Ensure the thawed contents are at the bottom of the upright vial and vortex vigorously at high power for at least ten seconds prior to dose preparation. Withdraw 0.5 mL (2 x 108infectious units) into a 1 mL syring e for administration by subcutaneous injection. 11.2.3 Storage Store intact vials of Recombinant Vaccinia-PSA(L155)/TRICOM at –70oC or colder. 11.2.4 Stability Shelf-life studies of the intact vials are ongoing. Once the intact vials are thawed, the vaccines maintain their potency for up to 4 days when stored at 2-8oC. Do not re-freeze thawed vials. Vials of Recombinant Vaccinia-PSA(L155)/TRICOM are for single-use only and do not contain a preservative. Administer prepared doses as soon as possible following preparation ( i.e., within one hour). If necessary, store prepared doses at 2-8oC for up to 4 hours following preparation. 11.2.5 Route of Administration Recombinant Vaccinia-PSA(L155)/TRICOM is administered by subcutaneous injection. 11.2.6 Special Handling and Precautions Vaccinia virus is classified as a Biosafety Level 2 agent. These agents are associated with human disease and are of moderate potential hazard to personnel and the environment. The recombinant vaccine is a preparation of a live virus affe cting humans and contains DNA sequences derived from the human genome. Handle the recombinant vacc ine as an infectious hazardous biological substance and dispose of waste materials as in fectious hazardous biological waste, with incineration according to local institutional policies and according to local, state, and federal regulations. Preparation, Handling and Disposal Recommendations 1. Prepare a biosafety manual which advises personnel of special hazards and specific instructions on practices and procedures. 2. Post warning hazard signs on access doors, identify ing the agents, the biosafety level, the name and phone number of the Principal Investigator or other responsible person, and any special requirements for entry. Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 593. Establish policies and procedures allowing only personnel who are knowledgeable of the potential hazards and meet specific entry requirements ( e.g., immunization) into agent preparation or storage areas. 4. Strictly adhere to standard microbiological practices and techniques. 5. Limit/restrict access to preparation areas while dose preparation is in progress.6. Use appropriate infec tion control measures ( e.g., thorough hand washing) after handling any materials. 7. Institute and follow policies for safe handling of sharps. Use only needle-lock syringes and needles for dose preparation. Use extreme cauti on to prevent autoinoculation. Do not bend, shear, or replace the needle guard from the syringe following use. Promptly place used needles and syringes in puncture-resista nt containers for disposal. 8. Perform all dose preparations in a certified Class II biological safety cabinet, generally using procedures, guidelines and personal protective apparel used during preparation of antineoplastic agents [ e.g., minimizing creation of aerosols; no eating, drinking, handling contact lenses or applying cosmetics in the work area; using appropr iate personal protective apparel - gowns, sterile latex gloves (double-gloving is reco mmended), respirator masks, protective eyewear, hair cover]. 9. Perform all procedures carefully to minimize aerosol creation.10. Decontaminate the biological safety cabinet pr ior to dose preparation with sterile gauze soaked in 10% bleach solution (0.52% sodium hypochlorite solution), or other appropriate disinfectant suitable for decontamination, rinsing, then wi ping down with sterile gauze soaked in 70% alcohol. Consult specific manufacturer’s reco mmendations with respect to disinfectant concentration, contact time and method of application. 11. Have all necessary supplies on-hand before be ginning the preparation procedure. Develop a detailed worksheet outlining all supplies, dose calculations, and preparation procedures, and keep it available. 12. Place an empty biohazard sharps container in the biosafety cabinet to dispose of all waste generated. 13. Transport the agent from the freezer to the work area in leak proof bag. 14. Wipe or spray items used for dose prepara tion with 70% alcohol before placing in the biological safety cabinet. Disi nfectants should remain in contact with the surfaces for at least five minutes prior to dose preparation. Avoid exposing the virus to disinfectants. 15. Wipe the syringe containing the prepared dose with 70% alcohol before removing it from the biological safety cabinet; transport it in a leak proof bag or container labeled with a biohazard symbol. 16. Place all waste into a sharps container lined with the leak proof biohazard bag and decontaminate the biological safety cabinet ag ain by wiping down all surfaces with sterile gauze soaked in 10% bleach solution, or other a ppropriate disinfectant, rinsing, then wiping down with sterile gauze soaked in 70% alcohol. Following decontamination, dispose of personal protective apparel in the biohazard safety bag. 17. Place all waste and protective apparel in a leak proof biohazard bag, and place the bag inside a biohazard sharps container fo r incineration according to institutional policy and according to local, state, and federal regulations. 18. Handle accidental spills similarly to antineoplastic spills and/or according to institutional policy: Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 60a. Prevent others from entering the area and allow aerosols time to settle (approximately 10 minutes).