What is Onco-Safe? Volume Pack size Compatibility What is Onco-Safe? The Onco-Safe SV provides maximum safety and protection for vials of 1ml to 10ml. The Onco-Safe SV is delivered in packs of 5. The Onco-Safe SV is compatible with all all commonly available transfer systems, such as Chemospikes, PhaSeal® and Clave®. Volume The Onco-Safe OS provides maximum safety and protection for vials for vials from 10 ml to 100 ml. Pack size Each vial is individually packaged maximizing safety from production to disposal. Compatibility Onco-Safe OS is compatible with all commonly available transfer systems, such as Chemospikes, PhaSeal® and Clave®. Material Onco-Safe SV is made of 100% degradable plastic; is free of solvents, dyes or pigments. Material Onco-Safe OS is made of 100% degradable plastic; is free of solvents, dyes or pigments. Disposal Onco-Safe SV has no special disposal requirements and is conveniently incinerated along with the vial it contains. Disposal Onco-Safe OS has no special disposal requirements and is conveniently incinerated along with the vial it contains. www.sandoz.com www.sandoz.com Cytotoxic drugs are essential in the treatment of cancer but their mutagenic and teratogenic potential poses a serious health risk to people involved in manufacture and preparation for use. Several studies have demonstrated that the vial exterior can carry residues of the cytotoxic drug it contains1,2,3 and that healthcare professionals handling these vials may be exposed to the drug on the vial, or subsequently contaminated work surfaces4. Outer vial surface contamination can occur even when strict high quality manufacturing processes are in place. Common measures to control vial contamination What methods are available for dealing with outer surface contamination of vials? Cytotoxic vials are often provided without any form of protection from outer surface contamination. In this case, the outer surface residues of cytotoxic drug can be removed by wiping the vial down in suitably equipped rooms. The safest way to avoid contamination from the vial however, is to avoid direct contact with the glass vial surface altogether. Several publications recommend to enclose the entire cytotoxic drug vial in a break-proof plastic coating, including the bottom of the vial, in order to isolate any residual contamination on the outer glass surface from the environment5,6. What does EBEWE/Sandoz do to lower the risk of contamination? As a first step after filling and closing the vial, EBEWE/Sandoz has developed and implemented a sophisticated multi-step cleaning procedure during the manufacturing process to reduce the risk of outside contamination to a minimum. Additionally, the vials are packed into Onco-Safe in order to provide optimal personal protection from contamination for health care professionals and environment. THE CONCEPT What is the Onco-Safe concept? The Onco-Safe concept is a secondary packaging container specifically designed to protect each vial from breakage and leakage, and isolate the outer vial surface from the user. The container features inner spacer ribs to firmly hold the glass vial and maintain a fixed distance to the inner wall of the container. A buffer area is created around the vial which effectively protects the vial against any mechanical damage during transportation. Furthermore, since there is no need to remove the vial from the Onco-Safe container, this significantly increases protection from possible outside contamination on the vial during handling and preparation. What are the advantages of the Onco-Safe compared with other commercially available protective measures? Onco-Safe has shown to be superior in preventing breakage and leakage during transportation and in protecting the user from vial surface contamination6,7. With the introduction of OncoSafe EBEWE/ Sandoz set a new standard for the safe handling of cytotoxic drugs. What is the Onco-Safe made of? Onco-Safe OS consists of polypropylene (PP) and polyethylene (PE). PP and PE do not contain solvents, dyes or pigments and are free of PVC. Onco-Safe SV is made of amorphous polyethylenterephthalate (A-PET)/polyethylene (PE). A-PET/PE does not contain solvents, dyes or pigments and is PVC-free. HANDLING How should Onco-Safe be used on the cytotoxics workbench (laminar airflow cabinet)? The unopened Onco-Safe container should be wiped with a surface disinfecting agent and brought into the workbench. Once inside the workbench, the plastic container is opened by either unscrewing the lid in the direction of the arrow (Onco-Safe OS), or tearing off the cap (Oncosafe SV). For Onco-Safe OS the exposed container screw thread should then be disinfected. Disinfect the neck of the vial, remove the flip-off cap and disinfect the puncture point8. There is no need to remove the vial from the plastic container at any time during preparation. The vial is fixed to the bottom of the Onco-Safe by the inner spacer ribs allowing Onco-Safe to be safely turned upside-down for the withdrawal of drug from the vial. Does the vial need to be taken out of the Onco-Safe before it is brought into the workbench? During manufacture, the vials are packaged into Onco-Safe in a sterile environment. It is not necessary to take the vial out of the Onco-Safe container before placing in a sterile workbench and disinfection of the outer container surface is sufficient. Can transfer systems be used with Onco-Safe? Onco-Safe has been designed to be compatible with all commonly available transfer systems. Can a particulates observations be performed with Onco-Safe in place? Any particles can easily be detected through the transparent plastic. How is the Onco-Safe disposed of? Onco-Safe has no special disposal requirements and is conveniently incinerated along with the vial it contains. Established procedures for proper waste handling and disposal should be followed according to local regulations. Incineration requires a minimum temperature of 1100°C, at which point PP, PE and A-PET break down into CO2 and H2O leading to safe disposal of container and any drug residues. Industry Recognized Innovation and Quality Nominations  Onco-Safe has been nominated for the Austrian Packaging Award 2002  Onco-Safe OS has been awarded the Pharmapack «Safety» Award 2008 (http://www.pharmapack.com.fr/Pages/EnAward.htm)  Onco-Safe SV has been nominated for the Austrian Packaging Award 2008 Publications  Improving the safety performance of the Onco-Safe system. Kittlaus W: EJOP. 2011:5;2;26-7.  Vertical shock tests with safety packaging materials for cytotoxic drugs. Teich mann W: EJHP Practice. 2008:14; 46-7.  Verpackungen zum Schutz vor Zytostatikakontaminationen. Kittlaus :. Onkol Pharm. 2008:10,1;4-10.  Safety concerns in oncology pharmacy - an evidence based approach. Mader M, Schwarz U.: EJHP 2006:6;28. References: 1) Connor TH, Sessink PJ, Harrison BR et al. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies. Am J Health-Syst Pharm. 2005; 62:475-84. 2) Favier B, Gilles L, Ardiet C et al. External contamination of vials containing cytotoxic agents supplied by pharmaceutical manufacturers. J Oncol Pharm Pract. 2003; 9:15-20. 3) Mason HJ, Morton J, Garfitt SJ et al. Cytotoxic drug contamination on the outside of vials delivered to a hospital pharmacy. Ann Occup Hyg. 2003; 47:681-5. 4) For additional information see NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings [DHHS (NIOSH) Publication No. 2004-165] 5) ISOPP Standards of Practice – Safe Handling of Cytotoxics, JOncol Pharm Practice (2007) Supplement to 13:1-81. 6) Schierl R, Autenrieth H, Pfaller A, et al. Surface contamination of antineoplastic drug vials: Comparison of unprotected and protected vials. Am J Health-Syst Pharm. 2010; 67:428-9 7) Teichmann W. Vertical shock tests with safety packaging materials for cytotoxic drugs. EJHP Practice. 2008:14; 46-7. 8) ADKA Statement. Recommendations for the disinfection of protective containers for cytostatic agents. Krankenhauspharmazie. 2011:32;12-3. EBEWE Pharma Ges.m.b.H. Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria Phone +43 7665 8123-0 • [email protected] • www.sandoz.com ONKO/A/01/2011/5 Copyright © Ebewe Pharma, Austria. Occupational exposure to hazardous drugs