13 November, 2024

Metpoint OCV validation

30 October, 2015

Beko Technologies’ Metpoint OCV monitoring system has been successfully validated from BfArM (German Federal Institute for Drugs and Medical Devices) as a method to determine residual oil content within medical compressed air. The validation has been executed and achieved within a strong co-operation project of a global gas company and Beko Technologies.


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.

www.beko-technologies.co.uk




Events
 
Buyers' Guide Search
 
Search for UK supplier by name
Browse by Product Group.
Magazine
OCTOBER 2024 IssueTo view a digital copy of the OCTOBER 2024 edition of Hydraulics & Pneumatics Magazine, click here.

For a FREE subscription please click here

To visit the Library for past issues click here

SEPTEMBER 2024 IssueTo view a digital copy of the SEPTEMBER 2024 edition of Hydraulics & Pneumatics Magazine, click here.

For a FREE subscription please click here

To visit the Library for past issues click here

JULY/AUGUST 2024To view a digital copy of the JULY/AUGUST 2024 edition of Hydraulics & Pneumatics Magazine, click here.

For a FREE subscription please click here

To visit the Library for past issues click here

BFPA YearbookTo read the latest BFPA Yearbook, click here ..
BFPA Training AcademyClick the image to go to the BFPA Training Academy website
Compressed Air & Vacuum Technology Guide 2018To read the official BCAS Compressed Air & Vacuum Technology Guide 2018 click here
Offshore Europe Journal
Newsletter
 
Newsletter