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.
A multidosagepackaging system
Tehran, May 2010
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)
SmartPakiscomposedoftwo separate bags:
(This material has been employed successfully for many years, and its compatibility with many anti-infective powders has been firmly established. )
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.
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?
ACS DOBFAR’S SMARTPAK PRODUCT LIST
CEFOTAXIME 100 g
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.
ALL PRODUCTS ARE AVAILABLE WITH STABILITY STUDIES!!!
ACS DOBFAR hasbeencommercializingSmartPaksince 7 years
Overallmorethan 120 hospitals worldwide areactivelyusing
Major question: GalenicPreparation or FinishedDosageForm?
ITALY AND OTHER EUROPEAN COUNTRIES
SmartPakisnotconsideredas anewFinishedDosageForm,butasa GalenicPreparation, thereforeno formalregistrationisneeded.
The Hospital Pharmacyhas the full responsability of the preparation.
SmartPakisconsideredas anewFinishedDosageForm, thereforeANDA (Abbreviated New DrugApplication) isneeded.
Whataretherequirements for reconstitution/fillingfromSmartPak®?RECONSTITUTION AND FILLING AREA REQUIRES
LABORATORY PERSONNEL INVOLVED IN:
Grade B – CLASS 1000 - ISO 6. (productsnotsubjectto the finalsterilization)
Grade C - CLASS 10.000 - ISO 7.
Grade D - CLASS 100.000 - ISO 8.