LONG ISLAND STERILIZATION

Long Island Sterilization is a contract sterilization and testing services provider operating since 2001 in Hauppauge, New York. Owned by Busse Hospital Disposables, the company operates a 30,000 sq.ft. facility specializing in ethylene oxide (EO) sterilization and comprehensive validation services for the medical device and disposable industries. Core service offerings include full product EO sterilization, sterilization validation, bioburden testing and reduction, process challenge device (PCD) development, feasibility studies, package validation, transportation studies, ship testing, and accelerated/real-time aging studies. The company provides complete turn-key solutions encompassing design, development, regulatory preparation, and FDA submission support for new medical products. LIS maintains cGMP and FDA-compliant quality assurance systems, with ISO 11135 (sterilization of medical devices) and ISO 10993-7 (ethylene oxide residuals) certifications. The facility includes dedicated EO processing, warehouse, preconditioning, and aeration rooms. The company has processed over 500,000 sterilization cycles and serves medical device manufacturers, contract manufacturers, and medical disposable companies. 24/7 accessibility and expert consulting on EO sterilization processes, bioburden management, and regulatory compliance are standard offerings.