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Published on: May 4, 2018
Evaluation of parenteral diluent contamination by caprolactam
Christophe Curti1,2, Elise D'Huart3, Edouard Lamy1,4
1Service Central de la Qualité et de l'Information Pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Hôpital de la Conception, Marseille.
Purpose:
A leachable cyclic amide (caprolactam) can be found in normal saline (NS) and 5% dextrose in water (D5W) plastic bags widely used in clinical practice if they contain polyamide in a multilayer sheeting. This contamination and the parameters that could influence its content have never been studied in a public work such as a scientific publication.
Methods:
Two independent laboratories validated a caprolactam dosing method and studied contamination levels in several containers.
Results:
Caprolactam content in multilayer polypropylene/polyamide/polypropylene plastic bags ranged from a mean (SD) of 5.43 (0.21) mg/L (D5W 1,000 mL) to 22.83 (1.26) mg/L (NS 50 mL). NS and D5W can be intravenously administered with a total daily dose of 3 L, corresponding to a minimal daily dose of 16.3 mg of caprolactam.
Conclusion:
The high levels of contamination we have reported and the possibility of administering caprolactam to high-risk patients (eg, neonates, the elderly) should make it imperative for pharmaceutical companies to communicate publicly on the safety of caprolactam.
