Micronization

Micronization technology has brought great developments in the chemical, pharmaceutical, food, cosmetic, energy and aerospace industry.

The trend to reduce the size of powders below 100µm is continuously increasing given the advantages such as bio-availability, dispersion (aerosols) in pharmaceutical applications, dispersion, blending effect, adherence, lasting effect and silky touch for cosmetic applications, increased surface area for other applications.

The adoption of fluid jet mill technology is the “clean” alternative to mechanical milling.

Typical fluid jet mill advantages over mechanical mills are:

  • No mechanical part in movement, no mechanical attrition
  • Average process temperature (allowing to process thermo sensitive products)
  • Light weighted, easy and rapid assembly/disassembly

Spiral jet mill technology is suggested for target particle size distribution below 30µm, while QMill or pin mill technology is suitable for PSD in the range 30-100µm.

Spiral jet mill

With spiral jet mill technology the size reduction is achieved by collisions between particles of the substance, previously accelerated by high-speed jet streams. Target PSD is generally below 30μm when adopting this technology.

The main advantages are represented by:

  • Easy Cleaning for Validation (to avoid cross contamination)
  • No mechanical parts in movement (no lubrication, strong reduction of metallic contamination)
  • No Heat Generation 
  • Constant Temperature 

Working principle

  • High pressure gas (typically Air or Nitrogen), from 2 up to 12 barg
  • Product particles acceleration in the milling chamber
  • Particle to particle collision for product fragmentation
  • Static classification

R&D Units

The R&D Jet Mill series is engineered to meet the requirements of R&D labs, where new product are developed and micronization process is requested on small quantities (from minimum 10mg to 100g).

The R&D Jet Mil series belongs to a jet mill family which is the result of an unparalleled optimization study. All connections of components are made to be in compliance with cGMPs and to assure quick and easy assembling and disassembling operations. The number of components is reduced at minimum in order to speed up also cleaning and validation activities.

The R&D Jet Mil series may be easily integrated into FPS isolators to allow the process of very high active or sterile products.

PilotMill-Zero

PilotMill-Zero represents the right solution for preliminary feasibility micronization trials with milligrams batches of New Chemical Entities, as well as of many other products.

  • Based on the proven FPS Spiral Jet Mill technology
  • Designed to effectively operate despite the miniaturized dimensions
  • Maintaining a high performance level and reliability

As per the trials performed in our laboratory using Lactose:

  • 10mg is minimum batch micronized with PilotMill-Zero
  • Recovered product: 190mg (95% of yield on 200mg batch)

At FPS R&D and Test Centre it is possible to perform technical trials with your products and PilotMill-Zero.

LaboMill/PilotMill-1

The LaboMill/PilotMill-1 is the FPS answer to R&D lab needs when it comes to very initial stages of development, when only extremely small "batch sizes" are available. This very limited amount of material - starting from 200 mg - asks for the use of very special equipment designed and developed via a "miniaturization" process.

Despite the reduced dimensions, the LaboMill and PilotMill-1 are able to assure full scalability of micronization process with other FPS jet mills.

The LaboMill and PilotMill-1 jet mills may be easily integrated within a FPS isolator system for the safe handing and processing of high potent API or toxic products.

Maintaining the same jet mill chamber size, LaboMill has a bottom discharge configuration, while PilotMill-1 has top discharge.

 

Pilot Units

The PilotMill series is able to meet the request for laboratory needs and small production batch sizes (from 3g to 100kg).

The PilotMill series belongs to a jet mill family which is the result of an unparalleled optimization study.All connections of components are made to be in compliance with cGMPs and to assure quick and easy assembling and disassembling operations. The number of components is reduced at minimum in order to speed up also cleaning and validation activities.

The PilotMill  series jet mills may be easily integrated into FPS isolators to allow the process of very high active or sterile products.

PilotMill-2

The PilotMill-2 jet mill is designed for product research and developments needs, where batches from 1g to 3kg are considered. In function of these process condition, the PilotMill-2 jet mill has been designed to assure higher micronized product yield. It is available in top discharge configuration with product recovery inside the filtering bag to further maximise product yield.

The PilotMill-2 jet mill may be easily integrated into glove box systems to allow the process of very high active or sterile products. It’s also available in ATEX configuration. Special configuration i.e. with PTFE or ceramic inserts/lining, in Hastelloy and others are available upon request.

PilotMill-3

The PilotMill-3 jet mill still more indicated for R&D activities, can start micronizing batch sizes as low as 3g with extremely contained product loss and can micronize batches up to approx. 10kg. It is available in top and bottom discharge configurations, to better fit different needs.

The PilotMill-3 jet mill may be easily integrated into glove box systems to allow the process of very high active or sterile products. It’s also available in ATEX configuration. Special configuration i.e. with PTFE or ceramic inserts/lining, in Hastelloy and others are available upon request.

PilotMill-4

The PilotMill-4 jet mill is designed for product developments needs, where batches from 5g to 60kg are considered. It is available in top and bottom discharge configurations, to better fit different needs.

The PilotMill-4 jet mill may be easily integrated into glove box systems to allow the process of very high active or sterile products. It’s also available in ATEX configuration. Special configuration i.e. with PTFE or ceramic inserts/lining, in Hastelloy and others are available upon request.

PilotMill-5

The PilotMill-5 jet mill is designed for product developments needs and small production campaigns, where batches from 100g to 100kg are considered. It is available in top and bottom discharge configurations, to better-fit different needs. The PilotMill-5 jet mill may be easily integrated into glove box systems to allow the process of very high active or sterile products. It’s also available in ATEX configuration.

Special configuration i.e. with PTFE or ceramic inserts/lining, in Hastelloy and others are available upon request.

PilotMill-6

The PilotMill-6 jet mill is designed for product developments needs and small production campaigns, where batches from 500g to 250kg are considered. It is available in top and bottom discharge configurations, to better-fit different needs.

The PilotMill-6 jet mill may be easily integrated into glove box systems to allow the process of very high active or sterile products. It’s also available in ATEX configuration.

Special configuration i.e. with PTFE or ceramic inserts/lining, in Hastelloy and others are available upon request.

Production Units

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.

All connections of components are made to be in compliance with cGMPs and to assure quick and easy assembling and disassembling operations. The number of components is reduced at minimum in order to speed up also handling, cleaning and validation activities. The ProMill  series jet mills may be easily integrated into FPS isolators to allow the process of very high active or sterile products.

ProMill-8

The ProMill-8 jet mill is designed for production needs. The typical batch sizes is between 2kg and 1000kg. 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

ProMill-12

The ProMill-12 jet mill is designed for production needs. Typical batch sizes is between 5kg and 2500kg. It is available in two configurations, 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-12 unit is available in:

- ATEX configuration

- with PLC control system

- with interchangeable inserts (AISI316L, HC-22, PTFE, HDPE or ceramic)

- WIP /CIP

ProMill-16

The ProMill-16 jet mill is designed for production needs. Typical batch sizes is between 20kg and 5000kg. It is available in two configurations, 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-16 unit is available in:

- ATEX configuration

- with PLC control system

- with interchangeable inserts (AISI316L, HC-22, PTFE, HDPE or ceramic)

- WIP /CIP

QMill

QMills technology is an alternative to mechanical mills.

Interchangeable with spiral jet mills, QMill series is designed to be a pharmaceutical alternative to pin mills and hammer mills.

PLUS

  • Fluid jet mill type
  • Larger inlet PSD
  • Outlet PSD to 20 μm
  • Micronization of plastic type materials
  • High throughput
  • Interchangeable with spiral jet mills

R&D Units

The R&D QMill isengineered to meet the requirements of R&D labs, where new product are developed and micronization process is requested on small quantities (from minimum 1g to few kgs).

All connections of components are made to be in compliance with cGMPs and to assure quick and easy assembling and disassembling operations. The number of components is reduced at minimum in order to speed up also cleaning and validation activities.

The R&D QMill may be easily integrated into FPS isolators to allow the process of very high active or sterile products.

QMill-2

The QMill-2 is designed for R&D laboratory needs. Starting PSD of raw material is 1mm approx. Bench top design assures easy placement on any laboratory desk or hood.

The QMill-2 is engineered to give high product yield with batch size from 1g to 3kg with productivity from 0.01 to 1kg/h. The QMill-2 may be easily integrated within a FPS isolator system for the safe handing and processing of high potent API or toxic products.

Pilot Units

The Pilot QMill series is able to meet the request for small production batch sizes (from 100g to hundreds of kg).

All connections of components are made to be in compliance with cGMPs and to assure quick and easy assembling and disassembling operations. The number of components is reduced at minimum in order to speed up also cleaning and validation activities.

The Pilot QMill  series jet mills may be easily integrated into FPS isolators to allow the process of very high active or sterile products.

QMill-6

The QMill-6 is required for final particle size between 15-20µm and 100µm (D50), Starting PSD of raw material is 2-3mm approx. The QMILL-6 is engineered to give higher product yield with batch size from 100g to 100kg with productivity from 0.2 to 3 0kg/h.

The QMill-6 may be easily integrated within a FPS isolator system for the safe handing and processing of high potent or toxic products.

QMill-8

The QMill-8 is required for final particle size between 15-20µm and 100µm (D50), Starting PSD of raw material is 2-3mm approx. The QMILL-8 is engineered to give higher product yield with batch size from 1kg to 500kg with productivity is from 0.5 to 50 kg/h.

The QMill-8 may be easily integrated within a FPS isolator system for the safe handing and processing of high potent or toxic products.

Production Units

The Production QMill series is engineered to encounter the request from production facilities, where large volumes are processed in a flexible and efficient operation.

All connections of components are made to be in compliance with cGMPs and to assure quick and easy assembling and disassembling operations. The number of components is reduced at minimum in order to speed up also handling, cleaning and validation activities.

The Production QMill  series jet mills may be easily integrated into FPS isolators to allow the process of very high active or sterile products.

QMill-10

The QMill-10 is required for final particle size between 15-20µm and 100µm (D50). Starting PSD of raw material is 2-3mm approx. The QMILL-10 is engineered to give higher product yield with batch size from 5g to 2500Kg with productivity from 2 to 150kg/h.

The QMill-10 may be easily integrated within a FPS isolator system for the safe handing and processing of high potent or toxic products.

QMill-14

The QMill-14 is required for final particle size between 15-20µm and 100µm (D50). Starting PSD of raw material is of 2-3mm approx. The QMILL-14 is engineered to give higher product yield with batch size from 10g to 5000kg with productivity from 5 to 300kg/h.

The QMill-14 may be easily integrated within a FPS isolator system for the safe handing and processing of high potent or toxic products.

Mechanical Mills

FPS Mechanical Mills are designed to reduce agglomerates of pharmaceutical, chemical and food products down to fine size. The system includes hygienic design mill housing with interchangeable rotor and stator. The size reduction of the product is considered function of:
 
•  the product being processed, with its chemical and physical properties;
 
•  the rotating speed;
 
• the product feed rate into the milling chamber, that defines the quantity of product inside the milling chamber;
 
• the process temperature
 
• the adopted tool (pins, knives, hammers, blades).
 
FPS Mechanical Mills available are: PinMill-100, PinMill-200, HammerMill-100 and HammerMill-200.

PinMill 100 / PinMill 200

PinMill is designed to reduce agglomerates of pharmaceutical, chemical and food products down to fine size. The system includes hygienic design mill housing with interchangeable rotor and stator. The size reduction of the product is considered function of:

•  the product being processed, with its chemical and physical properties;

•  the rotating speed;

• the product feed rate into the milling chamber, that defines the quantity of product inside the milling chamber;

• the process temperature

• the adopted tool (pins, knives, hammers, blades).

Milling head completed with pin rotor and stator, operating speed up to 100m/s. 

The available size are PinMill-100 and PinMill-200.

Multimilling Platform

The multimilling station is the best choice for the execution of milling operations in research departments and pilot plants, with different technologies integrated on a single system.

The platform considers:

-           Spiral jet mill type PILOTMILL-4, PILOTMILL-5 or PILOTMILL-6

-           Pin mill 100

-           Loop mill type QMILL-6

-           Conical mill

A minimum footprint is given for use in existing rooms.

The milling system can be operated in conjunction with a cryogenic exchanger which allows the reduction of process temperature down to -100°C.

Integration with isolator systems is possible for processing HPAPI.