June 10, 2005 Volume 1, Number 3
 
 

Investing Time to Make Money: A PAT Implementation Perspective-By John E. Carroll
API Scale-Up During Research and Development-By Nandita P. Shetgiri, Mahesh S. Phansalkar, Sandeep Patil, and Rupesh Kelaskar
Outsourcing Outlook-Seeking a Fresh Start
Packaging Forum-New Systems for Counterfeit Protection and Quality Control
Washington Report-Drug Specifications Under Scrutiny
Contracts, Mergers, and Announcements
People
Calendar
Contact
 
   


New Systems for Counterfeit Protection and Quality Control
Packaging Forum
New Systems for Counterfeit Protection and Quality Control (continued)
 
Aseptic advances
Aseptic fillers, long used in the food industry for bulk bags, fill product through a proprietary filling port with a dual membrane. In operation, the port is positioned in the machine where steam sterilizes the top membrane. The membrane is then pierced, and liquid is dispensed into the bag past the partially sealed internal membrane on the bottom of the port. After filling is complete, the lower membrane is heat-sealed in place, and the port is flushed with steam or sterile condensate (Intasept Port and Intasept 2416M Aseptic Filler for Bio Process Containers, Rapak, Romeoville, IL, www.rapak.com).

A filling machine suitable for cleanroom installation or barrier–isolator configuration targets small-scale production lines. Capable of handling 2–100 mL-glass vials at 50 containers/min, the machine features an integral checkweigh system, simple setup and pump calibration, and streamlined statistical data collection for fill weights. All stainless steel construction above the tabletop facilitates vapor-phase hydrogen peroxide sterilization (Model P-1510 Filler, M&O Perry Industries, Inc., Corona, CA, www.moperry.com).

Packaging line innovations
A new unscrambler handles square or round containers and eliminates belts that can mar bottles or wear out and cause downtime for replacement. An integrated rotary cleaner turns over bottles and injects a blast of air before returning them to an upright position (NERBU Unscrambler, New England Machinery, Inc., Bradenton, FL, www.neminc.com).

A tablet counter that can achieve speeds of 200 bottles/min in a dual-lane configuration relies on an infrared counting system. The self-tuning system detects space between tablets and adjusts vibrator motion to increase or decrease delivery speed (Swiftpack SP 200, IMA Nova Packaging Systems, Leominster, MA, www.novapackagingsystems.com).

A continuous-motion, high-speed, horizontal cartoner making its US debut combines positive carton opening with a personal computer-based control, a compact footprint, and an easily cleaned balcony design. Extremely quiet operation means the servo-driven machine is barely audible even when running at 200 cartons/min. This machine is highly flexible and is compatible with most automatic feeders to handle tubes, blisters, jars, pouches, or bottles. Changeover requires no tools and can be accomplished in 15 min because digital scales expedite manual adjustments (Promatic PC 4000 cartoner, Romaco, Inc., Pompton Plains, NJ, www.romaco.com).

A side-load case packer features a cantilevered design for easy cleaning. Servo systems for all main machine movements eliminate the need for change parts for various case sizes. The small footprint machine fits into a space measuring 3700 x 1750 x 1700 mm and operates at 20 cases/min. The unit can be set up for tape sealing, glue sealing, or a combination of tape and glue. Case sizes range from a minimum of 150 x 100 x 120 mm to a maximum of 500 x 350 x 350 mm (GSL20 Side Load Case Packer, MG America, Inc., Fairfield, NJ, www.mgamerica.com).

A new syringe labeling system labels plastic or glass prefilled syringes offline. An integrated denesting unit increases loading speed to 120 syringes/min and reduces manual handling (NVS2, Newman Labeling Systems, Inc., San Diego, CA, www.newmanlabeling.com).

Materials and supplies
As the September 2005 deadline nears that will require wood pallets shipped outside the United States to be heat treated and certified, interest in nonwood alternatives is growing. A 40 x 48-in. polypropylene pallet is competitively priced and can go straight into work-in-process or cleanroom environments. Thermoformed from a single sheet, the pallet weighs only 10 lb and is designed for one-way trips and forklift handling. It also can be used to store raw materials or finished products if the warehouse racking system will support it. Plastic pallets reportedly clear customs faster because officials don't have to check for certification or infestation (40 x 48 CISS PP Export Pallet, Orbis, Oconomowoc, WI, www.orbiscorporation.com).

A two-layer laminate with a 4-mil layer of Aclar (polychlorotrifluoroethylene, PCTFE) delivers the highest moisture barrier available from a clear film. The PCTFE–polyvinyl chloride laminate is roughly 25% less permeable after thermoforming than other clear films and can serve as an alternative to cold-formed foil for blister packaging. Other attributes include good optical clarity and excellent machinability (Pentapharm Aclar 400/02 film, Klöckner Pentaplast of America, Inc., Gordonsville, VA, www.kpfilms.com). (continued) 

 

 


 |  PharmTech   |
© 2005 Advanstar Communications. All rights reserved.
Reproduction in whole or in part is prohibited.   Please send any technical comments or questions to our webmaster.