Newsletter | February 11, 2014

02.11.14 -- Merck Wins Canadian Regulatory Approval To Launch GRASTEK Sublingual Tablet

Pharmaceutical Online Newsletter
Inspection QA/QC Manufacturing
Logistics Critical Environments Packaging
NuAire Offers High Performance Ultra Centrifuges
NuAire now offers the sales and service of Hitachi Koki High Performance Ultra Centrifuges to the North American market. These high performing machines help assist in research applications involving purifying proteins, DNA, RNA, viruses, nano-sized particles, and more by separating liquids at high speeds with model CS150NX reaching up to 150,000 rpm. To view NuAire's new offering and to take advantage of NuAire's sales and service networks click here.
» Featured Article
Spray Drying Enhances Solubility And Bioavailability Of Poorly Soluble Drugs
By Marianne Spaene, EVP Global Business Development, Siegfried Ltd.
In spray drying, a liquid feed (solution or suspension) is sprayed into a hot gas stream with the intent to isolate products in a solid-form state as well-defined powder. By application of spraying, the liquid evolves as small droplets with precisely defined volume(s). These droplets are then transported with the gas flow along a drying chamber (referred to as 'flight time'). During the flight time, the solvent evaporates from the droplets until only residual solids remain.
Featured Focus: Inspection
Particle Transport In Tubing
By Morgan Polen, VP of Applications Technology, Lighthouse Worldwide Solution
Often, the use of APCs requires the use of tubing for the sampling of the air, as the APC may be located some distance from the actual air being sampled.
WHITE PAPER: Increase Tablet Quality By Checking These Seven Inspection Points
WHITE PAPER: Steps To Improve Collection, Management, And Analysis Of Microbiology Samples
BROCHURE: Lock INSIGHT pH Metal Detector
BROCHURE: Vistus Metal Detectors
WHITE PAPER: Freeze Drying Generics: Cost Advantages And Considerations
By Dr. Kevin Ward, Biopharma Technology Limited
The FDA defines a generic drug as "a drug product that is comparable to a brand listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use."
WHITE PAPER: Trends In Pharmaceutical Leak Tightness Testing
By Hemi Sagi, Director, Advance Test Concepts (ATC) Inc.
Leak tightness of products is an ongoing concern for many product designers, manufacturers, and users. Automotive manufacturers, in particular, are facing increasing demands to reduce emission requirements that can be a result of leakage as well as warranty cost.
WHITE PAPER: What Is A Particle Counter?
By Dr. Hans-Walter Motzkus and Joe Gecsey, Beckman Coulter Life Sciences
A particle counter is an electronic instrument that detects and counts airborne or liquid particles. Particles are detected using laser-based optical systems that shine a powerful light through a detection chamber.
ARTICLE: Understanding Powder Flow Properties
DATASHEET: In-Line Leak-Testing Machine For Filled Bottles
By TASI Group: Bonfiglioli Engineering and Sepha
PRODUCT: Pharmaceutical POD Facilities
» Manufacturing
ARTICLE: Drug Development: Take The Guesswork Out Of Crystallization
By Alex Chen, CEO, and Robert Wenslow, VP of Business Development, Crystal Pharmatech Inc.
Batch-to-batch variability during the crystallization of active pharmaceutical ingredients (APIs) can have a profound impact on both safety and efficacy of the final drug formulation, and direct business and cost implications for both the API manufacturer and downstream drug-formulation partners.
WHITE PAPER: One Of The Biggest Challenges And Most Effective Tools For Managing Cold Chain Logistics
DATASHEET: Liquid IBC Container: TPS Unifold 1000
By Servolift LLC
BROCHURE: High-Voltage Leak Detection Machines For Blow/Fill/Seal Equipment
PRODUCT: Pharmaceutical Grater/Shredder
PRODUCT: Near-Infrared PAT System For Blend Uniformity Analysis For IBC Tumble Blending
» Logistics
GUEST COLUMN: Quality Trumps Cost: Moving From Preferred Providers To Strategic Partners
By Wes Wheeler, Marken
Part two of Marken CEO Wes Wheeler's ten-part blog series about the changing face of life sciences logistics in today's fast-paced pharmaceutical industry.
WHITE PAPER: Latin America Emerges As World Competitor For Global Trials Despite Tough Regulatory Environment
WHITE PAPER: Understand The Source Of Product Damage With Data Loggers
DATASHEET: Mobile Refrigerator/Freezer: AcuTemp
By CSafe Global
BROCHURE: An Affordable Way To Ship Temperature-Sensitive Cargo
» Critical Environments
WHITE PAPER: The Role Of Desiccators To Reduce Humidity In Critical Environments
By Mike Buckwalter, Terra Universal
Desiccator storage has become critical in more and more manufacturing operations. A look at the costly effects of moisture exposure explains why.
WHITE PAPER: The Benefits Of Isolator And Aseptic Processing
By Gary Partington, Walker Barrier Systems
Isolators have been around the pharmaceutical industry since the early 1980s, and in the nuclear industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process that provides absolute separation between the operator and product.
BROCHURE: Washer Sterilizers
PRODUCT: Containment: Pharmaceutical Powder
PRODUCT: Personal Exposure Monitoring
» Packaging
GUEST COLUMN: To Redeploy Or Dispose Of Surplus Assets — That Is The Question
By Tom Burton, President, Capital Assets Group at Liquidity Services, Inc.
The core business of pharmaceutical companies is geared toward research, manufacturing, sales, and marketing. However, when equipment used for the purpose of research and manufacturing, and even assets such as employee computers, have reached the end of their useful life, they oftentimes wind up sitting idle and taking up space, or are disposed of in an inefficient way.
VIDEO: Container Closure Integrity Testing And Micro Leak Detection Of Liquid Pharmaceuticals
PRODUCT: Canister Dispenser
PRODUCT: Used Cartoning Equipment
SERVICE: Pharmaceutical Contract Packaging Services: Capacity
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD): Successful Implementation For Pharmaceutical Development And Manufacturing
Date: Tuesday, February 25, 2014 • Time: 1pm – 2:30pm EST

Serialization Program Management And Governance: Defining Roles For Success
Date: Wednesday, March 5, 2014 • Time: 1pm – 2:30pm EST
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Merck Wins Canadian Regulatory Approval To Launch GRASTEK® Sublingual Tablet
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