Validatable Sealers

Medical Sealer
A fixed speed, continuous hot-air sealer is designed to meet the requirements of FDA process validation guidelines. The sealer does not use Teflon-coated bands, which means less replacement costs and a decrease in downtime. The removal of bands also means fewer particulates in the cleanroom. The sealing temperature is fully PID controlled, and the seal pressure is air regulated, allowing for complete system calibration of the dynamic parameters that affect the seal integrity. A pressure switch on the front of the machine ensures that if the air were to fall out, the machine would reverse. A full procedure manual is also provided. O/K International Corp.; Marlborough, MA; 508/303-8286; www.okcorp.com.

Pillow Pack Machines
Pillow pack machines provide increased versatility in pillow packing a variety of products in pouches with top seams. They can be hermetically sealed or gas flushed and can produce either loose or tight-fitting packages. The SIGHSI machines are suitable for items such as pharmaceuticals and will handle product either unpacked or prepacked and individually or in groups. The modular design allows the machines to be equipped with either a rotation sealing system or a long-dwell sealing system for cross-sealing airtight packages. The rotation sealing system handles up to 250 packages per minute with packaging material speeds of up to 45 m per minute. The modular construction allows for optimum system integration in combination with other processing systems and infeed units. There is a strict separation between product handling, packaging handling, and driving elements. SIG Pack Systems AG, Beringen, Switzerland, +41 52 6747419; bernard.fenner@sig-group.com.

Tabletop Heat Sealer
A line of precision impulse bar heat sealers are designed to provide a consistent, repeatable seal quality for medical pouch sealing applications. The sealers are suitable for header bags and poly bags and can also be used for Tyvek pouches and many other multilayer film structures. They offer digital display and alarming of all process control parameters (temperature, pressure, and dwell time). The cooling cycle can be either time or temperature based. The heat control system allows for a preheat temperature setting that will maintain a user-programmable, specific-ambient temperature level between cycles to minimize residual heat buildup. The instrument panel is enclosed behind a hinged, lockable clear Lexan guard to limit operator access to the process controllers. Output ports on the side of the machine are available for verifi-cation of the regulated air pressure, the heating time and the cooling time, and the seal temperature. Sencorp Systems Inc., Hyannis, MA; 508/771-9400; www.sencorpsystems.com.

Model 730
A medical sealer's seal jaw provides point-to-point seal pressure repeatability. The high force sealing reduces seal time. Other features include a flexible color-enhanced touch screen interface and password lockout of set points and alarms. The ergonomic design allows operators and supervisors ease of use during installation qualification, operational qualification, and performance qualification as well as during changeover and production. Accu-Seal Corp., San Marcos, CA; 800/452-6040; www.accu-seal.com.

Titan Rollbag
A bag filling and sealing machine opens, fills, and seals any premade bag on a roll from 2 X 2 to 12 X 22 in. The operator, scale, or counting machine drops the product into an automatically opened and positioned premade bag on a roll. The filled bag is then securely sealed by the Simpulse sealing system. The system features a pass-through jaw with filling and sealing accomplished at the same time. The filled and sealed bag is pulled down by the operator, separating it from the roll at its perforations. This single motion automatically positions the next bag for loading and sealing. Audion Automation, Carrollton, TX; 972/389-0777; www.audionautomation.com.