Choksi Laboratories

CLL Logo

Home» Pharmaceutical Analysis» Cleaning Validation Services

Cleaning Validation Services

At  Choksi Laboratories Limited, we understand the critical importance of robust cleaning validation processes in maintaining product integrity and regulatory compliance. With our expertise in both method development and validation, as well as bulk sample testing, we are well-equipped to support your cleaning validation needs across various industries.

Exposure to ETO residue is reported to cause severe health problems. Further, ETO degradation process generates Ethylene Chlorohydrin (ECH) which is much more persistent; ECH residues can remain in the food product even after one year.

Cleaning Validation

Here's an overview of our cleaning validation capabilities:

1.      Method Development and Validation: Our experienced team specializes in developing and validating cleaning methods tailored to your unique equipment, processes, and product specifications.

2.      Sample Testing: We offer comprehensive testing services for swab and rinse samples, filters, residual product determination in the next batch, and nitrosamines carry-over from previous batches/products. We also are having expertise in low level quantiation for Beta-lactam residues / derivatives on LC-MS/MS.

3.      Parameters Tested: Our rigorous testing protocols cover a wide range of parameters including:

  • System Suitability
  • Specificity
  • Solution Stability (upto 48 hours)
  • Intermediate Precision / Ruggedness
  • Hold Time Studies on swabs / rinse samples 
  • LOD-LOQ Determination & Confirmation
  • Linearity
  • Method Precision
  • Accuracy at three levels
  • Robustness (2 conditions * 2 states)
  • Statistical analysis 
  • Identification of unknown impurities & degradation by-products in rinse / swab solutions by LC-2D-QTOF
Scroll to Top