With over 50 years of experience in the glass sector and several hun-dred installations all over the world, OCMI provides the market with the most complete range of automatic lines for the production of ampoules and vials from glass tubes. Since 1998, and thanks to the acquisition of Moderne Mecanique from Schott, OCMI S.p.A. has become the largest supplier of production lines and accessories for tubular glass containers granting the best quality level requested by the pharmaceutical sector.The aim of this brief and simple presentation is to introduce the equipment and accessories that OCMI-OTG, together with Moderne Mecanique, is able to offer to this traditional production segment. OCMI-OTG has two divisions in Milan, one for tableware and technical glass under the AMIG brand name, and the other for glass machinery for ampoules and vials, along with machines for technical and pharmaceutical glassware, under OCMI and Moderne Mecanique brands. In Paris, France, Moderne Mecanique is involved exclusively in...
With over 50 years of experience in the glass sector and several hun-dred installations all over the world, OCMI provides the market with the most complete range of automatic lines for the production of ampoules and vials from glass tubes. Since 1998, and thanks to the acquisition of Moderne Mecanique from Schott, OCMI S.p.A. has become the largest supplier of production lines and accessories for tubular glass containers granting the best quality level requested by the pharmaceutical sector.The aim of this brief and simple presentation is to introduce the equipment and accessories that OCMI-OTG, together with Moderne Mecanique, is able to offer to this traditional production segment. OCMI-OTG has two divisions in Milan, one for tableware and technical glass under the AMIG brand name, and the other for glass machinery for ampoules and vials, along with machines for technical and pharmaceutical glassware, under OCMI and Moderne Mecanique brands. In Paris, France, Moderne Mecanique is involved exclusively in production lines of pharmaceutical glass – vials and ampoules – forming machines and processing lines, as well as the production of one of the machines for vials – the MM30.
AMPOULE PRODUCTION LINES
Facing a higher and higher demand of quality and efficiency coming from end-users, OCMI/ Moderne Mecanique produces today’s most updated ampoule production lines made up of the following forming machine models: FA36S & MM30 The main differences between these two models are:
• the number of chucks (30 sets for the MM30 and 36 sets for the FA36S); and
• the installation on the FA36S of the special section for the automatic manufacturing of the first bottom of every new glass tube that is loaded into the machine.
This device will enable to reject only the first part of cut glass tubes (approximately 20 millimetres) instead of the first ampoule that is normally produced without a bottom or with lower bottom quality.
Both models of machines are ready to be to be connected to the LA502 After-Forming Line, where all the most important accessories, required today from the market, can be installed:
• automatic controls;
• ampoule closing device (Form D ISO9187-2);
• colour break and colour code rings;
• annealing lehr;
• automatic packing.
All OCMI’s machines are able to produce all the main kinds of ampoules normally used by the international market.
With regards to ampoule production lines, the latest developments increasing the quality level of finished ampoules and the efficiency of OCMI’s forming machines can be seen in OPTISTEM/ 2 and OPTICUT®/2 .
The OPTISTEM/2 automatic self-adjust system is ready to be installed on OCMI’s FA36S or MM30 ampoule forming machines. The system includes two different control modes called CRC and CRM. CRC (control of the heating value) is designed to maintain the distribution of heating on a defined part of the glass tube under constant control. The system will allow a minimization of rejects as a result of:
• measurement before stem formation;
• detection and rejection of eccentricity and ovality.
Control is carried out by means of an infrared camera installed before the last two heating burners, which will arrange the control of the glass tubes during the heating phase, along with managing the proportional valves for the selfadjustment of the last two burner flames with the control of the heating value. In this way the CRC is able to self-adjust:
• possible variations of the heating value arranged by the burners installed before the camera;
• the quantity of the heating value in case of variation of the glass volume (diameter and thickness).
The main scope of the CRC function is to maintain machine set-up constant also in the case of variation of the heating value received from the glass tube.
CRM (control of the dimension value) is carried out by a camera installed at the end of the production cycle, and controls all the main dimensions of the ampoules (except total length) providing real-time production control of dimensions D1, D2, D3 and D4, plus eccentricity and ovality, with the possibility of creating a data sheet divided as per dimensions, chucks and so on. The system is prepared to transfer the statistical data in real time enabling it to be elaborated by a separate PC. The CRM uses the dimension values to reach three main objectives:
1. reject ampoules out of tolerance;
2. improve ampoule production with a feedback action to the CRC control;
3. generate a statistical database of the values controlled.
The LA 502 After-Forming Line, together with all the other accessories needed to finish the ampoules produced by FA36S or MM30 forming machines, is designed to install the OPTICUT ®/2 (O.P.C.), as an alternative ampoule easy break system to the standard Colour Break. The OPTICUT®/2 Ampoule Easy Breaking system allows to produce a higher quality level of the preli-minary cut and a reduced spread of breaking force values. A better control of the easy breaking system enables to obtain a lower rate of glass particles during ampoule re-opening operations. The new OPTICUT®/2 Electronic Control System was designed to have better programming and control of the main working parameters and replace the old style of Electronic Charts. The new Electronic Control System was designed to be easily integrated in the existing old Moderne Mecanique OPTICUT®, without replacement of any mechanical part and without cabling of the existing electrical components. The major advantages of this new OPTICUT®/2 Electronic Control System are:
1. replacement of the old “Electronic Charts” with a new Microprocessor, controlling the different parameter settings;
2. a new Panel View enables to move easily inside the main menu functions and easily arrange different set-ups. The new electronics grant easier and faster job changeover time with the possibility of fast parameter modification as per the different ampoule type;
3. on the old style OPTICUT® Control System, the various parameters were controlled by independent Electronics Charts and the different working conditions were indicated by means of LEDs. On the contrary, with the new Panel View, the set-up of the different parameters is expressed in absolute values, with the possibility of shorter modification time and an immediate check of the results; 4. the regulation of the Stepping Motor Stroke for the positioning of the ampoules is now electronically controlled. On the panel view you can identify the real working position, inside the theoretical working area, with the possibility of making faster and finer adjustments;
This new function enables to easily identify the required position corrections, in order to havebetter scribing wheel operations and more control of final cut quality. It also enables to reach higher possible speeds of the line, thanks to the optimization of the setting of the minimum stroke of the stepping motor;
5. thanks to new software, the regulation of ink quantity and the vacuum system used to provide the Colour Point will be more effective, with better control of quality.
VIAL PRODUCTION LINES
With regards to ampoule production, OCMI/Moderne Mecanique also manufactures the most complete and updated range of continuous rotary motion forming machines for tubular vials. Continuous motion technology, together with the high level of mechanical and electronic solutions adopted, grant higher production speed and constant production quality levels.The models of production lines today distributed worldwide are:
• FLA 20E or FLA20/S + LF 520After-forming Line; and
• FLA 35 + LF 535 After-forming Line.
Both models are able to produce all types of vials used on the market today, such as Penicillin, Insulin, Screw Neck and Blowback neck. With a set of special modifications, both machines are able to produce special containers such as dental cartridges, syringe bodies and glass droppers. The FLA 20E has been designed and realized with new electronic solutions, to allow:
• higher flexibility for markets where many different vial types (in diameters and shapes) are required with small production batches;
• very short and simple job changeover operations required for small/medium production batches.
The FLA 35 on the other hand, is designed to grant:
• higher efficiency for mass production of the same vials; and
• reduction of production costs so as to be more competitive with other low speed production styles machines.
The major differences between the two models of forming machines are related to the Production Speed for the different type of vials. Both forming machines can be completed with the automatic vial processing lines LF520 and LF535, which are equipped with all the required operations for the treatment of the vials after the forming machine. The transfer of the vial from the forming machine is controlled by the Electronic Synchronizer, while the transfer chain from the forming machine to the line is equipped with a special vial vacuum unloading device from the lower chucks of the vial machine.
This system is able to reduce possible breakages and scratches on the main vial body.
The dimensional control of the produced vials is granted by the “Electronic Quality Control Station” which checks main vial dimension parameters such as:
- total length;
- external diameter;
- lip thickness; and
- internal diameter, with automatic ejection of out of tolerance vials.
The printing of the vial body is carried out by the automatic “Silkscreen Vial Printing” station, which is equipped with a sensor to detect the presence of vials, thus eliminating the possibility of working without the presence of vials. The station is completed with a pre-drying station equipped with heating elements. Vials are annealed by means of an “Electrical Annealing Lehr” equipped with heating elements.
The lehr can also be supplied with a Gas Burners System to replace the electrical type. The temperature is controlled by two independent thermocouples and the vials are moved along by four tracks working in pairs.
This system enables safer transfer of the vials and better control of the heat constancy. The vials are progressively cooled in the final section of the tunnel to avoid internal strain that it is possible to create with sudden temperature changes. At the end of the production line, the vials are ordered in the final packing box by the unloading belt from the annealing chain with platform for the preparation of the final vial box. The packing station is supplied complete of vial storage.
THE INTERVIEW WITH SERGIO CORNO, SALES MANAGER AT OCMI
The two products we are presenting in this article are the OPTISTEM/2, which is mounted on forming machines, while OPTICUT®/2is an accessory for processing lines. The latter is an easy-breaking system, which involves a micro-incision on the neck of the vial. This micro-incision is made using a high-speed chuck – 12,000 rpm – with the difference between this system and the previous ‘old’ systems such as colour break being that this new system is much more controllable as the pressure and time of incision on the glass are controlled electronically – both by a sensor that ‘feels’ the ampoules and the vibrations of the same ampoules, as well as by programming. This enables to have greater control of the parameters regarding the formation of particles of glass during breakage (and reduce them) and control and reduce the range of breaking load needed to open the ampoules, making them much easier to open.
Has the use of electronic systems increased production quantity and not only quality?
We can say that OPTISTEM/2 installed on a forming machine – with its system of cameras and control and self-adjustment – is aimed precisely at increased production quantity and quality. Further aims include that of reducing to the utmost all the possible variables and parameters because the more these are under control and stable the more uniform and higher quality the final product will have.
This, of course, is valid for all production phases. In this particular process, we are working with a raw material that has its own type of variability and tolerance with regards to finished products, which is more or less constant depending on the manufacturer, where the product is made, environmental temperatures and conditions, etc.
Then, of course, there is the machine that makes the containers – using heat – all involving variables that we must try to maintain constant or at least controlled in the tightest range possible. The more we are able to control these variables and tighten this range, the more constant the quality of the final product will be.
Does the machine operator have the possibility of inserting data and characteristics relative to the glass tubes?
No. At present, there is a strong market aim to reach the possibility of including automatisms but until now the costs, the difficulty, and the quantity of variables necessary for this kind of control have not favoured the search for production machinery and processes, at least in part, automated.
What we have been able to obtain up to now is to try to include something that can help avoid fluctuations of the situation inside these processes as much as possible. It is, obviously, not at all
easy, also because there are numerous initial variables that we cannot change, such as, for example, the raw material – the glass tube – which can, in my opinion, almost be considered a living material and is, therefore, not constant. On the other, if it is true that in many cases the glass containers are produced following the requests of clients, a large part of the market is made up of standard vial production – as per international ISO certifications – but which, however, is still generally recognized only as ‘packaging’.
Pharmaceutical packaging, even if made of the highest quality borosilicate glass, however, as any kind of packaging product, has, at its origins, an industrial product that must be available in considerable quantities, immediately and always, and have a low cost.
What has happened during the last four to five years and during the recent economic crisis with regards to the organization of the company and with regards to glassworks for pharmaceutical glass? And, of course, how does OCMI work with these companies?
Many developing countries are certainly are undergoing a trend to shift their production to automatic lines such as those produces by OCMI. Previously, there was alarge difference between western countries, which already had and used automatic production, and such countries where these kinds of products were manufactured using semi-automatic production. In these countries, in the last 10-15 years, there has been a trend in development towards conformity, thus attracting companies such as OCMI, with their technologies, new for that area of the world.
This was also possible thanks to the acceptance of those countries of the compliances, rules and regulations set out by international pharmaceutical organizations, which also facilitated the entry of large pharmaceutical manufacturers. Glass is, as always, considered as the best type of container for many kinds of products, especially for the food and drink sector. And with pharmaceutical products, thaks to the borosilicate type, even more so, because of the need to protect the ‘formula’ of the product. This is also why borosilicate glass must be used for containers of this sector. As far as this market sector is concerned, there have not been many important changes for at least 10-15 years and the main producers of these items and, of course, the machinery needed to produce them, are the same.
There has been, however, as previously mentioned, a shift towards emerging countries, also with regards to players of the production sector, which have and are opening production units, with some consolidations taking place among the smaller companies, also due to the global economic crisis.
How has the pharmaceutical glass sector faced up to the crisis?
Luckily, and as far as my market sector is concerned, there have not been any major problems.
Therefore, this has also affected the other sectors with which we work. Production figures have not suffered too much and sales are at the usual levels, also thanks to the fact that this is, of course, a niche market. It does not undergo incredible sales growth and, on the other hand, does not have important drops in production and sales either.