Production environment – the essence of the validation procedure in maintaining the highest quality products

In the face of increasing quality, regulatory and market demands, maintaining an adequate production environment is increasingly challenging for manufacturers. This is especially true in the chemical industry, where the slightest oversight can lead to the production of a defective batch of product and significantly reduce its quality. Any company that wants to supply the market with chemical products of the highest quality must first ensure that all areas constituting the production environment are operating at the highest level.

In this context, validation procedures are a kind of foundation on which product quality and employee safety are based, but also build customer confidence. With a properly maintained production environment, production processes become repeatable, meeting stringent quality and safety standards. This minimizes the risk of defective product batches and optimizes production efficiency, resulting in better performance and customer satisfaction.

In this article we will elaborate on the essence of validation procedures, which are the glue in the entire chain of the production environment. The definition of validation procedures and their subsequent application ensures the continuity of production processes at the highest level and leads to greater safety for employees, but also for customers using chemical products.

Every manufacturer especially in such a complex industry as the chemical industry should ensure that appropriate validation procedures are in place, which cover all sensitive areas of the production environment with their scope.

The production environment in the chemical industry is nothing more than a complex system of areas that are involved in the process of obtaining the final product. All of these areas must work together to ensure safe, efficient and compliant production of chemicals.

The areas that make up the production environment are:

• the entire infrastructure, which includes production, storage and laboratory spaces, but also equipment and facilities
• technological processes, that is, all the processes by which raw materials are transformed into final products, as well as their testing at various stages of production to make sure that all quality standards are met
• safety rules, all regulations and risk management – a very important element especially in the case of manufacturing a product that must meet the stringent requirements imposed by standards such as REACH
• human resources, i.e. all employees making every effort to ensure that each stage of production is carried out according to the standard set by the company while meeting the standards imposed by numerous regulations

One of the activities to maintain a suitable production environment is validation. This is the process of systematically verifying that certain processes, systems and equipment meet established requirements and criteria, and are able to produce results as expected in a continuous and repeatable manner. To make this possible, it is necessary to develop appropriate test plans, protocols and procedures, which are then properly implemented and documented.

In the chemical industry, validation is the cornerstone of quality management and enables potential risks to be identified and thus eliminated by taking appropriate action. It is also an avenue for continuous improvement of production processes and adaptation to technological and market changes, so that products always meet the highest quality standards.

The validation procedure covers several areas:

• Scope of premises qualification – considers whether the premises have the right temperature and humidity
• The scope of qualification of systems and installations – covers how systems and installations are operated and built, and is based on reports and procedures appropriate to the system or installation in question
• The scope of equipment qualification and validation – covers how equipment is operated and constructed and is also based on the appropriate reports and procedures

Adherence to validation procedures makes it possible to maintain constant parameters in the production environment, but also indicates possible non-compliance with guidelines. With constant inspections, it is possible to detect errors at an early stage and correct them quickly.

There are several areas that are of particular importance in the production of nicotine products. Some of the chemicals and raw materials used in the further production of nicotine products can be damaged and lose their quality in the event of inadequate storage in warehouses or through contact with other substances that may be included in parts of equipment or installations.

The main parameters that affect the condition of raw materials are temperature and humidity.

Excessively high air temperature can affect the degradation of substances, as well as accelerate various chemical reactions, and this in turn leads to a reduction in the quality of raw materials and thus products.

Humidity is particularly important for hygroscopic substances, i.e. those that absorb moisture from the environment. As with temperature, inadequate humidity for a given raw material affects its quality and can lead to changes in the chemical composition of the substance and its properties.

To prevent this, both of these parameters are monitored with special sensors placed in the respective production and storage areas.

Read more about the control of these parameters here: How to maintain quality in the chemical industry: the key role of parameter control in the production environment

Chemical contamination refers to a situation in which undesirable substances are introduced into final products. They can come from parts that are part of equipment and installations, especially those that deteriorate, begin to corrode or are improperly maintained. Therefore, it is important to ensure the highest quality of materials used in the production of components that make up the construction of equipment and installations. Chemical contamination is also minimized by properly cleaning the installation and reducing the amount of time the substance is in it.

The effects of contamination primarily relate to a reduction in the quality of the chemicals produced, exposure of workers to harmful substances, and environmental pollution. Therefore, minimizing the occurrence of chemical contamination is very important in terms of ensuring safety in the production environment.

Cross-contamination refers to a situation where one substance inadvertently cross-contaminates into another during the production process or during storage. This can result from improper cleaning of production equipment or handling of substances by employees.

The risk of cross-contamination is removed by systematic and thorough cleaning of production equipment. Before the start of each production, the effectiveness of equipment cleaning is checked. Similarly, the quality control of the water that is used in the production process is also carried out. Thanks to these measures, the highest quality of the manufactured product is ensured.

The occurrence of cross-contamination reduces the quality of the product and creates the risk of dangerous chemical reactions, which can carry potential health risks for workers and consumers.

As with chemical contamination, following strict procedures for handling the substance and taking care of the production environment minimizes the occurrence of potential risks from cross-contamination.

It is also important to validate control and measuring devices that ensure the accuracy and reliability of measurement results. Incorrect operation of these devices can lead to a significant reduction in the quality of production processes, as well as an increase in danger. Therefore, care should be taken to ensure thorough inspection and calibration of control and measurement equipment, which can be confirmed by an appropriate certificate, as well as additional inspection by means of laboratory equipment. The validation procedure specifies the scope and method of inspection of these devices.

Taking care of the proper parameters and condition of the above production areas is a key element in delivering top quality products.

Remember:

• Maintaining an efficient production environment is possible through the use of proper validation procedures
• The validation procedure is the foundation of proper quality management and its scope covers key areas in the production of chemical products
• Paying attention to sensitive areas of production where deviation from the standard may occur is very important in terms of maintaining the repeatability of production processes
• Validation enables manufacturers to continuously improve processes and adapt to technological changes and new market requirements

The validation procedure enables the chemical industry to meet the challenges of today’s market while maintaining the highest standards of quality, safety and sustainability.

Meeting the challenges posed by market and regulatory requirements for manufacturers can be challenging. As Chemnovatic, we have been working hard to maintain the highest quality standards for years, and with our experience we can help you achieve your goals. When you begin working with our skilled legal team, you can be assured that all standards and requirements will be met every inch of the way. Learn more about our regulatory services here or contact us directly via sales@chemnovatic.com.

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