Newsletter | March 4, 2014

03.04.14 -- Pharmaceutical Online Newsletter

Pharmaceutical Online Newsletter
Departments:
Critical Environments Manufacturing Logistics
Inspection QA/QC Packaging
SPONSOR
Mixing And Blending White Papers Now Available For Pharmaceutical Manufacturers
» Featured Podcast
Opportunities And Risks In The Global Regulatory Environment
By Pharmatech Associates, Inc.
Todd and Todd interview Bikash Chatterjee, the president and chief technology officer at Pharmatech Associates. Bikash provides an excellent overview of the global regulatory environment, along with both the opportunities and risks for the pharmaceutical industry. Additionally, he offers expert insights into effective cross-cultural business collaborations and highlights science and technology innovations that will be game changing in the next five to ten years.
Featured Focus: Critical Environments
The Advantages Of A Mobile Cleanroom
By Gary Partington, Walker Barrier Systems
The mobile cleanroom (MCR) is a self-contained manufacturing space fully constructed in our facility. It is shipped to the customer’s facility on a double-drop flatbed trailer in one piece and ready to hook up and use upon moving into place. The MCR has 440 square feet of manufacturing or R&D space, with a main room size of approximately 25'L x 18' W x 9'H. The overall size is 48 ft. long, 18 ft. wide, 12 ft. high, with a weight of approximately 35,000 pounds. The MCR can include ISO 7 or ISO 8 Air Quality in the cGMP clean manufacturing space for aseptic products. It can also be designed for BSL1, BSL2, and BSL2+ clean manufacturing space for biological safety products. BSL 3 and BSL 4 preliminary designs are underway. It can be used inside a legacy facility or in green field construction, and offers a much faster delivery compared to stick-built facilities. Double-wide systems (48 ft. x 36 ft.) are available to provide increased manufacturing space.
WHITE PAPER: Factors To Consider When Cleaning Pharmaceutical Equipment
By Malcolm McLaughlin, Alconox
Typically, pharmaceutical operations require transitions from bench-scale R&D to pilot studies to full-scale manufacturing.
WHITE PAPER: Selection Of Cleaning Agents And Parameters For cGMO Processes
VIDEO: Reducing Contamination Issues With Air Showers
PRODUCT: High-Pressure Diffuser For Airborne Particle Counters
» Manufacturing
WHITE PAPER: Integrated Valve Systems vs. Conventional Automation Concepts
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
With conventional centralized automation of process valves in production units for food, drinks, and pharmaceutical products, it is often difficult to meet the necessary stringent hygiene and safety standards. Intelligent process valves with integrated automation functions offer an interesting alternative in this field and can help reduce planning, installation, and maintenance costs.
WHITE PAPER: The Challenges With Real-Time Viable Particle Counters
By Darrick Niccum, Senior Global Product Manager, Biotechnology, TSI Incorporated
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of remote monitoring and measurement instruments.
E-BOOK: Managing Safe, Secure Global Supply Chain
BROCHURE: Alkermes Contract Pharma Services
PRODUCT: Continuous Microbial Monitoring And Trending Instruments
PRODUCT: Used Fluid Bed Dryers
PRODUCT: MINI-POLYGRAN Roller Compactor
» Logistics
WHITE PAPER: A Model For Pharmaceutical Supply Chain Quality Agreements
By Rafik H. Bishara, Steve Jacobs, and Dan Bell, Marken
A decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and they were pretty much done by written bullet points.
WHITE PAPER: The Invisible Component Of Cold Chain Management
WHITE PAPER: Taming China's Clinical Trial "Dragon"
WHITE PAPER: New Lifecycle Comparison Analysis Demonstrates Environmental Impact Difference Between Reusable Thermal Shipper And Single-Use Container
VIDEO: Cold Chain Services: Understand And Ensure Compliance
» Inspection
APPLICATION NOTE: Determination Of Cell Aggregation In Bacteria Cultures With An Automatic And Reliable Method
By Andres Lobeiras, Product Manager, Beckman Coulter, Inc.
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as the electrical sensing zone (ESZ) technique. The ISO International Standard 13319 describes this technique.
WHITE PAPER: Rupture Test: A Quick And Easy Way To Avoid Soft Gel Capsule Failure
CASE STUDY: Risk Mitigation With Pouch Packaging Inspection
DATASHEET: High-Speed Checkweighers: CW3 6000M
By Loma Systems and Lock Inspection
SERVICE: Visionspect Contract Visual Inspection Services
» QA/QC
ARTICLE: Accelerate Regulatory Submission Documentation Creation, Review, And Approval
Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review, and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you've outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.
DATASHEET: Pharmaceutical Flexible Isolator: FlexiVac
By TSI Incorporated
SERVICE: Data Analysis Consulting
PRODUCT: Portable Cleanrooms
PRODUCT: Hygienic Load Cell And Mounting Kit: Contego
» Packaging
CASE STUDY: Pharmaceutical Company Cuts Packaging Costs
PRODUCT: Serialization And Track And Trace: In-Sight Vision Systems Series
PRODUCT: Laboratory Oxygen Headspace Analyzer For Lyophilized Vials
PRODUCT: Formed Packaging: Specialized Film/Foil Processes
SPONSOR
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 www.INTERPHEX.com.
» Most Recent News
FDA Wants Changes To Drug Review System
Andromeda Seeks Purchase From Unnamed American Drug Firm
EMA Accepts Review For The Medicines Co.'s Oritavancin
Pacira EXPAREL Phase III Trial Meets Primary Efficacy Endpoints
FDA Approves Pfizer's Xeljanz Label Update
Follow Pharmaceutical Online:
LinkedIn    Twitter    YouTube