Long Island Sterilization is owned by Busse Hospital Disposables and has been in operation since 2001 in Hauppauge, New York. We are conveniently located just a few miles from the Long Island Expressway thus offering easy access and transportation for your products.
LIS maintains and operates a complete quality assurance system as per cGMP and FDA guidelines. Long Island Sterilization complies with ISO 11135 and ISO 10993-7.
Our 30,000 sq.ft. Facility offers EO processing & warehouse space, Preconditioning and Aeration Rooms.
The LIS team will provide expert guidance and services to meet your technical, operational, regulatory, and financial project objectives. From contract sterilization to complete turn-key solutions.
Long Island Sterilization offers:
- New Product Development:
- Design
- Development
- Regulatory Preparation
- Submission.
- R&D and Cycle Development.
- Consulting for creation of a PCD for EO Sterilization
- Full Product EO Sterilization Validation and Package Validation Services including:
- Bioburden Testing
- Sub-lethal Cycle
- Half Cycle
- Sterility Testing
- Full Cycle
- EO Residual Testing including 2x qualification
- B&F Testing
- Pyrogen Testing – If Required
- Pyronema Testing – If Required
- Packaging Testing/Validation including 2x qualification following ISO 11607
- Transportation Studies / Ship Test
- Accelerated Aging and Real Time Aging Studies
- EO Validation Package
- Bioburden Testing
- Sub-lethal Cycle
- Half Cycle
- Sterility Testing
- Full Cycle
- EO Residual Testing including 2x qualification
- B&F Testing
- Pyrogen Testing – If Required
- Pyronema Testing – If Required
- Sterilization Qualification to see if a candidate product would react well to EO Sterilization
- Transportation Studies / Ship Test
- Accelerated Aging and Real Time Aging Studies
- Bioburden Reduction / Processing
- ISO 11135 Certified
- Lab Testing
- Bioburden Testing
Please contact us for information