Advanced Sterilization Products Releases the STERRAD CycleSure Self-Contained Biological Indicator

IRVINE, Calif....Advanced Sterilization Products (ASP), a division of Ethicon, Inc., today announced the U.S. release of the STERRAD CycleSure Biological

Indicator (BI) for use with its STERRAD Sterilization Systems. Already

used in countries internationally, the CycleSure BI features a self-contained design, which increases convenience by eliminating the manual transfer process associated with conventional biological indicator strips.

"The STERRAD CycleSure BI now makes it easier than ever for our

U.S. customers to monitor a sterilization cycle and provide clear,

accurate assessments of the validity of a sterilization process," said

Santi Corsaro, worldwide president for ASP. "The U.S. launch of the

CycleSure BI reflects our long-standing commitment to provide

customers with valuable products that increase productivity and

efficiency in the healthcare environment."

The CycleSure BI is for exclusive use with ASP's STERRAD

Sterilization Systems--low-temperature hydrogen peroxide gas plasma

sterilizers that process medical devices and surgical instruments. The

CycleSure BI confirms that conditions necessary to achieve

sterilization in STERRAD Systems have been met. The special indicator

on the BI vial cap changes from red to yellow--confirming exposure to

hydrogen peroxide during the sterilization cycle. The self-contained

BI also features easy-to-read results in a 48-hour processing time.

The CycleSure BI, which received Food and Drug Administration (FDA)

marketing clearance in May, replaces the STERRAD BI Test Pack

currently used for routine monitoring of STERRAD Systems in the United

States. Advances in research and design allowed ASP to develop the

self-contained CycleSure BI, which features Geobacillus

stearothermophilus (Bacillus stearothermophilus), the organism that is

most resistant to the STERRAD System sterilization process.

Introduced in 1993, the STERRAD Sterilization System is based on a

patented process involving the generation of low-temperature gas

plasma from hydrogen peroxide. The system leaves no toxic residues on

surgical instruments and equipment, eliminating the need for a lengthy

aeration phase, and sterile instruments may be used immediately

following the sterilization cycle. Because the process provides

terminally sterilized, "patient-ready" instruments that are dry and

wrapped, instruments can be stored for use when needed. With more than

5,000 units in use worldwide and 17.8 million cycles safely run to

date, the STERRAD System has allowed many hospitals to reduce or

eliminate dependence on EtO sterilization, a chemical deemed


Advanced Sterilization Products, a division of Ethicon, Inc., a

Johnson & Johnson company, manufactures and markets a full range of

innovative sterilization and disinfection technologies that safely and

effectively meet the needs of healthcare providers and patients.