Pharmaceutical Testing

Quality control is indispensable in the pharmaceutical product development process to ensure that the drug substance and other raw materials are suitable for use in your drug product and to ensure that the drug product manufactured meets the quality standards.

Quality control is required throughout the entire development process, from drug substance and raw material control, through intermediate drug product testing, to finished drug product release testing, bioavailability and stability studies. By having a comprehensive understanding of the physical and chemical properties of your drug substances and drug products, you can develop the most appropriate drug product formulations. Nikyang represents the pharmaceutical testing leader, SOTAX in providing the testing equipment in the development and production processes for our customers in the pharmaceutical industry. Our extensive market and process know-how enable us to meet our customers’ requirements and comply with the USP, EP and CP requirements relevant to them. We are also open to cooperation with new industries.

Dissolution

AT - A fully scalable and modular dissolution sampling apparatus

Incorporating the concept the modular, scalable and future-proof technologies, AT dissolution apparatus provides a complete and flexible sampling solution in R&D and QC laboratories.

AT 70smart

AT 70smart - Fully automated dissolution tester

For dissolution testing, the AT 70smart is a fully automated device that permits fast and efficient running of sequence testing of 10 (USP 1) or 15 (USP 2) batches. It is compliant with pharmacopeia methods including USP Apparatus 1 (basket), Apparatus 2 (paddle), Apparatus 5 (paddle over disk), Apparatus 6 (rotating cylinder), Intrinsic Dissolution, Stationary basket and Mini Paddles/Baskets/Vessels. It also fulfils all related EP, JP and CP requirements.

CE 7smart - Dissolution tester for poorly soluble and release control dose forms

The CE 7smart is the 4th generation of Sotax's design for dissolution of poorly soluble and release control dosage forms via USP Apparatus 4 (Flow-Through Cell Dissolution), and is compliant to USP, EP and JP for Small Volume Dissolution and Poorly Soluble Compound Testing under Sink conditions. Based on 35 years of experience, the CE 7smart meets USP requirements for the flow rate and temperature to be qualified, and is designed to overcome potential challenges linked to method development for a variety of dosage forms.

Physical Testing

DT 50 - Optimized tablet disintegration tester

DT 50 automates the tablet disintegration process in full compliance with current Pharmacopeia regulations. The compact and fashionable wireless design occupies a small footprint but carries all optimized functions in a user-friendly platform.

FT 2 - Automated tablet friability testing device

This microprocessor-controlled automated tablet friability testing device for single or dual drums is compliant with USP and EP requirements. Featuring convenient front loading of tablets and automatic discharge after test completion, the FT 2 is easy to use with an LCD display and scroll-down menus, and flexible operation including timer, counter or speed modes.

ST 50 - The SMARTEST Semi-Automatic hardness tester

Tablet testing has become much easier with the ST50 now. The integrated SmartAlign™ system sets new standards in fast and efficient testing of up to 5 physical parameters (weight, thickness, width, diameter / length, hardness). It also allows correct positioning for samples at different shapes, offering maximum flexibility for diverse laboratory and production environments.

MT 50 - The FASTEST manual hardness tester

It becomes much easier to perform tablet hardness test with MT 50. By integrating advanced features, you can now enjoy simplicity, efficiency even from a manual operation.

HT 100 - Fully automated tablet hardness testing device

The SOTAX HT 100 is the fastest and most sophisticated hardness testing device in the HT range, featuring automated testing of the most important physical parameters: weight, thickness, diameter or length and hardness of up to 10 different products or batches, e.g. tablets, dragées, oblongs, effervescent tablets or similar drug delivery systems.

TD 1 - Versatile tap density tester

The new Sotax TD 1 comes with new housing in contemporary silver design. It measures the tapped density and tapped volumes of powders, granules, pellets, flakes and other bulk substances according to EP, ASTM and USP regulations. This technique is useful in powder compression and flowability studies as well as to determine the amount of settlement during transit and packaging.

Sample Preparation

TPW - Automated Tablet Processing Workstation

The TPW Tablet Processing Workstation from Sotax performs fully automated sample preparation and analysis for the most common pharmaceutical tests in Development and Quality Assurance functions, such as Stability and Uniformity testing. The TPW is specifically designed to prepare and analyse pharmaceutical solid dosage forms and intermediate granulations.

APW - API Workstation

The APW Active Ingredient Processing Workstation from Sotax performs fully automated sample preparation and analysis for the most common Active Pharmaceutical Ingredient (API) tests in pharmaceutical Development and Quality Assurance functions, such as Stability and Uniformity testing. Fully automated sample preparation provides fast, consistent and accurate analytical results, greatly enhancing work efficiency.

MPS - Media Preparation Station for dissolution media

When USP 1,2,4,5 & 6 dissolution tests are carried out, the preparation of the media and its degassing, tempering and accurate metering into the test vessels involves substantial effort. The Sotax MPS (Media Preparation Station) automates these tasks, permitting the efficient preheating and degassing of the dissolution media using Sotax Thin Film Technology™, as well as fast and accurate filling. For even greater efficiency, the use of concentrates allows the system to further reduce media preparation time.

FS 7 - Automated filter change workstation

Suitable for all SOTAX dissolution systems, this automated filter workstation automates filter changes after each sampling point for extended testing and media change methods. The standalone FS 7 provides reliable filter changes and solves the filter clogging and saturation problems commonly associated with 25 mm diameter filters.

Online Message