QUALITY CONTROL SOLUTIONS

• Test Method Development For Package Integrity Testing

  A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).

• Analytical Method Development And Validation

  In pharmaceutical testing, the development and validation of analytical methods are absolute musts when it comes to reliable quality control. Natoli Scientific is at the forefront of offering comprehensive analytical method development and validation services designed to ensure the integrity of your company’s drug formulations. Our expert team develops robust methods tailored for each unique compound, with an approach that emphasizes precision, accuracy, sustainability, and compliance with regulatory standards such as the FDA and ICH guidelines. These methods are meticulously validated to confirm their reliability across a range of analytical parameters including specificity, sensitivity, linearity, and reproducibility.

  This validation process is critical for verifying that our methods produce consistent, trustworthy results throughout the product’s lifecycle, thus fostering confidence in the safety and efficacy of pharmaceutical products.

• Negative, Total Exhaust Containment Isolator

  Secure your laboratory environment when handling infectious materials. High-containment systems provide leak-tight protection for BSL 2+ through 4 applications, ensuring operator safety.

• Pass Boxes And Transfer Hatches For Controlled Environment Protection

  Safeguard your cleanroom environment with secure material transfer solutions. Interlocking pass boxes prevent cross-contamination and maintain critical sterility during item transit.

• Rapid Bioburden Testing System To Detect Microbial Contamination Earlier

  Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.

• Laboratory Services
• The Help You Need- Available Where And How You Need It
• R&D And Analytical Services
• The Full Range Of Mycoplasma Culture Media