Orbital welding

For many years FormaPharm Engineering Group is carrying out works on stainless steel pipelines execution, for provision of the process fluids distribution, within the “turnkey projects”.  Due to the rigid quality requirements for the welding joints, the main method for execution of such pipelines is orbital welding.

Thanks to many years of experience and high level of technical equipment that we own, we are capable of executing the pipelines welding on several facilities simultaneously. We possess 3 orbital welding equipment sets, ORBITEC 3, ORBITEC 4, and ORBITEC tigtronic 205.

In our staff we have certificated welders, who are, besides the orbital welding machines manipulation, also educated for handmade joint welding at places, difficult to access with welding machine head. We have 4 ESAB TIG 1500 handmade welding units. The quality of handmade welding joints, made by our welders, fully complies with the rigid requirements, set out in pharmaceutical and food industry.

For visual inspection of the inner welding joint surfaces we use endoscope with the 3,0 m sound, with option for making and printing the photos, attached to the documentation which is necessary for qualification and validation of the executed systems.

Besides the mentioned above, we also have machine for pipes preparation, ORBITEC, as well as all other necessary equipment and tools for execution of stainless steel pipelines works.

Process fluids, for which FormaPharm Engineering Group provides not only the work execution, but also the complete project design documentation, are:

  1. Purified Water, (PW),
  2. Water For Injection, (WFI),
  3. Softened Water, (SW)
  4. Pure Steam, (PS),
  5. Compressed air (process and instrument)
  6. Technical gases.

Design of production, storage and distribution systems for the mentioned above fluids is defined in accordance with and complies with all the relevant standards, codes and rules:

  • European Pharmacopeia – Ph.Eur
  • The Rules Governing Medicinal Products in the European Union – Eudralex Volume 4 – Good Manufacturing Practice – Medicinal products for human and veterinary use
  • 21 CFR Part 210 – Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • 21 CFR PART 11 Electronic Records; Electronic Signatures
  • ISPE Baseline® Guide, Volume 4, Water and Steam Systems
  • ISPE GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems…

Successful GMP inspection of all of our previously completed projects, accomplished by independent certificating domestic or foreign body, on behalf of our investors, is the best confirmation of the quality of works that we perform.

REFERENCE LIST:

2019.

  • JSC Hemofarm, Vršac – Reconstruction of tableting unit within the solid dosage forms site – Compressed air
  • Institute of Virology, Vaccines and Sera TORLAK, Belgrade, Serbia – Reconstruction of technical fluid production, storage and distribution system for pharmaceutical manufacturing, for the purposes of the Institute of Virology, Vaccines and Sera “Torlak” – Purified water, Water for injections, Pure steam
  • WEST PHARMACEUTICAL SERVICES, Kovin, Srbija Serbia – Turnkey delivery of construction work for the New microbiological laboratory – Compressed air
  • JSC Hemofarm, unit in Šabac, Serbia – Execution of reconstruction works on tableting, capsule filling and film coating unit – Compressed air

2018.

  • JSC Bosnalijek, Sarajevo, Bosnia and Herzegovina – Turnkey delivery of the Design and Construction of the non-sterile (liquid and semi-solid dosage forms) products manufacturing plant – Purified water, Compressed air, Technical gases, Softened water

2017.

  • JSC Bosnalijek, Sarajevo, Bosnia and Herzegovina – Work performance on the Purified water production, storage and distribution system at the Quality Control Department – Purified water
  • JSC Bosnalijek, Sarajevo, Bosnia and Herzegovina – Work performance on gas supply utilities at the Quality Control Department – Technical gases, Compressed air

2016.

  • JSC Hemofarm, Vršac – Reconstruction of the solid dosage forms packaging center within the JSC Hmofarm, Vršac – Purified water, Compressed air
  • JSC Hemofarm, Vršac – Construction works performance at “Hemofarm kvalitet” building, within the JSC Hemofarm complex, Vršac – Purified water, Compressed air, Technical gases

2015.

  • Nearmedik Farma, Obninsk, Ruska Federacija – Design and construction of solid dosage forms factory, Obninsk, Russian Federation – Purified water, Compressed air, Technical gases
  • Russian pharmaceutical, biotechnological and medical company, NEARMEDIC PLUS LLC, Russian Federation – Reconstruction of the existing laboratory premises for manufacturing of medical product “KOLLOST” – Compressed air

2014.

  • JSC Hemofarm, Vršac – Reconstruction works performance at ampoule manufacturing unit – Purified water, Technical gases
  • LLC Hemomont Podgorica – Design and construction works: reconstruction of the existing facilities within the LLC Hemomont complex, Podgorica, for the further construction of the new sterile nasal sprays (SNUP) manufacturing unit and mobile racking warehouse – Purified water, Water for injections, Pure steam, Compressed air, Technical gases

2013.

  • STADA Hemofarm S.R.L., Timisoara, Romania – Work performance at adaptation of the 2nd floor of the psysico-chemical laboratory – Purified water

2010.

  • STADA Hemofarm S.R.L., Timisoara, Romania – Construction of psysico-chemical laboratory – Purified water
  • Institute of Virology, Vaccines and Sera TORLAK, Belgrade, Serbia – Design and final works performance at Influenca vaccines department of Torlak institute  – Purified water, Water for injections, Compressed air