela Nalin, e-mail: min@hms.se or view website: www.anybus.com   Refer to next page

Production of glass containers for pharmaceutical use

SPAMI, a company forming part of the Stevanato Group, has developed an inspection system to improve the quality of glassware. It uses quality control technologies to screen the glass tubing on arrival at the plant as well as the final product. The system includes a visual inspection system (NoVIS), a system for continuous temperature measurement, and also a digital image processing system, called CLEANER, which is able to detect and remove defects in the glass as small as a few microns in the final product. The fully integrated process machinery provides measurement of glass tube diameter, wall thickness, and temperature using infrared pyrometers (Pyrometer Annealing control) for total quality control, and motorized burners provide close control of their positioning. The use of this system gives Stevanato their advantage in quality over other vial manufacturers. For this advanced system, S.P.A.M.I. uses HMS Anybus converters for the connection between remote visual inspection cameras and the PLCs controlling the production lines.

Founded in 1949 as an artisan workshop in a region with a strong tradition in the art of glass-making, Stevanato Group is now an established industrial enterprise producing high technology systems. The group comprises two divisions. The Glass Division specializes particularly in the production of primary packaging of glass tubing for pharmaceutical use. It offers a wide range of products from the most traditional primary packaging, such as ampoules and vials, to rapidly growing products such as cartridges for self-injectors and peninjection systems, including sterile ready-to-fill syringes.

The Engineering Division, made up of the companies S.P.A.M.I. and Optrel, focuses on the design and production of machinery and equipment for the conversion, visual inspection and monitoring of glass tubing containers. The synergy between the two divisions ensures that the Stevanato Group has full control over the entire production process, from the purchase of the raw materials right down to after-sales support.

"S.P.A.M.I.´s production is intended both for the companies within the group and for sale to other external companies." The mechanical and electrical solutions installed on the forming machines have been designed to provide the greatest precision and the best results in the production of glass containers.

All the components used to form the molten glass are installed and carefully checked to guarantee the dimensional tolerance of vials, syringes, cartridges and ampoules. The components installed in the forming machines and conveyor belts have been specifically selected to avoid contaminating the containers. The process is fully automatic, from the loading of the tube to boxing. The production cycle starts with the glass tubing which is acquired externally in pieces of approx. 1.5 m in length and with an appropriate diameter for the size of the finished product. The glass tubing is fed into rotary forming machines with several processing heads and is heated by burners. Depending on the processing cycle, which is selected according to the product to be made, the mouth and the bottom of the vial, a poule, syringe, etc. are formed in this way.

The following equipment is installed on the line
Downstream of the forming machines is a conveyor belt where dimensional and cosmetic inspections are carried out by means of cameras to ensure a thorough check of the glass containers. "These are basically dimensional measurements carried out by analyzing the image", Gobita explained. "Since the product is subject to mechanical stress during processing, there is also an annealing oven providing a heat cycle to eliminate the tension formed in the glass." Then the final stage comprises quality control of the finished product and automatic packaging. It should be noted that this final part of the cycle is carried out in such a way as to ensure the levels of quality and sterility required for use in pharmaceutical applications.

There are a number of competitors on the market that operate at international level. "Our main competitors are German and American, whereas the other companies in Italy are much smaller than ours", explained Gobita.

The value added offered by S.P.A.M.I. is to be found primarily in the quality of its products, which has enabled it to excel in this sector." Since they are used in pharmaceutical applications, our products have very high quality requirements and have to comply with very stringent regulatory limits. This requires a large number of very qualified Quality Control staff", continued Gobita. "The difference between us and our national competitors can be seen in this very aspect. Our capacity for research and development is also a factor: when pharmaceutical companies ask us for trial products that are different from the standard products, we can do the product design because we can modify our systems. Just like the mechanical division which produces the systems within the group, S.P.A.M.I. can modify and adapt these systems to suit production requirements. This ability to customize systems is another important value added we can offer our customers. It should be remembered that there are a number of standard products in the pharmaceutical sector, such as ampoules and vials that we all know about, but there are also many special products - and their numbers are increasing - that for the most part are developed ad hoc. In these cases, a specific machine is needed, so in the majority of cases a pre-existing machine has to be modified."

A positive collaboration with HMS
The association with HMS came about in order to resolve a specific communication problem. An application was developed by the mechanical division to carry out a series of product quality checks based on machine vision technology. More specifically, Cognex smart cameras had to be connected to Siemens PLCs. "We thus needed to enable cameras with Ethernet interface to communicate with PLCs with Profibus protocol", explained Gobita. "After some careful research, and through EFA Automation, the exclusive distributors in Italy of HMS´s GATEWAY solutions, we singled out the Anybus devices which enabled us to solve the problem of communication between our equipment."

Other potential suppliers were considered at the time, but HMS was the only company that could offer a wide range of protocol converters. "This widespread availability was central to our choice, because our various applications are often very different from each other. Initially, for example, we needed to manage the Profibus protocol since it was used by Siemens PLCs, but our company normally also uses programmable controllers from other suppliers. So it is essential for us to have an extensive product range." The first HMS product used was a device from the range of Anybus converters that converts from Profibus to Modbus on Ethernet: the Anybus X-gateway.

More than one Anybus converter may be installed on each production line. "Up to now we have used a number of converters, because the application has been used in various systems», continued Gobita. "Smart cameras are used to check the product's various quality aspects and must be installed in several different points in the system. Basically, this is not a "one-off" application of HMS converters, but an application that has become standard for us." "We are very satisfied with our choice. MMS's Anybus products are very sound, functional and simple to use compared to other similar devices that we tried. We all know that while it's very easy to find complex things, it isn't so easy to find simple things.

For further information, view website: www.anybus.com  Refer to next page