Regulatory Requirements for Cleaning Validation
How to Meet Regulatory Requirements for Cleaning Process Validation
Cleaning Validation, Preservative Efficacy and Disinfectant Studies by Honeyman provide simple and cost effective methods to ensure that your primary manufacturing (API) and secondary production facilities meet regulatory requirements for cleaning process validation.
Developed specifically to your exacting requirements our package can encompass:
- Protocol Definition
- Rationale Development
- Sampling Methods
Disinfectant Efficacy Testing
Our independent testing and support services will help you determine the quantitative value of bacterial activity on all your cleanroom surfaces. Tailored specifically to your requirements, we offer a complete package of services which includes the preparation of protocols which are applied using a range of organisms (including the typical environmental isolates found within your cleanroom environment) in accordance with the BS EN 13697 and USP regulatory requirements.
Preservative Efficacy Testing
Using Our EP and USP compliant methods, Honeyman is able to test pharmaceutical products including Multi-dose injections, Topical preparations and Oral Products.
Demonstrating that the anti-microbial activity of the particular product is adequate and will therefore prevent problems arising from the microbial contamination of pharmaceutical products during the in-use shelf life.
For further information please browse our knowledge hub, or contact us about your analytical testing requirements.