Help Ensure Package Sterility
Sterilizers provide high-temperature, high-energy environments designed to virtually eliminate microorganisms.
Patient safety remains the most important concern for a medical device company. A device must help, not harm, the user. In addition to a clean manufacturing environment, use of an effective sterilizer helps ensure that packaged devices are sterile. A variety of sterilizers are available to suit the particular device or type of packaging—if one sterilization process is inappropriate, then another may be especially suited to the purpose.
A steam unit offers compliance with ISO 11138 and 11140 part 2 standards. The ISOline BIER vessel features flexibility in operation and cycle design, a capacity of 8 in. diam X 24 in. depth, computer-compatible data logging, and integral cycle record archiving. Processing temperature range is from 80° to 145°C; pressure range is from subatmospheric to 45 psig. Optional features include an onboard steam generator and an air compressor. EHW Design Engineering Co., Rochester, NY.
Radiation sterilizing machines handle a wide range of pharmaceutical vials and bottles. The Neri NRT series achieve sterilization with medium infrared rays emitted by clean sources. Double-wall fiberglass-filled panels isolate the sterilization chamber. A microprocessor control unit ensures precision of time and temperature settings and tracks machine functioning and conveyor belt speed. Marchesini Packaging Machinery Inc., West Caldwell, NJ.
An electric Class 100 sterilization oven is suitable for the depyrogenation of glass, Teflon, and other heat-resistant materials. The unit has a maximum operating temperature of 260°C (500°F); temperature uniformity inside the oven is rated at ±5° at 250°C. The oven features a temperature controller, HEPA filters, and photohelic pressure gauges. It is made of stainless steel, and all door hardware is chrome plated. The Grieve Corp., Round Lake, IL.
A batch irradiation system can be installed in an existing warehouse and can be operational within six months. The MiniCell's steel shield keeps the cell compact, but the automated material handling system, programmable logic control system, and dose delivery are more characteristic of traditional irradiators. The MiniCell is available for lease; other system designs are offered for a variety of production volumes. SteriGenics International Inc., Fremont, CA.
A steam-in-place sterilizing system sterilizes the portions of a machine that come into contact with a product, using saturated steam with a temperature of 250°F. The interiors and exteriors of nozzles are sterilized in a process that takes less than 90 minutes. The system does not require disassembly and reassembly. Adtech Filling and Packaging Systems, Hatboro, PA.
A pulsed-light sterilization system directs intense pulsed light onto a sample at the rate of three pulses per second. Each pulse is powerful enough to kill high levels of microorganisms and to deactivate certain enzymes, according to the manufacturer. The SteriPulse-XL is designed to be fast and cost-effective. The short-duration pulses prevent substrate heat buildup even though the peak energy is 25,000 times more intense than sunlight at the earth's surface, says the company. Free of toxins such as mercury or microwaves, the unit is safe to use. Xenon Corp., Woburn, MA.
Energy delivered in rapid, intense light pulses has been demonstrated to kill microorganisms in pharmaceuticals and medical devices, according to the manufacturer of a sterilization process. The PureBright process combines rapid pulsed energy with broad-spectrum light to achieve sterilization at high speeds. Similar to sunlight, the broad-spectrum light is effective against a wide range of microorganisms, including vegetative and spore forms of bacteria, fungi, yeasts, molds, viruses, and protozoan oocysts. The sterilization system can be used in both batch and in-line applications. The process can be used for blow-fill-seal manufactured products, in barrier isolation and pass-through systems, and for disposable medical devices. PurePulse Technologies, San Diego.