We focus exclusively on cleaning technologies and cleaning validation for process manufacturing equipment in pharmaceutical manufacturing and other regulated manufacturing industries. The consulting services we offer include the following:
- Selection of cleaning processes (SOPs), including the cleaning agents, cleaning methods, and process parameters so that the SOPs are effective and validatable
- Writing or reviewing validation protocols, including selection of worst case conditions, residue limits, analytical methods, and sampling methods
- Determining effective grouping strategies to achieve a more cost effective cleaning validation program
- Writing cleaning validation master plans
- Assisting in responses to 483’s or other regulatory actions related to cleaning validation
- Auditing of existing cleaning validation programs
- Providing expert opinion on quality issues regarding cleaning process deviations
- Reviewing your cleaning program for validation confirmation as part of the “revalidation” process
- Troubleshooting difficult or intractable cleaning problems
- Training your professional staff on principles and practices of cleaning and sanitizing technologies
- Training your professional staff on principles and practices of cleaning validation
In addition, for suppliers of products and services to the pharmaceutical industry, we offer market research and consultation services to properly assist in product or service design to meet the needs of the pharmaceutical industry.
Services are offered on a fixed price basis (for a defined project) or on a “daily cost plus expenses” basis. To contact us about an opportunity to help your cleaning validation efforts, please click here.
