Pharmaceutical & Healthcare Quality Testing

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Pharmaceutical & Healthcare Quality Testing

Ensuring Safety, Efficacy, and Compliance in Medicinal Products and Controlled Environments

Zenith Laboratories provides microbiological and quality testing to meet USP and ISO requirements for pharmaceuticals, medical devices, and healthcare facilities.

Verification of sterility and quantification of microbial load in materials, products, and components.

Analyses Offered:

  • Sterility Testing (USP <71>, ISO 11737-1) – Product flush and membrane filtration methods for detection of viable microorganisms.

  • Microbial Limits Testing (USP <61>, <62>) – Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC).

  • Bioburden Testing (USP <61>, <62>, ISO 11737-1) – Enumeration and identification of microorganisms on raw materials and final products.

Detection of bacterial endotoxins and validation of culture media performance.

Analyses Offered:

  • Bacterial Endotoxin Test (USP <85>, ISO 11737-3) – Limulus Amebocyte Lysate (LAL) gel-clot method.

  • Growth Promotion Test (USP <61>, <62>, ISO 11133) – Verification that culture media support growth of designated microorganisms.

Validation of sterilization processes through biological challenge testing.

Analyses Offered:

  • Biological Indicator Testing (USP <55>) – Spore strip or ampule method to evaluate sterilization efficacy.

Support for cleanroom validation and contamination control programs.

Analyses Offered:

  • Environmental Viable Sampling (Air & Surfaces) – Enumeration and ID of microorganisms in cleanroom environments.