Containment Solutions for HPAPI Production
Production and handling of high-potency active pharmaceutical ingredients (HPAPI) or toxic products in gas, liquid or powder form need total product separation from the environment to protect operators.
Food and Pharma Systems (FPS) develops, manufactures, and installs fine size-reduction machines, as well as containment solutions of sterile and highly toxic active pharmaceutical ingredients (HPAPI).
Food and Pharma Systems (FPS) develops, manufactures, and installs fine size-reduction machines, as well as containment solutions of sterile and highly toxic active pharmaceutical ingredients (HPAPI). FPS aims to develop, design, and supply systems to improve process results for the pharmaceutical and fine chemical industries.
FPS’ systems meet a wide range of client needs and requirements due to the company’s approach of discussing any needs with the end user. Topics such as protection, productivity, and quality are considered to identify the most suitable solution.
FPS’ containment product portfolio includes isolators for the highest levels of protection, such as for sterile and toxic materials. For smaller volumes, laminar flow booths are available, as well as pack-off systems, which can safely discharge weigh and pack powders.
For general applications, FPS’ local extraction arms can reduce dust generation.
The company also offers a variety of cleanroom solutions, which includes partitioning walls, flooring with PVC mats, and co-planar surfaces.
FPS’ fluid jet mills and mechanical mills undertake micronisation processes to ensure high-quality fine grinding. The company’s experts can determine the best configuration for a client’s needs.
FPS’ micronisation product range includes spiral jet mills, the QMill, and the PinMill. Spiral jet mill technology is suitable for particle size distribution (PSD) below 3 µm, while the QMill and PinMill are better suited for PSD between 30 µm and 100 µm.
Spiral jet mill technology achieves size reduction by accelerating particles using high-speed jet streams. The particles are then collided to get a target PSD down to D90 µm < 3 µm.
Mechanical mills reduce pharmaceutical and chemical agglomerates to fine particles. FPS’ mills include a specially designed housing with an interchangeable stator and rotor.
QMill technology acts as an alternative to mechanical. Specifically designed for pharmaceutical applications, all connections are made in compliance with current good manufacturing practice (cGMP) standards and features quick assembly and disassembly. The number of components has also been reduced to a minimum to ensure easy cleaning and validation.
The spiral jet mill and QMill series are complete with dedicated feeding systems (volumetric or gravimetric) and final powder collection and filtration units.
Production and handling of highly potent active pharmaceutical ingredients (HPAPI) or toxic gases, liquids, and powders, require isolation to protect operators and the environment. In FPS’ isolators maintain a negative pressure regime and turbulent airflow is adopted. Containment levels between 0.01µg/m³ and 10µg/m³ can be achieved, with a variety of manufacturing solutions and configurations.
Any operator accessing the interior of the isolator must do so via its glove ports or half-suit.
Containment of HPAPI Oral Solid Form activity requires high-integration with the process machines without affecting functionalities and performance. The goal is to guarantee the best use of the process machines assuring high-containment capability.
The process is kept separated by means of closed rigid walls around the formulation machines. Suitable air barriers are provided when continuous operations are requested.
Dedusting machines and powder suction units are also proposed to be integrated inside the isolators to provide a higher containment.
FPS also produces isolators for sterile applications. These are available as either closed isolators or restricted access barrier system (RABS). They allow operators to avoid the use of sterile cleanrooms and reduce the sterile volume in the process. Unidirectional or turbulent airflows can be used for ventilation.
Applications for FPS’ isolators include sterility testing, aseptic filling lines for pharmaceutical or food production, vessel charging of sterile products, and sterile milling and micronisation.
Integrated decontamination systems such as vapourised hydrogen peroxide (VHP) generators are also generally used.
FPS proposes an innovative interchangeable milling station, which is used for milling operations in research and pilot plants. It contains different technologies integrated into a single system.
FPS produces high-quality systems and provides support through from initial discussions of a client’s needs to full-scale mock-up. The company can help clients comply to factory acceptance tests (FAT) and standardised measurement of equipment particulate airborne concentration (SMEPAC) tests, as well as assists customers after the delivery of equipment with maintenance and installation services.
As FPS machines are constantly evolving, its technical team is available to suggest possible upgrades and improvements. FPS employs about 50 people in Italy and has a wide network of agents, which assures a global presence.
Production and handling of high-potency active pharmaceutical ingredients (HPAPI) or toxic products in gas, liquid or powder form need total product separation from the environment to protect operators.
FPS is pleased to announce the developing of a new innovating solution for swabbing that will ensure the absolute safety of operators and patients.
30 March 2020FPS is proud to announce its participation at DUPHAT Tech show in Dubai on 25-27 February.
22 January 2020On Sunday 24 November, FPS took part in the initiative promoted by L'Economia, a section of the famous Italian newspaper Il Corriere della Sera, opening the doors of its renovated production plant in Fiorenzuola d'Arda to hundreds of visitors.
6 December 2019In collaboration with The Economy of ‘Il Corriere della Sera’, FPS is pleased to announce its participation in the “Open Factory” event, which will take place on Sunday 24 November from 2:00pm to 7:00pm, at the FPS operational headquarters in Fiorenzuola d’Arda (PC).
5 November 2019FPS is pleased to announce its participation at the 30th edition of the CPHI WW in Frankfurt, the largest trade fair in the world, which brings together over 45,000 pharmaceutical industry professionals and 2,500 exhibitors from over 150 countries.
9 October 2019FPS will launch the third edition of its micronisation seminar, which will take place on 15 October 2019 at its operational headquarter in Fiorenzuola d’Arda, France.
26 September 2019FPS, in collaboration with The Economy of Il Corriere della Sera, announces its participation in Open Factory, which will take place on 24 November, at the operational headquarters of FPS, in Fiorenzuola d'Arda (PC).
24 September 2019Taking place in Rome on 4 October, upon conclusion of the 5th edition of the HPAPI Summit, FPS will be the Gold sponsor and Speaker.
20 September 2019FPS and its partner Vonlanthen Group will be participating at the 5th Hpapi summit edition, Rome from 2-3 October. The event is taking place at the Hotel Eurostars Roma Aeterna.
6 September 2019FPS announces its presence at the most important events in the pharmaceutical field.
8 August 2019FPS has collaborated with industry experts to research jet mill practices in the pharmaceutical industry.
2 August 2019FPS is an Italian company specialised in the production of containment and micronisation systems for pharmaceutical, biotech and fine chemical companies.
11 June 2019Together with its staff, FPS will be attending the third edition of the CPHI North America fair to be held in Chicago.
23 April 2019FPS Food and Pharma Systems has confirmed its participation in the 57th edition of the CIPM event.
17 April 2019FPS has announced that it will be attending POWTECH in Nuremberg, Germany.
8 April 2019FPS is pleased to announce its presence at PHARMINTECH in Bologna.
5 April 2019For the second year, FPS is pleased to participate in the 7th edition of the PHARMACONEX, one of the largest gatherings in the pharmaceutical sector in Egypt and the Middle East.
1 April 2019FPS is proud to participate in the next edition of INTERPHEX.
26 March 2019FPS is proud to announce a new event for the containment field.
13 March 2019FPS is an Italian company specialised in the production of containment and micronisation systems for pharmaceutical, biotech and fine chemical companies.
22 February 2019FPS has announced its presence at the following events for 2019.
14 February 2019FPS has announced it will be showcasing its innovations on micronisation and containment at CphI India.
19 November 2018FPS has announced a new workshop on containment and micronisation that will be held in November in Fiorenzuola d’Arda, Italy.
10 October 2018FPS has announced it will participate at the world HPAPI summit in Basel, Switzerland.
26 September 2018FPS is pleased to announce a new workshop on containment and micronisation that will be held in October in Fiorenzuola d’Arda, Italy.
10 September 2018For the first time, FPS has confirmed its presence, in partnership with Dott.Bonapace, at CPhI Middle East & Africa.
20 August 2018Together with its local partner 1Supplier, FPS will be present at the next ISPE event.
14 August 2018FPS has announced it will be attending the ACHEMA trade fair, a worldwide forum and show for the process industries.
26 April 2018FPS has announced its presence at the forthcoming 2018 INTERPHEX (International Pharmaceutical Expo) event at the Javits Center in New York City.
3 April 2018FPS has announced it will be attending Pharmaconex 2018, Cairo, Egypt.
29 March 2018FPS has announced the delivery of a complex project that combines high containment within aseptic conditions.
21 March 2018FPS is proud to announce the opening of its new conference and training room, which will host a number of training events in the second half of 2018.
16 March 2018FPS and its local partner Codols Technology have announced they are to attend FarmaForum, Madrid, Spain.
6 March 2018FPS has announced it is opening a new office in Philadelphia to support the continued growth of its business in North America.
1 February 2018FPS Food and Pharma Systems has announced it will be present at the annual appointment CPhI India in Mumbai.
24 November 2017FPS Food and Pharma Systems has received the OHSAS 18001 certification from independent company RINA.
21 November 2017FPS has confirmed its presence at Pharmtech & Ingredients show in Moscow.
17 November 2017F.P.S. Food and Pharma Systems has announced it will be attending the 54th CIPM China in Chansha.
3 November 2017FPS Food and Pharma Systems will be present at the annual appointment CPhI World Wide in Frankfurt.
30 July 2017FPS Food and Pharma Systems has announced its presence at the forthcoming 2017 POWTECH event at Nürnberg Exhibition Center.
16 July 2017FPS has announced it will be attending the 3rd Highly Potent Active Pharmaceutical Ingredients Summit in Barcelona.
2 July 2017FPS has confirmed its presence at Expoquimia, Barcelona.
25 June 2017FPS has announced its official partnership with the 14th edition of the World Mountain Running Long Distance Championships, Italy.
19 June 2017FPS is pleased to announce it will be exhibiting at the EXPO PACK 2017 trade fair, which takes place 13-15 June in Guadalajara, Mexico.
28 May 2017FPS has announced delivery of a high-containment Integrated system for an Oncology plant in Bangalore, India.
25 May 2017FPS will be attending the first Annual Formulation and Drug Delivery Congress, which will be held in London, UK, from 22-23 May 2017.
30 April 2017FPS has announced it will be attending COPHEX, one of Korea's leading pharmaceutical and cosmetic industry exhibitions.
3 April 2017FPS Food and Pharma Systems will be present at the annual PharmaCongress Production and Technology in Dusseldorf
19 March 2017FPS has announced it will show its latest innovations in micronisation and milling technologies for pharmaceutical, cosmetic, and chemical applications at Interphex New York.
16 March 2017FPS Food and Pharma Systems has announced its presence at the forthcoming 2017 INTERPHEX (International Pharmaceutical Expo) event at the Javits Center in New York City.
11 March 2017For the first time, FPS Food and Pharma Systems and its local partner will attend Asia Pharma Expo
19 February 2017FPS Food and Pharma Systems has announced it will be attending FarmaForum, an event for the pharmaceutical, biopharmaceutical, and laboratory technology industries.
19 February 2017FPS Food and Pharma Systems has announced it is expanding its production plant in Fiorenzuola d'Arda for greater flexibility and timeliness on production systems.
21 November 2016FPS Food and Pharma Systems has developed software, which controls equipment functionalities of a sterile micronisation system.
23 October 2016FPS Food and Pharma Systems will display its innovative solutions for containment and micronisation at CPhI in Barcelona.
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