Home » March / April 2023 » HPAPI Cleaning validation considerations – Part 2
2023 | March / April 2023

HPAPI Cleaning validation considerations – Part 2

by cyb2025
F. Ohsiek
(HPAPI) cleaning validation
Cleaning validation execution concerns
Cleaning validation protocols
High potent active ingredients
HPAPI cleaning risk
HPAPI periodic monitoring
HPAPI product changeover
Stage 2 cleaning validation
Stage 3 cleaning validation

FRED OHSIEK
Sr Global Technical Manager, Life Science (Cleaning Validation), Ecolab Life Sciences

ABSTRACT

In general, Cleaning Validation (CV) is very complicated topic. The complexity is not only maneuvering within a site’s CV program, but also between industries (i.e., small molecule, biopharma, and API/finished product manufacturing). Regulatory guidelines discuss CV topics in general but specifically to any industry. Therefore, deciphering and implementing their recommendations or expectations is often difficult.
Because High Potent Active Pharmaceutical Ingredient (HPAPI) manufacturing is very high-risk from a patient safety perspective, every stage of the CV (from development to periodic monitoring (PM)) requires additional considerations and evaluation.
A thorough assessment of every stage of the HPAPI CV process was performed. This resulted in considerations, recommendations and solutions; which are published in this article.

INTRODUCTION
This article not only applies to the HPAPI production, but also to pharmaceutical production with HPAPIs. Therefore, the term “HPAPI manufacturing” and “HPAPI product” applies to both types of production.
It is important that the requirements for the finished manufacturing companies are not transferred back in the process to active pharmaceutical ingredient manufacturers without consideration for the different processes (i.e., carry-over risk) that take place at this stage (1).

ABOUT THE AUTHOR

Fred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. He earned his bachelor’s in chemistry from University of South Florida.
His professional work experience includes over 23 years of CV while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), Novo Nordisk, and Ecolab.
He has extensive RA; cleaning development and validation; project start-up; legacy remediation and justification; creating/improving PM programs; and increasing manufacturing capability experience in small molecule and large molecule API and finished product manufacturing.
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.

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