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1 TECHNICAL LEAFLET MEDI-MEDIA-FILL KIT SUPPLY PACKAGE (Code: MR-25/S) TEST AGAR PLATES FOR PERSONNEL AND ENVIRONMENTAL MICROBIOLOGICAL MONITORING COMPONENTS: Test Agar Plates Data Log Sheet Technical Leaflet APPLICATION AREA The MEDI-MEDIA-FILL KIT SUPPLY PACKAGE can be applied for making studies and controlling the bioburden (microbial contaminations) of the environment and personnel hygiene during aseptic techniques and procedures of radioactive and nonradioactive compounding for medical use. Microbiological monitoring is an important and unavoidable procedure for the validation and the maintenance of the aseptic conditions. The Test Agar Plate provides reagent and sampling tool for basic monitoring of environmental and personnel hygiene status. The MEDI-MEDIA-FILL SUPPLY PACKAGE is recommended for routine use in the monitoring the microbial contaminations during aseptic procedures, it also supports the usage of Medi-Media-Fill Kit (Code: MR-25 manufactured by Medi-Radiopharma Col. Ltd., Hungary). MATERIAL Test Agar Plate RODAC (Replication Organism Detection and Counting) Petri dishes are applied in contact plate form for the detection and enumeration of microorganisms present on surfaces to monitor the cleanliness of the environment and the operators. RODAC plates contain sterilized solid medium, Trypticase Soy Agar supplemented with neutralizers, lecitine and polysorbate 80, which can detect live microorganismss (bacteria, and molds/fungi). These plates are suitable for collecting microbial samples from various surfaces and evaluating the microbial contamination. The grid on the plate bottom makes the counting of microbial growing colonies easy for the analyst. Counts of CFU (colony forming unit) is usually used as an approximate measure of the microbial bioburden. PERSONNEL AND WORKING CONDITIONS

2 Before and after the sanitation of aseptic preparation rooms, instruments, and throughout the aseptic procedure simulation tests microbiological sample collection with RODAC agar plate should be done from critical surfaces of the instruments and the operator. Finger prints from at least one hand covered with sterile gloves and the sterile garb are considered as critical sampling sites to monitor personnel hygiene. Cleanliness of the critical areas under the laminar flow or isolator should be checked by contact plate during the procedure. Critical sampling sites are the frequently touched sites, e.g. shielded and unshielded areas during the preparations and manipulations of radiopharmaceuticals. The critical site in the laboratories, the frequency of sampling should be specified in accordance with the valid regulatory documents. PERSONNEL AND ENVIRONMENTAL MICROBIOLOGICAL MONITORING TEST The microbiological monitoring test is an important part of aseptic procedure simulation (media-fill) tests (see Medi-Media-Fill Kit) or it can be independently performed. a. Sanitize the package foil of RODAC agar plates before put into the working area. b. Open the lid of the plates and touch slightly the agar gel into the selected surfaces for at least 10 sec, then close, wrap and transfer them to the incubation facility immediately after the sampling. c. Incubate the contact plates at C for 48 hours then C for hours in an incubator. d. Count the separate colonies visible by naked eyes on the agar surface at the end of the incubation time. CFU (Colony Forming Unit) means the number of colonies. e. Record CFU values on Data Log Sheet. f. Interpret the results based on the recommended specifications shown in Table 1. The values for CFU exceeding the limit value indicate inappropriate environmental and/or personnel hygiene status. - Record and evaluate in Fail column on Data Log Sheet. The values for CFU not exceeding the limit value indicate appropriate environmental and/or personnel hygiene status. - Record and evaluate in Pass column on Data Log Sheet. TECHNICAL NOTES 1. Check visually the package components before their use. In case of any signs of deterioration the material must not be used (Please contact with the manufacturer via ). 2. When working with the agar plates under aseptic conditions always wear suitable and sterile garbs, protective goggles and sterile gloves. 3. Equilibrate the agar plates to room temperature, allow closed for minutes before use.

3 4. Each RODAC plate must be utilized after opening of the pack, and do not store for further usage. 5. To avoid the false positive results, close the RODAC agar plates with sterile adhesive strips and wrap with sterile alufoil or sterile bag (e.g.wipac) before taking out of the laminar air flow workbench and shipping to an incubation facility. 6. After the sampling procedure keep the agar plates at room temperature. Do not freeze or cool below 10 C or heat above 35 C. 7. Do not use the agar plates after the expiry date labelled on the package box. 8. To prevent the environment from any microbial contamination with agar from RODAC agar plate contacted with the surfaces during sampling, wipe the contaminated surfaces, clean with detergent and sanitize with disinfectant as soon as possible. 9. Handle all the waste materials as biohazard waste. 10.A detailed microbiological identification (determination of species and genus) from your positive samples is advisable, but it should be made by specialists. Knowledge of microbe types can also help you to plan and apply a more efficient disinfection procedure, and to exlude the existance of human patogen microorganisms in your laboratory. Consult with microbiologist and hygiene specialists. STORAGE The agar plates are stored at 2-25 C, protected from direct light. The expiry date is indicated on the package box. SAFETY PRECAUTIONS For laboratory use only. Not for ingestion. BIOHAZARD WARNINGS Although the solid medium do not contain harmful chemicals, they are considered as potentially biohazard materials because of its high potential for microbial growth. Therefore, even the uninfected, sterile agar plates must be discarded after steam sterilization (121 C for 1 hour in autoclave) or after chemical treatment with disinfectant (e.g. spray with 6% Hydrogen Peroxide, or immerse into 10% fresh sodium hypochloride solution and allow contact for at least 30 minutes). Put the remaining materials into appropriate biohazard waste containers. Biohazard waste must be handled including its transportation in conformity with the relevant national and international regulations. QUALITY CONTROL Each lot of Test Agar Plate in the package possess Certificate of Analysis. The following microorganism strains are used for quality control of Test Agar Plates: Bacillus subtilis ATCC 6633 Escherichia coli ATCC 8739 Staphylococcus aureus ATCC 6538 Pseudomonas aeruginosa ATCC 9027 Salmonella typhimurium ATCC 14028

4 Candida albicans ATCC Aspergillus brasiliensis ATCC Table 1 Recommended Limits for Viable Particle in Aseptic Areas Classified according to ISO Guides (ISO , ISO ) CLASSIFICATION (GRADE or CLASS) according to EU CGMP, ISO and US Federal Standard ISO Class5 A (Laminar air flow) ISO Class5 B C Contact plates CFU/plate Glove print CFU/5 fingers Class 100 < 1 < 1 Class 100 < 5 < 5 (Turbulent air flow) ISO Class6 Class 1000 <10 N/A ISO Class7 Class < 25 N/A D ISO Class8 Class < 50 N/A The CFU values shown in Table 1 are for guidance only. References: 1. European Pharmacopoeia 7th Edition published, by EDQM (European Directorate for the Quality of Medicines & HealthCare) in July,2010 Chapter Microbiological Examination of Non-sterile Products: Total Viable Aerobic Count; Website: US Pharmacopoeia US35-NF30 published by U.S. Pharmacopeial Convention in 2012 Chapter <61> Microbiological Examination of Nonsterile Products: Mibrobial Enumeration Tests; Chapter <797> Pharmaceutical Compounding-Sterile Preparations Website: 3. Operational Guidance on Hospital Radiopharmacy: A Safe and Effective Approach published by International Atomic Energy Agency, Vienna, 2008 Website: 4. EudraLex. Volume 4. Good Manufacturing Practice published in 2003 Website: 5.Giudelines on Current Good Radiopharmacy Practice (cgrpp) in the Preparation of Radiopharmaceuticals. cgrpp-guidelines version2 March 2007 EANM Radiopharmacy Committee Website:

5 TECHNICAL SUPPORT AND ORDERING MEDI-RADIOPHARMA Co., Ltd., H-2030, Érd, Szamos u , Hungary Phone: , Fax: , For technical support and ordering please contact to: or to the above phone/fax numbers.