Written before the text
Clean verification has been a hot topic of concern and discussion between domestic and foreign pharmaceutical companies and regulatory agencies in recent years. In national and local FDA inspections, the problem with cleaning verification is one of the top 10 most common inspection defects.
In order to prevent contamination or contamination of the previous batch of products, GMP requires adequate cleaning of the equipment at all stages of the production process, and the purpose of cleaning validation is to demonstrate that the cleaning protocol consistently provides a high degree of assurance for the cleaned equipment and systems, so that residues will not contaminate or mix with the subsequent batch of products and affect the purity and quality of the drug for human use.
With years of experience in trace analysis, Mingjie Pharma can provide customers with cleaning verification services with high sensitivity requirements through efficient implementation of perfect cleaning strategies and technical means.
01. Cleaning verification strategy
Cleaning validation is a requirement for industries such as pharmaceuticals that comply with Good Manufacturing Practices (GMP) and Quality System Regulations (QSR) and is specific to the cleaning methods and detergents used. Put simply, verification is a written assurance that cleaning can be performed reliably and repeatedly to meet a predetermined level of cleanliness. Validation is achieved by demonstrating at least three times that the cleaning process removes residues to acceptable levels.
Before the project begins, we need to design a comprehensive cleaning validation strategy that combines the type of cleaning, sampling method, and surface type to ensure efficient and high-standard project delivery for our customers
About the type of cleaning and the method of sampling
In the production of pharmaceutical products, the common types of cleaning are:Surface cleaning and parts cleaning。When using critical cleaning agents for sampling, a variety of sampling methods can be used, including rinse sampling, surface wiping, and more.
swab wipe
Drench sampling
Examples of commonly used SWABs.
About cleaning equipment.
The surface of the production equipment commonly used in the production of pharmaceuticals includes stainless steel, pom-c, teflon, ceramic, agate, perspex, silicon rubber, rubber, and white nitrile.
We need to determine the type of surface for the equipment involved in the production of different formulations. In general, 5 5-cm area = 25 cm2 area plates are commonly used for wipe&rinse** rate verification.
Common surface material types.
For different equipment components, the extraction rate is verifiedExamples of parts are as follows:
After we have a systematic understanding of the type of cleaning, sampling method and surface type, we move on to the second stage, which is to design the test method to verify the content.
Cleaning validation must be performed using a validated analytical methodThe sensitivity of the detection method developed by Mingjie can be as low as ppb level.
Specific parameters to be verified include: specificity, limit of detection, limit of quantification, system precision, extraction rate, linearity, and solution stability.
Limits are calculated on the basis of.
Target limit calculations are the basis for cleaning validation and are manufacturing risks that can be controlled by drugs.
The limits can be calculated based on the following:
PDE is calculated based on
02. Example of cleaning verification
In our years of professional experience, we have always adhered to the high standard of residue detection method validation and the implementation of the highest rate study to ensure the purity and quality of our customers' products. This time, we will use the compound of PbeCl3 as an example for specific analysis.