Newsletter | August 28, 2014

08.28.14 -- What You Missed From The FDA Last Week; Recipharm To Acquire Corvette Pharm Group

Pharmaceutical Online Newsletter
SPONSOR
The Rx For GMP Compliance: Robust And Reliable Checkweighing
» Guest Column
How To Select The Appropriate Flooring System For Your GMP Facility
By Eric Bohn, Partner, Jacobs Wyper Architects

In today’s construction industry, there is an overabundance of flooring materials available for installation in your facility. The quality, cost, and functionality of these options vary wildly. You can run down to your local home improvement store and purchase vinyl tile for less than $1/square foot or spend over $20/square foot for specialty products of exceptional quality and durability. With so many choices, it is not always easy to know which flooring system is appropriate for your cGMP facility. 

Featured Focus: Manufacturing
Essentials Of Moist Heat Sterilization Kinetics
By D. Pistolesi, V. Mascherpa, Fedegari
The F0 algorithm was first introduced in 1968 in the international practice of food industry, and proposed by the FDA in 1976 for the pharmaceutical sterilization of large-volume parenterals; it is now officially included in most pharmacopoeias.
CASE STUDY: Contract Development: Accessing External Innovation
By Janice Cacace, Ph.D, CoreRX, Inc.
In the outsourcing business, many outsiders assume price is the primary motivation of all this outsourcing, but in an industry in which the bestselling drugs bring in more than $1 billion a quarter, it makes little sense to risk delays by making decisions based solely on cost. The reality is the best service providers offer more than just financial flexibility.
WHITE PAPER: Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess
By Richard Lucas, Ph.D., Bioquell UK Ltd.
The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilization, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way.
BROCHURE: Continuous Tablet Manufacturing
PRODUCT: Aseptic Sampling Systems
» Critical Environments
WHITE PAPER: Green Washing: A Sustainability Checklist
By Deborah Ruriani, Miele Professional
Planning a lab that meets today’s requirements for sustainability is a top demand for lab planners and architects. The U.S. Green Building Council certified its first LEED Building in 2002 and since then the movement to create sustainable buildings has put pressure on architects to become experts in environmental efficiency.
PODCAST: How Biopharma Cleaning Validation Can Be Life Or Death
PRODUCT: Airegard: Cleanroom Air Shower
» QA/QC
APPLICATION NOTE: Cleaning Tablet Tools
EDUCATIONAL COURSES: Continuing Education Series: Pharmaceutical Water And Cleanroom Verification
APPLICATION NOTE: Recommended Mixing Equipment For Fish Oil Supplements
» Packaging
WHITE PAPER: A New HPMC Capsule For Optimum Formulation Of Pharmaceutical Dosage Forms
SERVICE: Packaging Permeation Studies
PRODUCT: Pharmaceutical Molding And Sealing Machine For Packaging
» Logistics
DATASHEET: Temperature Mapping Study
By Infitrak, Inc.
DATASHEET: Envoy Insulated Shippers
By Sonoco ThermoSafe
PRODUCT: Bio-STAR Technology: Clinical Trial Logistics Management
» Inspection
DATASHEET: Leak Testing Machine For Filled Bottles
By TASI Group: Bonfiglioli Engineering and Sepha
PODCAST: Cause And Effects Of Microbial And Particle Contamination In Your Facilities
PRODUCT: Cell Counter: Size Distribution In Number, Volume, And Surface Area
SPONSOR
When To Invest In Protein Production: The Risk-Reward Calculation
By Louis Garguilo, Executive Editor, Outsourced Pharma
Topics such as this regarding development and manufacturing outsourcing strategies, analysis, and advice will be discussed in a fully open format at the Outsourced Pharma West Conference and Exhibition, November 10 to 11 in San Francisco. The conference will provide the opportunity to learn from experts at pharma, biotechs, and CRO/CMO. For some informative pre-conference discussion.

For more insight on outsourcing strategies and CMO partners, Register Today for Outsourced Pharma West Conference and Exhibition.
» Most Recent News
MHRA Approves New Claris Lifesciences Plant In India
U.S. Government Reclassifies Hydrocodone, Hopes To Protect Patients From Addiction
What You Missed From The FDA Last Week — August 18 To 22, 2014
What Effect Do Patents Have On Drug Development?
Recipharm To Acquire Corvette Pharmaceutical Group
Follow Pharmaceutical Online:
LinkedIn    Twitter    YouTube