OUR PARTNERSHIP - YOUR PROJECT'S SUCCESS
250 sq.m. area | Classified Microbiology Labs | General Laboratories | HVAC | Control and Software | Commissioning & Validation
Production suites for main products | Clean rooms and HVAC | Clean utilities | Plant utilities | Automation, control and programming | Full commissioning | FDA compliant
2200 SQM area | Clean rooms and HVAC | Analytical laboratories | Chemical laboratories | Pilot manufacturing unit | HVAC and control | Offices
Purified water system | Pretreatment, production, storage and distribution | PC/PLC consolidated control system for all system/subsystems | Full commissioning and validation | 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
3,000 SQM area | Biotechnology laboratories | R&D laboratories | Chemical laboratories | Offices, storage, warehouse
Process Equipment | Purified Water system | Process Improvements | Clean Rooms | WFI system | Automation | FDA/EMEA compliant
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
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
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
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
Final compounding department | Aseptic filling line for vials | Aseptic filling line for cartridges | Aseptic filling line for pre filled syringes | Packaging department | EMEA compliant
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
600 sq.m Clean Rooms (A,B,C Class) | HVAC System | Clean utilities | Plant Utilities| Laboratories, Offices and General areas | EMA USFDA Compliant
Upstream, Downstream and final purification | Clean utilities | HVAC and Cleanrooms | Software per CFR21part11 | Complete commissioning and validation | EMEA compliant
Automated aseptic manufacturing unit | PW, WFI, PS production and distribution system | Multi pass CIP system | Control and automation | Commissioning and validation | FDA compliant
Clean Rooms 160 sqm (B,C class) | HVAC system | QC Laboratories | Storage | Offices | Software per CFR21part11 | EMEA, USFDA Compliant
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
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
Production rooms | Freeze drying suite | Packaging department | Clean utilities | Clean rooms ISO 5-7 | Laboratories | FDA, EMEA 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
Washing machine, sterilizing tunnel, filling machine | Clean Rooms and HVAC | WFI production and storage | PC/PLC control system | Full commissioning and validation
Production lines | Process equipment | Clean rooms | Clean and general utilities | Complete commissioning and validation| Software per CFR21part11
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
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
Fermentation buffer system | Preparation vessel | Media vessel | CaCl2 vessel | NH4OH vessel | Buffers distribution system | CIP | SIP | Automated Control | Designed as per cGMP
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
Sterile bulk multipurpose production | Final compounding and formulation | Powder filling in vials | Line manufacturer B+S | Packaging department | FDA , EMEA compliant
Decontamination | Civil construction work | Equipment erection and replacement | Piping installation | Control and programming | Full commissioning and validation| FDA compliant
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
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
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
600 Sq.m area | Biological laboratories | General area, offices, storage | HVAC and control | cGMP compliance
1,000 Sq.m area | Biological laboratories | General area, offices, storage area | HVAC and control | cGMP compliance