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CIP Cleaning Cycle Development Pitfalls and Solutions
Developing an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on developing the automated CIP process for a new facility, but most of the information shared will be useful for all types of cleaning development projects for CIP automated cleaning systems. Semi-automated and manual cleaning applications have either different or additional pitfalls and challenges.
There are several reasons why developing a CIP cycle prior to cleaning validation is often a struggle:
1. High construction management company expectations
2. Non-optimal detergent selection
3. Trusting in legacy cleaning processes
4. Pre-development trail preparedness
5. Weak or non-existent CIP system review
6. Minimalist sampling plan
7. Interdepartmental miscommunication
8. Long lead times
In addition to discussing each reason in detail, the article offers solutions and best practices; so, a CIP cleaning process can be developed with confidence and minimal issues.
Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America
Fred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. His main focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimization.
He earned his bachelor’s in chemistry from University of South Florida.
His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing.
The scope of his work involved drug substance and drug product manufacturing start-up; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.