Packaging Reliably with Form-Fill-Seal
Published: October 24th, 2013
Machines feature advanced systems for forming and sealing with integrated vision toward ensuring product quality and production output goals.
Implementing thermoform-fill-seal (FFS) machinery as an alternative to manual filling and sealing is a complex undertaking. Medical device companies planning automation with FFS must at the outset establish their current and future capacity requirements.
The suitability of new primary package and secondary packaging for devices will be evaluated. And changes to up and downstream equipment may be called for in moving to FFS.
Packagers have sought machines with Ethernet capability for reporting machine status and tracking reliability metrics. Vision inspection has been integrated for confirming product loading and positioning in the formed cavities, detecting seal imperfections, and discovering contaminants.
In preparing for FDA’s Unique Device Identification requirement, companies will require integrated cameras for the real-time verification of 2-D bar codes that may be printed onto packages in line.
“With regard to UDI, we are prepared, along with our partners in the printing industry, to supply exceptional solutions for these new requirements,” says Bob Koch, director of sales, medical, consumer, industrial, Multivac, Inc.
“The printer options that we offer in conjunction with software integrated into the Multivac packaging machine will provide superior print quality on multiple materials and will offer high-resolution print to meet the demanding bar code grade requirements. In an ideal situation, we would apply the print to the top web prior to it being heat sealed to the formed pouch. This can be done on multiple lane arrays at high speed,” Koch says.
Packagers will ultimately evaluate an automated FFS solution for its impact on product quality and production output such as through an overall equipment effectiveness (OEE) study.
Toward meeting customers’ quality, productivity, and cost-efficiency requirements, GEA Tiromat Packaging has improved the PowerPak family of thermoformers designed for sterile medical and pharmaceutical products packaging. Improvements include extending machine running times and reducing the time required for die set changing and maintenance.
The four-machine line features modular construction for customizing to customers’ on-site specifications. The modular design concept enables separation of processes in which core processes such as insertion and sealing can be segregated under cleanroom conditions. Film transport with chains enables precise film processing and positioning.
“With our machine solutions, customers are always on the safe side. We use a multiplicity of monitoring devices for example to monitor forming and sealing pressure and heat zones or to give warnings of protruding products which could have an impact on the sealing,” says Stefan Krakow, segment sales manager, technical packaging applications, GEA Tiromat.
In one application, a medical device maker has automated packaging of cardiology pumps using the compact PowerPakXT thermoformer, realizing an output of about 16 units per minute.
The package features complex contours with a specification for very clear transparency in the finished package.
The machine in this instance has a fixed web width of 380 mm. The formable web is PETG with a Tyvek top web for gas sterilization. The PowerPak XT features GEA Tiromat’s Optiform System and membrane sealing technologies.
Prior to forming, a sandwich heating system clamps the forming web between two heaters to enable the heat to penetrate the film from top and bottom in achieving the proper forming temperature.
In the Optiform system a vacuum valve is opened to create a negative pressure below the forming film when the forming tools close. Above the forming web plugs are applied in tandem with applied air pressure inside a closed dome. Speed and air flows of each process are regulated to achieve well-defined distribution of the material.
In GEA Tiromat thermoformers servo technology is used in driving the lifts at the forming and sealing stations and at the cutting station. “In the past pneumatic cylinders were used to place the plug on the packaging. Today servo motors are frequently used as an option. The plug parameters can be set more precisely thus increasing the reproducibility of the process significantly and reducing energy consumption and noise,” Krakow says.
In membrane sealing, the seal plate is pushed as air pressure is applied to the top of a flat silicone gasket housed in a chamber. The gasket seals off and pushes down to move the plate.
“With membrane sealing, pressure is generated evenly across the whole seal plate to achieve even and robust sealing with lower sealing temperatures. We can guarantee high and even seal strengths while the even distribution of pressure ensures a secure seal,” says Krakow.
For a customer packaging with infusion bags, GEA Tiromat made adjustments to the forming and sealing stations of PowerPak RT thermoformers that were replacing precursor Dixie Union models. A lifting tool for quick change over between three formats was designed. Two PowerPak RT thermoformers with a film width of 320 to 560 mm and index length of 650 mm are used.
In making bags in sizes from 50 ml to 2000 ml, hard-to-form PP-based composite structure films are thermoformed using compressed air and vacuum assist, without plugs. Seal station heating is regulated and monitored with calibrated temperature sensors.
Before cross sealing of the bonded top and bottom webs, vacuum is created to a preset specified level for package air volume evacuation. A throttle between the vacuum source and the evacuation chamber controls the vacuum to enable slower more accurately controlled air removal.
Multipack is addressing quality assurance and production efficiency with the introduction of the Multipack Clean Design form-fill-seal machine for medical and pharmaceutical packaging solutions requiring low microbiological and particle levels in a cleanroom environment, the company has announced.
The new model FFS machine is designed to deliver maximum process reliability and reproducible processes with comprehensive monitoring and recording of the individual process stages.
Design features ensure maximum visibility and avoidance of cross contamination. They include visibility of all processes related to machine areas, and strict separation between the product processing area and the machine technology area.
Additional features are deflector plates in the inside of the machine, the widest possible avoidance of hidden voids, minimum gap dimensions, cable and pipe work routing in enclosed ducts, and protective cladding of assembly modules.