Quality Control Laboratory Systems

Quality Control Laboratory Systems - Milkaya

Quality Control Laboratory Systems

Advanced analytical testing and quality assurance solutions for pharmaceutical and biotechnology industries, ensuring product safety, efficacy, and regulatory compliance

99.9%
Analytical Accuracy
21 CFR Part 11
FDA Compliance
24/7
Automated Monitoring
GxP
Validated Systems

Laboratory Equipment & Systems

Comprehensive analytical testing solutions for pharmaceutical quality control, method development, and regulatory compliance

HC

HPLC/UHPLC Systems

High-performance liquid chromatography systems for pharmaceutical analysis, impurity testing, and method validation

Sensitivity: pg/mL Level
Resolution: >2.0 USP
Compliance: 21 CFR Part 11
GC

Gas Chromatography

Advanced GC-MS systems for volatile compound analysis, residual solvent testing, and trace analysis

Detection Limit: ppb Level
Temperature Range: -100°C to 450°C
Automation: Full Sample Prep
SP

Spectroscopy Systems

UV-Vis, FTIR, and NMR spectroscopy for identity testing, structural analysis, and content uniformity

Wavelength Range: 190-1100 nm
Accuracy: ±0.3 nm
Speed: Real-time Analysis
MS

Mass Spectrometry

LC-MS/MS and MALDI-TOF systems for molecular weight determination and quantitative analysis

Mass Range: 2-20,000 m/z
Resolution: 100,000 FWHM
Dynamic Range: 6 Orders
DT

Dissolution Testing

Automated dissolution systems for tablet and capsule release testing with USP apparatus compliance

Vessels: 8-12 Positions
Temperature Control: ±0.5°C
USP Compliance: Apparatus 1-4
PA

Particle Analysis

Laser diffraction and dynamic light scattering for particle size distribution and characterization

Size Range: 0.01-3500 μm
Repeatability: <3% CV
Standards: USP <429>
TA

Thermal Analysis

DSC, TGA, and DMA systems for polymorphic analysis, stability testing, and material characterization

Temperature Range: -180°C to 1600°C
Sensitivity: 0.1 μW
Atmosphere Control: Inert/Oxidative
LA

Laboratory Automation

Robotic sample handling, LIMS integration, and automated workflow management for high-throughput testing

Sample Capacity: 1000+ Samples
Throughput: 500 Tests/Day
Error Rate: <0.1%

Quality Control Testing Process

Systematic analytical testing workflow ensuring pharmaceutical product quality and regulatory compliance

1

Sample Receipt & Chain of Custody

Secure sample handling with barcode tracking, temperature monitoring, and complete chain of custody documentation

2

Method Selection & Validation

Analytical method verification with accuracy, precision, linearity, and robustness testing according to ICH guidelines

3

Sample Preparation & Analysis

Automated sample preparation with extraction, dilution, and derivatization followed by instrumental analysis

4

Data Acquisition & Processing

Real-time data collection with automated integration, peak identification, and statistical analysis with audit trails

5

Quality Review & Approval

Multi-level review process with electronic signatures, specification compliance verification, and deviation investigations

6

Report Generation & Archive

Automated certificate of analysis generation with secure electronic archiving and regulatory submission support

Technical Advantages

Advanced analytical capabilities ensuring pharmaceutical quality control excellence

FDA 21 CFR Part 11 Compliance

Electronic records and signatures with complete audit trails and data integrity controls

High-Throughput Analysis

Automated workflows processing 500+ samples per day with minimal human intervention

🎯

Method Validation Suite

Comprehensive validation protocols following ICH Q2(R1) and USP guidelines

📊

Real-Time Data Analytics

Advanced statistical process control with trend analysis and predictive capabilities

🔒

Data Security & Integrity

Encrypted data storage with role-based access control and complete audit trails

🌐

LIMS Integration

Seamless integration with laboratory information management systems for complete workflow automation

Quality Control Applications

Comprehensive testing solutions for pharmaceutical and biotechnology products

Raw Material Testing

  • • Identity verification
  • • Purity analysis
  • • Impurity profiling
  • • Water content
  • • Residual solvents

In-Process Control

  • • Blend uniformity
  • • Dissolution testing
  • • Content uniformity
  • • Tablet hardness
  • • Coating thickness

Finished Product Release

  • • Potency assay
  • • Sterility testing
  • • Endotoxin analysis
  • • Particulate matter
  • • Microbiological limits

Stability Studies

  • • Accelerated testing
  • • Real-time monitoring
  • • Photostability
  • • Degradation products
  • • Shelf-life determination

Ready to Enhance Your Quality Control Laboratory?

Contact our analytical experts to discuss your specific quality control requirements and discover how our laboratory systems can ensure pharmaceutical excellence