MK Test Facilities offers solutions for insulators

Installation of the fully automatic glove testing system MK Simplex by MK Test Systems. The testing disc can be custom-made to fit each glove intervention. (Photo: MK Test Systems)

Effective from April 1, 2017, the new regulation will apply to all pharmacies providing sterile pharmaceutical preparations. The revision of DIN 12980:2016-10 stipulates that pharmacies manufacturing or refilling CRM substances or cytostatics must perform a pressure test on the access device of their isolator at least once per working day (Page 14, Point 8.6.2.2).

"This change presents significant challenges for pharmacies, as the technical and time requirements for manual glove testing have previously been considerable. With our many years of experience in developing and manufacturing glove testing devices, we have addressed this issue and introduce our fully automatic glove testing system MK Simplex to laboratories and pharmacies affected by the revision," says Dr. Dirk Rosencrantz, member of the management at MK Versuchsanlagen, offering quick assistance in complying with the new guidelines.

The special feature of the testing discs from MK Versuchsanlagen is that they can be individually adapted to all existing glove ports, regardless of whether they are round or oval, explains Dr. Rosencrantz. The handling is also very simple: "The testing disc only needs to be inserted into the glove port. Then, the glove is tested fully automatically. The entire process takes between 8 and 15 minutes, depending on the size and material. With the battery-powered testing disc, holes of ≥ 100 μm in the gloves are detected." Typically, the measurement results are transmitted wirelessly via WiFi to a laptop and securely stored," explains Dr. Dirk Rosencrantz, describing the simple principle of the MK Simplex testing disc.

For over 17 years, the company has been developing and manufacturing glove testing devices, offering users a cost-effective and automated way to test gloves. Due to long-standing business relationships with leading pharmaceutical companies worldwide, MK Versuchsanlagen's products meet the highest quality standards. MK Versuchsanlagen is an ISO 9001:2008 certified industrial company.