If you’re in the business of manufacturing pharmaceuticals, or any product that goes into humans, then you know that cleaning validation is an important part of ensuring product quality. The US Food and Drug Administration (FDA) encourages the use of cleaning validation to ensure all manufacturers follow safe cleaning practices and avoid product contamination.
But what is cleaning validation, exactly? And what do you need to do to ensure a successful cleaning validation protocol? This article will answer those questions and more! We’ll discuss the basics of cleaning validation, FDA guidelines and protocol development guide questions, and how a cleaning validation software can help make the process easier and more compliant.
What is Cleaning Validation?
Cleaning validation is the process of establishing evidence that cleaning processes of manufacturing equipment prevent product contamination and meets regulatory requirements. When done correctly, cleaning validation provides confidence that cleaning procedures are adequate to prevent product contamination.
Cleaning validation demonstrates ‘Current Good Manufacturing Practices (CGMP)’ for finished pharmaceuticals. It is a regulatory requirement in the US, Europe, and many other global markets.
FDA Guidelines for Cleaning Validation
As of the writing of this article, the FDA has yet to release official cleaning validation guidelines for pharmaceutical firms. However, they provide reference material that FDA investigators use for routine inspections. In the said document, the FDA generally expects the following:
- Written SOPs (standard operating procedures) for equipment cleaning processes that address different situations (e.g., one process for different batches, processes for product changes, etc.).
- Written cleaning validation procedures, including who’s responsible for performing and approving the validation study, the acceptance criteria, and when re-validation will be required.
- Written cleaning validation protocols for inspecting each piece of equipment that address common issues (e.g., analytical method, sampling procedures, etc.), conducting cleaning validation according to the protocols, and documenting its results.
- Management-approved and data-supported final cleaning validation report assessing whether or not the cleaning process for a specific piece of equipment or manufacturing system is valid.
Different Types of Cleaning Methods
While the total number of cleaning methods in use is practically endless, they can be broadly classified into six categories:
- Clean-in-place method: normally using fixed or rotating spray-like devices with a wash tank, associated piping system, and a recirculating pump.
- Clean-out-of-place method: often used for automated parts washing through a cabinet or tunnel washers with rinsing, cleaning, and drying cycles.
- Immersion method: cleaning smaller objects by dipping them in a cleaning solution. A cleaning agent in a process vessel is stimulated mechanically to achieve a cleaning effect.
- Ultrasonic washing: this method typically works best for intricate parts such as filling needles because it involves a tank equipped with ultrasonic transducers to induce cavitation.
- Manual cleaning: is usually the most challenging cleaning method to validate; it includes three common techniques: wiping, equipment brushing, and sink brushing.
- High-pressure spraying: service to remove any residue on the surface through high-pressure, direct, and continuous water or cleaning solution.
Pharmaceutical Terms Used in Cleaning Validation
Cleaning validation in the pharmaceutical industry commonly entails various jargon that every manufacturing personnel should be familiar with. With that said, here are twelve of the most common abbreviations that are commonly mentioned in pharmaceutical cleaning validation and their corresponding meaning:
- CGMP – Current Good Manufacturing Practice
- ADE – Acceptable Daily Exposure
- API – Active Pharmaceutical Ingredient
- MACO – Maximum Allowable Carry Over
- PDE – Permitted Daily Exposure
- LOEL – Lowest Observed Effect Level
- NOEL – No Observed Effect Level
- LOAEL – Lowest Observed Adverse Effect Level
- NOAEL – No Observed Adverse Effect Level
- LD – Lethal Dose
- LOD – Detection Limit
How to Develop a Cleaning Validation Protocol
A cleaning validation protocol should at least include the following:
- Title and description of the cleaning validation study
- Cleaning validation objectives
- Cleaning validation scope
- Cleaning validation approach
- Cleaning validation acceptance criteria
- Responsibilities of personnel involved in the study
- Cleaning validation schedule
- List of references used.
When developing a protocol, it is best to seek the help of software that can proactively guide you through the process and ensure regulatory compliance. That’s why you need DATAMYTE.
Why Use DATAMYTE?
DATAMYTE is a quality management platform that provides tools and processes for real-time data collection, analysis, and visualization throughout the product development lifecycle—from design to post-market surveillance.
The DataMyte Digital Clipboard is the software that will help you execute proper cleaning validation and manage cleaning validation data. It features tools for effective data collection from any location.
DATAMYTE offers the following features:
- Workflow management
- Data collection
- Offline data storage
- Analytics and reporting
- Drag-and-drop capabilities
- User management
- Audit trails
- Smart forms and checklists
Request a demo today to see how DATAMYTE can help you with cleaning validation protocol development and data management.
Cleaning validation is critical to the pharmaceutical manufacturing process, as it helps ensure that products are free of contaminants and meet quality standards. DATAMYTE’s quality management platform can help you easily collect, manage, and monitor cleaning validation data in real-time. Request a demo today to see how DATAMYTE can help you with cleaning validation protocol development and data management.