"Excellence in Service"

Cleaning validation is complex, time consuming, expensive, and risky. Why tackle an area with this level of challenge without an expert on your team. Gavin Pharmaceutical Services has developed expertise over a wide range of cleaning situations.

Key Areas of Expertise

• High Level Assessment of Cleaning Validation Needs
• Risk-Based Cleaning Program Planning
• Cleaning Validation Development
• Cleaning Validation Execution

Capabilities

We start at the top, evaluating the cleaning challenges. We review the product mix, evaluate product families, consider matrix based studies for time and cost efficiency. We can determine the cleaning method options (manual, automatic, detergent use), prepare a procedure based program to control and document cleaning. We design master plans, create protocols, execute protocols, perform data analysis, create the final reports.

High Level Assessment of Cleaning Validation Needs

If you are starting your program, or responding to deficiency findings, there is no substitute for starting well. We help assess your products, your equipment, your analytical capability, and other critical factors critical to accurate assessment. We will help you put it all together, ready for the next step.

Risk-Based Cleaning Program Planning

If you have ever experienced an adverse reaction to a drug, such as penicillin, you are at the heart of the FDA concern in this critical area. Flexible manufacturing is only effective if is properly mitigates any risk to your patients. We help you to understand, evaluate, and mitigate the risks of cross contamination (product-to-product), microbiological contamination, same-product contamination and cleaning agent contamination.

Cleaning Validation Development

The nuts and bolts of your cleaning validation can make the engine compartment of today's automobile look like child's play. We will develop the entire program, including the master plan, analytical development plan, cleaning validation protocols, and the cleaning execution plan.

Cleaning Validation Execution

If you simply have no experience in actual surface testing for cleaning effectiveness testing, swab recovery testing, and the like, we can assist you, train you, or do it all for you.

[ Home ] [ Up ]

Send mail to webmaster@gavinps.com with questions or comments about this web site.
Copyright © 2009 Gavin Pharmaceutical Services