05/10/2021|High Potent API: can 1 containment system accommodate all this?
From solid liquid separation to micronized Highly Potent API (CPT = 200ng/m3) all contained in isolators: Filter dryer discharge, Vacuum transport system to 8” ProMill-8 jet mill in a micronization Isolator.
04/10/2021|Giorgia Bianchi and Marco Jussen, spare parts managers, talk about the spare parts management for CONTAINMENT SYSTEM
Why is it important to have spares in stock?
An important point for FPS team is to make customers aware of the importance of having a complete spares inventory.
27/07/2021|How to best micronize a dusty product and be ready for POTENT APIs?
- Particle size reduction down to low micron is needed
- Operators must be protected because product is very dusty
- Large campaigns with expensive product: highest productivity is needed
- High Potent apis will be added in the future
“High Potent Ready” solution:
15/07/2021|Flexible or Rigid Containment?
There are many options today but HOW TO CHOOSE? Here’s a quick guide.
FOR CONTAINMENT OF POWDERS
Favor rigid containment when:
- Material is Highly Potent (1 µg/m3 or less, OEB5 & 6)
- Frequent usage
- High resistance needed to aggressive materials, pressure, solvents, etc
- Process equipment needs to be integrated
- Capital is available
Favor flexible containment when:
01/07/2021|How to safely do In-Process Quality Control for High Potent powder, tablets or capsules?
How to safely do In-Process Quality Control for High Potent powder, tablets or capsules?
What are the issues?
17/05/2021|Biodecontamination of sterile isolators
FPS and Amira: a strategic partnership allowing high quality standard for the biodecontamination of sterile isolators.
Discover more reading the article on May issue of NCF magazine (Italian version attached).
05/05/2021|Pack off systems
Why do people use it?
- To transfer potent in-process API from a process vessel into drums or bags, through a sieve
What are the issues:
- Api is highly toxic (OEL 10 µg/m3)
- Particle size can be uneven: there could be some abnormally large particles
Possible solution (open process):
13/04/2021|Spray Dryer integrated in an isolator
How to safely discharge a Spray Dryer and mill the potent API?
Feed slurry into the Spray Dryer, collect the potent dry powder, micronize if necessary, weight and dispense (for pilot application: max 5 kg)
What are the issues?
31/03/2021|Dispensing Isolator for big quantities of processed product
How can OSD facilities safely dispense HIGH POTENT products?
Can containers and IBCs of very different sizes be used for the dispensed product?
Load drums, weight & dispense Highly Potent API into various containers or IBCs
What are the issues?
- Highly Potent APIs (CPT < 300 ng/m3)
- Large variety of incoming drum sizes (5-20 kg)
- Receiving containers range from bottles, to bags to IBCs
- Installation room is small: 6.5 m x 3.5 m (21’ x 11.5’)
17/03/2021|Micronization isolator 500 ng/m3
How can a lab safely weight & dispense toxic APIs and liquid solutions?
How to get more protection than the current flexible isolator?
- Introduce bags of potent API, weight & dispense in smaller bags
- Bring in flasks, add solution and dispense in smaller flasks
- Test samples of potent powder or liquid
Challenges of the current flexible isolator:
12/03/2021|Pack-Off 0.1 µg/m3
How can you protect your operators when filling bags of Potent API?
- filling bags generates a lot of dust and exposure to High Potent API
- PPE doesn’t provide the required protection (OEB 5 - 0.1 µg/m3)
- pack-out activities in an open cleanroom requires a lot of cleaning
24/02/2021|Toxic-sterile Isolator for preparation vessel charging
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?
Weight & charge a HPAPI into a process vessel in Grade A-ISO 5 conditions
What are the issues?
09/02/2021|Pack-Off 10 µg/m3
How can you transfer potent in-process API from a filter dryer into drums or big bags?
- Transfer potent in-process API from a filter dryer into drums or big bags
What are the issues:
15/01/2021|Process equipment integrated isolators
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.
07/12/2020|R&D and Pilot Plant Isolator
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.
- What do we mean by isolators for R&D and Pilot Plants?
These machines are installed in research laboratories and/or pilot production plants, to ensure safe handling of active substances in a contained environment.
18/09/2020|FPS presents customized solutions for dispensing needs
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).
15/09/2020|ISO 9001: 2015 certification
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).
05/08/2020|FPS presents milling isolator
FPS presents milling isolator
16/07/2020|FPS Virtual Tour
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.
15/07/2020|The new FPS High Containment isolator for Micronization
In recent years more companies working with High Potent APIs
18/06/2020|ICP interviewMrs Chiara Colombo, FPS Marketing Manager, describes how FPS has faced the COVID-19 emergency.
03/06/2020|International growth plan financed with POR FESR funds
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.
26/05/2020|Interviewing Stefano ButtiSilvana 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!
26/03/2020|New FPS innovation swabbing solution
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.
11/03/2020|Coronavirus - Official Press release
Dear Customer / Supplier / Partner
Following the new provisions of the Italian Government aimed at stop the spread of Coronavirus, we wish to inform you that FPS is currently open and operational, in line with the necessary prevention and security measures.
02/03/2020|Coronavirus usefull information
Due to the current global health situation related to the expansion of COVID-19 or Coronavirus, FPS has promptly taken all necessary measures to protect the health of its employees and visitors, while guaranteeing high quality and continuity to its customers.
FPS does not stop: despite the reduction in unnecessary travels and the cancellation of trips to areas and countries at risk, FPS does not stop! Our business is regularly carried out, within the limits imposed, and a dedicated team constantly monitors the evolution of the situation.
19/02/2020|Spray Drying isolator: FPS solutions for Pharmaceutical and Fine Chemical industries
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.
10/07/2019|Jet milling industrialization of sticky API using QbD
FPS has recently cooperated with pharmaceutical industry experts to research best jet mill practices for pharmaceutical.
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.
21/03/2018|Tailor-made containment system match with asepsis
FPS has recently delivered a very complex project that combines high containment within aseptic conditions.
01/06/2017|High containment Integrated system for Pharmaceutical application
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.
22/09/2016|Sterile Contained PM8 Micronizing systems
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.