Projects

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PALL – Microbiology Lab Renovation

250 sq.m. area | Classified Microbiology Labs | General Laboratories | HVAC | Control and Software | Commissioning & Validation

TEVA – API manufacturing plant Tech – transfer and scale up

Production suites for main products | Clean rooms and HVAC | Clean utilities | Plant utilities | Automation, control and programming | Full commissioning | FDA  compliant

TEVA TECH – API R&D center – Pilot scale production

2200 SQM area | Clean rooms and HVAC | Analytical laboratories | Chemical laboratories | Pilot manufacturing unit | HVAC and control | Offices

TEVA – OSD manufacturing plant – Stouffville and Hood Road sites

Purified water system | Pretreatment, production, storage and distribution | PC/PLC consolidated control system for all system/subsystems | Full commissioning and validation | FDA compliant

TARO – Multi-purpose API manufacturing plant – FDA compliant

Fully automated manufacturing facility Wet production block of 4 floor vertical flow 2 MPP 1 dedicated reaction lines Automated batch processing Dry processing – drying, milling, blending suites Micronization suite Clean rooms, clean utilities, utilities PC/PLC consolidated control system for all plant consumers Commissioning and validation

Merck – Biotechnology R&D center – Multi product pilot – FDA, EMEA Compliant

3,000 SQM area | Biotechnology laboratories | R&D laboratories | Chemical laboratories | Offices, storage, warehouse

Perrigo – API – CILOSTAZOL & MODAFINL Plant

Process Equipment | Purified Water system | Process Improvements | Clean Rooms | WFI system | Automation | FDA/EMEA compliant

Abbott – Process Skids – Feno Penta

Detail engineering | Process Skids ASME BPE compliant | Process Piping | CE certified electrical control | 21 CFR compliant Automation and control | Integration of Process Skid paraphernalia Equipment & Utility | Biopharmax awarded Abbott Business Performer of the year  2014/2015  

VBL – Anticancer – Injectable Gene Therapy

Mammalian Cell Process upstream & downstream | Clean Rooms & HVAC | Cold storage | Clean Utilities, WFI, CO2, OFA, O2, Nitrogen, Glycol | Plant Utilities | 21 CFR compliant Automation and control | Laboratories and offices | EMA, USFDA Compliant

Omrix JP – Raw material human plasma and Cryo

Thrombin Production Suite | Fibrinogen Production Suite | Aseptic Filling Suite | Replacing of Filling line with Lyo (MLP)| Near 2,000 of clean rooms and HVAC | All utilities, WFI, Soft Water, OFA, CIP, SIP, CHW, PS,  Glycol, IPA, drainage | Commissioning and validation | EMA compliant

HTBT – Biotechnology production plant – Insulin crystals and other recombinant products

7,500 SQM building | Process equipment, fermenters | Upstream, Downstream and final purification | Clean utilities and general utilities | Warehouses, laboratories, offices | Software per CFR21part11 | Complete commissioning and validation | EMEA compliant

HSBBS – Biotechnology fill finish plant – Insulin & Hep-B

Final compounding department | Aseptic filling line for vials | Aseptic filling line for cartridges | Aseptic filling line for pre filled syringes | Packaging department | EMEA compliant

Scigen – Biotechnology production plant – Insulin crystals and other recombinants

10 acres site, 9,000 SQM building | Process equipment, fermentors | Upstream, Downstream and final purification | Clean utilities and general utilities | Warehouses, laboratories, offices | Software per CFR21part11 | Complete commissioning and validation | EMEA compliant

Gamida Cell – Cell Therapy Production Facility – Blood Cancer and other blood disorders

600 sq.m Clean Rooms (A,B,C Class) | HVAC System | Clean utilities | Plant Utilities| Laboratories, Offices and General areas | EMA USFDA Compliant

Biogenomics – Biotechnology production plant – Recombinant Biopharmaceuticals – Insulin Analogs

Upstream, Downstream and final purification | Clean utilities | HVAC and Cleanrooms | Software per CFR21part11 | Complete commissioning and validation | EMEA compliant

Ferring – Biological manufacturing plant – Recombinant multi products

Automated aseptic manufacturing unit | PW, WFI, PS production and distribution system | Multi pass CIP system | Control and automation | Commissioning and validation | FDA compliant

Cell Cure – Cell Immunotherapy R&D Facility

Clean Rooms 160 sqm (B,C class) | HVAC system | QC Laboratories | Storage | Offices | Software per CFR21part11 | EMEA, USFDA Compliant

BOL Pharma – Medical Cannabis Production Facility – Multiple application Medical Cannabis production

Extraction and separation of Cannabinoids | Sublingual/Tablets/Dermal/Aerosol | HVAC & Clean rooms | Dry Room for floral drying | Safe Room for fresh floral | Laboratories, storage | Offices and general areas | Commissioning and validation | IMH compliant

Tel Hashomer Shiba – Cell Therapy – Project Completion

Clean Rooms construction from previously purchased panels | Installation of previously purchased AHUs and completion of HVAC system | Completion of HVAC system | Working according to 3rd party Design | Electrical works – design and implementation | Control system including instrumentation other HW and software In-House design and implementation | Commissioning & Validation

Ethicon J&J – Aseptic production of biological glue – Fleece matrix compounding

Production rooms | Freeze drying suite | Packaging department | Clean utilities | Clean rooms ISO 5-7 | Laboratories | FDA, EMEA compliant

Omrix J&J – Human plasma manufacturing plant – Factor VIII, IVIG, Albumin – FDA Compliant

100,000 liter per year | IVIG production department | Albumin factor VIII production facility | Biological glue production facility | Filling and packaging | Clean utilities, clean rooms, HVAC, laboratories | Commissioning and validation

PBE – Human plasma manufacturing plant – Sterile albumin filling

Washing machine, sterilizing tunnel, filling machine | Clean Rooms and HVAC | WFI production and storage | PC/PLC control system | Full commissioning and validation

Protalix – Biotechnology sterile production – Plant cells technology – EMEA Compliant

Production lines | Process equipment | Clean rooms | Clean and general utilities | Complete commissioning and validation| Software per CFR21part11

Colbar J&J

Aseptic collagen production | Injectable application | FDA, EMEA Compliant | Water for injection production and storage | CIP systems | UF skids | PC/PLC consolidated control system | Warehouse and packaging department | Complete commissioning and validation

Datum Dental

Collagen based dental implants for soft tissue and bone regeneration | Production of purified collagen, Ossix | FDA, EMEA,MOH Compliant | Automated Process | CIP system | Waste collection system | HVAC and clean rooms | Laboratories | Warehousing | Plant Utilities & Electricals | Validation

Sigma Aldrich – Biotech process skids

Fermentation buffer system | Preparation vessel | Media vessel | CaCl2 vessel | NH4OH vessel | Buffers distribution system | CIP | SIP | Automated Control | Designed as per cGMP

SOREQ – Nuclear Research Center – Automatic Aseptic Production Plant – EMEA – Compliant Netherland Health Authorities

Freeze drying with SIP | Autoclaves | Aseptic filling line | Washing machine, sterilizing oven, sterile filling machine, capping machine | Purified water production | Water for injection production and storage | PC/PLC consolidated control system | Full commissioning and validation | Clean rooms and HVAC, 400 SQM class 5-8

Unimark Remedies – Sterile API fill and finish plant – Penem multi products

Sterile bulk multipurpose production | Final compounding and formulation | Powder filling in vials | Line manufacturer B+S | Packaging department | FDA , EMEA compliant

Prosintex Restoration and re-operation – Chemical production line within 39 days after explosion

Decontamination | Civil construction work | Equipment erection and replacement | Piping installation | Control and programming | Full commissioning and validation|  FDA compliant

Inotek – Turn Key – API – pilot plant

Clean rooms 100,000 and 10,000 class (1000 SQM) | HVAC + control | 1000 SQM technical equipment floor | Laboratories to Israel Standard 1530 (120 SQM) | Installation and validation of API production | PW production and storage | Thermal oil heating and cooling stations (-20-+200 Deg C) | Scrubber, vacuum dust collection systems

Cure Medical – Production equipment for IV solutions – Dual production systems

Filling machine, over wrapping, automatic sterilization in autoclave | Clean rooms for sterile production |  HVAC system to supply the clean rooms | Purified water system | Water for injection | Pure steam system | PC/PLC consolidated control system for all the plant machinery | ERP computerized system

Pluristem – Stem cell processing facility – Human Placenta source – EMEA Compliant

1,400 SQM production site | Upstream, downstream and filling | Clean utilities | Software as per CFR 21 part 11 | Complete commissioning and validation | Laboratories and Offices

Valin Technologies – Laboratory

600 Sq.m area  | Biological laboratories | General area, offices, storage | HVAC and control | cGMP compliance

Evogen – Laboratory

1,000 Sq.m area | Biological laboratories | General area, offices, storage area | HVAC and control | cGMP compliance

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