Application of Raman Spectroscopy to the analysis of complex Therapeutic Objects: Analytical Quality Control and Release Testing of portable infusion devices with a polyisoprene membrane charged with 5FU
18 October 2011A. Amin, Ph. Bourget, F. Vidal, L. Falaschi, R. Clément Service de Pharmacie Clinique, GH Necker - Enfants Malades,
AP-HP, 149 rue de Sèvres,
F-75015, Paris, France
Analytical Quality Control and Release Testing (AQCRT) of Therapeutic Objects (TO) is becoming widely adopted as it plays a role in making the medication circuit safer. Now, some commonly used TOs have a design and/or volume that is hardly compatible with the implementation of AQCRT. Portable infusion devices belong to this category: are they eligible for AQCRT by Raman Spectroscopy (RS)?
To evaluate the performance and practicality of RS applied to AQCRT of portable infusion devices with a polyisoprene (PI) membrane charged with a 5FU solution.
Equipment and methods
Quantification of the 5FU is conducted in conditions representative of the usual therapeutic protocols by CLHP-UV and RS. Dilution series (n = 9) and CQs (n = 4) prepared with 0.9% NaCl and 5% glucose cover an interval of concentrations of between 1.5 to 50 mg/ml. The quantification model for 5FU was validated vs complex TOs, i.e. BAXTER SV2Infusor® infusion devices.
Analysis in spectral dissociation reveals a differentiating, intense and specific band quantification of the 5FU (777-747 cm-1). The dilution series are linear in the retained interval (r2>0.99). The technique shows satisfactory repeatability (CVs ≤ 10 %) and accuracy of between 95 and 105 %. There is a strong correlation between the concentrations of 5FU measured via RS vs CLHP (p < 0.00001; n = 36 - Spearman test and rs Kendall).
Discussion – conclusion
CQAL by RS of nevertheless complex TOs such as infusion devices with PI membrane again appear to be a choice technical option. We confirm the relevance of RS application and its multiple advantages including:
- respect for the integrity of the formed TO,
- removal of any risk of operator exposure,
- preservation of the environment (no consumables),
- simplicity of analysis,
- practically no maintenance needed.
In addition, the present study considerably widens the field of application for RS to AQCRT of TOs with a broad spectrum of uses and complex geometry for which no other analytical solution had hitherto provided a response.