2015년 3월 12일 목요일

Proper Gowning In OSD Facility; Infectious Specimens Shipping Tutorial


Pharmaceutical Online Newsletter | March 12, 2015
Pharmaceutical Online Newsletter
» Featured Article
How To Implement Proper Gowning Procedures In An OSD Facility
By Christine Hofnagel, AIA Associate, JacobsWyper Architects
Within an oral solid dosage (OSD) manufacturing facility there are typically three levels of product exposure: general, protected, and controlled. Generally, the division of levels is directly related to the product or product component exposure, as well as to the physical environment and function within the facility. These levels vary, as many manufacturing processes differ from site to site. This article addresses specific gowning regulations for each of the three levels, as well as how to achieve them with a quality risk assessment program.
Logistics
Efficiencies Of Natural Convection In Passive Pallet Shippers
By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick
Bulk transportation of temperature-sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains.
BROCHURE: AT&T M2M Business Solutions
VIDEO: Shipping Infectious Specimens By Air Tutorial
» Critical Environments
ARTICLE: Drastically Reduced Isolator Decontamination Cycles
APPLICATION NOTE: Instantaneous Microbial Detection Defined
BROCHURE: Glacier: Ultralow Laboratory Freezer
» Inspection
BROCHURE: Digital Inspection Microscope
VIDEO: VisionScan: Vision-Based Leak Detector
VIDEO: Packaged Product Inspection In Food And Pharma
» QA/QC
WHITE PAPER: Serialization And The Drug Quality And Security Act: A Top-Down Synergistic Approach
By Glenn Restivo, Mike Salinas, M&W Group, and David DeJean, Systech International
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA).
WHITE PAPER: The Utility Of Specific Surface Area Measurement For Pharmaceutical Materials
APPLICATION NOTE: Be In The Clear: Turbidity Measurement Of Infusion Solutions
» Packaging
WHITE PAPER: Realizing Business Productivity Through Supply Chain Segmentation
DATASHEET: In-Sight Track And Trace Identification And Verification
By Cognex Corporation
BROCHURE: VHolopack: Innovative Contract Filling, Certified DIN EN ISO 9001:2000
» Manufacturing
WHITE PAPER: Integrated Flash And Preparative Chromatography = Greater Purification Versatility
By K. John Morrow, Jr., Ph.D.
Traditional purification platforms can be time consuming, wasteful, and sometimes inefficient. These critical needs in today's drug discovery environment have been addressed by a new, integrated instrument.
WHITE PAPER: Developments In Laboratory-Scale Lyophilization For Purification Laboratories
By Rob Darrington, Genevac
For many years lyophilization, or freeze drying, has been used to dry samples in the laboratory.
APPLICATION NOTE: Replacing Activated Carbon Depth Filter Cartridges In Pharmaceutical Applications
PODCAST: Causes And Effects Of Microbial And Particle Contamination
PRODUCT: Vial Washer For Compounding Pharmacies, RW-250
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