Cleanroom
We manufacture under clean room conditions and in certified clean room GMP grade D / ISO class 8.
Drug Master Files
elm-plastic GmbH holds DMFs at the competent authorities and provides its customers with LOAs for support of their applications. Specifications are available ready to use for registration purposes.
Development & Mould Making
Through our product development department and our own mold shop we are able to provide our complete service and our know-how from the idea up to series production.
We develop, design and manufacture the molds used in our production. That way, we are able to react flexibly and quickly to our customers requirements.
Production
Our machine park includes 24 injection molding machines as well as printing, assembly and packaging equipment. All production steps are done in our production and in accordance with our customers requirements.
Quality & Environment
Production processes are monitored and controlled by SPC (Statistical Process Control). A CAQ system (Computer Aided Quality) saves measuring results and documents process quality.
Visual and measuring tests are carried out regularly. For every delivery we provide our customers with a CoA (Certificate of Analysis).
elm-plastic GmbH is certified according to ISO 9001 and ISO 13485 and Annex V, Section 3 of Directive 93/42 / EEC (CE marking) as well as according to OHSAS 18001 (Health and Safety Management System).
We have joined the United Nations Global Compact and are committed to its ten principles with a focus on human rights, labor standards, environmental protection and fighting corruption.
