Compliance Consultants has worked in various device sterilization
projects for both materials and liquids.
Liquids. Compliance Consultants has worked on liquid sterilization systems that might be used to sterilize pharmaceutical preparations for abbreviated new drug applications.
Materials. Compliance Consultants has worked on sterilization of devices using Ethylene Oxide (EtO) in a fixed chambers, autoclaving (Moist Heat & Steam) and Gamma Radiation or Ozone (O3).
Compliance Consultants has organized complete gamma sterilization processes and the ensuing validation for blood tubing sets and single use only (disposable) devices. The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of different products. Processing with gamma radiation yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials. Compliance Consultants has created quality control systems necessary to have these devices validated for 510(k) applications.
Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile issued December 12, 2008, which if issued as final, will replace the currently available guidance.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm072783.htm
Liquids. Compliance Consultants has worked on liquid sterilization systems that might be used to sterilize pharmaceutical preparations for abbreviated new drug applications.
Materials. Compliance Consultants has worked on sterilization of devices using Ethylene Oxide (EtO) in a fixed chambers, autoclaving (Moist Heat & Steam) and Gamma Radiation or Ozone (O3).
Compliance Consultants has organized complete gamma sterilization processes and the ensuing validation for blood tubing sets and single use only (disposable) devices. The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of different products. Processing with gamma radiation yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials. Compliance Consultants has created quality control systems necessary to have these devices validated for 510(k) applications.
Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile issued December 12, 2008, which if issued as final, will replace the currently available guidance.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm072783.htm
