Cleanroom – this is a specially created space in which the concentration of aerosol particles, microorganisms and other contaminants is controlled. If necessary, other parameters are adjusted to the norms established by the standard. Cleanrooms are generally designed to prevent processes and products from being exposed to potentially harmful contaminants.
Spaces are often equipped with special systems for ventilation, air filtration and movement, temperature and humidity control. Maintaining specified parameters and requirements reduces the risk of defective products, loss of functionality and performance. In rooms of a high degree of cleanliness, basic elements are used, such as:
- ✅ enclosing wall structures;
- ✅ air circulation units, humidity control devices and sensors;< /li>
- ✅ sealed panel ceilings;
- ✅ engineering systems control devices;
- ✅ air locks.
There are several classes of room cleanliness, depending on the requirements of specific industrial or scientific processes.
Indoor cleanliness standards
GMP – a set of international standards and guidelines that are developed to control the quality and safety of products. Room cleanliness standards and ratings define pollution level and control requirements for various industries and applications. Classification of zones is carried out depending on the size and number of suspended particles per unit volume of air. International standards for determining the types of clean rooms provide for the definition of the following categories:
- ✅ Class A. Area for performing manipulations under conditions of complete sterility. The parameters and limits are very strict and require highly efficient filtration and environmental control systems.
- ✅ Class B. Less restrictive zone. Used to prepare materials and solutions before sterilization and can be used in other parts of the manufacturing process with lower requirements than class A.
- ✅ Class C. Class C defines the requirements for controlling the cleanliness of air and surfaces in production areas to prevent contamination of sterile medicinal products.
- ✅ Class D. Used to work with components after washing.< /li>
The indoor working environment must represent all measures to protect products. All clean zones undergo a mandatory check of the actual value of the calculated particles. In the premises it is necessary to carry out technical diagnostics and maintenance, disinfection and the corresponding parameters – mandatory security requirements. Sterile spaces should be designed and equipped in such a way that they provide maximum protection against the penetration of dust particles, chemicals and microorganisms.
PET container production: importance of clean zones
Cleanrooms play an important role in the production of PET containers, which are widely used for packaging materials and various other products .
The main purposes of using such zones are:
- ✅ Prevent pollution. Cleanrooms provide control over the levels of particles, microorganisms and other contaminants in the air and on surfaces. This is especially important for the production of PET containers, as even small dust particles or microorganisms can affect the quality and purity of the final product.
- ✅ Compliance with quality standards. Preform production implies strict quality requirements to ensure that the product meets the declared characteristics.
- ✅ Contamination minimization. In clean areas, special ventilation and filtration systems are used to minimize the likelihood of product contamination. The safety, quality and durability of the packaging depends on this.
- ✅ Product safety. Clean zones help prevent harmful contaminants from entering PET containers. This is especially important for the packaging of medicines and other medical devices, where a high level of purity is a must.
Cleanrooms in pharmacology and food industry
In the pharmaceutical industry, cleanrooms are used to manufacture medicines. It is important that they have a certain cleanliness class (eg ISO 5, ISO 7, ISO 8). In scientific research, it is important to have controlled conditions in order to avoid external influences on the results of experiments. Clean zones can be used to handle sensitive samples, biological material and other substances. In the food industry, cleanrooms can be used to produce high quality products such as groceries, confectionery, beverages and dairy products. When developing new products or conducting research in the field of food technology, cleanrooms are designed to ensure the sterility of samples and to exclude possible external contamination. Such areas are also used for packaging and storage of products in order to minimize the risk of contamination and maintain the freshness of food.