CLEANING VALIDATION SUPPORT
Establish reliable cleaning procedures – and prevent your product from being contaminated.
In our experience, pharmaceutical companies often struggle with cross-contamination control and cleaning validation. Studies such as the Annual GMP Inspection Deficiencies Report show that they’re among the most observed critical and major deficits during inspections.
If different pharmaceutical products are manufactured in the same facility, there’s always a risk of cross-contamination due to residues of pharmaceutical ingredients, by-products, or detergents. To make sure the quality and safety of your product doesn’t get compromised, the cleaning process is essential.
The first step to reduce danger for people using your product is to determine how many residues of a certain substance could still be in the used equipment without causing any harm.
- We calculate the Permitted Daily Exposure (PDE) that marks the dose of a specific substance that’s unlikely to cause an adverse effect if the same person is exposed to this amount – or less – every day, for a lifetime. Learn more about our PDE services here.
- We also perform cross-contamination risk assessments and develop cross-contamination control strategies.
After determining limits and risks, we ensure that any residues in facilities and equipment are removed down to acceptable levels through cleaning. We assist you in to detailing the process: cleaning validation serves as a documented guarantee that your cleaning procedures are effective and can be performed reliably and repeatedly.
In order to achieve this, our team of toxicology experts takes care of
- developing cleaning validation strategies
- supporting you in the preparation of cleaning validation risk assessments
- developing analytical methods and validating residue computation
- on-site performance support of cleaning validations.