Process Division
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Consultancy/ Engineering
- New manufacturing and laboratory conceptual layout, feasibility study, PURS, etc.
Facilities Set Up and Services
- Design and engineering of clinical labs, pilot plants and production facilities.
- EU. FDA, NPCB, TGA cGMP, GTP, OECD GLP compliance consultation.
Manufacturing Process Design, Sizing & Selection of Equipments and Systems
- Supply of Upstream to Downstream equipments from lab, pilot, production scales and custom designed skids.
- Design, Installation, Commissioning and Validation (DQ,IQ,OQ,PQ).
- Application support and training.
- Maintenance & Service Programs.
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NATIONAL INSTITUTE FOR NATURAL PRODUCTS VACCINES & BIOLOGICAL [ NINPVB], MINSTRY OF HEALTH, ENSTEK, SEPANG
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- A cGMP Pilot Plant for bacterial, mammalian vaccines/biologicals, and natural products research and development.
- A formulation, fill and finish plant, acting independently from the biocontainment facility and the Pilot Plant, will produce pre-filled syringes or vials of products from an imported bulk product manufacturer (biologics or vaccine). The bulk product can be from a national or international supplier (products still to be determined).
- A cGMP production plant will manufacture bacterial, mammalian vaccines and biologics, and natural products. Products from here will be channeled to the formulation, fill and finish plant.
- An elaborate 3 stage PMP report (engineering & financial) was submitted to the Ministry of Health in a period of 6 months for the design of the facility
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GTP/QS, GMP Consultants & Engineers
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Cell Therapies Pty. Ltd. Australia
- Providing consultation, training and laboratory service of the collection, manipulation and storage of human blood cells and tissue for cellular therapeutics in compliance of Good Manufacturing Practice (cGMP).
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Technolutions Projects Pvt. Ltd. [TPPL] India
- Providing consultancy services to pharmaceutical and biotechnology industry.
- Designed more than 50 facilities located from Europe to Asia.
- More than 25 years experiences.
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API / NUTRACEUTICAL FACILITIES
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- Supported the entire phase of process development clarification and purification studies and the eventual scale up to a 500 l pilot plant capacity.
- Project management of the facility from installation, testing, commissioning, approvals and hand-over featured this project.
- 3 Phase Decanter, Clarification, CrossFlow Filtration, Ultrafiltration, Nanofiltration , SIP skid & PLC Control with SCADA Control System are housed in a Class 100,000 Clean Room Pilot Plant.
- Process optimization due to raw material changes, improvements in process conditions.
- The current output is approximately 200 l of purified antioxidant product ready for commercialization.
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Hospital UKM cGMP Facility - Human Tissue Engineering
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- Develop a complete set of architectural, engineering and controls deliverables in line with the cGMP regulatory guidelines.
- Construction management of renovation of the building and fit out of a cleanroom with several purpose built suites.
- Procure, deliver, install, validate and commission facility and equipment in line with objectives.
- Prepare inspector ready quality documents for certification process.
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Malaysia Nuclear Agency: PC-2 Green House
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- Develop a complete set of architectural, engineering and controls deliverables in line with AS/NZL2243.3:2002 PC-2 compliant for GMO Plant.
- Construction management and works supervision at site.
- Procure, deliver, install, validate and commission facility and equipment in line with objectives
- Prepare inspector ready quality documents for certification process.
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IOM - Tuberculosis Testing Lab
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- Design, construct and deliver Tuberculosis testing laboratory.
- Construction management and work supervision at site.
- Install and commission facility and equipment in line with objectives.
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Sime Darby Tech. Centre: Enzymatic Reaction Process & Facility
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- Layout design and process development.
- Develop a complete set of architectural, engineering and controls.
- Procurement of process equipment, coordination of installation & commissioning.
- Project execution and site supervision.
- Generating S.O.P. and training.
- Preventive maintenance programs.
- Engineering and service training.
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