03.23.24 -- Quality Assurance Product Showcase

Discover USP <1207> and ASTM (F-3287-17) recognized mass extraction technology that works on the principle of rarefied gas flow and is particularly suitable for testing IV bags, pouches, or glass vials.

Gain a detailed understanding of high voltage leak detection (HVLD), a sensitive and nondestructive technology to test container closure integrity, and Nikka Densok’s HVLD pinhole detection systems.

APEX Biological Indicator products are designed specifically for use with today’s isolator and filling line applications in the pharmaceutical and medical device industries utilizing H₂O₂ vapor sterilization.

TrackWise is the world’s leading on-premises QMS software. It brings all your quality processes together in a single place to give you the big picture of your compliance and operational effectiveness.

TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.

METTLER TOLEDO Safeline pharmaceutical metal detector systems are designed to offer maximum flexibility in process areas. A compact footprint enables systems to be inserted into areas where space is restricted.

Explore a range of rigid stainless steel containment isolators from Dec designed for handling potent compounds and that can offer guaranteed levels of operator protection as low as 10ng/m3 (task duration).

SoftMax Pro 7.2 GxP Software is the latest and most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity.

Figurate™ automation for DeltaV™ DCS is a bioprocess automation software solution that applies process and equipment expertise to a distributed control system (DCS) platform. 

The MiniCapt Pro Remote Microbial Air Sampler incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring.

The IsoSphere-AF is a positive pressure unidirectional airflow isolator or RABS for small-, medium-, and large-volume aseptic filling. Eliminate the risk of high start-up costs, extended deadlines, and possible contamination.

From a single component to complete systems for bulk material handling, Coperion & Coperion K-Tron design and manufacture equipment for the pneumatic transport of bulk solids materials for small and large systems.

All Alconox Inc. detergents are Class I medical devices and listed as FDA-registered detergents. The list of the detergents can be found on the FDA website. Alconox Inc. is also ISO9001:2015 and ISO13485:2016 certified.

The Class 2 Type A2 laminar flow biosafety cabinet provides a high degree of localized protection from particulate and aerosol hazards, eliminating cross-contamination and the release of aerosols to the outside environment.

Increasing visibility, efficiency, and control to ensure quality for CDMOs and Generics.