About Cleaning Validation
This cleaning validation procedure is applicable to the validation of the manufacturing equipment cleaning procedures to remove pharmaceutical, cleaning agent and biological residues as well as media fill materials. Cleaning validation applies to drug products and to medical devices.
It applies to potential product contact surfaces on manufacturing equipment and components of manufacturing equipment including visual, chemistry, and microbiology testing. Pharmaceutical products could be contaminated due to several factors such as cleaning agents, microorganisms, dust and particulates, product residue, etc.
The objective of cleaning validation is to provide documented evidence that a specific cleaning process will consistently clean to predetermined limits to prevent contamination that could adversely affect the safety, efficacy, purity and quality of the products. Therefore, implementation and validation of cleaning procedures are essential.
Roles and responsibilities of Validation Engineer in Cleaning Validation
- Validation engineer will help client with all aspects of cleaning validation program, from cleaning procedure feasibility to determining detection limits of analytical methods used for testing.
- Developing scientifically defendable acceptance criteria and ensuring the execution is conducted in an orderly manner.
- Validation engineer will deliver a complete cleaning validation package from development and execution of protocols to creation of standard cleaning procedures, cleaning logs and training documentation.
- Validation engineer will select and evaluate effective cleaning methods and processes with complete understanding of regulatory requirements, guidelines and expectations.
- Performing cleaning development studies, Development and execution of Cleaning Validation and Verification protocols..
- Also involve in Hold time studies.
- Support documentation in whole Cleaning Validation Process/Cycle
- Product Evaluation and Selection for Cleaning Analysis.
- Equipment Evaluation and Residual Sampling Site Selection.
- Solution Cleaning Process/Procedure and Optimization.
- Cleaning Residual Sampling Methods.
- Establishment of an Effective Residual Recovery Method.
- Establishment of Limits (Maximum Allowable Carryover) for Residual Product in a Subsequent Batch.
We excel in our industry so that you can get in yours
-
Get in Touch
- Address:
Sathram Corp 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 - Email:
hr@sathramcorp.com - Phone:
732-380-5181 - Office Hours:
Monday - Friday : 9.00AM - 5.00PM