Facilities Built, Systems Qualified
More than 50 projects for 25 clients across pharma, biotech, medical devices, semiconductors, food-tech and medical cannabis, in Israel and abroad, with 15 running now.
Pharma & Biopharma
Turnkey Pharmaceutical Facility, 6,000 m²
Turnkey project management for Mapi Pharma's production and R&D facility in Jerusalem - 3,000 m² of cleanrooms and 3,000 m² of laboratories and offices, through municipal and fire approvals.
11-Year Engineering and Validation Partnership
Embedded engineers in Omrix's engineering and validation departments for more than 11 years, the company's shipping validation program, and engineering for new cleanrooms, laboratories and archives.
Sterile Cleanroom and Bioprocess Validation
Ongoing validation of MediWound's sterile cleanrooms, bioprocess and filling equipment and critical utilities, with audit support for FDA, EMA and Israeli MoH inspections.
Cold-Chain Shipping Validation and Validation Consulting
Shipping validation for UroGen Pharma's temperature-controlled distribution, from protocols and thermal profiling to GDP procedures, plus ongoing facility, utility and equipment validation consulting.
Medical Devices
4,000 m² Cleanroom Manufacturing Plant, Hangzhou
Senior engineering expert and lead technical authority, on behalf of Keystone Heart, for Venus Medtech's 4,000 m² cleanroom manufacturing plant in China, delivered during the COVID-19 pandemic.
Turnkey ISO 7 Cleanroom with HMI Controls
Turnkey project management and engineering for Pi-Cardia's new ISO Class 7 cleanroom, with HMI and HVAC automation and the full validation lifecycle through PQ, plus an ongoing engineering retainer.
Facility Relocation - Cleanrooms, Utilities, Equipment and HMI
Full commissioning and qualification for BioProtect's move to a new manufacturing facility in Netanya - cleanrooms, critical utilities, production equipment and the cleanroom HMI/PLC system.
Structural Heart Manufacturing - Cleanrooms, Utilities, Equipment and HMI
Validation of Cardiovalve's cleanrooms, HVAC and utilities, assembly and packaging machinery and cleanroom HMI panels for transcatheter heart valve production.
Embolic Protection Devices - Cleanrooms, Utilities and HMI
Commissioning, qualification and computerized system validation of Keystone Heart's cleanrooms, utilities, assembly machinery and cleanroom HMI panels.
Global ERP Computerized System Validation
Risk-based CSV of Quasar Medical's enterprise ERP across its manufacturing sites in Israel, Asia, Europe and North America, under GAMP 5, 21 CFR Part 11, EU Annex 11 and ISO 13485.
Cleanroom, Process Equipment and ERP Validation with Audit Support
Engineering and validation partner to LipoSphere - cleanroom improvements, qualification of formulation and filling equipment, ERP validation and support during regulatory audits.
Computerized Systems Validation and Data Integrity
Risk-based CSV of Tixel's digital quality, software and manufacturing systems under GAMP 5, 21 CFR Part 11, EU Annex 11 and ISO 13485.
Semiconductors & Photonics
Silicon Photonics Cleanroom - Construction Supervision
The client's engineering representative on site during construction of Teramount's (Molex) new silicon photonics cleanroom in Jerusalem, through commissioning and hand-over.
Cleanroom Expansion in Yokneam and Site Design in China
Engineering advisory for expanding Nanomotion's operating cleanroom in Yokneam without stopping production, and cleanroom design guidelines for its site in China.
Food-Tech
Precision Fermentation Pilot Plant Design
Engineering and architectural design for Remilk's precision fermentation pilot facility in Rehovot - zoning, process flows, clean utilities and hygienic design.
Fermentation Pilot Plant and R&D Laboratories Design
Functional engineering design for Imagindairy's pilot fermentation plant and analytical laboratories at Matam, Haifa.
The Projects We Take On
- 01Clean room suites · Design, construction management and qualification of classified areas
- 02GMP production facilities · Layout, utilities, equipment installation and commissioning
- 03QC and microbiology labs · From user needs to a built and equipped lab
- 04Equipment qualification · Autoclaves, ovens, process and packaging equipment
- 05Computerized systems · Control systems, QMS and track & trace validation
- 06Serialization · GTIN allocation, line upgrades and TraceLink integration
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