NSTS

NASAL SPRAY TEST SYSTEM

Designed to Standardize the Process of Pressing on the Nasal Spray Squeeze Bottle

Nasal spray test sytem

Nasal Spray Test System (NSTS) is a device designed to standardize the process of pressing a nasal spray squeeze bottle, which is used in quality control of primary packaging (nasal spray squeeze bottle/ nasal spray bottle and used components), quality control of finished products (determination of the dose mass and number of doses in a nasal spray bottle), as well as in the development of medicines in the form of nasal sprays.

When carrying out quality control of nasal sprays, the dosing of which is carried out by pressing the nasal spray squeeze bottle, it is necessary to provide a standardized, reproducible, reasonable and as close as possible pressing to the pressing of a person on the nasal spray squeeze bottle. Only such pressing will allow you to accurately control the amount of drug released with one press on the nasal spray squeeze bottle and the number of doses that can be obtained from one nasal spray squeeze bottle.

Superficial visual control, as well as the availability of certificates from the manufacturer, will not give a complete picture of the quality of the primary packaging for nasal sprays. Parameters such as nasal spray bottle rigidity (density of the plastic used), diameter and internal shape of the capillary, nozzle diameter, alignment of the nozzle and capillary after assembly, roughness of internal surfaces, defects arising from plastic molding are difficult to control visually, but later they can critically affect dosing. drug. In this case, it is advisable to use the primary packaging control method, which will show whether this kit can provide the required dosage, i.e. in fact, assemble a set of primary packaging, fill it with a solution and, using standardized pressing, control the dose weight and the number of doses in the nasal spray bottle.

According to the requirements of GMP, FDA, Pharmacopoeia and other regulatory documents, quality control of a medicinal product must be carried out before it is placed on the market. Quality control of nasal sprays involves the release of doses of a drug for subsequent counting or physicochemical analysis. In this case, the way of pressing on the bottle will be of critical importance and influence on the control results. Pressing the nasal spray bottle by a person will not give a standard and reproducible result, this pressing cannot be measured or characterized. Only the use of a device capable of reproducing a standardized pressure on the nasal spray squeeze bottle to release a dose will make control results correct and reproducible.

Even at the stage of drug development, specialists determine important parameters of both the drug itself and the parameters of subsequent production and quality control. In this case, the presence of a device capable of reproducing a standardized pressing on the nasal spray squeeze bottle will make it possible to understand the amount of medication that the patient will receive after pressing the nasal spray squeeze bottle, the number of clicks required to provide a therapeutic dose, the number of doses in the nasal spray bottle, and many others. All these parameters form the basis for the subsequent the technological process of manufacturing a medicinal product, and the presence of this device will make it possible to verify that the applied technology allows reproducing all the parameters laid down at the development stage.

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