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HPLC

Shimadzu Ai-Series/N-Series redefine integrated and modular LC technology, delivering exceptional performance and analytical intelligence. Seamlessly suited for pharmaceutical applications, including assay analysis, formulation evaluation, purity checks, in-process analysis or scale-up.

LCMS-8060NX

Shimadzu’s flagship triple quadrupole MS system, features the IonFocus™ electrospray unit, dual ionization source, enhanced ion guides and ultra fast detection speed for exceptional sensitivity. This is ideal for reliable analysis of NDSRI (e.g., N-Nitroso Dabigatran, N-Nitroso Sertraline and NTTP ), Nitrosamines (e.g., NDMA, NDEA, NMBA) and GTIs, it is widely adopted for products like API, formulations, and intermediates.

MDAP & Single Quadrupole LC-MS

Shimadzu’s Mass Directed Automated Purification (MDAP) system coupled with single quadrupole MS enables high-yield purification of in-house impurities even in complex matrix samples, by directing a small amount of sample into the highly sensitive LC-MS using automated proportioning valve.

Triple Quadrupole GC-MS*

Shimadzu triple quadrupole GC-MS has a novel, highly efficient detector as well as three types of noise-reduction technologies. It has several applications including volatile nitrosamines, GTI, and residual solvent analysis.

Living Laboratory

Shimadzu AI-assisted automation integrates hardware and software to create a future proof laboratory. It connects every part of the laboratory from sample preparation to COA release and provides work from anywhere / 2-day work/ weekend automation.

Software

Shimadzu LabSolutions CS, an innovative data system for networked laboratories in Pharmaceutical industry, ensures comprehensive data management and compliance with CSV, PIC/S GMP, and U.S. FDA 21 CFR Part 11 regulations. It facilitates efficient handling of equipment and analytical data for quicker operations in a networked environment, ensuring data integrity.

Q-TOF

Shimadzu Q-TOF provides accurate mass measurement ideal for discovery workflows, impurity characterization, E&L studies.

Sterile Filling & Freeze Drying

ATS modular filling machine offers customizable solutions for aseptic manufacturing, including robotic filling for RTUs, ophthalmic bottle filling, and a comprehensive range of linear filling modules. Their Line of SightTM freeze dryer tools, equipped with advanced PAT, facilitate efficient process development.

Washing and Sterilization

De Lama’s versatile autoclaves cater to diverse applications, including terminal and component sterilization, as well as low-temperature sterilization. These autoclaves seamlessly integrate GMP washing. The H202 sterilizer, featuring Hyperpure technology, provides a high-tech solution for low-temperature applications, serving as an alternative to ETO and Gamma sterilization.

lnline Particle Measurement

SOPAT photo optical and image based inline analyzer quantitatively characterizes particles in multifaceted systems like crystallization, microspheres, suspensions, emulsions both in sterile and non sterile applications. Parsum enables direct measurement in continuous and batch processes, covering powders, pellets, granulation, and drying.

Dispersion, Wetmilling & Homogenization

Kinematica MT-SV inline dispersers meet sterile process requirements for sterile suspension, emulsion, microspheres, and encapsulation. Designed with full CIP and SIP capabilities, the MT-SHS achieves particle sizes down to 1 micron in wet milling, ideal for batch sizes of 10,000 L and above. The HPH Atomix ensures high efficiency in dispersions and emulsions, achieving the smallest particle and droplet sizes for both sterile and non-sterile applications.

Content Uniformity, Reaction & Drying Monitoring

Enwave high sensitivity NIR Analyzer provides precise measurement and real time chemical values in various API and OSD manufacturing segments, covering reaction monitoring, drying monitoring, and content uniformity measurements. Their handheld Raman, designed for rapid material identification, ensures GMP compliance in diverse applications.

Parenteral & OSD Inspection/Leak Detection

LIGHTHOUSE Instruments head-space platform provides both manual and automated inspection of oxygen, moisture, water activity, and CO2 in sealed containers. PTI high-sensitivity leak detection solution, uses vacuum decay, pressure decay, and high-voltage leak detection to cater to applications such as PFS, vials, and infusion bags. Their volumetric imaging technology is specifically crafted for blister inspection.