FLUID BEDS FOR PRODUCT DRYING, GRANULATING AND COATING (by Bosch Hüttlin)

Bosch Hüttlin machines for drying, granulating and coating processes, integrated in a single fluid bed system. Standard system versions can handle outputs in the range of 256-10,000 L/batch, with 3 to 48 nozzles.
They include multiple options for process filters (fabric, Teflon or metal), containers, spray systems, number of nozzles, disk jet design, cleaning and discharge systems.
All fluid beds can be executed in an “Ultraclean” version with CIP system.
Complete granulating lines that integrates a fluid bed, a high shear mixer, as well as a transfer, discharge and cleaning system, all controlled as a single piece of equipment from a GranuLean unit. This compact line is available in 300 L – 1,200 L rated volumes and 75 L- 960 L process volumes.

HIGH SHEAR MIXER, GRANULATORS AND DRYERS (by Bosch Hüttlin)

Bosch Hüttlin machines with bottom drive, top drive and Single Pot technologies to suit product requirements and customer demands; their fluid bed solutions may be executed in Ultraclean versions.
Cleaning of the granulating machines can be performed as WIP or CIP.
The volume capacity of the standard models ranges from 300 L to 1.800 L.


Bosch Huettlin HBG

TABLET COATING (by Bosch Hüttlin)

Bosch Manesty machines for tablet and pellet coating with water based solutions, organic films, sugar coating, function-end coating or active ingredient layers.
These machines comply with ATEX standards and 21 CFR directives part 11, and feature protection for coating solutions through operator levels OEB 4 and 5; they may be executed in “high containment” versions for highly potent products.
Bosch Manesty provides coaters for small, medium and high outputs, as well as for laboratory batch processing; their work performance ranges from 8 L to 800 L.

TABLET PRESSERS (by Bosch Manesty)

Manesty Bosch machines and stations for tablet production with options for micro-tablets and bi-layer tablets. All the equipment is controlled through touch panels and complies with cGAMP standards.
Die options: D, B, BB and BBS.
Maximum tablet diameters: 11 mm to 25 mm according to the die.
Outputs: 24,000 to 1.000,000 tablets/h

STERILIZATION (by Fedegari)

Fedegari provides a wide range of equipment for the sterilization of pharmaceutical products; they can be specially produced to meet product and customer requirements.
Saturated steam autoclaves, model FOF, for sterilizing solid and liquid products or for final sterilization processes, in versions with cylindrical and rectangular chambers.
Steam-air autoclaves, FOA, for the sterilization of liquids in closed deformable containers, and for dry product final sterilization. Options for automatic product loading and unloading systems with a special version for rotary loading.
Sterilization autoclave by superheated water, FOW, for the sterilization of liquids in closed deformable containers, and for final sterilization of pre-filled syringes. The product loads can rotate within the chamber.
Autoclave-washer, FOWS, that integrates the sterilization, decontamination and washing processes; they can be programmed for sterilization only. Special option for load rotation.
Class 100 depyrogenation oven, FOD, with batch-like intermittent process mode for sterilization of solids, containers, product filling accessories, glass, etc.
FWS washer that uses steam, both as a cleaning medium (reducing the detergent demands) and as a heating medium for the washing process water.
Cabinets and chambers for chemical bio-decontamination by hydrogen peroxide vapor (with anti-bacterial, anti-fungal and anti-viral properties at low temperatures), ideal for decontaminating products and instruments that cannot be heat sterilized; capable of bioburden reductions of 6 log and fit for trials in sterile chambers with H2O2.
Fedegari also offers special applications and auxiliary equipment such as:
Sterilization for elastomeric seals, which includes cleaning, rinsing, siliconizing and sterilization through a special slow spinning drum within an autoclave that features an automatic unloading to the sterile zone.
HEPA carts, models FHC, for aseptic storage and transportation of products, materials and instruments.


Fedegari Passion for sterilization

PRODUCTION of APIs (by OLSA)

OLSA filter-dryers and vacuum dryers for API production with a CIP/SIP internal vessel cleaning function and various agitator options.
Filterplus stationary filters and Oyster portable filters for liquid/solid separation.
Drymix low temperature vacuum dryers for thermo-unstable products and Rotovac vacuum and hot air flow dryers, as well as rotary dryers.


Solidi area multimedia

PRODUCTION OF PHARMACEUTICAL WATERS (by Stilmas)

Stilmas designs and manufactures complete pharmaceutic water and steam production plants that suit customer production requirements.
Pharmaceutical Water Production Plants by Reverse Osmosis
Stilmas’ standard plants can meet production demands of 500 L/h to 30,000 L/h of pure water (PW) or highly purified water (HPW).
Stilmas also offers reverse osmosis and electro-deionization machines, as well as pre-treatment systems by ultra-filtration.
Multi-effect Stills
Pharmastill modular machines of different outputs ranging from 60 L/h to 22,000 L/h of distilled water for injectable drugs.
Thermo-Compression Stills
Mascarini thermo-compressors for the production of distilled water for injectable drugs, with outputs between 50 L/h and 24,000 L/h.
Pure and Non-Pyrogenic Steam Generators
Pure steam plant generators by Stilmas PSG for the sterilization of equipment and process lines with outputs between 50 kg/h and 6,000 kg/h.

REACTORS FOR INJECTABLE PRODUCTS (by Olsa)

Olsa preparation vessels for the production of sterile injectable drugs, ophthalmologic products, syrups and other liquids, with volume capacities of 2 L to 50,000 L, designed and manufactured in compliance with cGMP and FDA standards, and ASME/PED certified.
Wide range of agitators including magnetic agitators for sterile products and homogenizers; CIP/SIP integrated system.


Liquidi area multimedia

SEMI-SOLIDS PRODUCTION (by Olsa)

Olsa blade mixers for manufacturing all kinds of creams, softgels, gels and similar products.
For outputs of 5 L to 30,000 L, Olsa offers the Olsamix, SpeedyCream and Speedymix models with CIP/SIP internal cleaning systems, GAMP and 21 CFR part 11 compliant.


Semi solidi area multimedia

LIFTING, HANDLING AND MIXING (by Servolift)

Servolift offers lift columns, stationary and portable, manual and automated (with options for weighchecking loading cells and screening system); these columns are intended for lifting, dumping, mixing and handling pharmaceutical drums and containers.
Servolift machines can be perfectly combined with fluid beds, high-shear mixers, capsule filling machines, tablet pressers and coaters in order to conform comprehensive solid product processing lines.
These columns can deal with loads of 30 kg to 3,000 kg, and provide for multiple possibilities of container handling and CIP cleaning; they can be mounted in clean rooms, and are 21 CFR part 11 compliant.


Fassmischer mit Handlingsfunktion


Containerentleerstation


Einwaage Einfüllstation


Container Mischer


Drumtipper discharge


Servolift Image Film English


SL 250


SL 250


Beschickung einer Tasblettenpresse

CONTAINER WASHING (by Servolift)

Semi-automatic washing and drying stations and automatic washing cabinets that can be GMP validated for pharmaceutical Servolift containers. Cleaning processes can be configured separately according to container formats, either to ensure a validated cleaning or to reduce processing times and utility consumption.


Reinigungskammer


Reinigungskammer Komplettzyklus

DRUMS AND CONTAINERS (by Servolift)

Servolift designs and manufactures all kinds of pharmaceutical containers (in different shapes, for different volumes, etc.) satisfying customer needs and observing the industry’s hygiene and cleaning requirements.
Standard drums with 0.5 L to 200 L volume capacities.

VALIDATION AND QUALIFICATION SERVICES (by DOC)

DOC provides counseling and validation services for equipment, systems, processes and products ensuring compliance with GMP and FDA standards. DOS offers validation services for:

Processes

  • Preparation of URS, FDS, QDR
  • Process optimization
  • Validation of filters and supervised areas, etc.;

Primary Packaging

  • Material qualification
  • Container integrity
  • Toxicology assessment
  • Endotoxin limits, etc.;

Maintenance

  • SOP, calibrations, re-validations, etc.
  • Training: in GMP, Risk Analysis, etc.
LABORATORY EQUIPMENT (by Bosch, Fedegari and Servolift)

Mycromix, Pilotmix and Pilotlab laboratory equipment by Bosch Hüttlin for mixing, granulating and drying batches of 0.1 kg – 60 kg, featuring top or bottom drive technology with possibility for CIP Ultraclean or Singlepot executions. The Pilotmix features a mobile container and pneumatic discharge system.

Solidlab 1 and Solidlab 2 are fluid bed drying, granulating and coating lines by Bosch Hüttlin for processing 50 g – 15 kg batches, featuring WIP function and ensuring controllable, repeatable and scalable results in industrial production lines.

Bosch Manesty Flexitab pressing machines for tablet production with outputs from 5 to 17 tablets/min and possibility for bi-layer tablets.

Bosch FHM liquid filling equipment for clinical trials with scalable results and compliance with cGMP, QbD, ICH and Q8/Q9. It consists of three modules: control system by HMI, peristaltic pump and filling needle.
Servolift laboratory mixer for product trials and small batch processing, with a 5 L pharmaceutical container, controlled mixing rates, protective guard, control display and qualification documentation.

Fedegari’s laboratory autoclaves with different chamber volumes, vertical or horizontal loading and option for an integrated pure steam generator to sterilize products, laboratory materials and microbiology.

Models:

  • FVA – Vertical loading, 75 L-140 L volume.
  • FVG and FVS – Vertical loading, 30 L-140 L volumes. Standard laboratory sterilization.
  • FOB 2 and FOB 3 – Horizontal desktop loading and double door, 47 L – 122 L volumes.
  • FOB 4 – Horizontal loading with double automatic door and sterilization against pressure, optimum drying and 147 L to 210 L volume.
  • FOB 5 – Same as FOB 4 model, with embedded Thema4lab operating system and 325 L-700 L volumes.

Minilab and Maxilab machines by Olsa for the production of semi-solids such as creams, gels, lotions, etc.; with 2.7 L- 30 L capacities.

bosch

fedegari

servolift


Bosch flexible laboratory high shear mixer


Bosch Solidlab 1: Compact tri-functional lab equipment


Bosch Solidlab 2: flexible laboratory production unit


Bosch flexible laboratory system Tablet Press


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