Need to Validate Your Cleaning Procedures? We Can Help!
If you work in a regulated industry, you already know, there’s more than one way to validate a cleaning process. But which one is best for your process?
The Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide has established the expectation that cleaning procedures be validated—meaning that scientific data must show that the systems work exactly as expected and produce a result that consistently meets predetermined specifications.
Many reports on the cleaning validation of drug residues have been published in recent years, but reports related to the cleaning validation of cleaning agent residues are not as common. One reason for this is that most cleaning agents are proprietary formulated products, so the suppliers are not willing to disclose the ingredients. Without knowing the nature of each ingredient, it’s difficult for end-users to develop a specific cleaning validation method.
At International Products Corporation, we provide a variety of validation methods designed for use in Food and Drug Administration (FDA) regulated establishments complying with Good Manufacturing Practices (GMP). These methods include: High Performance Liquid Chromatography (HPLC), gas chromatography (GC), inductively coupled plasma atomic emission spectroscopy (ICP-AES), atomic absorption spectroscopy (AAS), ion-mobility spectrometry (IMS), total organic carbon (TOC) analysis, and ultra-violet spectroscopy (UVS).
HPLC—with all types of detectors—is the most popular method used due to its convenience and the availability of instruments. When we use this method for the cleaning validation of MICRO-90® residue, the results show good resolution and absence of interference from the matrices and the common excipients.
Test our cleaning products and let our technical experts provide you with relevant validation information.