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Article Dans Une Revue Analytica Chimica Acta Année : 1991

Detection of bacterial adenosine triphosphate through bioluminescence, applied to a rapid sterility test of injectable preparations

Résumé

Adenosme tnphosphate measurement based on holummesccnce IS a rapid method for detectmg contammatmu m mjectable pmparatmns F&r&ton through a Stentest system or duect mcubatlon wth double concentration broth me&n (for non-f&able solutmns) was used A speafic mcxlmm to reprove the fungal growth was selected Sabouraud dextrose broth wth 1% yeast extract. Wtth the proposed protocol, the penod of mcubatlon can be reduced after vahdatmu usuq the European Pharmacopoa a reqmrements (from 72 h to 24 h) The method was tested on about 30 dlffercnt mJectable preparations and the sensltwty was compared W&I that of the stenbty test accordmg to the routme protocol Tbe advantage.s are a reduced mcubatxm tune, whmb allows an antxxpated release of the products, and an easuz mterpretahon of falwpoetwe reacttons of chemwally mterfermg, opaque or non-fltrable solut~m Parametric standards are proposed for tbe &ease of mJectable preparations The revealmg of bacterml adenosme tnphos-phate (ATP) through blohunmescence 1s a rapld techmque used m the quahty control of food products and cosmetzs It IS not, however, par-tlcularly sensiQve Theoretically the currently used reagents allow for the detection of lo3 cells ml-', the bactena contammg about lO_ " g ATP per cell and the hnmnometers detectmg about lO_ " g ATP [l] However, the sensltiwty threshold of the method is about 5 X lo4 cells ml-' for raw mdk [2] and 10' cells ml-' for urme [3] TUG process has been used ~th a few enhancements m order to reach a concentration of cells compatible with the test sensltivlty wlvle trymg to reduce conader-ably the tnne penod (8 days or more) reqmred for the stetity test of the mJctable products accord-mg to the method of the European Pharma-copma EXPERIMENTAL Mzcroblologml technrques Most mJectable solutions were fdtered usmg a Stentest system (Milhpore), then mcubated m the culture m&a, whereas the non-f&able products (parenteral nutntion or ternary mutturea, o&, etc) were titnbuted by volume dvectly m the prepared double-concentration culture broth All cultures were incubated for 24 h at 30°C m flmd tioglycolate medmm without rezazurm (FTM, I)lfco Labs), m trypk soy broth (TSB, Dlfco Labs) and m Sabouraud dextrose broth (SDB, Dlfco Labs), Hrlth 1% yeast extract added In thus case, mcubabon was prolonged to 72 h at 24 o C The last medmm was selected after many trials m order to optnnze the reveahng of the fungal con-0003-2670/91/$03 50 Q 1991-Elsener hence Pubbshers B V All nghts resexved

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Médicaments

Dates et versions

hal-01383025 , version 1 (18-10-2016)

Identifiants

Citer

F C Decool, V Goury, A Tibi, S Gibaud, F Vincent, et al.. Detection of bacterial adenosine triphosphate through bioluminescence, applied to a rapid sterility test of injectable preparations. Analytica Chimica Acta, 1991, 255, pp.423 - 425. ⟨10.1016/0003-2670(91)80078-8⟩. ⟨hal-01383025⟩
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