Location: Webinar

Consideration for Cleaning Validation with Automated Washing Systems
March 21, 2019
10:00 AM - 11:00 AM EST

This presentation provides insights that may help to respond to these questions:
  • What is cleaning validation and where does it fall in the global Life Cycle Validation scheme?
  • How can an automated washing system be validated?

Topics Covered: 

The Life Cycle Approach is a good way to standardize a company’s manufacturing and cleaning processes. The 2011 FDA Guidance document entitled: ‘’Process Validation: General Principles and Practices’’ describes process validation activities into 3 stages; Process Design, Process Qualification, and Continued Process Verification.

Stage 1
For an automated washing system comprises the User Requirement Specifications aspect, in other words, what exactly should be considered when acquiring an automated washing system and what outside parameters have an impact on its proper use.

Stage 2
Covers the validation strategy, load configuration, cycle operation, acceptance criteria, analytical and sampling methods, among other things that will be further explained.

Stage 3
Discusses preventative maintenance activities and how continuous monitoring of the cleaning process can help maintain a state of control when producing drugs at a commercial scale.
Who Will Benefit: 

Anyone working in a pharmaceutical or biopharma manufacturing environment along with those involved in cleaning validation:
  • Project Leaders
  • Equipment Operators
  • Quality Control personnel
  • Validation Group
  • Process Engineers

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