We collaborate across geographies to deliver top-notch engineering, technical and project management support that enables our customers to achieve the best outcomes.
Pro-DMS consults and supports companies in hygienic, sterile and aseptic process industries all over the world. Our technical and commercial solutions are sustainable, cost-effective and built to last in a fast-acting world.
Life Sciences
Consulting and engineering support for critical equipment FATs across Europe for EU based facilities under construction.
Technical support to project team to manage critical vendors, design and specify additional process systems for major upgrade to sterile high potency API manufacturing facility.
Re-modelling an existing blood products parenteral facility into a two-suite facility for mAbs and mRna bulk drug substance manufacture.
Engineering consulting for various site facilities from production/utilities and warehousing to site management.
Consulting and engineering support for critical equipment FATs across Europe for various vial and pre-filled syringe production facilities under construction in Ireland.
Design of contrast media process system based on a two-tank media preparation system with powder handling, oil addition system and integrated CIP. Tank sizes 40,000 L. Chinese NMPA, EMA and US FDA compliant.
Design, construction, installation and validation of a scalable multipurpose process system for sterile injectables. Industry 4.0 concept with complete traceability of process but with full mobile, modular versatility. Fully automatic system complete with SCADA and batch data recording systems (EBR). Full GAMP5 automation system with MES compliant to CFR 21 Part 11 and validated to Chinese NMPA cGMP.
Design, construction, installation and validation of a standalone, mobile, automated, continuous in-line blender for medical food. This unique concept allowed the customer to process and fill at a co-packers facility. In-line emulsion blending with continuous monitoring and oxygen removal with full CIP as well as a fully automatic system complete with SCADA and batch data recording systems (EBR), validated to NMPA, USA FDA, EU EMA and with automation to GAMP5 with CFR 21 Part 11.
Concept design improvement, basic design including process design for a vaccine facility with E.coli technology with media, buffer preparation, inoculum preparation, harvest, purification, ultrafiltration, microfiltration and multiple chromatography steps, fill-finish, clean utilities and bio-kill.
Complete modular designed facility for multiple processing lines, including sterile processing of creams and gels and aseptic processing of eye care products. BFS filling as well as a traditional sachet, vial and bottle fillers. Sterile API transfer systems and multiple CIP Systems. GAMP5 and CFR 21 Part 11 control system. Full supply including installation, commissioning and project management. Chinese NMPA validation.
Design, construction, installation and validation of a complete lipid emulsion pilot line for injectables. The process system can produce pilot batches for different product types including oils, solvents, lipids, powder and WFI based solutions. Fully automatic system complete with SCADA and batch data recording systems (EBR) and GAMP 5 automation. Validated to Chinese NMPA.
Complete turnkey for oral solid dosage facility with multiple wet and dry granulation suites for capsule and tablet production, pilot production facilities, clean and black utilities, cleanrooms and fume extraction systems. Full GAMP5 automation system with MES compliant to CFR 21 and validated to Chinese NMPA, US FDA, EUEMA and UK MRHA guidelines.
Delivery of 4 complete media preparation and storage systems for a new oral liquid dosage workshop including high shear blending, clean and black utilities as well as CIP. Modular design for an integrated limited footprint with full automation to GAMP5 and CFR 21 part 11 and validated to Chinese NMPA and PIC/s.
General contracting for a greenfield construction of an antibacterial topicals solution workshop with BFS. Includes cleanroom design and delivery, process design and installation and complete utilities delivery for a centralised system for 4 workshops. Validated to Chinese NMPA.
General consulting, design and build for amino acid sterile infusion production workshop, compounding, PAC and sterile filtration and filling systems. In-line blending with oxygen removal to 0.1ppm and lower. Full GAMP5 automation system with MES and compliant to CFR 21 Pt11 and validated to Chinese NMPA, US FDA and EU EMA.
Organic solvent purification and concentration of harvested cells using vacuum; full aseptic application with nitrogen blanketing and solvent recovery; integrated CIP/SIP with ATEX construction, small footprint. Completely automatic. GAMP 5 and CFR 21 Part 11 compliant and validated in accordance with EU EMA.
Food & Dairy
German-made plant, EPC project including facility design, provision of a production line, utilities, cold storage and waste treatment equipment. Project management for cleanroom construction and HVAC.
Beer & Beverage
4 complete high-speed filling lines; Allen Bradley PLC systems; 6 million litres per day output.
Sugar handling, dissolving, AC & DE treatment, storage, 5 stream blending, carbonation and CIP.
Improved quality, efficiency, reduced chemicals and CIP.
Bespoke CO2 collection system for 3,500 kg/hr (120 fermenters) in partnership with Norit Haffmans. Full CIP facilities. This was a technically challenging project because of large pipework due to very low pressures.
2x complete simple syrup systems for carbonated soft drink production with hot continuous sugar dissolving systems with sugar handling facilities, 65 Brix with activated carbon filtration, final syrup storage and CIP.
Other Sectors
Biotech pilot innovation for Europe's largest bioethanol manufacturing facility. As senior designers and consultants we designed, improved and implemented a pilot plant system that uses genetically modified plant cells in a perfusion fermentation process to convert CO2 to MCT (medium chain triglycerides) and then to castor oil. Successful 20,000L trial carried out over one year and now the system is ready for scale up to manufacturing. This project will revolutionize the development of clean energy as well as PAT concepts for biotechnology in life sciences.
Explore our project references
Covid antiviral solid dosage facility, Pfizer
Ireland
Consulting and engineering support for critical equipment FATs across Europe for EU based facilities under construction.
High potency API facility upgrade, AbbVie
Ireland
Technical support to project team to manage critical vendors, design and specify additional process systems for major upgrade to sterile high potency API manufacturing facility.
Biotech facility, Wuxi Biologics
Germany
Re-modelling an existing blood products parenteral facility into a two-suite facility for mAbs and mRna bulk drug substance manufacture.
Animal vaccines API, Zoetis Animal Healthcare
Ireland
Engineering consulting for various site facilities from production/utilities and warehousing to site management.
Biotech facility, Sanofi Genzyme
Ireland
Consulting and engineering support for critical equipment FATs across Europe for various vial and pre-filled syringe production facilities under construction in Ireland.
Contrast media production, Roche Diagnostics
Suzhou, China
Design of contrast media process system based on a two-tank media preparation system with powder handling, oil addition system and integrated CIP. Tank sizes 40,000 L. Chinese NMPA, EMA and US FDA compliant.
Sterile injectable CMO system, Only Biotech
Shantou, China
Design, construction, installation and validation of a scalable multipurpose process system for sterile injectables. Industry 4.0 concept with complete traceability of process but with full mobile, modular versatility. Fully automatic system complete with SCADA and batch data recording systems (EBR). Full GAMP5 automation system with MES compliant to CFR 21 Part 11 and validated to Chinese NMPA cGMP.
Medical food inline blending, Optimega Biotherapeutics LLC
USA
Design, construction, installation and validation of a standalone, mobile, automated, continuous in-line blender for medical food. This unique concept allowed the customer to process and fill at a co-packers facility. In-line emulsion blending with continuous monitoring and oxygen removal with full CIP as well as a fully automatic system complete with SCADA and batch data recording systems (EBR), validated to NMPA, USA FDA, EU EMA and with automation to GAMP5 with CFR 21 Part 11.
Vaccine facility, Innovax Bio
Xiamen, China
Concept design improvement, basic design including process design for a vaccine facility with E.coli technology with media, buffer preparation, inoculum preparation, harvest, purification, ultrafiltration, microfiltration and multiple chromatography steps, fill-finish, clean utilities and bio-kill.
Opthalmics & sterile gel facility, Zhaoke Bio-Sciences
Guangzhou, China
Complete modular designed facility for multiple processing lines, including sterile processing of creams and gels and aseptic processing of eye care products. BFS filling as well as a traditional sachet, vial and bottle fillers. Sterile API transfer systems and multiple CIP Systems. GAMP5 and CFR 21 Part 11 control system. Full supply including installation, commissioning and project management. Chinese NMPA validation.
Infusion pilot production facility, Beijing Sciecure Pharmaceutical
Beijing, China
Design, construction, installation and validation of a complete lipid emulsion pilot line for injectables. The process system can produce pilot batches for different product types including oils, solvents, lipids, powder and WFI based solutions. Fully automatic system complete with SCADA and batch data recording systems (EBR) and GAMP 5 automation. Validated to Chinese NMPA.
Oral solid dosage facility, Beijing Sciecure Pharmaceutical
Beijing, China
Complete turnkey for oral solid dosage facility with multiple wet and dry granulation suites for capsule and tablet production, pilot production facilities, clean and black utilities, cleanrooms and fume extraction systems. Full GAMP5 automation system with MES compliant to CFR 21 and validated to Chinese NMPA, US FDA, EUEMA and UK MRHA guidelines.
Oral liquid dosage, Bright Future Pharmaceutical
Hong Kong, China
Delivery of 4 complete media preparation and storage systems for a new oral liquid dosage workshop including high shear blending, clean and black utilities as well as CIP. Modular design for an integrated limited footprint with full automation to GAMP5 and CFR 21 part 11 and validated to Chinese NMPA and PIC/s.
Topicals production with BFS filling, Lustre Pharmaceutical
Shantou, China
General contracting for a greenfield construction of an antibacterial topicals solution workshop with BFS. Includes cleanroom design and delivery, process design and installation and complete utilities delivery for a centralised system for 4 workshops. Validated to Chinese NMPA.
Sterile infusion production, Beijing Sciecure Pharmaceutical
Beijing, China
General consulting, design and build for amino acid sterile infusion production workshop, compounding, PAC and sterile filtration and filling systems. In-line blending with oxygen removal to 0.1ppm and lower. Full GAMP5 automation system with MES and compliant to CFR 21 Pt11 and validated to Chinese NMPA, US FDA and EU EMA.