Success stories
Integral solution for the relocation and expansion of the clean room steam system.
Project description
Steam solution to ensure a stable and validatable thermal supply in a leading biotech plant.
Original situation:
Challenges posed by the client:
A biotech company needed to secure a stable, safe and validatable supply of steam to power its fermenters and other critical thermal processes.
The existing installation, the result of the plant’s accelerated growth, had several limitations that made it difficult both for daily operation and to meet the standards required in a clean room environment:
- Inadequate location of the generator and condensate tank: the plant needed to free up space in the existing room and move both equipment to a contiguous area, maintaining active production and without compromising hygiene. The change involved 15 m of displacement and new vertical downspouts, in addition to the complete reconnection of all steam and condensate lines.
- Difficulty of access to the reduction and filtering stations: both sets were installed on a mezzanine, making operation and maintenance work difficult, and compromising routine visual inspection of critical elements such as valves, pressure gauges, filters and traps. They had to be disassembled and reinstalled in an accessible area next to the generator.
- Need to extend and reorganize the process lines: the relocation required extending the existing filtered steam, direct steam and condensate return lines, each by approximately 15 m. The new installation had to ensure adequate flow, minimize thermal losses and avoid condensate pockets. The new installation had to ensure adequate flow, minimize thermal losses and avoid condensate pockets.
- Strict clean room requirements: the new location required fully stainless materials(AISI 316/316L), hygienic press fittings, piping insulated with mineral wool and aluminum protection, and an orderly, clean and easily inspectable layout, compatible with GMP regulations.
- Ensuring safe steam for biotechnological processes: The fermenters needed stable, dry, filtered and particle-free steam. The existing infrastructure was not optimized to meet these requirements in the new room without comprehensive intervention.
- Integration without production interruptions: the execution had to be carried out without affecting fermentation cycles, without stopping CIP/SIP sterilization processes and without risk to ongoing batches, which required extremely careful planning and coordinated work steps.
Proposed solution:
Customized steam solution developed by Giconmes.
Proposed solution:
After analyzing the limitations of the existing installation and the new operational requirements of the plant, Giconmes designed and implemented a comprehensive solution to ensure a stable, safe and clean room compliant steam supply.
The intervention combined engineering, infrastructure expansion and equipment relocation, taking advantage of the fact that the plant already had a 60 kW stainless steel Giconmes electric steam generator installed in a previous phase.
- Complete relocation of the generator and condensate tank: the entire unit was moved to the new clean room, respecting the hygienic-sanitary conditions of the production process. The 15 m displacement and the 3 m vertical downpipes were executed with AISI 316/316L piping, ensuring mechanical continuity, absence of losses and correct condensate drainage.
- Removal of the mezzanine and reinstallation at the foot of the machine: the pressure reduction and filtration stations were removed from the mezzanine – where accessibility was limited – and rebuilt next to the generator, allowing for much safer operation and quicker maintenance. The new layout improves traceability of critical parameters such as pressure, steam quality, drainage and sterile filtration.
- New complete lines for filtered steam, direct steam and condensate return: new lines of approximately 15 m each were installed, all made of AISI 316/316L pipe and assembled with press fitting technology, eliminating welds and guaranteeing cleanliness, uniformity and speed of assembly.
- The steam lines were supplied with mineral wool thermal insulation and a protective aluminum jacket, reducing energy losses.
- An orderly, aerial and dead zone-free layout was implemented, optimizing drainage and avoiding the risk of water hammer.
- Specific adaptation for GMP / clean room environment: the redesign contemplatedhygienic materials, straight routes and a stainless steel support system compatible with visual inspection. The final section to the reactor was made with flexible Teflon tubing reinforced with stainless steel mesh, guaranteeing safety, flexibility and chemical compatibility.
- Integration with existing lines and system tuning: the three lines freed up by the dismantling of the previous location were connected to the new extensions without interrupting production, thanks to a phased planning that allowed the steam supply to be kept active during the work.
- An additional ball valve was also installed to allow independent shut-off of the old and new lines, facilitating future interventions without affecting the operation.
- Optimization of steam supply to the fermenter: thanks to the reorganization of the system and the new piping architecture, steam reaches the reactor: with stable pressure, better thermal quality (drier steam), lower pressure drop and more accessible and validatable filtration.
- Use of the 60 kW stainless steel generator previously installed: the solution was fully integrated with the steam generator previously supplied by Giconmes, an equipment designed in stainless steel and compatible with the requirements of the pharmaceutical and biotechnological industry. This technological continuity made it possible to maintain the sanitary and mechanical coherence of the system and to reduce integration times.
Technology used:
- Giconmes 60 kW electric steam generator in AISI 304/316 stainless steel pre-installed and fully integrated in the new architecture
- AISI 316/316L sanitary piping for 15 m of new filtered steam, direct steam and condensate return lines, assembled with press fitting technology.
- Mineral wool thermal insulation with an aluminum outer jacket to minimize energy losses and protect the circuit.
- Stainless steel support system suitable for clean room use, with straight lines and no dead zones to facilitate drainage and visual inspection
- Final section to the reactor by means of flexible Teflon tubing reinforced with stainless steel mesh, compatible with GMP environment and biotechnological processes.
- New pressure reduction and filtration station relocated at the foot of the machine to improve safety, accessibility and maintenance
- Additional ball valve for independent shut-off between old and new line, facilitating future interventions without stopping production.
- Complete relocation of generator and condensate tank through AISI 316/316L lines with vertical downspouts and optimized drainage
CHALLENGES
We meet customer requirements
Steam solution to ensure a stable, safe and validatable thermal supply in a biotech plant with GMP environment. We achieved the following results:
Stable and continuous supply,
thanks to the new piping architecture in AISI 316/316L, with straight runs, no dead zones and optimized drainage.
Improved steam quality,
obtaining drier steam, with lower load drop and with the filtering station located at the foot of the machine for more accessible validation.
Integration without stopping production,
through phased planning and the installation of an independent shut-off valve that allowed the operation to remain active during the work.
Safe, hygienic and clean room compatible operation,
with sanitary materials, stainless steel support, reinforced Teflon end section and relocation of the equipment to the new GMP room.
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There are no emissions beyond those produced during the electricity production process. Consequently, emissions can be neutral depending on the electricity mix. Electric steam boilers are the present and the future.
Absolutely. In fact, it is recommended to achieve maximum efficiency. There is no problem with remote control as long as it complies with current regulations.
A steam generator is a pressure vessel that, together with the piping network, is subject to regulatory control and complementary technical instructions, according to the regulations published in Royal Decree 809/2021, of September 21. Maintenance is divided into a part that can be easily fulfilled by the owner:
- Know and apply the manufacturer’s instructions regarding use, safety measures, and maintenance.
- Not to put the installation into service or prevent the operation of pressure equipment if the requirements of the Regulation are not met.
- Having at least the following documentation for the pressure equipment while they are installed: Declaration of conformity, manufacturer’s instructions (if applicable), and, if necessary, installation certificate, along with other supporting documentation (such as installation project, record of the last periodic inspection, certifications of equipment repairs or modifications, and any other documentation required by the relevant technical instruction complementary to this regulation). For detailed contents, refer to Annex IV of the regulation. Making this documentation available to the competent authority of the autonomous community and the companies responsible for maintenance, repair, or periodic inspections.
- Use the pressure equipment within its intended operating limits as specified by the manufacturer and take it out of service if it no longer meets the necessary safety requirements.
- Perform maintenance on the installations, pressure equipment, safety accessories, and control devices in accordance with the operating conditions and manufacturer’s instructions, and examine them at least once a year.
- Arranging for the necessary periodic inspections as required by Article 6 of the regulation.
- Having and maintaining an up-to-date record of pressure equipment categories I to IV, as defined in RD 709/2015, of July 24, or equipment similar to these categories according to Article 3.2 of the regulation, as well as their installations.
It is known that by applying heat to water, it transforms into steam at the boiling point and atmospheric pressure. From there, depending on the required saturation degree of steam for its proper application, we need to increase the pressure to obtain a higher temperature. To change the temperature and saturation degree of steam, we always need to modify the pressure.
It is a unit of pressure equivalent to 1 kg/cm2, 0.98 atmospheres, or 14.50 PSI.
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