Medical Devices Pharmaceutical

Introduction

ALS Malaysia provides a wide range of sampling, testing and consulting services to the medical device, pharmaceutical and health care related industry. We have resources, facilities and capabilities to carry out testing and analysis of medical devices, pharmaceutical, health care, traditional proprietary medicine and cosmetic products.

The testing methods are set up in accordance to International Organization for Standardization (ISO), United States Pharmacopeia (USP) and European/British Pharmacopeia (EP/BP) standard testing methods. The laboratory set up and process flow also meets regulatory requirements for a Good Manufacturing Practice (GMP) quality control laboratory.

Testing Services in support of :

• Microbial Testing & Identification
  • Bioburden (ISO 11737-1)
  • Growth Promotion Testing
  • Bacterial Endotoxin Test (USP 85)
  • Compressed Gas Microbial Monitoring
• Sterilization Verification
  • Sterility Test for Medical Products (ISO 11737-2)
  • Biological Indicator (BI) Sterility
  • Ethylene Oxide Residual Testing (ISO 10993-7)
• Antimicrobial Activity Study
  • Bacteriostasis & Fungistasis (USP 71)
  • Antimicrobial Effectiveness Testing
  • Evaluation of Disinfectants and Antiseptics
• Environmental Testing
  • Bioaerosol Test (NIOSH Method 0800)
  • Settle Plate Test
  • Surface Hygiene Testing
• Water Testing
• DNA Halal and Chemical Testing

ISO 17025 Accredited under STANDARDS MALAYSIA

Please contact us to discuss your analysis

md.my@alsglobal.com
marketing.my@alsglobal.com