Ferhat Pertekli Email & Phone Number

I have been working in the Biotechnology and chemical pharmaceutical sector as a Maintenance Engineer since 2015. I have advanced experience in primary operations and secondary packaging in the chemical pharmaceutical sector. I have sterile filling and DS (MAb) production experience in Biotechnology and Aseptic operationsChemical facility production areas;In the primary field: I worked in Tablet and Capsule Packaging, Tablet printing-coating and granulation stages, Syrup-pomade operations. In secondary fields: I worked on many machines such as Blister, Ampoule, Pomade, Syrup cartoning machines, QRCoding, Shrink Wrapping, Labeling etc.Biotechnological and Aseptic fields:Sterile area: A-B-C classes: Solution preparation, Filtration, Particle counter devices, vial-cartridge filling and capping processes and Lyophilization machineCNC- D class and Laboratory areas: I worked Vial-Cartridge washing, Sterilization tunnel, CCIT, Isolator, Autoclaves and other equipment.In the DS (MAb) production areaIn the Upstream area: Bioreactors (Glass, Wave, Mass Scale 50 L to 2000L), Media solution preparation, Cell bank, IncubatorsIn the Downstream field: I worked on Harvest- Filtration (Particle Filtration and electro affinity capture chromatography), Buffer Preparation, Purification (TFF) equipment.In addition;Pay attention to aseptic production rules and requirements are significant for us in chemical drug and aseptic operations I regularly follow the changes in GMP applications and Annex-1 regulations.I follow sterile area behavior movements, Single-USE systems, PUPSIT, SURF assembly connections. I consider and follow classified areas (Differential pressure, Laminar flow, particle and microbial measurement), Water system, Pure steam production as a significantAs quality operations: We use our SOPs such as Maintenance Instructions, Technical Reports, Risk Analysis effectively and carry out our work accordingly. We initiate actions such as Corrective and Preventive Activities (CAPA), Deviations (Deviations) and Change Controls (CC) and implement them according to Annex-1 and GMP rules and our own SOPs.