Cleaning Verification

Cleaning Verification

Cleaning verification represents the procedure of verifying whether the manufacturing equipment is maintained as clean and uncontaminated to ensure the pharmaceutical products are produced without risk of residual unwanted substances. Those potential contaminants mainly include residues of the active pharmaceutical ingredients, degradation of certain compounds and even the detergents or solvents generated during the cleaning process. In this case, cleaning verification is an effective tool that can ensure that the process and processing equipment are suitable for manufacturing, prevent drug contamination and improve drug quality.

Below is a list of our Cleaning Verification Services (include but not limited to the following):

  • Elaborate design and optimization of Cleaning Verification
  • Preparing a comprehensive sampling plan
  • A full range of standard operating procedure (SOP)
  • Highly trained and experienced sampling personnel
  • Efficient method development, validation and transfer
  • Strictly controlling of certain critical cleaning parameters
  • Comprehensive cleaning verification reports

Our techniques and tests such as:

  • IC and TOC analysis
  • ICP/ICP-MS/ICP-OES
  • UV/Vis
  • BCA assay
  • pH meter
  • HPLC/HPLC-MS
  • Conductivity test
  • Bioburden test
  • Endotoxin assay

Why Choose BOC Sciences?

By establishing high standards and designing cleaning programs, our experts guide our clients through all stages of the project. Combined with a series of qualified analytical methods, which have a satisfactory sensitivity to the manufacturing processes and equipment, BOC Sciences is able to bringing quality and safety to your products. Through a variety of state-of-the-art equipment, our analysts can provide you with accurate tests, even with only one part of the residual solvent in one million extracts. As an important part of your project team, our experts will assist you in eliminating potential sources of solvent contamination and optimize your development strategy to ensure the safety of pharmaceutical raw materials and finished products.

References

  1. Caimi, R. E., Lin, F. N., & Thaxton, E. A. (1998). U.S. Patent No. 5,730,806. Washington, DC: U.S. Patent and Trademark Office.
  2. Liu, L., & Pack, B. W. (2007). Cleaning verification assays for highly potent compounds by high performance liquid chromatography mass spectrometry: strategy, validation, and long-term performance. Journal of pharmaceutical and biomedical analysis43(4), 1206-1212.
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