Our cell based clinical grade products for clinical trials were manufactured in a world class state-of-the-art cGMP facility / laboratory. This is the first cGMP laboratory in Malaysian government institute, specifically meant to cater to human living cells and tissue engineering. The lab was built at a cost of RM10 million and fully completed in 2012. This cGMP facility is another hallmark achievement in advanced medical technology in the country.
The facility is in conformance with the requirement of Good Manufacturing Practice (GMP) in accordance to the current Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guides, accredited for processing, constructing and storing of human cells and, approved by National Pharmaceutical Regulatory Agency (NPRA) of Ministry of Health (MoH).
The facility is divided into three areas based on air cleanliness classification, functionality, and access status mainly the General Area, Unclassified Area and Classified Area. In terms of grades, they are classified as Grade A, Grade B, Grade C and Grade D, according to the ISO 14644-1:1999 Classification of Air Cleanliness and PIC/S Guideline. In equivalence with ISO, during operation, Grade A can be classified as ISO 5, Grade B as ISO 7, and Grade C as ISO 8 whereas Grade D is not defined.
The air pressure and even particle count is also strictly controlled and monitored, to assure safety of our products. Cleaning and environment monitoring takes place during operation, and even at rest, when no operation is going on, in a quarterly manner.
Personnel and material flow is unidirectional and strictly controlled with keylock, digilock and/or access-cards. Communication is facilitated among operators in different parts of the facility using 16 intercoms. The facility is equipped with 15 CCTV cameras to monitor different area of the clean rooms.
A Building Monitoring System (BMS) is also in place to control air pressure, relative humidity and temperature. On top of that, there is also an Equipment Monitoring System (EMS), which is a wireless, expandable, primary monitoring system, in place to monitor all critical equipment of the facility. The environmental parameters are recorded constantly and any deviation sends alarm notifications.
CTT is also equipped with a general R&D lab for research and development and for producing research grade products. The facility is also used for one to one hands on training of basic cell culture technique.
The facility is in conformance with the requirement of Good Manufacturing Practice (GMP) in accordance to the current Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guides, accredited for processing, constructing and storing of human cells and, approved by National Pharmaceutical Regulatory Agency (NPRA) of Ministry of Health (MoH).
The facility is divided into three areas based on air cleanliness classification, functionality, and access status mainly the General Area, Unclassified Area and Classified Area. In terms of grades, they are classified as Grade A, Grade B, Grade C and Grade D, according to the ISO 14644-1:1999 Classification of Air Cleanliness and PIC/S Guideline. In equivalence with ISO, during operation, Grade A can be classified as ISO 5, Grade B as ISO 7, and Grade C as ISO 8 whereas Grade D is not defined.
The air pressure and even particle count is also strictly controlled and monitored, to assure safety of our products. Cleaning and environment monitoring takes place during operation, and even at rest, when no operation is going on, in a quarterly manner.
Personnel and material flow is unidirectional and strictly controlled with keylock, digilock and/or access-cards. Communication is facilitated among operators in different parts of the facility using 16 intercoms. The facility is equipped with 15 CCTV cameras to monitor different area of the clean rooms.
A Building Monitoring System (BMS) is also in place to control air pressure, relative humidity and temperature. On top of that, there is also an Equipment Monitoring System (EMS), which is a wireless, expandable, primary monitoring system, in place to monitor all critical equipment of the facility. The environmental parameters are recorded constantly and any deviation sends alarm notifications.
CTT is also equipped with a general R&D lab for research and development and for producing research grade products. The facility is also used for one to one hands on training of basic cell culture technique.
CELL TISSUE TECHNOLOGY SDN BHD
Malaysia's FIRST Tissue Engineering Firm |
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