In a joint project, the companies have validated a procedure for monitoring oil vapours in compressed air systems for medical air. The suitability of the monitoring method was validated on the basis of the requirements of the latest version of CPMP/ICH/381/95 as well as reference measurements obtained with recognised test procedures. All measurements in this validation process were obtained using Metpoint OCV photoionization detectors (PID) from Beko Technologies.
Positive review
The available data was submitted to the German Federal Institute for Drugs and Medical Devices (BfArM) as a variation subject to approval in relation to the marketing authorisation dossier. It encompasses threshold monitoring not only of the oil vapours arising during manufacture of the active pharmaceutical ingredient (production of compressed air), but also of the filled batches of medicinal products (compressed gas cylinder). The variation was reviewed positively by the BfArM.
Metpoint OCV is therefore validated as a method to determine residual oil content within medical compressed air.
