Validation Software Speeds Up Packaging Process

Originally Published MPMN September 2002

EQUIPMENT NEWS: Packaging and Assembly Equipment

Validation Software Speeds Up Packaging Process

Enhancements can shorten production times and increase safety

Susan Wallace

In order to assist manufacturers in complying with the ISO 11607 standard requirements for packaging process development, equipment manufacturers are increasingly incorporating validation software and equipment into their machines. Rod Jennings of Van der Stahl Scientific Inc. says that his company's new pouch sealer "will incorporate real-time seal-integrity monitoring to enhance validation compliance."

Enhancements to validation services can also "ensure the efficient and safe operation of our packaging solutions in the medical industry," says Michel Defenbau, president and CEO of Multivac Inc.

This article looks at various validation additions to packaging machinery and also at equipment designed to speed up the packaging process.

Enhancement Package for Validation Services

A three-part Multivac Inc. validation service for its RS30 rollstock medical device packaging system surpasses FDA guidelines and includes a factory documentation package, multiple machine features, and installation qualification.

"This enhancement service allows customers to significantly shorten time to productivity by ensuring problem-free validation of the installation, operational parameters, and packaging process," says company president Defenbau.

The R530 features measurement and control redundancy. Control monitors with independent redundant sensors enable a backup warning system to alert operators of potential problems that can affect system uptime.

Prior to shipping, each machine undergoes a documented factory checkout, ensuring that the customer receives specified features, capabilities, and sequence of operations. Documentation includes a software validation certificate, factory acceptance testing documentation, calibration certification of the instruments used in manufacturing, and certificates of accuracy for all sensors used on the machine.

Medical Pouch Sealer

A pouch sealer checks all key set-point constituents for good scientific validation. The Model MS-350 from Van der Stahl Scientific Inc. monitors temperature at the heat platen to ensure that temperature tolerances are within the set-point range. The unit does not rely on air pressure, and can deliver constant repeatable pressure with a robust electronic solenoid, despite possible fluctuations in the facility's system.

A menu-driven Hitachi microprocessor ensures that dynamic pressure is applied to each pouch and constantly monitors the servo's pressure at the seal bar. The unit can also be set to an autocycle mode, which allows the machine to be set in tenth-of-a-second increments up to 5 seconds for automatic cycling.

Because the sealer does not use a pneumatic-driven pressure bar, no air is required, just a 110-V receptacle. The machine features a 10-mm seal width, and is 350 mm long.

Pouch-Opening Machine

A pouch-handling machine can speed up pouch opening by a factor of two or more, according to Quickpouch The QuickPouchMicro is designed to reduce handling of the pouch by holding the pouch open while it is filled, enabling the operator to have both hands free. This can decrease operator fatigue, which can lead to carpal tunnel syndrome and other repetitive-stress injuries.

The pouch opener features intuitive adjustments for different-sized pouches, a foot pedal for operator triggering, an auto mode that will cycle the machine at a set speed, and built-in resettable counters. The unit's footprint is less than 12 in. wide by 18 in. long, and it weighs less than 25 lb. The base model opens pouches from 2.5 to 6 in. wide, and 4 to 8 in. tall.

Four-Side-Seal Packaging Machine

A rotary side-seal packaging machine runs at 50 m/min and can produce more than 400 packs per minute. The 4SS Model 400 from Doyen Medipharm Inc. will package medical devices such as wound-care dressings, diagnostic devices, drapes, catheters, and sutures, and can also be used to produce three-side self-seal bags for hand packaging of devices. The maximum package size is 330 mm wide and 500 mm long.

The 4SS model doubles the speed of the previous model, according to the company. The increase in speed was achieved by improving the sealing characteristics through a combination of processes, including adding multiple sealing units and the company's pressure control system. The machine provides product changeover in less than 10 minutes and can store up to 50 package designs in the product memory.

The unit is supplied with complete installation qualification and operational qualification documentation, and is compliant with all QSR, OSHA, and CE requirements.

Medical Device Bagger

A machine is designed for fully automated packaging, beginning with a kit or a specified device entering the machine through a right-angle infeed conveyor. Once the product enters the filling station, the individual bag-opening section of the Medi-Bagger from Optima Machinery Corp. works to position the bag opening for product insertion. This is accomplished with a servo-controlled bag infeed conveyor and a vacuum system for accurate bag positioning.

The machine comes equipped with features including an infeed pusher and manually adjustable bag grippers and clamps. To assist in the sealing portion of the process, the unit incorporates a controlled sealing drive and a monitoring system. A hot-wire weld will generate a seal that can be validated by recording the correct values for time, temperature, and pressure.

Automatic Assembly Solutions

A multipurpose system incorporates its own conveyor belt for independent commissioning of individual cells. The Flexcell-S from Mikron Assembly Technology measures 3 m in overall length and provides optimum flexibility during line reconfiguration. Each cell is autonomous, fitted with industrial PC control and built-in high-performance monitoring.

A numerically controlled indexing system is used for pallet flow control during assembly, processing, or special testing. Low-cost changeover of the pallet configuration is achieved by means of minimizing the customer-specific part of the pallets and retaining all the tooling in the cell.

Base configurations incorporate palletization and depalletization units, cam or NC pick-and-place units, testing units, and inspection stations.

The design of the cells and the use of permanently lubricated elements ensures ease of maintenance and conformity with the production requirements of a Class 10,000 cleanroom. The Flexcell can also be equipped with a laminar-flow unit that introduces clean, superfiltered air directly above the fixture pallets for use in cleanrooms exceeding Class 10,000.

Assembly Machines

A completely integrated spring-loaded safety device assembly system provides spring coiling, component assembly, 100% inspection and testing, a boxing system, and complete lot traceability. The system from Kahle Engineering Corp. can process from 60 to 360 parts per minute.

Each spring-coiling machine is linked directly to a nest assembly position of the assembly machine. If one of the spring coilers fails, the assembly machine automatically stops component loading and assembly operations on that individual nest position, while production in all other nest positions continues. When the spring-coiling machine comes back on-line, the nest position assembly is restarted, thus minimizing component waste and unnecessary machine operations.

The system is designed with modular cam stations that enable the machine to cycle down to slower speeds to perform complex sampling inspections without product waste or assembly error.

Copyright ©2002 Medical Product Manufacturing News