Cleaning Validation for Packaging Equipment

Sometimes I am asked about cleaning validation for packaging equipment, and the thought behind the question appears to be that this is not a critical cleaning process and therefore doesn’t require cleaning validation. While it is true that effective cleaning of some packaging equipment may be much easier to achieve, it is not necessarily true that the effectiveness of such cleaning is non-critical.

Before I discuss the topic, let’s make sure of some definitions. By packaging equipment I am referring to primary packaging equipment, usually of a finished drug product. That includes such examples as liquids being filled into vials and then capped, and tablets being filled into bottles and then capped.

Author(s):
Destin A. LeBlanc,Cleaning Validation Technologies Technical Consulting Services
Journal:
Cleaning Memo for MARCH 2005

2 comments:

Debendra mahalik said...

I discuss the topic, let’s make sure of some definitions
. By packaging equipment I am referring to primary packaging equipment, usually of a finished drug product.

Andree Symond said...

Focuses on the validation of laboratory equipments used in the production of pharmaceutical products.
Determination the requirements of the end user,
which are often defined in the User Requirements Specifications.equipment validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.

equipment validation