This paper discusses the primary benefits of the vented balance enclosure, which is critical to the safe and effective weighing of potent powder compounds, APIs, and nanomaterials.
Many existing research labs, pharmaceutical and biopharmaceutical manufacturers, and contract manufacturing organizations (CMO’s) are not designed nor are they equipped with the engineering controls to safely handle the manufacture of ADC’s. The safe manufacture of ADC’s requires more modern facilities, equipment, and engineering controls as well as programs, practices, and procedures to adequately protect the operators and the work environment. Read the steps that must be taken to consider a glovebox workstation fully validated to manufacture ADCs safely.
This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.
Mixer testing simulation trials are needed to confirm the suitability of a specific mixing strategy. This white paper explores five ways to increase energy efficiency in new and existing mixing processes.
Designed for high-speed powder dispersion, the Ross Solids/Liquid Injection Manifold Mixer is well proven in the preparation of tablet coatings.
This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.
Creating and following proper inspection, cleaning, lubrication, handling, and storage procedures provide tooling integrity and ensure the consistent and efficient manufacturing of tablets.
Read how upgrading to modern single-use powder handling gets a product to market without time wasted on complicated weigh and dispense steps, cleaning validations or powder in the air and in the suite.
Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.
Flexible containment solutions must work well for every stakeholder. With high potency active pharmaceutical ingredients (HPAPIs) come a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.
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