Review, edit, and approve EO sterilization validation process for manufacturer of vaccine injection products.
Update sterilization methods for manufacturer of sterile injectable combination product.
Review and revise protocol and final report for ethylene oxide / parametric release validation, for manufacturer of medical bandage products.
Conduct annual revalidation for prevacuum autoclave processes for human tissue recovery center.
Conduct annual revalidation for hydrogen peroxide (STERRAD) sterilizer, for manufacturer of neonatal monitoring devices, and conduct another Sterrad annual revalidation for manufacturer of orthopedic implants, and another for manufacturer of venous catheter products .
Update gamma sterilization program for manufacturer of urological permanent implant products.
Conduct annual revalidation of EO process for manufacturer of disposable custom sterile surgical kits and procedural packs.
Write EO validation protocol for manufacturer of catheter products.
Advise on bioburden, sterility testing, bacteriostasis/fungistasis (B/F), and EO residuals issues for manufacturer of custom kits/sterile surgical disposables.
Conduct research and developmental testing in order to also conduct validation of cleaning/disinfectant methodology, for qualification of cleanroom processing areas for human tissue bank HCTP facility. Also conduct similar sporocidal/terminal disinfection processes for same facility.
Conduct similar (as described in previous bullet point) cleaning, disinfection, and sporocidal process development and validation for cleanroom use, for another human tissue bank facility. Per USP <1072> and ASTM E2614-08. Develop screening for coupon material selection, and develop test soil for validation assays.
Conduct reviews of microbiological test results associated with these various annual sterilization revalidations, such as BI resistance, product bioburden, cytotoxicity, peroxide residue analysis, environmental monitoring, etc.