It is Marco Bellentani’s turn to speak! Enjoy this Selekta presentation…
See our Alessandro Recupero introducing Tekna, during last Interpack 2014!
We would like to thank whoever took part at Interpack 2014: our Customers, our Sales Network, our colleagues who worked hard on the booth, as well as those who spent months in organizing this big event, the journalists and peolpe who came to pay a visit. It was a great edition! Let’s see you again in 2017!
FlexaLAB for containment is the evolution of the well-known MG2’s capsule filler for laboratories mod. FlexaLAB. The containment system features a particular liftable isolator concept, which allows the machine to keep its peculiarity to change different dosing units. This result is obtained while ensuring proper production safety, for both the operator and the environment; in fact, the system allows the machine to satisfy the highest containment class, OEL5, guaranteeing a concentration of active substance lower than 1 µg per cubic metre. FlexaLAB containment version can be equipped with a Wet-in-Place system, which allows to fix powders when the production cycle ends, before opening the isolator.
Through the same spray gun it is possible to use both liquids and compressed air. By adding some spray balls and other devices, FlexaLAB is configured for a complete Wash-In-Place system, to further automate the cleaning process. Other optional devices enable to customize the production outfeed to an external container or a continuous liner, as well as the connection to other devices, such as a deduster or a metal detector.
Quality is not achieved only with a good production but also through knowledge of the production process, combined with its efficient design. MG2 and Valpharma worked together to improve the process in terms of both quality and efficiency.
Valpharma: experience of over 30 years in filling capsules
The Valpharma group is an active reality within the contract manufacturing of modified release solid oral formulations marketed throughout the world, who has thirty years of experience in dosing of capsules and tablets, both as single or multi-components. In 1987 was inaugurated the headquarters of San Marino with the aim of collaborating with clients in the development, registration and production of drugs. The company is strong of 12 international patents and 150 registrations worldwide. These results were achieved thanks to the stable relationship that Valpharma has with its customers, to long-term production contracts for the entire duration of the drug on the market, to the constant upgrading of production facilities, to the employment of its own production technologies in relation to the product, and the general propensity for in-depth knowledge of the process as a basis for its continuous improvement.
MG2: ideal partner for continuous improvement and technological innovation
MG2 has always been focused on innovation and quality: from the constant search of the most innovative technologies to the best adopted practices in the industry. The understanding of the process, its control and its improvement, have always been the basic philosophy of the designers of MG2, from the early development of machines and related control systems. Valpharma began collaborating in 1987 with MG2. MG2 has accompanied Valpharma all these years in the adoption of new technologies to meet the increasing demands of optimization and process improvement.
The first experience of Valpharma
Since the mid-90’s, Valpharma doses combinations of pellets within the same capsule. The types of product’s combinations are mainly two. The first consists of components containing the same active ingredient but with different release times, while the second consists of components containing different active substances between them. Valpharma initially used an MG Futura capsule filler, with speeds of 48,000 capsules/hour, able to dose up to 4 components within the same capsule with two pellet dosing units and equipped with a statistical weight control system for the gross weight (sum of the various components). The lack of information on the weight of each component required the adoption of structured start-up procedures for the production and final control for congruence. The production process of a batch would start with manual adjustment of each dosing chamber, running a small production lot with the dosage of only one component at a time. During the production was then carried out an automatic in process control for the total estimated net weight, using the statistical weight control system. The batch was divided into sub-batches of 1 day of production, so as to reduce the risk of waste in the event of problems. At the end of the day an indirect control was made to evaluate the quality of production verifying, for each component, the congruence between the amount of product loaded into the hopper during the day, what was supposed to be dosed and the residual. As a result, if the residual product’s quantity deviated significantly from the expected, they would proceed with discarding only the sub-batches involved.
The improving objectives of Valpharma
This configuration of the process was time consuming for both, the machine preparation during the start-up phase as well as for the quality control at the end of the day, and did not provide data on individual components nor automatic feedback on the process. This led Valpharma, in 2005, to set themselves on ambitious targets, in particular the increase in production capacity, the simplification and optimization of the production start-up procedures and, above all, an improved quality control for filled capsules. In fact, to ensure the effectiveness on the patient in case of different combinations of active ingredients, it is essential to control the correct dosage of each single component.
Optimization of the process: the chosen solution
The solution proposed by MG2 to meet the demands of Valpharma, has requested the use of a new machine model, a “Planeta 100”, with production capacity of up to 100,000 capsules/hour, able to dose up to 4 pellets in the same capsule. The selected configuration was providing the statistical control for the weight of each component and for the total, the self-adjustment of each single dosing chamber, the automatic stop in case of out of limits for the components and a 100% weight control for the total net weight, as an additional guarantee for the correct dosage. During the starting phase and validation, the machine automatically performs the control of the individual component, by sampling the capsules containing only one pellet component, excluding the others in an automatic mode. To ensure correct and constant operation of the critical devices present on the machine, therefore keeping quality under control, it was created a document called the “Device List” – developed in accordance with the Good Practice Guide on Calibration Management of ISPE (International Society for Pharmaceutical Engineering) – which lists the devices and measuring instruments present in the machine, identifying the level of criticality and describing the calibration and control procedures to be performed periodically.
The system has proven to be very accurate in selecting and isolating the single component .This accuracy brings improved reliability of qualitative judgments on the production and certainty for the decisions on the process. Since 2005 Valpharma has produced over 120 million capsules without complaints from end users, with minimal amount of defects in production and a drastic reduction in waste for capsules out of specs. The analyses provided by the machine are very useful for understanding and improving the process and to make investigations in the event of claims from end users. In addition to the fundamental results on the efficacy of quality control, Valpharma obtained benefits in terms of efficiency for the production process. For a batch of 1 million capsules with 3 different components, considering the complete cycle of start-up, batch production and quality control, it has gone from 24 hours with the MG Futura to 11 hours with the Planeta. The result is a reduction of over 50% of the production time. If we consider only the time of start-up and quality control, which mainly depends on the type of machine and its weight control system and only marginally from the machine speed, it goes from 3 hours with the MG Futura to 15 minutes with the Planeta. The reduction of over 90% is the merit of the in-process quality control, both on the total as on the individual components.
The adoption of “in-line” and “on-line” controls, integrated into the machine, allows to collect fundamental data to take immediate decisions on the process or to evaluate improvement actions in the medium to long term. The understanding and the integrated control of the process, concepts in line with the philosophy of PAT (Process Analytical Technology), immediately lead to the reduction of the total production time, the prevention of waste and defects, and the elimination of reprocessing. The future prospect is to achieve the “real time release” of production lots.
MG2’S Technical Assistance Department plays its essential role since the FAT (Factory Acceptance Test), which is performed to the customer, at MG2’s premises, after the internal test of the sold machine. This is the right occasion to introduce the team that will become the main reference point for any matter concerning the product. During the SAT (Site Acceptance Test) and machine start-up, the most skilled technicians support the customer while executing the IQ (Installation Qualification) and OQ (Operational Qualification) validation tests. On demand, MG2 can also support the customer in the Performance/Process Qualification phase.
The company is sure that training is fundamental to get good results in operation both in terms of quality of the product and in terms of efficiency of the process; as properly trained operators, maintenance personnel and supervisors are the most effective and rapid service as they are naturally on-site, MG2 has created proper training programs. As a reference for the training execution, the complete set of User and Technical Documentation is available on the OnlineService MG2 website. MG2 can support the customer also during the production of the first batches.
This is a great opportunity to consolidate knowledge gained during the training sessions (training on the job).
During operation, the customer can also get on-site service worldwide, carried out by skilled technicians directly from MG2 or by our subsidiaries.
Sometimes, remote support is also available, as the customer can connect to MG2’s network and let its technicians check the status and data of the machine.
MG2 is keen to help its customers move from Breakdown Maintenance strategy (BM), which tends to perform activities only when the problem occurs, to Time Based Maintenance (TBM) or Preventive Maintenance, which perform activities on a regular basis, in order to ensure the operation within tolerances, minimizing wear and/or preventing failures. The relevant service includes the list of checks to be periodically performed, the list of spare parts to be periodically replaced (depending on the specific machine and type of product) and a tool that enables MG2 technicians to record activities performed and parts changed on the machine.
Maintenance management is supported by e-SPARES; it is an interactive catalogue containing all spare parts that can be ordered, which allows to ask for an offer and then order the spare parts needed in a very fast and intuitive way.
After-sales service can also be involved in the upgrade of the machines installed. For this purpose, many “kits” are available, such as improved mechanical parts, software upgrades to get new features or comply with new regulations, weight control system’s upgrade and many more. These kits can extend the machine’s life, increasing the return of investment of an MG2 solution.
Interview with Mr. Fabio Trippodo, President of MG America Inc.
What is MG America’s role in the North American pharmaceutical marketplace?
MG America has a proud tradition of service and support in the North American pharmaceutical market and offers its customers a range of processing and packaging machinery. Our team is comprised of proven industry professionals who excel at meeting our customers’ most challenging needs with today’s finest equipment and technology solutions.
With whom is MG America associated? Is the company a subsidiary?
MG America works in close cooperation with our parent company, MG2, to ensure that we deliver precisely what our customers will require both now and in the future. In doing so, we are able to consistently meet ever-evolving and expanding market demands.
What are the prevailing trends that MG America is seeing in the pharmaceutical industry?
Throughout 2014, the pharmaceutical industry will continue to see major evolution and continuing challenges. Considering worldwide economic uncertainties, healthcare reform legislation, increasing healthcare costs and expiring patents, the industry appears to be in a state of turmoil. At the same time, markets are diversifying and new fields of growth are opening up. Rapid development of certain emerging markets, progress in drug research, rises in generics production, the availability of high-potency drugs, and innovations in manufacturing processes will sustainably modify the global pharmaceutical landscape for years to come.
How is MG America reacting to these trends?
With so much change in the landscape, responsive and supportive project management is vital to our future growth. Because our customers have multiple product lines operating in multiple locations, careful line integration is a core strength at MG America. We work very hard to position our capsule filling and packaging equipment for maximum performance and longevity across all geographic borders. In particular, we anticipate an expanded role for our team in serving the growing needs of the South American pharma market, where many of our customers now have manufacturing locations and distribution centers.
In light of these trends, what industry needs are emerging, and how is MG America addressing these needs?
Globally harmonizing manufacturing processes and an increasing focus on quality control technologies are two main areas of growing interest in the pharmaceutical industry. In order to comply with strict pharmaceutical quality and safety standards such as the FDA, PAT and GMP, the industry requires reliable and high-end inspection technology equipment to be integrated into production lines. Manufacturers are continuously challenged to increase output and improve efficiency as well as inspection accuracy, placing their main focus on fully automated solutions. MG America is ready to help our customers throughout the market with specific solutions to these topics…from track and trace offerings and weight control innovations to enhanced product efficiencies.
How have the growing concerns over supply chain security affected MG America’s business?
Combating the threat of counterfeit pharmaceutical products and eliminating weak links in the global supply chain continues to rank high on our customers’ priorities lists. Our newest Track and Trace solutions will help address some of these concerns right on the packaging line. At the 2014 Interphex Show in New York City, these new technologies generated intense interest from visitors (and industry media outlets) at the MG America booth.
What other trade shows will MG America be attending this year?
MG America has traditionally been an active participant in US trade shows and conferences, and 2014 will see our team at many events, including: Supply Side West, Interphex Puerto Rico, Pack Expo/Pharma Expo, and the AAPS Show. We look forward to seeing existing customers at these shows and to introducing MG America’s product lines to potential customers from around the world.
The ACE CT/400 Track & Trace is a marking and verification system which has the ability to print a unique identifying 2D-Data Matrix code onto cartons and simultaneously to read, verify and constantly monitor the code printing quality of each carton. After each print job is inspected, the respective carton is either fed toward the conveyor or, in the case of faulty printing, discharged from the packaging line. Using the smallest foot-print, the ACE CT/400 prints and verifies up to 400 cartons per minute and can be integrated into any existing or new packaging line. It features a positive carton controlling system, yet an easier and safer carton handling management, even at high speed. The ACE CT/400 system has the ability to process cartons measuring from 20x20x80mm up to 120x80x200 mm. MG2 can also supply Track & Trace solutions for packaging lines for bottles or bundles, featuring a reduced footprint which can be easily integrated to existing lines, suitable to handle a wide range of shapes and sizes, thanks to easy and minimum adjustments, in order to get the maximum flexibility of use.
Mitaca and MG2 are two standout manufacturers in their own fields of expertise: capsule systems for espresso and hot beverages for Mitaca, automatic dosing and packaging machines for pharmaceutical products for MG2. Two apparently distant operators have met and developed a successful cooperation.
The protagonists of the story
MG2 is based in Pianoro, in the province of Bologna, in the heart of the Italian Packaging Valley; the company employs approximately 170 people, and counts on more than 48 years of highly qualified experience in the development of proposals made to measure, in order to meet the requirements of its customers (mainly multinational companies and subcontractors of the pharmaceutical sector).
Mitaca is based near Milan, the epicentre of Italy’s most developed industrial district, and has been working for years to offer an excellent coffee and the best products for its preparation to the most exigent consumers in offices, companies and public spaces. In fact, the Lombard firm aims to become a leader in the Office Coffee Service and Automatic Distribution, thanks to the innovation and quality of its products and services. Mitaca espresso machines are the result of careful design, offering innovative solutions to simplify their use and guarantee an espresso that is always excellent. The I-Espresso System and Mitaca Professional System capsules employ an exclusive, patented technology, which guarantees the capsule opening solely by water pressure.
Mitaca’s production lines
Mitaca decided to rely on MG2 to cover the increasing requirements of its production line for coffee capsules. Each line starts with coffee beans and ends with the final product, palletized and ready for shipping. A first machine grinds the coffee, doses it into the capsules and closes them, thus making the product which the user will insert into the dispenser to make the relevant drink. Then, depending on the kind of final user, each capsule is individually packed in a flowpack with protective atmosphere to preserve its freshness and aroma, or else packed in multi-capsule bags. Both bags and individual flowpacks are finally packed into cardboard boxes. To carry out this final phase, MG2 offered a very simple solution to pack the bags, by using a horizontal case packer Mod. GSL10. For the final packaging of flowpacks, the Bolognese company designed and carried out a custom made solution which employs two vertical case packers Mod. GTL30.
For this application, the basic machine which handles the case (opening, conveying and closing it by hot glue) was combined with a specially designed infeed system. In fact, it was necessary to solve some specific problems such as the high production speed (reaching up to 500 flowpacks per minute), the impossibility of accumulation (as the flowpacks must not touch themselves during conveyance) and the need to work with a product flow which is characterized by inconstant spacing and orientation. MG2 therefore adopted a series of belts with different speeds to stabilize the flowpacks feed, combined with a counting system with photoelectric sensors and a preload hopper equipped with opening and closing system driven by servomotors.
GTL30 was warmly welcomed by Mitaca thanks to its reduced footprint and ease of operation, enabling to set the number of products and case size from the operator panel. Moreover, the machine also proved particularly reliable in both counting and delicate handling of the product during the packaging phase.
MG2 does not only give designing support, from the preliminary phases of the project to after-sales operations; MG2 also puts its scientific-pharmaceutical expertise at customer’s disposal, to carry out product trials and preliminary tests.
We are not talking about mere machine tests: MG2 has started a cooperation with a research institute which refers to Graz University, which enables the company to offer their customers a service for powders’ profiling, through the analysis of some features strictly related to the dosing process.
During the product’s formulation, MG2 can suggest which features to change, in order to make powder suitable for the required dosage. Similarly, it enables to set up the most suitable processing parameters for each product, for a quick and correct parametrization of the process itself. MG2 can also offer its support for process quality improvement and process efficiency improvement (OEE).