OUR OFFER
Pharmaceutical Industry
Design
We offer 2D, 3D design and custom selection:
1 Systems for the production, storage and distribution of critical utilities:
- PW, WFI water production stations,
- pure steam generators,
- ozone generators with measuring equipment,
- reactors with capacities of 0.5m³ to 20m³ with proper roughness of the internal surface, made of stainless steel,
- vessels with capacities of 0.5m³ to 20m³ with proper roughness of the internal surface, made of stainless steel,
- water distribution loops with diaphragm valves of required material and roughness,
- clean steam installations
- peripheral equipment according to FDA requirements,
- instrumentation and control equipment meeting cGAMP requirements,
- thermal insulation in clean and technical rooms,
- automation and control.
2 Media installations for heating, cooling, compressed air in clean rooms and technical areas:
- chilled water units, steam boilers, oil-free propeller compressors,
- control valves, relief valves, cut-off valves,
- stainless and carbon steel pipelines,
- thermal insulation in clean rooms and technical areas.
3 CIP/SIP systems:
- CIP/SIP skids – mobile or stationary
- CIP/SIP pipelines.
Service
Orbital welding of pipelines
in inert gas shielding
Manual welding of pipelines
in inert gas shielding
Pipeline assembly
and peripheral equipment
Positioning and connection of machines
Modernisation of production lines
Modernisation of production lines
Vessel modernisation:
pressurised, non-pressurised, low-pressure
Dismantling of existing installations
As-built documentation
Visual inspections:
certificates VT1, VT2
Ferrite measurement
- more than 600m² of production space including a storage area,
- micro-station for the production of purified water. Installations for distribution of water and compressed air for the qualification tests of the prefabricated skids in the workshop
- power sources and orbital welding heads
- professional pipe cutting machines
- endoscope with probe Ø 6mm and length 3m
- ferritometer to measure ferrite content
- experienced personel
- tool sets
Everything that has contact with the intermediate product impacts on the quality of the final product – the medicine. This is why the pharmaceutical industry puts such high requirements on critical media installations.
Important aspects for the installation of critical media:
Selection of the material that is in contact with the medium, both stainless steel for pipelines, valve bodies, connections, as well as synthetics from which e.g. FDA-approved valve gaskets, roughness of surfaces in contact with the medium, roughness classes of Ra<0.8 Ra<0.6 Ra<0.4, or higher, fittings, connections and pipeline gradients ensuring good flowability to prevent the multiplication of bacteria, the “no dead legs” principle, diaphragm valve technology made of FDA-approved materials, appropriate roughness of the wetted parts, tests to confirm process repeatability.
LAF LAMINAR FLOW DIFFUSERS
Our company offers the manufacture of laminar flow diffusers for pharmaceutical and biotechnology laboratories and production plants.
To find out more contact our sales department: handlowy@gmproces.pl.
QUALITY CONTROL
Quality control of the fabrication pharmaceutical pipelines includes checking the quality of the welds performed, checking the supply of the following materials
- welding work is carried out according to specific company procedures based on Polish Standards, ASME-BPE standards,
- regular checks on welders’ qualifications confirmed by certificates allowing them to work in the pharmaceutical industry,
- the level of oxygen in the shielding gas is controlled during the welding proces
- boroscopy examinations are performed according to specific porcedures by qualified personnel with VT1 certificates, VT2 for visual examination of welds
- surface roughness tests
- ferrite content test
- pressure tests carried out in accordance with specified company procedures or requirements included in the factory specifications
- passivation of installations carried out in accordance with specified company procedures or requirements included in the factory specifications
AS-BUILT DOCUMENTATION
Usually the as-built documentation is provided in several paper copies and an electronic version
QUALIFICATION AND VALIDATION
We perform qualification and validation of equipment and pipelines for the pharmaceutical industry.
- PQ, OQ, IQ qualification
- VSR validation report
- on-site testing
- documentation in Polish or English
On request, we also carry out microbiological testing of water and air.