PharmTech AI Pulse Check panelists explain why attribution, audit trails, and sign-off matter more than AI watermark detection for GxP quality teams.
|Articles|December 2, 2019
- Pharmaceutical Technology-12-02-2019
- Volume 43
- Issue 12
Cube Plus for Pharmaceutical Manufacturing
Cube Plus by GiroNEX is an automated precision powder dispensing system for use in manufacturing powder-filled capsules and vials for early phase clinical trials and related drug development studies.
Cube Plus by GiroNEX is an automated precision powder dispensing system for use in manufacturing powder-filled capsules and vials for early phase clinical trials and related drug development studies.
The cube comes equipped with a 24-well dial plate and can dispense from one milligram to one gram of single or formulated pharmaceutical powders into each capsule. It also includes controlled user access levels and is capable of recording all user details and capsule weights into electronic records.
Designed with reusable stainless-steel powder dispensing heads, the device is comprised of a series of interchangeable heads for a range of powder types and behaviors. The cube’s AI-driven dispensing technology allows for the characterization of the powder’s behavior during every dispense, optimizing dispense times and cycles and eliminating other dispensing methods.
Articles in this issue
almost 7 years ago
Applying Lessons Learned from the Semiconductor Industryalmost 7 years ago
Visualization Enhances Facility Designalmost 7 years ago
Bio Diol and IEX Columnsalmost 7 years ago
Two-step Disposable Autoinjectoralmost 7 years ago
Triple Shaft Mixer with Powder Induction Manifoldalmost 7 years ago
Fighting the Good Fightalmost 7 years ago
Managing Excipient Interactionsalmost 7 years ago
‘Polling’ All the Wayalmost 7 years ago
The Challenges for Regulators in the Digital Agealmost 7 years ago
Tackling Solubility in Drug DevelopmentRelated to this article
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.