JVT

Methodology for Assessing Product Inactivation During Cleaning Part II: Setting Acceptance Limits of Biopharmaceutical Product Carryover for Equipment Cleaning | IVT

For multi-product biopharmaceutical facilities, setting the acceptable level of process residues following equipment cleaning is an important regulatory, business, product quality, and patient safety consideration. Conventional approaches for setting an acceptance limit for process residues have been based on the assumption that the active pharmaceutical ingredient (API) (depending on the process soil, API refers to the active pharmaceutical ingredient in the drug product, drug substance, or drug substance intermediate) is chemically or functionally intact following the cleaning process. These approaches include Maximum Allowable Carryover (MAC) Health Based Exposure Limits and other “dose” or Permissible Daily Exposure (PDE)-based limits. The concept for cleaning acceptance limits based on intact product originated from the manufacturing of small molecule pharmaceuticals (1). In contrast to pharmaceutical small molecules, biopharmaceutical products are large molecules that are likely to degrade and become inactive when exposed to cleaning conditions. Therefore, an alternative approach to setting cleaning acceptance limits for biopharmaceutical products based on the actual process residues that could potentially be present on production equipment should be considered.

Part I described the methodology to assess and verify API inactivation during cleaning (2). In Part II, alternative approaches for setting acceptable levels of process residue will be described building upon the basis that API inactivation by the cleaning process has been demonstrated.

This content is only available to IVT members.
Get help maintaining your knowledge in Cleaning Validation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.