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Biotech & Pharmaceutical

We have worked for more than two decades with both international and domestic companies within the pharmaceutical and biotech industry. In biotech our know-how covers all process phases from upstream processing to cultivation and downstream purification with a variety of strategies for purification processes. We also have experience of engineering work for BSL3 facilities (bio-safety level).

Our customers include big international companies such as GE Healthcare, Novo, Pfizer, AstraZeneca, PerkinElmer, Q-Med and Santen and domestic Finnish companies such as Orion. In addition to our engineering professionals in Finland, we can complement our engineering teams with up to 50 engineers from our Mumbai office, who are fully dedicated to biopharmaceutical and pharmaceutical industries. The proof of our know-how and experience in Biotech & Pharmaceutical are the numerous facilities we have worked on that have passed inspections by EMEA and FDA.

Deep domain knowledge in:

  • Biotechnical manufacturing processes
  • Biopharmaceuticals
  • All pharmaceutical dosage forms
  • Highly potent compounds
  • Diagnostics production
  • Clean utility systems
  • Clean rooms
  • Automation
  • Qualifications and Validation

Broad in-house engineering scope

  • Process engineering
  • Plant engineering
  • Mechanical engineering
  • Construction engineering
  • HVAC engineering
  • Electrical engineering and Instrumentation
  • Automation system engineering
  • Information system engineering

Qualifications and Validation

Validation process

Elomatic offers a full range of validation and commissioning services to process industry customers. In validation we ensure that our customers’ devices, spaces and software packages meet the requirements imposed on them and are applied in their intended use according to good manufacturing practices. We also ensure that processes repeat expected results with the greatest possible certainly.

Our commissioning services include post-design device, space or software measures taken up to the delivery of the device, space or software. Commissioning post-design inspections or tests start from design inspections and end with site acceptance tests (SAT). Commissioning is undertaken when the device, space or software is not GMP-critical and as such does not necessitate validation.


Validation (qualification)

  • DQ (Design Qualification)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • PV (Process Validation)

Commissioning tests

  • DR (Design Review)
  • FAT (Factory Acceptance Test)
  • Acceptance Inspection
  • Installation Inspection
  • SAT (Site Acceptance Test)

Supporting your success during operation

To support our customers, on top of consulting and engineering and throughout the site life cycle, we offer a set of targeted professional services to enhance our customers’ productivity, safety and information management.

List of Life cycle services

Throughout investment projects

  • EPCM services
  • Technical and/or economical feasibility studies
  • Conceptual, basic and detailed design
  • Project management services
  • Procurement services
  • Site management services
  • Commissioning and starT-up services
  • Laser Scanning
  • Panoramic imaging
  • Visualization

Productivity enhancement services

  • Energy efficiency audits and analysis
  • Carbon footprint audits and analysis
  • Production flow simulations and debottlenecking
  • OEE and MES systems
  • Process measurements
  • Process and CFD simulations
  • Process and production troubleshooting

Safety enhancement services

  • Risk evaluations
  • Rescue Planning
  • ATEX services
  • CE marking
  • Validation
  • Usability services

Information management services

  • Elodoc - document management system and services
  • Elomap – interactive browser based tool for sites, facilities and offices
  • NetInfo – dedicated tool for district heating network data management

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Contacts

Aulis Rajala

Aulis Rajala
Biotech & Pharmaceutical
Tel. +358 2 412 4311
Mob. +358 40 0522 532

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References

Project references

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