Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

PharmTech Manufacturing
MANUFACTURING ARTICLES
Understanding the Cleaning Validation Lifecycle
The cleaning validation lifecycle includes assessment, development, validation, and monitoring.
Advances in Continuous Biopharmaceutical Manufacturing
Both upstream and downstream processes can benefit from continuous manufacturing advantages.
European Union Regulation Reforms Affect Cold-Chain Management
Tony Wright, CEO of Exelsius Cold Chain Management, answers questions about the new requirements for temperature-controlled pharmaceutical distribution.
Increased Efficiency Key to Competitiveness in Downstream Bioprocessing
Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.
Appropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.
MANUFACTURING NEWS
FDA Details National Vaccine Plan
HHS plan makes progress in ensuring availability of safe vaccines.
FDA and European Medicines Agency Announce Generic-Drug Application Inspections Initiative
FDA and EMA launch initiative to share bioequivalence inspection information.
MHRA Recalls Novartis Cough and Cold Medicine
Agency issues precautionary recall due to manufacturing fault.
MHRA Recalls Boots Pharmaceuticals
Agency issues precautionary recall due to manufacturing fault.
Wockhardt Receives FDA Warning Letter
FDA cites cGMP violations and data-integrity issues and raises concerns over the company's ability to implement a robust and sustainable quality system.
MANUFACTURING PRODUCTS
Wall Pass-Through System Enhances Aseptic Transfer
The AdvantaPass wall pass-through system from AdvantaPure permits aseptic transfer of fluids between suites.
Milling Isolator Handles Multiple Mills
A universal Milling Isolator from Powder Systems Limited (PSL) handles multiple mills.
Thermal Ink-Jet Technology Prints on Non-porous Surfaces
A patented cartridge using fast-drying inks allows high-resolution coding for pharmaceutical packaging.
Biosafety Cabinet Enhances User Experience
The Purifier Logic+ cabinet from Labconco provides a safe and comfortable work environment.
Crane Introduces Next-Generation Diaphragm Pump
The DEPA DH next-generation double air-operated diaphragm pump from Crane features a new design.
SPONSORED WHITEPAPERS
Where Should I Place My Sensors in Mapping Studies?
This 1-hour webinar covers best practice for deploying sensors in environmental mapping studies, including how many to use and where to put them. We examine how to justify sensor placement in environments of all sizes, from table-top incubators and small refrigerators, to cold rooms and warehouses.
GMP Warehouse Mapping
Vaisala recommends a nine-point process for successful mapping of a GxP-compliant warehouse or storage space. These nine steps will ensure that you take into consideration the most important elements of validation, especially understanding where temperature and humidity pose risks to product quality.
Impact of a Customized MALDI-TOF Library for Microbial Identifications
This study assesses the suitability of the Biotyper platform for identifying environmental isolates, demonstrates our systematic approach to broaden the reference library and shows the impact of adding new library entries on reportability for this industrial sector.
Three Steps to USP H2O Success
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection - cost effectively and with minimum maintenance. Here's how.
Graceful Scale-Up of Mixing Systems
When acquiring a process that involves one or several mixing steps, foresight for scale-up or expansion remains to be a subtle but important factor for long-term success. As production requirements grow, your ability to shift gears smoothly, quickly, and efficiently is critical because it can spell the difference between an economical transition and a financial disaster.
PACKAGING & LABELING
European Union Regulation Reforms Affect Cold-Chain Management
Defining the Sterile Barrier of Complex Drug Delivery Systems
INTERPHEX Features Packaging Innovations
MANUFACTURING EVENTS
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