One of the most important projects of this year has been the construction of a production scale sterile contained micronisation system that was delivered to a pharmaceutical manufacturer in Spain last July.
The equipment, designed to be installed across different floors, is composed of a glovebox to discharge the batches from a filter dryer without affecting the product sterility; a jet mill isolator provides a confined environment in which the product is micronised; downflow booths are integrated on the airlocks of the pack-off isolator to guarantee the high sterility grade.
The system is fully automated. FPS internally develops the software that controls all the equipment functionalities. The machine is sterilised with both hot steam and VHP.
The ground-breaking unit will allow the customer to complete different phases of a sterile production of APIs avoiding the risk of contaminating the product and reducing the operator’s exposure to the potent compound.
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FPS has recently delivered a high containment Integrated systems for an Oncology plant in Bangalore.
The system is composed by an ANFD discharge Isolator, a Vacuum Transport System (VTS) and a Micronization equipment PROMILL-8 in Isolator.
“Our client searched an appropriate solution for -grinding material and clean packaging after the filtering and drying process-“ say Eng. Bissola, FPS technical sales manager. “We offered a filter dryer discharge system in combination with a VTS and micronization equipment for the high potent particles (HPAPIs) handling. It’s a customized system, using solutions and technologies derived from similar units supplied in the past”.
The isolator for product discharge from an existing Agitated Nutsche Filter Dryer (ANFD) is complete with discharge chute for product to be re-processed and for product to be transferred to micronization unit, conical mill for product sieving before micronization and Rapid Transfer Port (RTP) for material inlet/outlet.
The Vacuum Transport System (VTS) transfers the product from the ANFD discharge isolator to a buffer vessel installed on top of micronization system, for complete batch transfer.
The vessel is complete with an active Split Butterfly Valve to allow connection of bins in safe way in case the VTS cannot be used due to poor material flowing properties; a lifting column is supplied for the bins handling.
The micronization equipment PROMILL-8 is installed inside isolator and is complete with gravimetric feeder for product discharge inside the jet mill and a separation cyclone filter for gas product separation after micronization. A pack-off systems and exit chamber allows for controlled discharge inside drums, with weight control, and safe exit from the system.
This solution provides optimum operator and product protection and permit to work in high safety environment, while assuring top micronization performances according typical FPS jet mill design.
FPS is used to give process support to customers during the project development and after the commissioning, assisting the users in the operation and increasing knowledge of the supplied process for further development of APIs manufacturing.
FPS managing Director and micronization expert, Eng. Giovanni Gianola, completed in May 2017 a 4 sessions training seminar in each API plants of FPS customer for deep explanation of micronization process.
The training sessions, distributed over a period of different months, were followed by almost 100 people coming from operations, engineering, maintenance and plant directors, with the aim to share FPS approach to the process, its main parameters, the possible equipment configurations and the safety aspects to be considered.
Also it was an occasion to discuss solutions to specific plant situations occurring while operating the jet mills, indicating possible improvements strategies.
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FPS has recently delivered a very complex project that combines high containment within aseptic conditions.
It’s composed of 2 ANFD systems (Agitated Nutsche Filter Dryers, respectively in AISI316L and HC22 material) with integrated sampling, discharge, milling and packing-off station suitable to handle OEB4 dry product under sterile conditions. Discharged product can be moved to a final dispensing containment system for the preparation of final product in different packages. As an alternative in case of ultra fine powder requirement, after preliminary drying and milling the product can be moved to a dedicated Micronization and final dispensing isolator (with an integrated FPS spiral Jet Mill type PilotMill-6).
Key features of this system are
The FPS Sales director and micronization expert, Eng. Stefano Butti, says: “It is a plant where the product is processed in conditions of high containment and asepsis, starting from its filtration and drying and through the milling, micronization and final dispensing. All process steps and control systems were managed entirely by us as main contractor, both for isolators and for the various process machines. It was a challenge but our success was certainly due to the experience we gained in similar projects and the ability to combine these experiences, even in a critical way, with the aim of further improving what has already been done. “
A dedicated team worked closely with the customer throughout the project to ensure that all specific requirements were met (sterility, containment, process performance), and superior quality of manufacture and containment levels were maintained.
The experience gained in 16 years of activity allows FPS to be a world leader and offer a service with high-quality standards for the global market.
The design and production process of the systems is carried out entirely in the plants of Fiorenzuola d’Arda (PC), starting from a careful listening of the customer’s requests to the final test before delivery.
The ability to listen and the flexibility in adapting to the needs of the customer are the strengths that over the years have rewarded FPS.
The initial study of the project is carried out by several hands: a specialized team works closely with the customer to ensure compliance with the technical specifications required.
As far as containment systems are concerned, FPS usually proposes the construction of a mock-up of the system to be supplied.
“It is a structure that faithfully reproduces the machine on a 1:1 scale and provides a visual representation, as detailed as possible, of what the final system will look like. The way in which the mock-up is created allows the designer and the customer to easily make any changes and improvements during the verification stage” – explains Ms. Ilenia Lindi, head of Project Management at FPS.
“A mock-up is created to outline the aspects and some details that will make up the final machine, in order to establish the optimal positions of all the components, simulate the planned operations and examine any problems that were not discussed in the offer stage. The customer is supported in each stage by the project team, that under the coordination of the Project Manager, works together with the customer to find the best solutions“.
The steps to consider when making the mock-up are:
Before making the mock-up, a careful preliminary study of the machine is carried out, starting from the supply specifications, considering the spaces available at the installation site and the components integrated into the machine (such as process machines or different types of containers to handle). The 3D model of the plant is the starting point for the construction of the mock-up.
In order to achieve the best result, it is necessary to simulate all the operations that the operator will perform inside the isolator; FPS therefore not only simulates the system, but also the main internal components on which the desired operations will be performed.
“Sometimes it happens that in the offer stage, the customer does not recognize the importance of this stage and considers it as “redundant” taking into account the experience of FPS in the construction of containment systems.
However, when FPS’s suggestion is followed and people come into the company and touch with their hands what their machine will be, they “enjoy playing” moving components and evaluating solutions different from those they had initially considered. Once I happened to follow a customer for a whole day in this “play”, looking for solutions that he thought to be better, and then I ended up confirming the initial solution we proposed. However, I did not feel that this time was wasted! It is very important to us that the end user is fully convinced of how the final solution will be implemented in the best configuration” – Lindi continues.
“Since these systems are complex and require major economic investments, this procedure gives us the opportunity to evaluate at the design stage all the integrations that involve extra costs and possible reductions. For example, we also happened to eliminate a work chamber because the entire process could be carried out in a single chamber, to the benefit of the costs and overall sizes for the end user.”
The great advantage of making a mock-up is to let real end users perform the manipulations and “play” with the machine and then define/observe the operations as they will actually be performed.
“For the ergonomic test of one of the last projects – continues Lindi – a very complex system, there was a large delegation: the project manager, the process engineer, the electrical manager, the operator and some technicians of the engineering company that followed the project. We worked together 4 days to verify the solutions proposed and each contributed its part.
A customer has never been dissatisfied after a mock-up had been verified. On the contrary, even the most skeptical ones have always recognized the usefulness of the work carried out. For example, we have recently made an isolator similar to one already in operation in the same company. We could have “skipped” this step and reproduced the same machine. Instead, in agreement with the customer, we invested a day of work together to study a new mock-up and evaluate, based on their experience, the improvements to be adopted for this new project.”
This passage can be advantageous from the electrical point of view too. The head of the electrical department, Mr. Luca Abbà, explains: “It is true that the mock-up is more useful for an ergonomic, mechanical and space evaluation, but it is very advantageous also from the electrical point of view. For example, we are working closely with a US customer to propose a solution suitable for this market, that applies standards different from those implemented in Europe.”
FPS strongly believes in this sensitive stage because it allows to get a very accurate idea of the machine that will be manufactured, to optimize the ergonomics and logistics for the flow of components and to achieve savings in terms of costs and time on both sides.
“The creation of the mock-up takes 2-3 weeks in the development of the project, which in the case of projects with tight construction deadlines can be a significant time,” says Gianola, President and Sales Director. “However, experience has taught us that investing in mock-ups can avoid problems during installation/commissioning and in the use of the system, which might otherwise take much longer to resolve.”
As always, the objective of FPS is to be of service to the chemical and pharmaceutical industries. The mock-up is one of the tools that helps us be increasingly in tune with the expectations of our customers.
FPS has recently cooperated with pharmaceutical industry experts to research best jet mill practices for pharmaceutical.
FPS strongly believes in knowledge sharing and continuous improvement. For this reason, FPS President, Eng. Gianola, and Vice President, Mr Corsini, both experts in milling and micronization technologies, worked with M. Nakach Ph.D on a research published in the Pharmaceutical Development and Technology Magazine. Mr. Nakach works at Sanofi. He is the Head of formulation and process development for the Biologic Drug Product Development Department.
As you may know JetMills are particularly useful in pharmaceutical when micronization is used to boost drug activity by increasing particle surface or by allowing active substances to reach their target by reducing the particle size. By increasing the specific surface area (in terms of m2/g) the dissolution rate is also improved. The purpose of the article is to define a scale-up methodology for sticky Active Pharmaceutical Ingredients (APIs) using Quality by Design (QbD) and a scientific best-practice approach. As a result, a commercial manufacturing process of sticky APIs and their industrialization has been documented.
Particular attention has been paid to the cleanability of the system which must be suitable for the process of multiple products while avoiding cross-contamination when batch changes are necessary.
The studies areconducted for sticky Active Pharmaceutical Ingredients on the complete productionprocess that was developed following two industrial Key Performance Indicators (KPIs): high process yield and compliance with Environmental Hygiene and Safety regulations(EHS) .
Finally, an industrial installationwas proposed to deliver the product with high productivity yield, compliant with safety regulation and clean in place.
Please note that FPS cooperation with Mr M.Nakach Ph.D is continuing and FPS is proud to announce the next session of the Micronization Workshop Series focused on this project.
This one-day workshop will be held on 15th October at FPS Production Plant (Fiorenzuola d’Arda (PC) Italy). The three authors of the study will be present and available for discussion.
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As far as containment systems are concerned, spray-drying is a commonly adopted technology in pharmaceutical to obtain a powder from a liquid solution. Given that pharmaceutical companies are handling High Potent API more than ever before, high containment solutions are necessary to safely operate the equipment.
In the past year, some of the isolators that FPS has designed and manufactured have been specifically to contain spray drying equipment. By using an isolator, pharmaceutical manufacturers want to ensure full operator protection without the need for bulky Personal Protection Equipment full-suits that can be cumbersome, costly and may provoke falls.
One of the key requirements that pharmaceutical companies have for isolator manufacturers is not to alter the current process. The goal is to avoid lengthy and costly process re-validation. Another requirement is to ensure excellent ergonomics to avoid operating errors, product loss and work injuries. The FPS design team is very familiar with those aspects and can also accommodate others. For example, one of FPS customers flagged that their multi-cultural team had a very wide variation in height. Their workers were very concerned that the isolator would be too low or too high for their own height and they worried about potential long-term health issues. Another customer had to fit the isolator into a very tight space and the equipment had to be brought in the installation room through narrow doors.
To address those issues FPS engineers worked in close collaboration with the end-user technical, safety and process engineering departments to design the isolator. Mock-up of those systems were built to simulate the activities and validate the technical solutions. Operators were also part of the process.
In the end these isolators had the following features:
“The users were very excited to do away with the cumbersome personal protective equipment. The ergonomics are much improved to perform the process and they like the flexibility of going in and out of the lab without gowning and disgowning” says Frederic Le Pape, the FPS America General Manager.
One customer uses a micronization step in a separate chamber of the spray drying isolator and sees many benefits. For example, there is no need to use a split butterfly valve for product collection which are costly and time consuming to assemble, disassemble and clean.
Finally, the isolator protects the product from moisture during feeding and collecting phases for the spray dryer (and for the jet mill when used after the spray drying).
As always, the objective of FPS is to be of service to the Pharmaceutical and Fine Chemical industries. The mock-up is one of the tools that helps us fulfill 100% of the needs of our customers.
FPS is pleased to announce the developing of a new innovating solution for swabbing, that will ensure the absolute safety of operators and patients.
Inspired by the Korean hospital of Yangji in Seoul, FPS has designed the first prototype of Safety Box to perform the swab for COVID-19 on a high number of people in a few minutes and in total safety, both for the operator and the patient.
The cabins are easily transportable and, once positioned in strategic points, will allow doctors to perform between 12 and 15 swabs in one hour.
Given its experience in the containment sector, FPS has chosen to concentrate all its efforts on the realization of these “swab isolators” in a short time, maintaining the high standards of safety and quality. These systems will consist of two cabins and will be equipped with a negative pressure ventilation system.
Carlo Corsini, the owner, says: “I’m proud of our team for working together and putting their technical skills at the service of public health on such short notice, working with enthusiasm despite the difficult period we’re all going through”
The project was presented to the Ausl in Piacenza two days ago, in the hope that it can be used to contain the spread of the virus.
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Silvana Maini from Tekno Scienze Publisher & Event Organiser interviewed our Technical Sales Director, Stefano Butti. They talked about the company history and Stefano commented the sentence on the website which says: “The starting point of a project is not our machine, but our customer need”. Watch the video and share it!
For FPS, a company on the market for 18 years, the foreign market is of fundamental importance. Today, FPS is recognized in the chemical and pharmaceutical industry as a serious, reliable and high quality partner. For the two-year period 2018-2019, FPS has planned its presence at various events both on the European and non-European market.
Per FPS, azienda sul mercato da 18 anni, il mercato estero ricopre un’importanza fondamentale. Oggi infatti FPS è riconosciuta nel settore chimico e farmaceutico come un partner serio, affidabile e qualitativamente elevato. Per il biennio 2018-2019, FPS ha pianificato la sua presenza a diverse manifestazioni sia sul mercato Europeo sia extra Europeo.
Collected more than 180 new contacts, concluded a major order in Spain and planned business meetings in France.
Raccolti più di 180 nuovi contatti, concluso un ordine importante in Spagna e pianificazione di incontri commerciali in Francia.
Mrs Chiara Colombo, FPS Marketing Manager, describes how FPS has faced the COVID-19 emergency.