How do you inspect your cleaning processes?

In my experience, sampling and testing are crucial for verifying the effectiveness of cleaning processes in GMP environments, as they provide quantifiable measures of cleanliness beyond visual inspections. This method can detect hidden contaminants like microorganisms, biofilms, and chemical residues, essential for ensuring product safety and quality. However, it can be resource-intensive and costly, with variability in results due to differences in techniques and analysis. Careful management is necessary to maintain consistency and reliability.

● One of the simplest methods used is visual inspection. 1️⃣ Before cleaning • Conduct pre-cleaning checks to ensure equipment is properly taken apart, labeled, & ready for cleaning. • Verify that cleaning supplies and chemicals are available & correctly labeled. 2️⃣ During cleaning • Observe the cleaning staff to ensure they follow established procedures. • Check for proper use of cleaning agents, adequate rinsing, & thorough cleaning of all surfaces. 3️⃣ After cleaning • Visually inspect the areas using your checklist. • Pay attention to high-touch surfaces & critical areas. • Look for residues, dirt, or any signs of incomplete cleaning. • Inspect cleaning equipment & tools and ensure they are free from damage or corrosion.

To inspect the cleaning processes, I start by reviewing the procedures and ensuring everyone is well-trained. I conduct regular visual checks and use tests to measure cleaning effectiveness. I also verify that cleaning records are up to date and carry out internal audits to ensure everything is running smoothly. If any issues arise, I take immediate action to fix them.

● Sampling and testing methods can be used for cleaning inspections. ● One of these methods is ATP testing. ● It is used in the cleaning industry to ensure that surfaces are properly cleaned & disinfected. ● ATP stands for adenosine triphosphate (a molecule found in all living cells). ● ATP testing is conducted using: • A Luminometer (a device that measures ATP). • A testing swab. ⚫️ To do the test: 👇 1️⃣ Identify the area you want to test, and then take a swab of the surface. 2️⃣ Then, the swab is placed in the Luminometer to measure the ATP level. 3️⃣ The reading on the device is measured in Relative Light Units (RLU). 4️⃣ The higher the ATP score, the greater the level of contamination, and the less cleaning effectiveness.

The most important challenge facing sampling for cleaning effectiveness is recovery, which may be affected by: Solubility: When the substance is insoluble, its recovery by the rinsing method is useless. Sampling tools: The API/s may be absorbed onto the sampling sponge (swab) and not come off easily. Sampling method: The sampling method is unable to recover the entire quantity present, no matter how we repeat the scanning operations horizontally and vertically. Safety: The use of certain solvents during sampling may not be acceptable due to the toxicity of these solvents.

Sampling and testing are important methods for checking cleaning effectiveness. This involves collecting samples from cleaned equipment and surfaces to analyze for contaminants. Methods like swabbing, rinsing, or direct contact are used based on established procedures. These methods provide objective data and help detect invisible residues like microorganisms and biofilms. However, sampling and testing have challenges: they can be time-consuming and costly, and results may vary based on the technique and frequency used. Therefore, it’s crucial to have a well-defined validation plan to ensure consistency and accuracy in inspections.

The design of the process equipment and its lines plays a vital role in design/ fixing the cleaning process parameters with the contact time , force and flow rate. Even though we fix the parameters, all the time it may not achieve the same due to some other thing( We need to physically observe all the time the valves are opening as per the program, and the flow rate is achieved as in initial qualification). If not we have to identify the issue, after rectification the clean process shall be repeated .

In my experience to inspect the cleaning process, process parameters are widely used in pharma industry due to complexity of the process systems. Monitoring and measuring of the Process parameters are easy and time saving method which allows cleaning inspection without hampering the running process and well as without dismantling of the systems. In pharma industry conductivity parameters is largely being used for the cleaning validations. Where incoming water conductivity and drain conductivity is used to evaluate effective cleaning of the process systems.

I inspect the cleaning processes with visual checks, regular testing, monitoring of parameters, and ongoing improvements to ensure everything is always up to standard and continuously improving.

Reviewing cleaning SOPs, ensuring compliance with validated cleaning methods, and conducting visual inspections for residue or contamination. Regularly monitor cleaning logs, verify the use of appropriate cleaning agents, and ensure that equipment is cleaned according to specifications. Swab and rinse samples are tested to verify the absence of contaminants. Cleaning validation studies are periodically reviewed to ensure continued effectiveness. Additionally, employee training is regularly assessed to ensure proper execution of cleaning procedures and compliance with GMP requirements.

Continuous improvement is more than just a method; it’s a mindset. It involves regularly reviewing, evaluating, and adjusting your cleaning processes to make them more efficient and effective. This can be achieved through audits, reviews, or feedback sessions. By identifying gaps and opportunities, you can adapt to changes and foster a culture of quality. However, continuous improvement requires commitment, planning, training, and resources, and it should be supported by a clear vision and defined goals for your cleaning processes.

In biopharma, cleaning validation limits must align with the Permitted Daily Exposure (PDE) to ensure equipment cleanliness and patient safety. The strategy involves calculating Acceptable Residual Limits (ARLs) based on PDE values to prevent cross-contamination. A risk-based approach is used, with PDE-derived limits determining cleaning effectiveness. Validation includes sampling (swab/rinse), using sensitive analytical methods, and demonstrating reproducibility in three consecutive runs. Regular monitoring and revalidation are required, ensuring compliance with regulatory guidelines like FDA and EMA.

● When inspecting cleaning processes, check for:   ✅️ The intended use of the cleaning agents.   • Ensure that they are compatible with the surface or equipment being cleaned. • Some chemicals may damage certain materials. ✅️ The concentrations, dilution ratios, expiration dates, and storage conditions of the cleaning agents. • Using incorrect concentrations can reduce effectiveness or cause safety hazards. ✅️ Effectiveness of the cleaning agents. • Conduct test cleaning on a small area to verify the effectiveness. • Ensure that they remove contaminants as expected without causing damage. ➡️ Also, ensure that personnel are trained in the proper use of cleaning agents, including dilution, application methods, and safety precautions.

To further enhance your cleaning process inspections, consider implementing ongoing training to keep everyone up-to-date with best practices. Utilize advanced technologies, such as high-definition cameras or cleaning sensors, to detect issues not visible to the naked eye. Maintain thorough documentation of inspections and corrective actions to identify patterns and areas for improvement. Encourage feedback from your team to gain valuable insights into potential improvements. Lastly, conduct external audits for an unbiased assessment of cleaning effectiveness and to uncover additional areas for enhancement.