An IMA Safe Uniline supports small batch and full production bottle volumes.
Rx Pharma-Pack Inc. has established contract packaging for pharmaceutical solid dose packaging with the setup of its first bottling line.
Designed to meet the packaging requirements of prescription drug manufacturers, the line is housed in a new 35,000-sq-ft facility rebuilt from the four walls in to support cGMP packaging processes, says Doug Bausch, vice president sales, Rx Pharma-Pack.
Originally in business as a unit-of-use packager for the retail pharmacy industry, Rx Pharma-Pack is expanding to meet growing market demand from ethical drug manufacturers for contract services, says Joseph J. Mollica II, president, Rx Pharma-Pack.
“While our retail pharmacy services remain a viable piece of the business, there has been explosive interest in Rx Pharma-Pack by pharmaceutical manufacturers that require our assistance in packaging their own products,” Mollica says.
“Having only been operational for a short period of 14 months, we are garnering not just general interest but have acquired and developed relationships with several customers to date. Not only have we been fortunate enough to be awarded business, but we have already cleared a number of “big Pharma” quality audits and are listed on their approved vendor list. The response has been overwhelmingly positive,” Mollica says.
For its launch into contract bottling, Rx Pharma-Pack has installed the Uniline monoblock tablet and capsule counting line from IMA Safe, with IMA Safe’s SwiftPharm electronic counter.
The Uniline at Rx Pharma-Pack incorporates container loading, filling, and counting; cottoning; and capping all in a compact footprint of less than 14 feet.
“The Uniline’s significant design and technological advances lend itself to the very specific needs of the ethical drug business. The design of the machine especially from a cGMP perspective allows us to make a very compelling case,” Mollica says.
Rx Pharma-Pack has a 30-year relationship with IMA. “Our company pioneered the launch of IMA’s Press Fit Gelcap configuration back in 1995. What really intrigued us about the Uniline is that this unit is American-made,” Mollica says.
In the Uniline, bottles are positively held and shift register-controlled throughout the packaging process. Bottles must pass a series of sensor-based inspections—for count checks, count verification, cap placement verification—to be proven good. The system’s “fail safe” logic ensures that only good bottles continue down the line.
|Shift register-controlled bottles must be proven good to proceed in bottle-filling production in the Uniline monoblock filler and capper.
The Uniline requires minimal change parts. Accommodating bottle sizes from 30 cc to 750 cc, it features push-button, electronic changeover for bottle diameters so there are no change parts for bottle transport. The
SwiftPharm counter would only require a change of funnel sizes to match the bottle-neck size being filled.
The SwiftPharm tablet counter uses an advanced vibratory feed system to feed and separate product into four containers simultaneously. Optical infrared sensors count the product as tablets break light fields in the counting head. Electrostatic field sensors measure the size and density of the product, comparing the information to predetermined, learned-value parameters.
This allows the SwiftPharm to detect the presence of partial/broken tablets or tablets that may fall simultaneously through the field. Tablet count and product density must be confirmed or the bottle will be rejected and indexed to a reject station.
The Uniline’s capping technology is a combination of servo control and magnetic clutch technology. Servo motors control the indexing, placement, and speed of the cap application, while magnetic clutches grasp, apply torque, and release the cap after it is properly applied.
Currently fully installed, validated, and operational, the line was manufactured, integrated, factory acceptance tested, and supplied from IMA Safe’s Leominster, MA, facility.
An IMA Safe Model A-300 unscrambler with IMA conveyor system feeds bottles to the monoblock. Post monoblock, an AutoMate Model AM-250 induction sealer is deployed.
An IMA Libra New Sensitive ECO labeler applies labels to the filled units. Variable lot code and expiry data can be printed directly onto the label using an OpenDate Digi-3-Coder hot stamp printer or directly onto the bottle using a VideoJet Model 1510 Excel printer. A Keyence Model CV-3002P vision system verifies the printing.
If the applied label contains a printed bar code, a DataLogic Model CBX-100 bar code reader verifies each label is correct. The finished unit is rejected if any label and lot coding defects are detected.
The final packaging of the filled bottles is done per customers’ requirements, with units packed into single boxes, multiple-unit trays, shrink filmed, and placed into master shipping cartons.
Designed for Rx Pharma-Pack’s specific requirements, the line features a maximum output of 150 bottles per minute.
“With this system, we are not restricted by batch size. We can run full production batches as well as smaller validation batches economically (from 100,000 to 12,000,000). The universal feeding system provides accurate count and product movement without count or piggybacking issues,” Mollica says.
The company is in the process of acquiring a second bottling line as well as a blister line, in building out capabilities for Rx pharma manufacturer requirements.
“Many of the auditors reviewing our facility have never seen anything quite like the Uniline and have been extremely complimentary about the Uniline and its installation. We always say, ‘you don’t get a second chance to make a first impression,’ and the Uniline equipment and installation makes a great first impression,” Mollica says.