Sterility Testing

Sterility Testing – Aseptic Integrity Verification

To safeguard research integrity, particularly in applications involving injection, cell culture, or sensitive in vivo models, all applicable products undergo stringent sterility testing. We utilize USP-compliant microbial culture techniques to assess for bacterial and fungal contamination. This testing protocol includes aerobic and anaerobic incubation in multiple nutrient-rich media over a 14-day observation period, with continuous monitoring for microbial growth.

Bioburden testing is a microbiological examination to determine the number of viable microorganisms (such as bacteria, yeast, and fungi) present on a product, raw material, or surface before sterilization. It is a critical quality control measure in pharmaceuticals, medical devices, biotechnology, and food production to ensure compliance with regulatory standards and product safety. Bioburden testing helps assess contamination levels, monitor manufacturing processes, and validate sterilization methods by identifying and quantifying microbial load before final sterilization. The results are typically expressed as colony-forming units (CFU) per unit of material tested.

Related Quality Testing Protocol

Our multi-layered approach to ensuring research-grade excellence.

Purity – HPLC

Mass Spectrometry (MS) verifies the molecular weight and structure of each compound. This ensures the product exactly matches its intended identity.

Safety – Endotoxin Testing (LAL)

Bioburden testing measures microbial load before sterilization. This helps prevent contamination and ensures a clean, controlled research environment.

Heavy Metals Testing

Using ICP-MS, we screen for heavy metals like lead and mercury. This ensures our compounds are free from toxic elements and meet safety standards.

Mass Spectrometry (MS)

This technique is particularly essential when dealing with structurally similar analogues, where minor sequence variations or stereochemical differences can alter pharmacological behavior.

Sterility Testing

To safeguard research integrity, particularly in applications involving injection, cell culture, or sensitive in vivo models, all applicable products undergo stringent sterility testing

Visual Inspection

Each finished unit undergoes dual-layer visual inspection prior to packaging. This includes human review under high-lux lighting and magnification

Dissolution Testing

This evaluation informs users of the most appropriate vehicle for their specific applications and is particularly critical for peptides that exhibit sequence-dependent solubility properties