One of the major advantages of working with the AMW GmbH is the close interaction between development and production: we can offer our clients from the pharmaceutical industry a smooth technology transfer from the laboratory scale to production for the international market in accordance with the GMP (Good Manufacturing Practice) regulations.
The quality of our work is regularly certified with a manufacturing permit for the delivery of clinical studies as well as for product market delivery by regional regulatory authorities, the governing bodies of Upper Bavaria. Numerous successful audits by our clients in the international pharmaceutical industry are further confirmation of the high quality standards of the AMW GmbH. Above and beyond that, we have been granted handling permits in accordance with the Narcotics Law.
The videos and Photographs give an impression of our manufacturing capabilities:
Prototype patches are made in the development lab with semi-automatic machines. You see the process of coating a foil with pressure sensitive adhesive in a small coating machine.
GMP-compliant patch manufacturing starts with precision weighing by means of a computer-controlled weighing system in a cleanroom weighing cabin.
The counterpart of the lab coating machine is a fully automated coating line for routine production.
In order to become a prototype patch, the intermediate product, which is the drug containing laminate made in the lab coater, is converted in a semi-automated lab rotary die punching machine. The finished patches then have to be isolated manually.
In this case, the drug containing laminate, which is manufactured in the automated coating line, is converted into patches by a fully-automated rotary die cutter, the same principle as in the rotary lab die cutter.
Finished patches are leave the die cutter and are placed on a conveyor belt.
Patches are transferred from the conveyor belt to one side of the packaging film by a pick-and-place robot. The pouches are formed together with the film’s counterpart.
The best possible mixture quality of the powder blend for implants is essential for the precise dosage of highly active drugs. The video shows the mixer for this process. The powder blend is agitated in three-dimensional directions and is subject to alternating, rhythmically pulsating movements.
An homogeneous powder mix is needed to produce implants in this kind of computer-controlled production line. We adhere strictly to cleanroom technology.