Cleaning Validation
Cleaning validation has become the focus of recent regulatory audits. Quantitative analysis of residual surface matter verifies that traces of product or detergent, or media broth trial, are routinely cleansed to an acceptable low level in order to control the risk of chemical and microbiological carry over contamination. Our cleaning validation services are performed by consultants and engineers with over 10-20 years of experience in a regulatory environment. Our cleaning validation experts are highly knowledgeable in the latest cleaning validation techniques and methods thus providing our clients with an extremely efficient and compliant service. Our cleaning validation forum also provides our staff with key insights to the latest trends and issues concerned with cleaning validation in the life science sector
Our Services
Premier Validation 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
