Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
|Articles|November 2, 2014
- Pharmaceutical Technology-11-02-2014
- Volume 38
- Issue 11
Biodecontamination System Reduces Cycle Times
Telstar's ionHP biodecontamination system is designed to use ionized hydrogen peroxide in aseptic processes.
Telstar’s ionHP biodecontamination system is designed to use ionized hydrogen peroxide in aseptic processes. The system requires a low concentration of H
2
O
2
and is designed for aseptic isolation technology.
The ionHP system includes a process of ionization by passing a mist through an ionized plasma field. In the process, an electrostatic charge is imparted on the mist, making it similar to a gas, and causing positively charged particles to be attracted to negatively-charged surfaces. Compared to traditional H2O2 systems that use a base concentration of 30-35% volume, ionHP uses 7.5%. The ionHP system requires a short decontamination process time and does not require temperature regulation, eliminating the need for air conditioning units.
Telstar
Articles in this issue
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New Era for Generic Drugsalmost 12 years ago
Hype vs. Healthalmost 12 years ago
Advances in Large-Scale Heterocyclic Synthesisalmost 12 years ago
Steritest Symbio Pumps Increase Productivityalmost 12 years ago
Tackling Drug Shortagesalmost 12 years ago
Injecting Highly Viscous Drugsalmost 12 years ago
Cleanroom Filtration System Minimizes Costsalmost 12 years ago
Using Flow Sensors to Monitor Process System Healthalmost 12 years ago
Parenterals, Particulates, and Quality by Designalmost 12 years ago
GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VIRelated to this article
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.