FD-Pharma®

FD-Pharma® Unit Dose Packaging System

MPI’s FD-Pharma® Unit Dose Packaging System with built-in printing and pumping system is an automated, barcoding packaging solution for unit dose oral liquid medication. FD-Pharma® offers precise liquid dosing, in a convenient unit dose cup. The FD-Pharma® has a small footprint and a small price point, with professional results! Adding the FD-Pharma® to your production equipment portfolio would add liquid cup packaging capability able to address clinical trials, small production and validation runs, and full production mode, all in one machine. The FD-Pharma® is a re-engineered version of our Fluidose® system which has been supplying institutional liquid unit dose packaging to hospital pharmacies worldwide for over 20 years.

Our Drug Master File enables MPI to rapidly support customers’ compliance and filing needs within the pharmaceutical industry as well as meet the needs of pharmaceutical drug manufacturers and contract drug manufacturing organizations (CDMOs) for FDA-compliant liquid cup packaging capabilities.

Key Benefits

  • A complete proven solution which includes the packaging system, barcode labeling software and all required materials.
  • The longevity that MPI’s UDCUP™ and packaging solutions have been in use.
  • MPI’s proprietary packaging materials conform to FDA regulations for use in direct food contact.
  • Labels are generated on the machine while packaging, eliminating the cost and waste associated with pre-printed label lidding.
  • Small footprint, small price point.
  • The FD-Pharma is easy to operate by line technicians with minimal training required to be proficient.
  • Quick changeover with minimal cleaning required.
  • Low cost per dose (CPD).
  • Cost of ownership is very low with the FD-Pharma® due to very low maintenance costs for operating and maintaining the machine.
  • Barcoding and serialization capabilities (when using Pak-EDGE® UD Barcode Labeling Software) are standard features.
  • FD-Pharma® with its built-in scanner provides 100% verification of a readable barcode on the unit dose package.
  • Package 35mL at rates up to 35 per minute.

Machine Features

Printing

  • The FD Pharma® is integrated with a label printing system.
  • Supports serialization.
  • Supports standard barcodes and serialized barcoding.
  • Does not use pre-printed label stock.
  • Monochrome printing performed online prior to filling on top of lid.
  • 300 d.p.i. Thermal Transfer printer.
  • Full resin ribbon.
  • Includes Pak-Edge® UD Barcode Labeling Software.

Pumping System

  • Two individual fully programmable linear drive stepper-controlled pumping stations.
  • Positive displacement; using two 50mL stainless steel syringes which are fully autoclavable.
  • Pumping system operations with 2 intake and 2 output pinch valves designed for 50 Dur silicone tubing. Check valves can be used in place of pinch valves.
  • Pump Controls – Pumping draw rates, dispense rates and dwell are fully programmable through touchscreen interface. Pumps can be individually calibrated.
  • Tubing setup will vary based on product being packaged.
  • Pumping setup (syringe, tubing and pinch valves) can be customized for specific requirements.

Sealing

  • Single linear drive sealing station controls two seal platens.
  • Seal Temperature Control Sealing temperature 220°C; programmable range 150°C to 230°C.
  • Programmable low limit set point.
  • Operational temperature warnings for low limit, over limit and broken or damaged thermocouple.
  • Programmable seal dwell, seal rate and seal pressure are set through touchscreen interface.
  • Change parts for 7mL, 15mL, 25mL and 35mL.

Cup Feeder

  • Automated cup indexer.
  • Includes two cup magazines.
  • Holds up to 180 large or 300 medium or Small cups.

Interface

  • Resistive touchscreen controls.

Tooling

  • Minimal tooling required.

Sensors and Safety

  • Door switch prevents machine from operation when door is opened.
  • Lidding out sensor.
  • Cup Drop Sensor – Detects that a cup has dropped from the cup feeder.
  • Cup In Place – Detects that a cup is in place prior to filling.

Convenience

  • Minimal maintenance.
  • Single operator.
  • Open design so users can easily access operational areas of the system.

Options

Barcode Verifier

  • The optional barcode verifier scans each package as it leaves the FD-Pharma® conveyor belt to assure that it has a readable barcode. If an unreadable barcode is detected, the system will pause to allow the user to retry or remove the package from production.

Air Rinser

  • Assists in limiting any loose contaminate that may be present by targeting a short burst of air into the cup directing debris into collection netting prior to the advancing and filling the next cup.

Die Cut Feature

  • MPI offers the option to add a die cut feature to the FD-Pharma® liquid packaging system. The die cut module is a separately powered device connected to the exit area of the FD-Pharma™ and interfaces with the FD-Pharma® during operation. The external device trims the lidding to the perimeter of the cup leaving one tabbed section. It is the ideal tool to add a professional die cut labeling capability to liquid unit dose cup packaging. Production speed is up to 23 cups per minute when using the die cut option.

Material Specifications

Cups

  • High Density Polyethylene (HDPE).
  • 15mL: 2.0” Rim x 0.78” height.
  • 25mL: 2.0” Rim x 1.21” height.
  • 35mL: 2.0” Rim x 1.49” height.
  • Standard colors include: Blue, Red, Yellow and Amber.
  • Custom colors available, minimum purchase required.
  • Meets the requirements of the Food and Drug Administration regulation 21 CFR 177.1520.
  • Meets USP UV light resistance (Stock colors: Red and Amber).
  • Class A.

Lidding

  • Lidding Width: 2.125”.
  • Class A.
  • Peelable sealant HDPE lidding.
  • Printable PET matte surface.
  • Constructed with LDPE and foil layers.
  • All lidding is produced in accordance with Good Manufacturing Practices and complies with Applicable FDA regulations for most food, beverage and pharmaceutical products.

Machine Specifications

Size

  • 37″ L x 14″ W x 18″ H

Weight

  • 130 lbs.

Power

  • 115VAC, 500VA

Sealing

  • Temperature 220°C

Production Speed

  • Up to 35 cups per minute

Nominal Capacities

  • 3mL (recommended minimum)
  • 35mL (recommended maximum to fill line)

Machine Format

  • Linear, conveyer, double index.

Packaging Format

  • Unit Dose Cup with non-die cut lidding.

Applications

  • Pumping system/tubing can be arranged to support a range of fluids of varying viscosities.
  • System has been designed for oral medications, however all possible applications have not been determined; providing samples for review will aid in this determination.

Die Cut Module Specifications

Size

  • 22″W x 12″D x 24″H (Includes input and output chutes)

Weight

  • 40 lbs.

Power

  • 115VAC 50/60Hz, 50VA

Air

  • 100PSI, 10CFM; 60PSI working