Equipment Update

Initial outlay pays off handsomely in part quality, reduction in cycle time and extension of tooling life span, says contract moulder

By: Yvonne Klopping

EQUIPMENT UPDATE

A company specialises in developing tray sealers for medical applications. The firm’s ruggedly built machines feature welded tubular steel frames and are constructed without the use of bolts. Designed to be simple to operate and easy to maintain, the sealers from Belco Packaging Systems (Monrovia, CA, USA; www.belcomedical.com) feature a temperature alarm circuit to assure that sealing occurs at the proper temperature. It warns the operator of any temperature differential by not allowing the machine to be cycled. The tray sealers are suited for use in Class 10,000 cleanrooms.

To minimise the risk of downtime, the company assures equivalency among its tray sealers line, which allows the shifting of packaging between work cells with minimal process qualification. The firm also guarantees parallelism between the platen and sealing fixture in its sealers.

The tray sealers are built to published specifications for time, temperature, pressure and parallelism. Their unique frame construction holds a tolerance of 0.003 in. in the seal area. These tight tolerances deliver verifiable process control equivalency among multiple sealers in the same or remote cleanrooms.

A variety of engineering options are available to accommodate custom packaging requirements. Examples include advanced embedded machine control systems that include tool recognition RFID tags, wireless bar code scanning for the input of batch and process data, data acquisition of every seal cycle characteristic and networking of multiple machines for data recording. Autoshuttle indexing of the seal fixtures and off-site diagnostics are also available.

Heat-sealing machines designed for easy programming

A range of universal heat-sealing machines for medical blister-packaging applications is available from a complete-system supplier that also can provide cleanroom blister-packaging services on any scale. Three machines in the Medipacker TS line from Medipack AG (Schaffhausen, Switzerland; www.medipack.ch) feature a high level of control for sealing preformed trays with die-cut lids made of Tyvek, medical paper or foil laminates. Compact and durable, the tabletop machines have been developed for medical product manufacturers and for use in cleanroom environments. They allow regulation of time, pressure and temperature parameters to tight tolerances. Operational speed, not counting placement and removal of trays, is approximately eight cycles per second.

This series of heat sealers offers users easy programming of seal parameters via a touch screen that displays actual and desired values as numbers and in bar graph form. The screen can be locked by means of a numerical code. Because exhaust air is collected and filtered, the machines can be operated in cleanrooms down to Class 100. Optionally, production data can be printed out over an interface. The various models offer seal surface areas of 350 × 350, 350 × 500 and 350 × 700 mm. Sealing components are interchangeable among the machines as spare parts.

Thermoforming machine suited for small-scale production

A medium-capacity thermoforming machine is designed specifically for medical and pharmaceutical device packaging applications. The modular PowerPakRT from CFS Tiromat (Biedenkopf-Wallau, Germany; www.cfs-tiromat.com) retains the high-performance features of the predecessor machine, the PowerPakNT, including its reliability, user-friendliness, flexibility and open access to machine functions, but is an economical alternative for smaller-scale production requirements. Made up of plug-and-play functional modules, the thermoformer can be configured by the user as desired and provides complete flexibility for reacting to changing standards and requirements. The machines are interchangeable with the larger PowerPakNT thermoformers, which can reduce space claims for spare parts storage. Machine data can be used for preventive maintenance. Short time requirements for maintenance and retooling maximise the machine’s uptime.

New thermoforming equipment is validated for medical applications

Designed specifically for the packaging of sterile medical products, a new range of thermoforming machines brings versatility to the processing of flexible, semirigid and rigid films.

The line of MT thermoformers from Doyen Medipharm (Wymondham, UK; www.doyenmedipharm.com) offers users a variety of forming and sealing options for the top and bottom web along with multiple cutting configurations. The machine design facilitates customisation to suit customer requirements and accelerates changeovers.

“The design is specifically validated for medical and pharmaceutical applications,” stresses Martin Beriswill, Vice President of Engineering and Product Development. “We design and validate our equipment to be fit for purpose.”

Many medical devices are not suited for effective four-side-seal packaging, adds Beriswill. “With the MT, Doyen now provides packaging machines for flat as well as three-dimensional products that meet the highest standards.”

Pouching systems designed for configurability

A variety of pouching systems suited for medical device applications are available from About Packaging Robotics (Thornton, CO, USA; www.aboutpackagingrobotics.com). One example is the company’s Pouchmaster Automatic Bar Seal (ABS) system, which is designed to fill the gap between labour-intensive manual pouch open-fill-seal methods and expensive form-fill-seal processing. The automatic open-fill-seal system can be used with automatic fillers.

The modular system incorporates both pick-and-place and bar heat-sealing technology. In the event of an alarm condition, the ABS unit holds pouches in place until the alarm has been corrected and reset, eliminating the need to inspect the entire lot.

Equipped with a single ABS unit by default, the company’s Maverick Poucher system can open, fill and seal large premade Tyvek, strip header bags, foils and barrier pouches. Capable of accommodating bulky medical devices and trays, the Maverick Poucher provides repeatable heat sealing. Offering gentle, automatic, horizontal product loading, the machine supports both manual and automatic product insertion.

Ultrasonic sealing system delivers reliability under difficult conditions

An ultrasonic sealing system is designed to produce repeatable, reliable hermetic seals on the heavy-gauge monolayer films used within the medical device industry. The sealing system cuts through contamination such as water in the seal area to produce a hermetic seal. Available from Paramount Packaging Systems Ltd (Fleet, UK; www.paramount-packaging.co.uk), the ultrasonic sealing system, which is reportedly the first of its type to cover both fin and end seals, has been developed to ensure reliable sealing under difficult conditions and also to simplify validation of the sealers. The other benefit, apart from a reduction in energy consumption, is that the fin and end seal units of the ultrasonic system remain cold, so that products susceptible to heat damage can be packed with ease.

The wrapper control program monitors the sealing process. Providing the predetermined frequency is reached, the wrapper allows the pack to exit the system, ensuring positive release of only fully sealed packs.

Automatic cohesive taping machine facilitates medical tubing packaging

A cohesive taping machine from S-Y-M Products Co. (Litchfield, CT, USA; www.symproducts.com) is suited for use by medical device manufacturers that tape tubing and catheter sets before placing them into packages. The TAYP-R machine can be used in the production and packaging of medical tubing sets and other products that need to be secured without leaving an adhesive residue. During operation, a user inserts a bundle of tubing into the jaws of the machine and pulls out the finished product, which has been sealed with tape. The machine automatically feeds and cuts paper cohesive tape in a continuous operation. Designed to be easy to use, the machine can prevent repetitive hand injuries by relieving stress to fingers and wrists. It is said to be faster, more efficient and safer than manual methods.

The system seals cohesive tape around a coil to facilitate easy packaging. It can dispense flat strips of cohesive tape in virtually any length. Performing coiling and taping in a single operation, the TAYP-R is frequently used by manufacturers in conjunction with other tubing-processing machines. The machine is available for tape widths of 25.4, 19 and 12.7 mm. The TAYP-R is all electric and it operates using standard voltage.