The cleaning and disinfection of a pharmaceutical fill line & surrounding areas is a critical component of contamination control. We all think we are familiar with the principles of cleaning protocols, but it is deceptively easy to get this form of control wrong without applying the standards of QbD to the new equipment and facility at the design phase. There are many things to consider from the equipment/building parts and materials to the cleaning products and techniques themselves.
Below are the varied topics related to cleaning and disinfection that should be considered to develop a robust cleaning protocol for equipment and areas that were and were not designed with QbD principles at the design phase
Topics to consider when evaluating Cleaning and Disinfection operations for fill lines designed without QbD:
The best investigative question to begin with is “What is the likelihood of Biofilm formation?”:
- Is this a product that is prone to biofilm formation? Due to lack of scientific product knowledge during the design phase, this is a question that may have not been thoroughly addressed.
- Are there any fill equipment parts that are very difficult to or are unable to be cleaned that might promote biofilm formation?
- Is it possible to replace parts that are challenging to clean to reduce the probability of a biofilm forming?
- Are the correct cleaning techniques being used to prevent biofilms from forming on equipment and facility surfaces in the first place?
Topics that would be considered at the design phase when evaluating Cleaning and Disinfection operations for fill lines designed with a PMS QbD solution:
- Evaluation of and improved design of machine parts that are difficult to clean.
- Evaluation of the materials used to build the filling line for shedding and biofilm formation.
- Evaluation of the cleaning products for their interaction with the pharmaceutical drug substance being filled.
- Disinfection: Manual (open RABS)
- Define the right disinfectant and sporicidal agent
- Disinfectant rotation
• Disinfection technique
- Vaporization
- Support for reviewing validation documentation from OEM
- Cleaning techniques employing the use of a detergent.
In the next blog in this series we will examine what Set up and Process Interventions on a new fill line look like with and without QbD implemented at the design phase. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
Click here to learn more about how our Advisory Services Team can help you identify problems and suggest solutions to preserve the high quality of your products and processes.
See links to additional supporting resources below:
- On-Demand Webinar: Developing an Isolator Filling Line Using a Quality Risk Management Approach
- Corresponding Application Note: Developing an Isolator Filling Line Using a QRM Approach – FAQ’s
- Blog: It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
- Blog: Applying Quality Risk Management to Develop an Isolator Filling Line
Want to read more? Jump to other released posts in this series:
- Part 1 of 6: Intro and Regulatory
- Part 2 of 6: Surrounding Areas
- Part 3 of 6: Cleaning and Disinfection (You are here!)
- Part 4 of 6: Set up and Process Interventions
- Part 5 of 6: Environmental Monitoring
- Part 6 of 6: Activity Organization
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