Cleaning Validation in a Pharmaceutical Environment
Pharmaceutical cleaning validation from SGS – validate small molecule drugs, peptides, proteins and cleaning detergents, and identify contaminants.
In a pharmaceutical environment, ensuring that your equipment and utensils are cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions or contamination in your drug products is essential. Our pharmaceutical cleaning validation service includes total carbon analysis and total organic carbon (TOC) testing – a quick, accurate and inexpensive screening protocol for validating small molecule drugs, peptides, proteins and cleaning detergents.
Why choose pharmaceutical cleaning validation from SGS?
We can help you:
- Validate small molecule drugs, peptides, proteins and cleaning detergents
- Salvage expensive production runs through rapid detection of contamination
- Identify and quantify contaminants using our extensive range of chromatography and mass spectrometry equipment
- Meet your regulatory obligations, such as the Code of Federal Regulations (CFR) – Title 21 CFR 211.67
Trusted pharmaceutical cleaning validation from a leading provider
As a world-leading provider of pharmaceutical cleaning validation and TOC analysis in cleaning validation, we provide you with the experience, technical and regulatory expertise, and unique global network you need.
TOC can be used with all relevant standard sampling methods such as swabs, wipes, rinse and immersion techniques and be operated under full good laboratory practice (GLP) protocols if required. TOC can also be utilized in conjunction with both Cleaning in Place (CIP) and Cleaning Out of Place (COP).
Our Shimadzu Total Organic Carbon Analyzer offers measurement options including:
- Total Carbon (TC) with a measurement range of 0~3000mg/L
- Inorganic Carbon (IC) with a measurement range of 0~2500mg/L
- Total Organic Carbon (TOC) testing
- Non-Purgable Organic Carbon (NPOC)
All methods have short analysis times and typically require sample volumes in the 350~20,400µl range.
To find out more about our pharmaceutical cleaning validation, contact us today.Email us