It is imperative that pharmaceutical companies conduct adequate cleaning procedures before production to prove that product residues on the surface of equipment can be effectively removed. The residual amount of the product after cleaning is required to meet the regulations, so that the subsequent production of products will not be contaminated and endanger patients' safety.
Cleaning verification is to confirm the effectiveness of a company's cleaning procedures. Cleaning validation is mandatory for shared equipment to ensure that the efficacy, quality and safety of the next batch of products are not compromised. It is necessary to select a suitable analytical method for cleaning verification. An appropriate analytical method should be able to accurately detect residues, and the results determine whether the cleaning method is feasible or needs further improvement.
Our Services
Commonly used cleaning verification analysis methods in pharmaceutical enterprises include HPLC and TOC (Total Organic Carbon) detection. Total organic carbon (TOC) method can monitor and determine total organic residue substances online quickly. However, TOC is only applicable to water-soluble samples and has poor specificity. HPLC has high specificity, excellent sensitivity and low detection limits. Our company provides HPLC-based cleaning validation analytical methods and sample testing.
Our services for pharmaceutical companies include the development and validation of cleaning verification analytical methods, and sample testing. We provide authentic and accurate original records, electronic data and inspection reports. We can also offer cleaning verification plans and report writing services according to customer needs.
Our Service Process
1. Determination of residual limits
General residue limits should be referred to the relevant guidelines. Acceptable standards for cleaning validation can be established based on the 10ppm standard and toxicological calculation methods. According to the calculation results, the most stringent residual limit is selected for the limit.
2. Development of analysis methods
Our industry experienced team develops accurate, highly sensitive and time-saving detection methods based on product characteristics.
3. Validation of analysis methods
The analysis method used to detect product residues shall be specific to the substance being analysed, and reflect the acceptability of the cleaning procedure.
System suitability
The system suitability parameters of the cleaning verification method include theoretical plate number, separation degree, repeatability and trailing factor.
Specificity
The specificity of cleaning validation analysis methods refers to the ability to accurately detect the analyte in the presence of disturbances (including excipients, solvents, sampling swabs, cleaners, etc.).
Accuracy
Accuracy refers to the degree of similarity between the true value or approved reference value and the measured value, generally expressed by the recovery rate.
Precision
Precision refers to the degree of approximation of a series of test results from multiple samples taken under specified conditions. Precision can be measured in terms of repeatability, intermediate precision and reproducibility.
Linearity
Linearity refers to the ability of the test result to be proportional to the analyte concentration in the sample within a given range.
Range
Range refers to an interval of higher and lower concentrations of the analyte, and it is proved that the method has excellent accuracy, precision and linearity in this range.
Detection limits and quantification limit
The detection limit refers to the minimum amount of analyte that can be detected in the sample. The quantitation limit refers to the minimum amount of analyte that can be accurately quantified in the sample.
Durability
Durability refers to the ability of the analysis method to remain unaffected by appropriate changes in the detection parameters, which can be used for the reliability of the method. For HPLC methods, typical parameters include mobile phase pH change, mobile phase component change, column temperature change and flow rate change.
Solution stability
Samples placed under certain storage conditions prior to analysis may degrade. The stability of the sample is analyzed by measuring the difference in the results of the same solution at a selected time interval.
Recovery rate
Sample recovery studies need to demonstrate that appropriate analytical methods and sampling procedures are used to adequately measure residues on equipment surfaces. According to the calculation result of the product residual limit, a solution with the concentration calculated residual limit is prepared. Apply the solution with the target concentration to the same board sample as the inner surface of the equipment and allow it to dry naturally. By sampling, the recovery rate can be determined. Common sample recoveries are wipe and rinse samples, and recovery studies can be part of the validation of analytical methods.
Use a swab with sufficient solvent absorption capacity as a wiping material. The solvent used for wipe extraction should be the solvent used for sampling and analytical testing. The ability to quantitatively remove residues from the sampled surface is determined through a wipe recovery study.
The study of the recovery rate of the elution method is similar to the wipe method, and the elution procedure needs to be simulated in the laboratory. The simulated elution conditions are as similar as possible to the actual equipment leaching conditions.
