Originally Published April 1998
PRODUCT UPDATE
In-House Sterilizers
New equipment makes on-site sterilization an economical option.
Medical device and pharmaceutical manufacturers are continually exploring ways to drive down their costs. One way to achieve this goal is by bringing the sterilization process in-house. This can result in lower product transportation costs, faster turnaround, and reduced inventory requirements. Several types of equipment are currently available including E-beam, steam, plasma, gamma, and UV-light sterilization systems.
In-house E-beam sterilizers offer 10 MeV at 4 kW of power and are capable of processing 500,000 cu ft of product per year. Surebeam On-Site machines are self-shielded by steel plating and can be upgraded in power and processing speed capabilities. A control system ensures that the product is accurately controlled throughout the process. Titan Scan Systems, San Diego, CA.
Plasma sterilization systems provide terminal sterilization of devices and equipment through a synergistic two-phase process. The Plazlyte systems are compatible with in-line manufacturing operations and emit only nontoxic, noncarcinogenic gases. Peroxygen vapor alternates with the plasma-based gas and leaves no toxic residue or carcinogenic by-products. AbTox Inc., Mundelein, IL.
In-line E-beam sterilization systems bring cost-savings advantages and packaging flexibility to disposable medical product manufacturers. The Minilac system provides 3 MeV at 10 kW of power. A control system reads a bar code on each product as it passes through the system to verify that the machine settings are correct. RPC Technologies Inc., Hayward, CA.
A cost-effective sterilizer uses concentrated energy in short, high-intensity pulses to kill microorganisms without using heat, chemicals, or ionizing radiation. The PureBright system is effective against vegetative bacteria, yeasts, molds, bacterial spores, and viruses, and is compatible with clear packaging materials, fluids, and air. PurePulse Technologies Inc., San Diego, CA.
An irradiation system was designed for device manufacturers with high-volume production schedules that want to maintain an in-house operation. The MiniCell system offers the simplicity, reliability, and the flexibility of gamma processing but eliminates the need to ship products to off-site sterilization facilities. A high-efficiency batch-type system delivers target doses at any range. SteriGenics International, Fremont, CA.
An in-place steam sterilizer offers complete sterilization of a liquid filling line without disassembly and reassembly. The SIP100 series system sterilizes the entire product contact system with a flow of pure saturated steam at a minimum temperature of 250°F. The system is validatable in order to conform with FDA requirements, and complete sterilization data can be printed out for documentation purposes. Adtech Filling and Packaging Systems, Hatboro, PA.
Pulsed UV sapphire lamps destroy microorganisms on medical devices and pharmaceuticals by subjecting them to intense pulses of short-duration UV light. The XL-Starone-series lamps are effective in killing such microorganisms as vegetative bacteria, yeasts, molds, and bacterial spores, and will also deactivate certain enzymes. Xenon Corp., Woburn, MA.
