The designing and manufacturing of the glass or stainless steel bioreactors and
fermenters for the production of vaccines and biotechnological products are made
compliance with GMP and ASME BPE rules at various scales (laboratory, pilot and
production) with the semi-automatic or fully automatic options.
Sterile/non sterile liquid, semi-solid and solid mixture preparation tanks used in
manufacturing of medicinal products.
The biotechnological and pharmaceutical product manufacturing facilities
are designed based on The Turkish Ministry of Health, The Turkish Ministry of
Agriculture, EU, PIC/S, FDA and WHO cGMP guidelines.
In line with cGMP and GEP principles, detailed engineering projects of biotechnological
and pharmaceutical manufacturing facilities are drawn on the basis of basic design.
It involves identifying areas where companies
cannot perform well and underlying root causes
and recommending improvement plans (troubleshooting)
for those root causes.
The strengths and weaknesses of the quality management system
owned by the manufacturers are determined and recommendations
are made for the establishment of an effective and feasible system
within the scope of GMP, ICH Q10 and ISO 9001