Quality Laboratories at BioTechnique®
Ensuring Excellence in Pharmaceutical Manufacturing
At BioTechnique®, our Quality Laboratories are committed to upholding the highest quality and compliance standards during all stages of pharmaceutical product development and manufacturing. Our expert team utilizes advanced technology to guarantee that each product fulfills rigorous regulatory standards and client expectations. BioTechnique® offers a wide array of R&D and QC laboratory testing services, utilizing the latest equipment and innovative technologies.
Key Instruments in Our Quality Laboratories
Analytical Capabilities
Our quality laboratories offer comprehensive analytical testing, including:
- Chromatography
- HPLC/UPLC Analysis: Quantitative and qualitative compound separation and detection.
- Spectroscopy
- FTIR: Molecular fingerprinting and structural analysis.
- UV/Vis: Absorbance-based quantification for a wide range of compounds.
- Physical Testing
- pH & Conductivity: Critical measurements for solution quality and consistency.
- Osmometer: Osmolality testing for formulation stability.
- Chemical Analysis
- Karl Fischer: Moisture content determination.
- TOC: Monitoring organic contaminants for water and cleaning validation.
Microbiology Capabilities
BioTechnique offers advanced microbiological testing and identification using industry-standard technologies and controlled environments:
- Endotoxin Testing – Detects bacterial endotoxins in raw materials, water, and final products.
- Bioburden Analysis – Quantifies microbial contamination in non-sterile products and manufacturing environments.
- Sterility Testing (SKAN Isolators) – Isolator-based systems ensure aseptic conditions for sterility testing.
- MALDI-TOF Microbial Identification – Rapid, accurate species-level identification using mass spectrometry.
Lyophilized Product Development Capabilities
- Lab-Scale Lyophilization
Small-batch freeze-drying to evaluate and optimize formulations. - Freeze Drying Microscopy (FDM)
Visualizes freeze-drying behavior to determine critical formulation temperatures. - Micropress Analysis
Characterizes mechanical properties of freeze-dried cakes for stability and performance. - Differential Scanning Calorimetry (DSC)
Identifies thermal transitions for precise cycle development.
Electronic Quality Management Systems
At BioTechnique®, we utilize ACE®, our cloud-native Electronic Quality Management System (eQMS), purpose-built for the rigorous demands of pharmaceutical and medical device manufacturing. ACE® streamlines quality processes through real-time tracking, controlled documentation, and data-driven reporting.
Key Features of Our eQMS Capabilities:
- Controlled Document Management
- Change Control & Deviation Management
- CAPA (Corrective & Preventive Actions)
- Training & Audit Management (Internal & Supplier)
- QC Sampling, Testing & Inventory Control
- Equipment Qualification, Calibration & Maintenance
- Environmental Monitoring & Data Integrity
- Stability Testing & Shelf-Life Studies
- Regulatory Compliance & Gap Assessments