Microbiological & Biological Services
Ensuring the microbial safety and biological integrity of pharmaceutical products, medical devices, and healthcare materials is critical to product quality, patient safety, and regulatory compliance. At Keysight Chemtech, we provide comprehensive microbiological and biological testing services that help detect microbial contamination, assess antimicrobial performance, and maintain product safety throughout the development, manufacturing, and commercialization lifecycle.
Our laboratories are equipped with state-of-the-art microbiological testing infrastructure and staffed by experienced microbiologists who follow internationally recognized standards and validated methodologies. Through rigorous testing procedures, strict quality controls, and detailed reporting, we generate reliable data that supports regulatory submissions, product release, and ongoing quality assurance.
Our Services
Sterility Testing
Sterility testing confirms that pharmaceutical products and medical devices are free from viable microorganisms. Using validated procedures, we ensure that sterile products meet regulatory and safety requirements, providing confidence for injectable, parenteral, and other critical-use products.
Microbial Enumeration(TAMC/TYMC)
Our microbial enumeration services measure contamination levels in non-sterile products, raw materials, and production environments. These tests ensure that microbial counts remain within acceptable regulatory limits, reducing contamination risks and supporting quality control.
Environmental Monitoring
Maintaining a controlled manufacturing environment is vital to prevent contamination. We monitor cleanrooms, production areas, air, surfaces, and personnel, ensuring compliance with cGMP, ISO, and other industry standards.
Antimicrobial Effectiveness Testing(AET)
AET evaluates the efficacy of preservatives or antimicrobial agents in pharmaceutical formulations. This testing confirms that formulations inhibit microbial growth over time, supporting long-term stability and product safety.
Biological Assays
We conduct detailed biological assays to assess biological activity, potency, and functional performance of pharmaceutical substances and biological products. These assays generate critical data for product development, regulatory compliance, and quality control.
Ensuring Microbial Safety and Regulatory Compliance
At Keysight Chemtech, our microbiological and biological testing services are built on scientific expertise, advanced laboratory infrastructure, and strict quality systems. By partnering with our clients, we:
- Identify potential microbial risks early in the product lifecycle
- Maintain cleanroom and manufacturing hygiene standards
- Ensure products meet global regulatory expectations
By delivering accurate, reliable, and validated microbiological data, we enable pharmaceutical and medical device manufacturers to protect patients, ensure product integrity, and maintain compliance across all stages of development and production.