ContactDr Emily Cheah, General Manager
Email:
emilycheah@brass-asiapacific.com
Nature of Business
BRASS is a strategic solutions provider for the pharmaceutical, biologics and medical device industry in South East Asia, serving large-industry leaders, small-medium enterprises and start-ups in the industry. Our key strength is in specialised microbiology testing, providing consultancy, training, risk assessment and validation services for contamination control, sterilisation, cleaning and disinfectant and other areas for pharmaceutical and medical device manufacturing. BRASS also represents NAMSA (US' premier medical device safety evaluation laboratory) for the full range of ISO 10993 biocompatibility tests and Charles River Biopharmaceutical Services for a variety of biologics services in the region. BRASS is also the sole distributor for the Charles River Endosafe brand of LAL bacterial endotoxin test reagents in Singapore, Malaysia and Indonesia. We are constantly forging ahead in being a focal point in the Asia Pacific region as a LEADER IN REGULATORY TESTING and in providing top-notch services to our clients.
Validation Services:
- Cleanroom validation and development of environmental library
- Cleaning and disinfectant validation of facilities
- Sterilisation Validation (Gamma, Ethylene Oxide, Steam, Dry Heat & Depyrogenation)
- Reusable device cleaning, disinfectant and sterilisation validation
- Contract microbiological R&D
- Training and consultancy
Test Services:
- LAL Bacterial Endotoxin Tests (first laboratory in Singapore to be accredited SAC-SINGLAS
ISO 17025 for full range of bacterial endotoxin tests)
- PCR identification of bacteria and fungi
- Mycoplasma testing
- Sterilisation assurance monitoring (sterility testing, bioburden)
- Routine QC and lot release testing (USP 61 and 62 for microbial enumeration tests)
- Environmental monitoring
- Microbiological method validation (neutralisation validation and other services)
- ISO 10993 Biocompatibility Testing (via NAMSA)
- Biopharmaceutical/biosimilar testing (via Charles River)
- Training and consultancy
LAL Bacterial Endotoxin Test Products and Services:
- Charles River Rapid LAL Systems (handheld portable test system, PTS)
- Charles River LAL reagents and test accessories
- Microplate readers
- Method development and validation services
NAMSA Sterilisation Monitoring Products:
- Biological indicators
- Chemical indicators
- Growth promotion test organisms
- Spore suspensions
Brand Names
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CHARLES RIVER ENDOSAFE
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NAMSA
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