Organization of production in accordance with the GMP requirements
The official confirmation of the high level of medicalproducts quality is the compliance of the manufacturer’s activities with the international GMP standard. This regulation, developed by the European Commission and the Food and Drug Administration (FDA), is the basis of modern pharmaceutical and veterinary industries. The conclusion of the company's compliance with the GMP standard is made on the basis of an analysis of the organization of production and quality control in the enterprise.
“AURORA” develops, manufactures and supplies high-tech equipment, the introduction of which will achieve compliance with all key factors of proper production of pharmaceutical and veterinary drugs in accordance with the GMP standard:
• The composition of the drug corresponds to the stated
Most medicinal tablets, solutions, ointments and other drugs have a multi-component composition. Each active substance is added in a strictly defined quantity, and, in combination with other substances, contributes to the achievement of the desired therapeutic effect of the product. To ensure the accuracy of the filling of all the components of the drug, we produce reliable packaging equipment, which is manufactured in accordance with the type of packaging used and individual production needs. The line of installations of this type is represented by such models as Automatic monoblock of packing plastic and laminate tubes “Master” MZ-400ED, Filling machine MDP-200L, Automatic syringes filling and sealing monoblock MZ-400ЕD, Manual tablet press MD-500Т and other filling machines.
• The product does not contain impurities.
The purity of the vial is one of the most important factors on which the save of the properties of the drug depends. Dust and other contaminants are conduits for pathogens, the entry of which can lead to a decrease in the activity of the agent, up to the complete disappearance of its therapeutic properties, or, even more dangerous, to provoke the opposite effect, becoming a threat to the health of consumers. Washing equipment developed by our specialists specifically for the pharmaceutical and veterinary industries will allow you to achieve perfect cleanliness of glass and plastic bottles before filling the drug.
• The drug is securely packed.
Packaging of the drug plays an important role to ensure its effectiveness throughout the shelf life. Improper packing can result in spilling of the product during transportation. In addition, extraneous substances that adversely affect its properties may enter the vial. In order to achieve the tightness of the medicine package, we offer a wide selection of capping equipment, which will ensure the preservation of the drug in the right amount and with the desired properties. Automatic capping machine MZ-400E4M, Automatic capping machine with a lifting table (cup holder) MZ-400E3, Automatic capping machine with a conveyor and turn table MZ-400E2M and other machines for packing by our production will become the guarantor of reliability of capping of bottles, tubes, cans and other capacities of any dimensions and with different types of caps.
• The product is labeled accordingly.
In accordance with the rules of GMP, drug labels should convey the information about the composition of the product, its properties, release date, series and other important parameters to the consumer as fully as possible. The readability and presentability of the label largely depends on the technology of its application, therefore, responsible manufacturers pay special attention to this process. The labeling equipment manufactured by our company will ensure even and accurate labeling of bottles, as well as high-quality labeling of products. Depending on the individual characteristics of the production complex, the installations can be performed with various additional options and the required degree of automation. Semi-automatic labeling machine AE-2 with dating function; Automatic labeling line for double-sided labels AE-5 Plus for big bottles and other models in this category are ideal for both small pharmaceutical manufacturing and large pharmaceutical and veterinary complexes.
All components of installations are made using high-strength materials permitted by the GMP regulation. At all stages of production, multistage quality control is carried out, which guarantees reliability and long service life of our equipment.
