12.03.22 -- Bioprocessing Product Showcase

Germfree’s bioGO Modular Cleanrooms are available in multiple configurations to meet a wide variety of cGMP product development, production, and training applications.

The Glovebox Workstation series provides containment for highly toxic applications using APIs that need more safety than an opened face enclosure. FSI engineering controls are built in to prevent loss of containment.

Your future cleanroom is the most crucial asset within the entire manufacturing environment. It surrounds critical manufacturing processes where your pharma or biotech company makes its lifechanging products. AES is the cleanroom expert because it's the only thing we do. 

Use new technology and operations expertise to reduce costs, improve efficiencies, mitigate risk, and deliver a workplace that attracts top talent. Put the right procedures and certifications in place to ensure GXP environments are compliant. 

ILC Dover Liquid Single-Use Bioprocessing Bags are single-use containers for fluid storage and transfer in cGMP manufacturing. They are highly configurable with a variety of sizes, ports, and components to safely store and transfer buffers, media, and bulk product.

Ensure compliance and improve efficiency by automating your paper-based systems. The right electronic batch record (EBR) software system removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.

AST’s ASEPTiCell is a flexible fill/finish system that can efficiently process midsize clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

ChargePoint’s single use ChargeBag PE-S is a cost-effective and convenient container for the handling, storage and transfer of biopharmaceutical powders. The PE-S reduces the risks associated with cross contamination and eliminate the time and expense associated with cleaning and validation.

Pharmatec Fermentation Systems and Fermentation Units are designed for the production of complex solutions with multiple process steps (cascade, fermentation, or dialysis fermentation). Preparation is carried out in temperature-controlled stainless-steel tanks with stirring units under addition of chemicals and/or nutrient solutions.

The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering design principles and criteria for robust mixer design to deliver the ultimate in mixing performance.

Having your commissioning agent (CxA) involved in the design phase brings value that is not realized until the project is finished. A CxA has been through many different configurations and knows what works, and what does not.

Thermo Scientific HyPerforma Glass Bioreactors are available in 1, 3, 7, and 15 L sizes. They offer easy operation and rapid assembly and are manufactured with the highest standards for materials and surface finish. Developed using a computational fluid dynamics (CFD) simulator, the HyPerforma Glass Bioreactor impellers provide maximum mixing with minimum shear force.

These rigid stainless-steel containment isolators have been designed for handling potent compounds that can offer guaranteed levels of operator protection as low as 10 ng/m3 (task duration). These include designs for sampling, dispensing, and subdivision, mixing, milling, and vessel charging, as well as containing integrated process devices.

Qosina is your one-stop source for single-use bioprocess components, with low minimum order quantities, full bill of material kitting, and a liberal sampling policy, all supported by regulatory documentation and supplied with Qosina's assurance of supply.

Weiler Engineering’s ASEP-TECH blow/fill/seal machines are ideal for processing temperature-sensitive products such as biological and protein-based materials — providing a level of enhanced sterility assurance.

The MiniCapt Mobile Microbial Air Sampler from Particle Measuring Systems (PMS) is an innovative, light, and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.

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

Parenteral products, specifically vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. 

Our USP <1207> and ASTM (F-3287-17) recognized mass extraction technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV bags, pouches, or glass vials.

Nikka Densok USA offers complimentary feasibility testing for your CCIT project. Whether the need is for stability testing or initial inspection capability, Nikka’s HVLD systems are here to support your CCIT needs.

The Coperion K-Tron PH line of pharmaceutical design loss-in-weight feeders is ideal for the contained batch dispensing of powders direct to the reactor tank or vessel.

Apex biological indicator (BI) products are designed specifically to meet the unique needs of the pharmaceutical, food, and medical device industries utilizing vaporized hydrogen peroxide (VH₂O₂) decontamination.