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SmartPak ®

SmartPak ®. A multidosage packaging system for injectable antibiotics Tehran, May 2010. What is SmartPak ® ?. SmartPak ® is a patented Drug Delivery & Packaging System designed to simplify the reconstitution of antibiotics in the Hospital Pharmacy Compounding Center.

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SmartPak ®

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  1. SmartPak® A multidosagepackaging system forinjectableantibiotics Tehran, May 2010

  2. WhatisSmartPak®? • SmartPak® is apatentedDrug Delivery & Packaging Systemdesigned to simplify thereconstitution of antibioticsin the Hospital Pharmacy Compounding Center SmartPak® providesthe CentralizedPreparation of intravenoussolutions in UNIT DOSES startingfromRawMaterials(CompoundingPhilosophy). It can beconsidered one of the mostimportantstepsfor the future of HospitalPharmacies. Centralizationsmeans: fromRAW MATERIALthroughoperationstepsto UNIT DOSES(no vials) 2

  3. HowisSmartPak®builtup? SmartPakiscomposedoftwo separate bags: • The inner bagismadeof low density polyethylene in direct contactwith the injectableantibioticraw material and itassures the stability of the powder. Innerbag (This material has been employed successfully for many years, and its compatibility with many anti-infective powders has been firmly established. ) • The outer bagprotects the inner bag (and the material contained within) from light, moisture and oxidation. This bag is not in contact with the drug product. It consists of a laminated aluminum foil of four layers joined together, with the internal layer made of an additive-free polymer. Outerbag 3

  4. WherecanSmartPak®be applied? • The bestfield where CENTRALIZATION can beappliedis thepreparation of antibioticsforprophylaxis, whereconsumptions of antibiotics are high and standardized. • However, the CentralizedPreparation of antibioticscreates a lot of incoveniences due to: • the vastamount of work • the contaminationrisks SmartPakis a new delivery system designedby ACS Dobfartosimplify the reconstitutionofinjectableantibiotics in the Hospital PharmacyCompounding Center. Reconstitution of raw material isdone in theinner bag and the preparation of unitdosesready-to-use are performed in atotallyclosed system. SmartPak® iscompatiblewithcommerciallyavailablepumps, tubing sets, syringes and filling systems. 4

  5. SmartPakis a high-tech and easy-to-use delivery system : reconstitution and syringe/minibag fillingoperation are performedbyonlytwooperators, in a cleanroom, under laminar flow. WhatareSmartPak®benefits? • Preparation of unitdosesready-to-usein the Hospital Pharmacymeanshigh quality of the finisheddosageforms . Sterility and Concentrationare guaranteed directlyby the Hospital Pharmacy . • Chemical-PhysicalStability of the unitdosesreadytobeusedisguaranteedby ACS Dobfar (StabilityStudiesdeveloped in ACS Dobfar’s labs). All the availableproduct are stable once theyhavebeenreconstitued (eg.Cefazolin and Ceftriaxone – 28 days at 5°). • The high reproducibility of the centralized-preparation system and the use of the SmartPak multi-dosage bag mean optimization of the reconstitution time. • No glassmeansno breakages. Fewermanipulations reduce riskofcontamination. (risk management) 5

  6. HowdoesSmartPak®work? 1 2 3 • Take out theinnerbag out of theouterbag of SmartPak • Prepare the sterile transfer tubes • PrepareconnectionbetweenSmartPak and diluentchosenfor reconstitution 4 5 • Place thetubeinsidetheperistaltic pump • Allowthereconsitution to take place 6 7 • Reconstitutioncheck and hangingthemultidosecomparment on a rack • Preparation and measurement of solutionin unit dosessuch as minibagsorsyringes 6

  7. SmartPak Video: Alzano Lombardo Hospital, anexperiencestarted in 2008.

  8. WhatantibioticsareavailableinSmartPak®delivery system? ACS DOBFAR’S SMARTPAK PRODUCT LIST Cephalosporins: CEFAZOLIN 100g CEFAZOLIN 300g CEFTAZIDIME 100g CEFOXITIN 100g CEFTRIAXONE 100g CEFTRIAXONE 300g CEFUROXIME 75g CEFUROXIME 225g CEFOTAXIME 100 g CEFALOTHIN 100g • OtherAntibiotics: • VANCOMYCIN 100g As theinner bag has a capacity of four liters, the compounding pharmacist has a great deal of latitude in supplying the concentrations that are most appropriate for the patient population being served. 8

  9. ALL PRODUCTS ARE AVAILABLE WITH STABILITY STUDIES. 9

  10. ALL PRODUCTS ARE AVAILABLE WITH STABILITY STUDIES ALL PRODUCTS ARE AVAILABLE WITH STABILITY STUDIES!!! 10

  11. WhatisSmartPak®market situation? ACS DOBFAR hasbeencommercializingSmartPaksince 7 years inthe followingcountries: • ITALY USA • GERMANY BELGIUM • HOLLAND UK CEFAZOLIN CEFTRIAXONE CEFAZOLIN CEFUROXIME CEFTAZIDIME CEFAZOLIN CEFAZOLIN CEFTAZIDIME CEFUROXIME CEFTRIAXONE Overallmorethan 120 hospitals worldwide areactivelyusing • SmartPak ®delivery system 11

  12. WhatisSmartPak®regulatory situation? Major question: GalenicPreparation or FinishedDosageForm? ITALY AND OTHER EUROPEAN COUNTRIES USA SmartPakisnotconsideredas anewFinishedDosageForm,butasa GalenicPreparation, thereforeno formalregistrationisneeded. The Hospital Pharmacyhas the full responsability of the preparation. SmartPakisconsideredas anewFinishedDosageForm, thereforeANDA (Abbreviated New DrugApplication) isneeded. • Only the localMinistry of Health orrelevant health • authoritiescan take the finaldecision. 12

  13. WhatareSmartPak®approvals as FinishedDosage Form? ACS Dobfarreceivedapprovals for thefollowingANDAs: • CEFAZOLIN 100g and 300g • CEFUROXIME 75g and 225g • ANDA alreadyfiledwithpendingapproval: • CEFOXITIN 100g • CEFTRIAXONE 100g and 300g • VANCOMYCIN 100g 13

  14. Whataretherequirements for reconstitution/fillingfromSmartPak®? RECONSTITUTION AND FILLING AREA REQUIRES • compliancewith existing security rules • to meetrequirementsof QualityAssurance 1 CLEAN ROOMREQUIRES 2 LABORATORY PERSONNEL INVOLVED IN: • to be separated and isolated • to be controlledwithauthorized access 3 • preparation of the material • packaging of theready-to-useunitdoses 14

  15. Whataretherequirements for reconstitution and fillingarea? • RECONSTITUTION AND FILLING OPERATION AREA – REFERENCE STANDARD: GMP-EEC Annex 1 1997 – FS209E • RECONSTITUTION AND FILLING AREA UNDER LAMINAR FLOW: Grade A - CLASS 100 - ISO 5.(productsnotsubjectto the finalsterilization) • PREPARATION OF STERILE MATERIAL / LABELLING & FILTER AREA NOT UNDER LAMINAR FLOW: Grade B – CLASS 1000 - ISO 6. (productsnotsubjectto the finalsterilization) • DRESS ROOM: Grade C - CLASS 10.000 - ISO 7. • PASSAGES: Grade D - CLASS 100.000 - ISO 8. A B C D 15

  16. Whatareadvantages for HospitalsusingSmartPak®? • improved safety as itistotallyclosed system • reduction of number of operators exposed to any sensitization • improved service in terms of convenience and efficiency (ensures optimization of the preparation time of the antibiotic) • increased quality of thepreparations and their traceability. At the same time traceability pathway allows Hospital Pharmacist to generate a large number of epidemiologic information. 16

  17. ThankYou!

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