Products > Process Division (GxP)
Process Division (GxP)
Process Division
  1. Consultancy/ Engineering
    • New manufacturing and laboratory conceptual layout, feasibility study, PURS, etc.
  2. 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.
  3. 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.
NATIONAL INSTITUTE FOR NATURAL PRODUCTS VACCINES & BIOLOGICAL [ NINPVB], MINSTRY OF HEALTH, ENSTEK, SEPANG
  • 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
GTP/QS, GMP Consultants & Engineers
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).
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.
API / NUTRACEUTICAL FACILITIES
  • 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.
Hospital UKM cGMP Facility - Human Tissue Engineering
  • 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.
Malaysia Nuclear Agency: PC-2 Green House
  • 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.
IOM - Tuberculosis Testing Lab
  • Design, construct and deliver Tuberculosis testing laboratory.
  • Construction management and work supervision at site.
  • Install and commission facility and equipment in line with objectives.
Sime Darby Tech. Centre: Enzymatic Reaction Process & Facility
  • 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.