FPS Pharma
About us
FPS Pharma is a highly specialized Italian company renowned for its advancements in engineering and manufacturing innovative custom pharmaceutical isolators, containment and micronization systems for HPAPIs and sterile pharmaceutical ingredients. With over two decades of industry expertise, more than 1800 custom systems delivered, and a global presence spanning across 45 countries, FPS Pharma has established itself as a frontrunner in delivering bespoke solutions tailored to the most stringent requirements of our clients.
At FPS Pharma, we don't just meet expectations; we exceed them.
Products
Dispensing isolator
This dispensing isolator ensures high throughput dispensing and optimal ergonomics, while minimizing product loss. Key features: - CPT ranging from 300 ng/m³ down to single-digit nanogram levels and below (OEB 7 isolators) depending on customer containment requirements. - Design integrates platform and drum lifter/tilter for safe material loading. - Integrated weight scale. - Flush door. - Continuous liner for samples and waste disposal. - Material transfer via SBV into IBC underneath. Discover all the technical features and custom solutions. Reach out to us and request the new borchure: sales@fps-pharma.com
OSD Process Isolator
This isolator is ideal for OSD milling and blending lines. It gives you all the tools you need to achieve the required PSD for optimal blending. Key features: - Containment performance: CPT = 100 ng/m³. - Compact design for a very tight space. - Design integrates hammer mill, sieve, ball mill and blender. - One control system to operate all integrated pieces of process equipment. Request the new brochure at sales@fps-pharma.com
Isolator for Milling and Micronization
As a global expert in milling and micronization systems, we have become a preferred choice for this type of containment. Key features: - Containment performances: OEB 5, OEB 6 or OEB 7. Custom-engineered to integrate: - Gravity discharge or vacuum transport; - Milling: mechanical mills + 12” jet mill; - Automatic sampling; -Weighing and packing. Request the new brochures! Reach out to us at sales@fps-pharma.com
ANFD Discharge Isolators and Pack-off
FPS Pharma engineers and manufactures custom ANFD discharge isolators tailored on customer requirements. Key features: - Containment performances: OEB 5, OEB 6 or OEB 7. - Design integrates sampling, automated discharge, heel recovery, milling, weighing, and pack-off. - Highest product yield (minimal product loss). Reach out to us to discover all the technical features and unique advantages of these FPS Pharma custom isolators: sales@fps-pharma.com
Reactor charging isolator
This reactor charging isolator is a movable solution that allows the safe opening and handling of third-party drums. Key features: - Containment performances: OEB 5, OEB 6 or OEB 7. - Design integrates drum lifter/tilter for safe material loading. - Integrated inertion systems for flammable/explosive substances. - Corrosion-resistant loading chamber. - Discharge by gravity or vacuum transport system. To discover all the reactor charging isolators and containment systems, reach out to us at sales@fps-pharma.com
OEB 7 isolator for Micronization and Milling
This OEB 7 high-containment isolator ensures the requested Particle Size Distribution is met thanks to all the micronization and milling technologies within the isolator. This design also allows easy cleaning for minimal downtime and quick turnaround between different milling processes. Key features: • Containment performance: OEB 7 (CPT = 1 ng/m3). • Compact design for easy integration into pilot plants, equipped with double material inlet and outlet chambers. • Various milling technologies on board: Cone Mill, Pin Mill, Q Mill, Spiral Jet Mill. • Cryogenic milling capabilities for elastic and temperature-sensitive products. • Advanced sampling systems for frequent and safe sampling. Discover all the advantages and technical features of FPS Pharma OEB 7 isolators. Request the brochures at sales@fps-pharma.com
Containment isolators
FPS Pharma negative-pressure custom isolators with turbulent airflow deliver exceptional containment levels, from 10 μg/m³ to single-digit nanogram levels and below. These isolators are designed to perfectly meet your specific requirements, global regulations, and the most stringent safety standards and guidelines, whether you are dealing with powders, liquids, or gases. Each isolator is engineered to simplify your process steps, minimize risks for the operators and ensure maximum product quality. To address space constraints and optimize your process workflow we engineer the best design. For large systems, it could be a multilevel isolator by using platforms of various kinds (permanent, movable or sliders tucked when not in use). The internal space of the isolator is attentively engineered to ensure optimal ease of movement for operators. Whether scaling up from small-volume or managing large-volume production, FPS Pharma isolators are ideal for: - ADCs development and manufacturing - Laboratory applications - Sampling & dispensing - Reactor Charging - Filtration & Drying - Process vessels charging / discharging - ANFD (Agitated Nutsche Filter Dryers) - Milling - Micronization - Quality control Discover all the features and unique benefits of FPS Pharma high containment isolators. Request the new brochure at sales@fps-pharma.com
Containment Isolator for Synthesis, Filtration, Drying & Dispensing
FPS Pharma's custom isolators for synthesis, filtration and drying are the all-in-one solutions for HPAPIs processing. Safety and Comfort first: - Highest containment level down to single-digit nanogram level. - Easy HPAPI transfer between each process phase. - Engineer for user-friendliness to minimize human errors. - Ideal to complete the HPAPI process in one single structure. Integrated systems for maximum efficiency: - Indipendent weighing chamber. - 25L and 50 L reactor chambers. - ANFD integrated chamber. - Drying and dispensing chamber with vacuum tray dryer. - Outlet chamber. - Ergonomic design for best operator comfort. Discover all FPS Pharma's isolators included the new OEB 7 isolators! Request the new brochure: sales@fps-pharma.com.
Spiral Jet Mills series - Production Unit - PilotMill-8
The ProMill-8 jet mill is designed for production needs. The typical batch sizes is between 2kg and 10,000kg. It’s available in two configurations, cosmetic/chemical and pharmaceutical, to better-fit different requirements. At FPS R&D and test center it’s possible to perform technical trials with products on ProMills. ProMill-8 unit is available in: - ATEX configuration - with PLC control system - with interchangeable inserts (AISI316L, HC-22, PTFE, HDPE or ceramic) - WIP /CIP The ProMill series is engineered to encounter the request from production facilities, where large volumes are processed in a flexible and efficient operation. The ProMill series belongs to a jet mill family which is the result of an unparalleled optimization study. This optimization brings FPS Jet mill to low process gas consumption, to process performances and yields, quick product change operations. KEY ADVANTAGES: • Custom-designed to ensure perfect integration into your installation room. • Quick product changeover and cleaning: easy assembly/disassembly minimizes downtime and cleaning time. • Efficient and continuous production to hit your annual KPIs. Contact us to request the new brochure: sales@fps-pharma.com
Automatic Glove Leak Tester for Glove Integrity Testing
GloveXpert performs reliable and repeatable leak tests using the positive pressure decay method, accurately assessing the integrity of both gloves and glove ports. Seamlessly integrating with RFID systems, it provides comprehensive test traceability. GloveXpert simplifies data management and, thanks to the integrated WI-FI, enables smooth communication with existing infrastructure, such as SCADA systems or others. GloveXpert ensures full compliance with: • FDA 21 CFR part 11 • EU Annex 11 • GAMP 5 • Guidelines and Annex 1 of the GMP • ISO 14644-7 Annex E.5 Key Benefits: • 1st to check 100% of the glove and glove port • NO calibration required • NO risk of false positives or negatives • Test time: 4–9 minutes• 120 test cycles on a single charge. • Full recharge in just 4 hours • Detects holes as small as 100 microns GloveXpert is the new patented wireless glove leak tester from FPS Pharma, designed to eliminate the risk of false positives and false negatives when testing glove integrity. Engineered to meet the stringent requirements of pharmaceutical environments, including aseptic and toxic processing, it ensures full compliance with industry regulations and guidelines while delivering exceptional ease of use and precision. This innovative glove integrity tester for isolators and RABS requires NO operator calibration, thanks to advanced pressure sensors, and features an integrated RFID reader for enhanced functionality. Unique benefits: 1 – Faster and Safer 2 – Lighter and Sturdier 3 – High-Tech and User-Friendly