Fluipharm
Fluipharm

Innovation and product safety of the highest standard Fluipharm®

Perfected for the use of the hot water cascading method, the Fluipharm® offers everything necessary for research and development, the production of sterile materials and, last but not least, the treatment of parenteral solutions in hospital pharmacies. After all, fast sterile reprocessing is a key ingredient to the success of any business in the pharmaceutical or biotech industry.

Fluipharm
Fluipharm

Technical data

Machine type
Internal chamber clearance in mm (H x W x D)
Volume in L
External machine dimensions in mm (H x W x D)

H model 969

1,000 x 650 x 990

644

1.918 x 1.900 x 1.360

H model 9612

1,000 x 650 x 1,340

871

1.918 x 1.900 x 1.710

H model 9618

1,000 x 650 x 1,940

1,267

1,918 x 1,900 x 2,310

Technical data subject to change without notice

Fluipharm

Sterilization of liquids in closed containers.

MMM developed the Fluipharm® in response to the stringent requirements of the pharmaceutical industry on design and process reliability. The machine uses the water cascading method and is ideally suited for sterilizing solid and porous materials as well as liquids in tightly sealed containers.

The Fluipharm® complies with the Pressure Equipment Directive (PED) 2014/68/EU and the Machinery Directive 2006/42/EC, CE marking according to PED 2014/68/EU. The standards applied are: DIN 58950-2 Sterilization, AD 2000 Design of Pressure Vessels and DIN EN 62304 Medical device software.

Fluipharm

Highlights

  • Individual design and equipment
  • Fast and reliable process sequence
  • Special programs:
    -Vacuum drying
    -Ampule check
    -Wash and rinse program for ampules
  • Siemens controller
  • 12” or 15” display, or customer-specific size
  • Clamp or aseptic threaded connections
  • FDA-compliant sealing materials and lubricants (21 CFR)
  • F0 value controlled process sequence
  • Sterile filtration of compressed air
  • Air-tight separation
  • “Vacuum programs” equipment package
  • Additional programs: “Vacuum drying, ampule check, rinse cycle”
  • Heat exchanger with heating steam
  • Connection to cooling circuit
  • Heat exchanger fully drainable on product side, hygienic process connections
  • Barcode reader for identifying the material being loaded
  • Remote diagnostics, central control room
  • Connection to a DIN A4 printer or network to print out or archive the cycle report
  • Air-tight bulkhead as barrier between the sterile and non-sterile area
  • Clamp or aseptic threaded connections
  • FDA-compliant sealing materials and lubricants (21 CFR)
  • F0 value controlled process sequence
  • Filter housing and elements can be sterilized inline
  • 15“ display
  • Compressed air filter
  • “Solid and porous materials” equipment package
  • “Infectious materials” equipment package
  • Water saving: The vacuum pump is connected to a closed cooling circuit
  • Cooling circuit connection: The heat exchanger of the recirculation circuit is connected to the on-site cooling circuit for additional operating water savings
  • Hot water cascading process for liquids in closed containers
  • Pre-vacuum process with drying for solid materials
  • Pulsed vacuum process with drying for porous materials
  • The contents of the cycle report are regulated by law. The structure can be customized
  • Printing to a DIN A4 printer
  • Transmission of data over the network for saving on a connected PC
  • Operator identification in the cycle report
  • Internal cycle data memory for up to 50,000 cycles

High-tech – harnessed intelligently

Combined with MMM’s SiSoft control software, the latest generation of Simatic controllers enables intuitive operation, password-protected data management, and parameter-controlled free process programmability that allows all project-specific details to be individually accounted for.

Precise process control
» State-of-the-art industrial controller
» Redundant sensors for superior process reliability
» PPV system: Process Parameter Verification
» Interfaces for optimal integration

The software
» Secure and user-friendly
» Software development and validation according to DIN EN 62304 Software life-cycle processes.
» The sophisticated parameter structure provides a high level of flexibility when configuring the machine
» User management features ensure excellent access security.

Custom machine configuration
» Continuous monitoring of all measured values
» Precise regulation of the actuators
» Barcode reading system with automatic program selection (optional)
» Autostart for automated program sequences, such as vacuum test, heating (optional)
» Versioning and release of programs (optional)
» Active P&ID diagram (optional)
» External communication interfaces, e.g., via Profinet (optional)

Conformity with 21 CFR Part 11
» User management
» Data archiving with checksum
» Audit trail

  • Liquids in closed containers
  • Vials
  • Ampules
  • IV bottles/IV bags

Downloads

Download the brochure and find out more about the Fluipharm®

Kontakt

MMM Group
Semmelweisstraße 6
82152 Planegg/Munich
Germany

+49 89 899 18-0 info@mmmgroup.com Contact

Costumer Service

service@mmmgroup.com