Advanced Technology & Quality Systems

Zifam Pyrex Myanmar Co., Ltd. operates a world-class Analytical & Microbiology Laboratory, equipped with advanced instrumentation to ensure the highest standards of quality, accuracy, and regulatory compliance.

Our Quality Control Laboratory is accredited to ISO/IEC 17025:2017 by ANAB (ANSI National Accreditation Board, Washington DC), demonstrating internationally recognized competence in testing and calibration.

Our laboratory infrastructure includes:

• Instrument Laboratory for advanced chemical analysis
• Wet Laboratory for physicochemical testing
• Microbiology Laboratory for sterility and microbial evaluation
• Stability Chambers supporting both accelerated and long-term studies

All raw materials, intermediates, and finished products are rigorously tested on-site through:

• Physicochemical analysis
• Microbiological evaluation
• Advanced instrumental testing

This ensures full compliance with pre-defined specifications and global regulatory requirements.

To maintain the highest standards:

• All testing activities follow validated analytical methods
• Data integrity and traceability are strictly maintained
• Laboratory operations comply with GMP and ISO 17025 standards

For specialized analyses, selected tests may be conducted by qualified external laboratories under strict Technical Quality Agreements (TQA), ensuring consistent quality and regulatory compliance.

• Sophisticated analytical instruments (HPLC, GC, IR, UV systems)
• Dedicated microbiological testing laboratories
• Stability study programs and documentation systems
• In-process quality monitoring and validation protocols

Our Quality Control Laboratory is equipped with advanced analytical, microbiological, and environmental monitoring instruments to ensure the quality, safety, and compliance of all products throughout their lifecycle.

The laboratory supports comprehensive testing through a wide range of sophisticated equipment, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Visible Spectrophotometry, FTIR Spectroscopy, Atomic Absorption Spectroscopy (AAS), and Total Organic Carbon (TOC) analysis. Additional physicochemical testing capabilities include dissolution testing, pH and conductivity measurement, moisture determination, polarimetry, and refractometry.

Sterilization and laboratory support activities are facilitated through validated autoclaves and purified water systems, enabling reliable and accurate testing operations.

With modern infrastructure, qualified personnel, and robust quality systems, our laboratory ensures accurate, reproducible, and regulatory-compliant testing to support product development, manufacturing, release, and stability programs.

Our Analytical & Microbiology operations ensure:

• Accurate and reliable test results
• Compliance with global regulatory standards
• Continuous monitoring of product quality and stability
• Consistent delivery of safe and effective pharmaceutical products