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Hygiene and Validation

Hygiene and Validation
 

Hygiene validation is a necessary practice in industries that adhere to Good Manufacturing Practices (GMP) and Quality Systems Regulations (QSR) such as food and health, especially pharmaceutical production. The validation process varies depending on the cleaning method and cleaning materials used. Simply put, hygiene validation is a method of demonstrating that the cleaning process is reliable and can be repeated to ensure a predetermined level of cleanliness. Validation shows that the cleaning process keeps residues at acceptable levels. For this, some tests and analyzes are carried out:
 

• Residue identification
• Residue detection method ion
• Sampling method ion
• Determination of residue acceptance criteria
• Method validation and improvement studies
• Writing procedures and training operators
 

Hygiene validation is a very complex and detailed process. For this reason, it is necessary to continue the studies in a systematic way. Otherwise, it will be impossible for the studies to produce accurate and safe results. Changing any part of the cleaning procedure, including the cleaning process, necessitates revalidation. This will require cleaning new cleaners or methods first, collecting data, and then cleaning the equipment with the pre-approved process before using the equipment. These previously approved steps need to be followed until the new procedure is fully validated. In this case, the organizations that are required to carry out hygiene validation receive professional support in this regard, which will make the work accurate, fast and safe.

Generally, three phases are followed in the validation of a process: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment and operations. Hygiene validation can also be partially incorporated into the PQ process. This validation is done when it is impractical to verify cleanliness on all production equipment used in high-volume production operations. Therefore, in larger volume productions, such as in the pharmaceutical industry, the hygiene validation process includes critical cleaning steps that affect the quality or safety of the final product.

In the hygiene validation procedure, a plan including the following topics is generally implemented:
 

• Aim
• Responsibilities of validation committee members
• Equipment / products / procedures
• Test acceptance limits
• Analytical methods
• Sampling procedures
• Cleaning process design
•    Data analysis
• Assumptions
• Change control / maintenance
•    References



Hygiene Validation Advantages


Validation studies for cleaning applications provide many advantages in the short and long term. We can list some of them as follows:

• Providing assurance on quality and safety
• Compliance with state laws and other regulations on hygiene
• Ensuring product integrity, microbial integrity and cross-contamination integrity
• Making equipment reusable
• Reducing quality costs
• Planning and implementation of sustainable and efficient business processes
• Shortening of downtime
• Reduction of errors in products



Hygiene Validation Program



There is a validation program that should be followed by businesses, public or private sector organizations that carry out validation studies on cleaning. The information, steps, applications, product and service activities included in this program vary depending on where, when and by which methods cleaning operations are performed. However, in general, we can say that the following subjects should be included in a hygiene validation program:

• Cleaning level ion
• Selection of cleaning method
• Selection of the sampling method
• Selection of the scientific basis and accordingly the acceptance criteria for the contamination limit
• Identification of the worst situation or scenario related to the equipment
• Determination of the storage period after cleaning
• Analytical method ion
• Documentation and documentation

Hygiene validation is one of the most important customer requirements as it ensures the purity and safety of the product. In addition, active pharmaceutical raw materials often come to the fore as a legal requirement in product manufacturing. It also ensures the quality of internal control and compliance processes. All these advantages and requirements show how important validation studies are in cleaning and hygiene operations.


Exceeding Consultancy at Your Side in Hygiene Validation Applications


Hygiene and cleaning validation studies are carried out within a certain program and spread over a very long time depending on the process and product characteristics. Therefore, professional support for these studies may become timely. In an enterprise, it is necessary to receive training from the person responsible for the validation work or from the basic level. It is also intended to provide guidance in making and maintaining validity planning. Such complementary Transcendence is the best solution for you in the whole way of Counseling. With Aşan Danışmanlık, you can bring validation almost for detailed information as much as the preparation of purchase validation.

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