FORMAPHARM ENGINEERING GROUP - Serbia
www.formapharm.net
Official exclusive plant designer of HEMOFARM (STADA GROUP).
Our current expertise covers pharmaceutical products projects.
We are confident and have immense experience in the following pharma-engineering services fields:
Plant/Facility design in compliance with GMP (sterile/aseptic processes, oral solid dosage forms, semi-solid dosage forms, liquids, ointments, nasal sprays, APIs). Design includes all process steps, from formulation to finished products, including specific processes such as freeze-drying (Conceptual design, Basic design, Detailed design, Construction, Qualification).
Warehouse design, QC Labs (physico-chemical and microbiological), R&D Labs, in compliance with GDP/GMP/GLP (Conceptual design, Basic design, Detailed design, Construction, Qualification).
Clean utilities (purified water (PW), water for injection (WFI), pure steam (PS), clean gasses (Conceptual design, Basic design, Detailed design, Installation - including welding, Qualification).
HVAC (Conceptual design, Basic design, Detailed design, Installation, Qualification).
BMS, EMS, Process automation (Conceptual design, Basic design, Detailed design, Installation, Qualification).
Requirements and specifications (URS, FS, HDS, SDS).
On-site construction management and start-up support.
System commissioning.
Equipment, Utilities, Clean Rooms Qualification (IQ, OQ, PQ).
Additional to these engineering services we have also in our company the design and installation of:
Clean Rooms
Stainless steel tube systems with orbital welding
We are working with all well-known companies in Europe and also we have a good network for:
API (worldwide)
Dossiers for licensing of different drugs and contract manufacturing
Purchasing of all necessary equipment (Plant and Process Machines) and laboratory furniture
www.formapharm.net
Official exclusive plant designer of HEMOFARM (STADA GROUP).
Our current expertise covers pharmaceutical products projects.
We are confident and have immense experience in the following pharma-engineering services fields:
Plant/Facility design in compliance with GMP (sterile/aseptic processes, oral solid dosage forms, semi-solid dosage forms, liquids, ointments, nasal sprays, APIs). Design includes all process steps, from formulation to finished products, including specific processes such as freeze-drying (Conceptual design, Basic design, Detailed design, Construction, Qualification).
Warehouse design, QC Labs (physico-chemical and microbiological), R&D Labs, in compliance with GDP/GMP/GLP (Conceptual design, Basic design, Detailed design, Construction, Qualification).
Clean utilities (purified water (PW), water for injection (WFI), pure steam (PS), clean gasses (Conceptual design, Basic design, Detailed design, Installation - including welding, Qualification).
HVAC (Conceptual design, Basic design, Detailed design, Installation, Qualification).
BMS, EMS, Process automation (Conceptual design, Basic design, Detailed design, Installation, Qualification).
Requirements and specifications (URS, FS, HDS, SDS).
On-site construction management and start-up support.
System commissioning.
Equipment, Utilities, Clean Rooms Qualification (IQ, OQ, PQ).
Additional to these engineering services we have also in our company the design and installation of:
Clean Rooms
Stainless steel tube systems with orbital welding
We are working with all well-known companies in Europe and also we have a good network for:
API (worldwide)
Dossiers for licensing of different drugs and contract manufacturing
Purchasing of all necessary equipment (Plant and Process Machines) and laboratory furniture