Mrs Chiara Colombo, FPS Marketing Manager, describes how FPS has faced the COVID-19 emergency.
In recent years more companies working with High Potent APIs are asking for high flexibility and a very low containment level at the same time. Relying on almost 2 decades of experience, continuous improvement and 100% in-house manufacturing, FPS is now the leader for containment and micronization systems.
The latest challenge was to design a multi-purpose isolator used to micronize down to a few microns covering a wide range of batch size and assuring a Containment Performance Target (CPT) of 50ng/m3. Inside the isolator, a 4”, 8” or 12” jet mill can be used. To achieve this, a 9-chamber isolator has been designed (with 2 platforms to work at 3 different levels). It is one of the biggest isolators installed in the USA. The design of the isolator follows best ergonomic principles, and is optimized to significantly reduce the maintenance and cleaning time. For example, in the 4” jet mill configuration, only 3 of the 9 chambers are used. This significantly reduces cleaning, turn over time and reduces operating costs. The machine is fully automated with a centralized control system and HMI touchscreen panel.
The software is developed in-house, fully customized to the customer needs and optimized to be user-friendly. The project has been developed starting from the GA and P&ID drawings, going through a full-week mock up tests and then the Factory Acceptance Test (FAT). The installation and validation activities are executed by the FPS customer service team.
“For us at FPS it was an important project”, underlines Eng. Sebastiano Mancarella, FPS Sales Manager, “we are proud to have accepted this new challenge and to have successfully faced it together with the customer. Our FPS never stops motto is the demonstration that we like to innovate and find optimal solutions for our customers. It also shows how we like to offer a very personalized service to each customer.”
During this pandemic, fewer people have been able to visit FPS physically, however the need to see for oneself the facilities is still strong. FPS turned to an innovative idea: to immerse customers into our reality with a series of very detailed virtual tours.
The virtual tours were made in our Fiorenzuola d’Arda, Italy, plant, in collaboration with Biswiss. With a simple click it will be possible to discover all the areas of the company, a complete tour from the reception in the hole to the R&D and test center, from the warehouse spare parts to the production area, from the assembly area to the academy showroom.
Come with us, enter the FPS world! https://my.matterport.com/show/?m=Lfkt7JWqqZ5
In addition, to promote our new R&D and Test Center we decided to create a specific, quickly and in detail virtual tour about this area. It is equipped with ISO8 grade test suites allow the execution of short to medium duration micronization technical tests, starting from laboratory to production quantities. The center is equipped with up-to-date machines and modern instruments in order to assure product and operator protection during activities to assess process validity / optimization.
Find out more with a click -> https://my.matterport.com/show/?m=RWhvQAq7XUK
The milling and micronization processes create a lot of dust as the powder has a very low Particle Size Distribution (PSD) at the end of the process. This dust level may result in an unacceptable exposure to the operators when HPAPI is involved.
FPS focuses on both containment and micronization systems. We offer Jet Mills and mechanical mills integrated into a containment system (all mills are 100% designed and manufactured in-house just like the isolators). The products line covers the full range of productivity and the isolator is designed around the process following best practices and ergonomic principles.
The milling/micronizing Isolators can be designed for small R&D batches (e.g. Isolator with integrated PilotMill-2), to pilot applications, up to the production scale (e.g. Isolator with integrated ProMill-12). The FPS engineering department designs and customizes these isolators depending on the customer needs, so that for the same containment target the design can look very different depending on the customer’s requirements and constraints.
The software is developed in-house and allows to manage both the isolator and the milling/micronization system with one single PLC/HMI.
The remote audit techniques represented the solution to carry out the surveillance visit for the ISO 9001: 2015 certification, successfully passed on 10/08/2020.
A success FPS wants to share with collaborators and technical partners who made it possible even keeping social distancing.
Thanks to: Eng. Paolo Giostra, Eng. Andrea Frazzani (AF Consulting) and Vittorio Severin i (GSI tecnoprogetti).
For dispensing we mean all activities than involve dosing or mixing APIs with a liquid(s), resulting in a solution or suspension. It can also involve mixing other solid excipients to get an intermediate which will be later used as a starter for the manufacturing of solid dosage forms.
FPS designs and manufactures isolators to process toxic products, sterile products or a mix of both (toxic/sterile compounds).
Our machines are tailor-made and fully customized to fulfil the needs of the final customer. In terms of size, we have designed a wide range from small isolators to large systems that have multiple levels (with operator platforms and an automatic system for handling large bins of raw materials).
Here are some examples of our flexibility:
Attention to detail is fundamental to us. FPS can offers:
We typically integrate in our isolators the following connection systems: continuous liners, bag-in bag-out systems, rapid transfer ports, split valves or secondary chambers for bringing the materials in or taking them out. We can integrate systems for powder transport and weighing.
We use state-of-the-art instrumentation and safety sensors.
To achieve the best design we value most our interactions with the customer. Only a deep dialog can lead to the best performances in terms of containment and ergonomics. It also allows to build the custom isolator around the process of the customer and not the other way around.
Mock Up phases
In order to find the best configuration for the machine, location of instruments and accessories, as well as to try all the functionalities of the internal equipment, we strongly encourage an ergonomic study with a wooden mock up before the final design. This is a great way for the customer and the design team to try out the isolator (made at a 1:1 scale). Due the current pandemic, we now perform some mock-up sessions remotely with one of our staff member acting as the operator. It works well.
We also welcome customers to visit our facilities to see physical examples of isolators in our permanent showroom or to perform particle size reduction trials with our process experts. In case you cannot come physically, you can visit our plant with our Virtual tour!
Early drug development is increasingly important, and FPS supports that activity by offering new custom solutions that fit the specific needs of the Pharmaceutical, Biotech and Fine Chemical sectors.
These machines are installed in research laboratories and/or pilot production plants, to ensure safe handling of active substances in a contained environment.
When you must prevent external contamination during all potent powder handling activities and to ensure the safety of the operator from the potent substances. In the study of new drugs, it happens often that during the chemical reaction phase, intermediates are created. The issue is that, at that stage, their toxicity and their potential averse effects are unknown. Using a barrier isolator will prevent the operator exposure to this compound.
The type of containment system is determined by the quantity of product handled, by the OEL “occupation exposure limit” which is expressed in μg/m3, by the chemical/physical characteristics of the substances and by the type of activities performed inside the isolator.
First, compared to any other system, an Isolator is designed to guarantee a perfect separation between the working area and the surrounding environment. An isolator, working under a pressure differential regime, guarantees an additional barrier to avoid contamination. Using an isolator, the operator can work without a breathing device, a protective mask or any other cumbersome PPE (Personal Protective Equipment). Also the ergonomics are greatly improved with an isolator and the operator safety is significantly increased.
Secondly, another way to ensure operator safety is the safe filter change feature. And after the filter change the contaminated HEPA filter can be safely removed through a Bag-In Bag-Out port.
A third benefit is that an isolator can guarantee a low level of moisture or a low oxygen level inside the working chamber, this is crucial for some sensitive products.
And here are some example of applications for which FPS designed tailor-made solutions:
Contact us and define together with us your suitable configuration to your needs
A new multipurpose High Potent API facility needed a containment solution for pilot production. It already owned a few pieces of process equipment. To have those integrated in an isolator could be tricky.
Here is a summary of the issues they faced and the solutions implemented by FPS (2 mn read)
Process:
To filter Highly Potent API, dry the product and dispense it to containers (for pilot production).
Process steps:
What are the issues?
Benefits of FPS Solution:
Description of FPS custom solution:
A hard-wall multi-chamber Isolator including a chamber for filtration, a chamber for drying and a chamber for dispensing. In addition, the isolator offers a pre-chamber for material inlet. This adds a valuable functionality: the same isolator can also be used as a “stand alone” unit for dispensing activities and for the preparation of product to be loaded into reactors.
Custom solution highlights:
“Glass filters have been used instead of steel ones for their transparency, which allows the customer to better follow the filtration activities. Moreover, with particular condensers it is possible to collect the evaporated parts of the solvent too. This material also allows the processing of products sensitive to contamination and the use of even particularly aggressive solvents,” explains Fausto Castellana, Project Manager at FPS. “The real challenge for us was to build the containment system ‘around’ the delicate filtering system. The filters used are 30l and 10l, about 1.60m high. After a careful ergonomic study and the creation of a detailed mock-up, we defined the most comfortable and efficient configuration with the customer.”
How can you transfer potent in-process API from a filter dryer into drums or big bags?
Process:
What are the issues:
Benefits of FPS Solution:
Description of FPS solution:
FPS present the Toxic-sterile Isolator for preparation vessel charging
How to weight and dispense a HIGH POTENT STERILE into a process vessel?
How to maintain the API sterility and protect the operator without using PPE?
How to avoid cross contamination from processing different products?
Process:
Weight & charge a HPAPI into a process vessel in Grade A-ISO 5 conditions
What are the issues?
Process steps:
Benefits of FPS Solution:
Description of FPS custom solution:
