"STERITEK" LLC

Q1: What is the address of SteriTek's Silicon Valley facility?
A1: The address of SteriTek's Silicon Valley facility is 48225 Lakeview Blvd., Fremont, CA 94538.

Q2: What type of products does SteriTek specialize in sterilizing?
A2: SteriTek specializes in sterilizing sensitive materials such as combination devices, drugs, biologics, allograft tissue, and other complex products that require highlevel sterilization services.

Q3: In what year was SteriTek established?
A3: SteriTek was established in 2016.

Q4: What is the name of SteriTek's proprietary system for optimizing Ebeam/Xray sterilization of sensitive materials?
A4: The name of SteriTek's proprietary system is not explicitly mentioned in the provided text, but it appears to be a customized solution developed by the company for optimizing Ebeam/Xray sterilization of complex products.

Q5: What are the turnaround times offered by SteriTek for its standard and rush services?
A5: SteriTek offers a standard turnaround time of 26 business days, with 24hour and sameday RUSH service available for an additional fee.

Q6: Is SteriTek registered with the DEA to process controlled substances?
A6: Yes, SteriTek is DEA registered and approved for processing controlled substances (Schedule II and higher) with restricted access and continuously monitored secured storage cages for pre and postprocessed products.

Q7: What types of temperaturecontrolled rooms does SteriTek offer?
A7: SteriTek offers validated cold (16C to 26C) and freezer (2C to 8C) temperaturecontrolled rooms, both with separate doors and areas for pre and postprocessing, and are validated to pharmaceutical standards.

Q8: What is the name of the sterilization validation package offered by SteriTek?
A8: The name of the sterilization validation package offered by SteriTek is a "Turnkey Sterilization Validation package" which includes all irradiation services routinely performed for production validation, generation of original validation protocols, handling and management of needed microbiological laboratory services, completion of the validation protocol, and a final comprehensive report.

Q9: What are the dimensions of the medical shipper box configurations that SteriTek can sterilize?
A9: SteriTek can sterilize medical shipper box configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall at the highest service level.

Q10: Is Xray sterilization already approved by regulatory bodies such as FDA and international standards?
A10: Yes, Xray sterilization is already included in international standards and FDA guidelines, and its usage is already approved by regulatory bodies.