Newsletter | March 5, 2013

03.05.13 -- How 4th-Gen Barrier Technology Is Revolutionizing Aseptic Processing

Pharmaceutical Online Newsletter
Departments:
Solid Dose
Logistics
Liquid Dose
Critical Environments
Packaging
Inspection
QA/QC
Featured Focus: Liquid Dose
How 4th-Gen Barrier Technology Is Revolutionizing Aseptic Processing
By Sterling Kline, IPS
Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional cleanroom facilities of the 20th century are being rapidly replaced with advanced barrier-based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients.
WHITE PAPER: Creating The Next Generation Of Isolation
BROCHURE: High-Pressure Homogenizers And Pumps
PRODUCT: Maximize Containment With The Task-Specific Workstation
NEWS: West Introduces Novel Intradermal Adapter For Disposable Syringes
NEWS: New Bioterrorism Vaccine Gets First Test In Humans
» Solid Dose
ARTICLE: Freeze-Drying Generics: Cost Advantages And Considerations
By Dr. Kevin Ward, Biopharma Technology Limited
The imperative for successful generic production is ruthless management of production costs within a large scale manufacturing process that achieves robust, replicable, and dependable results. The competition for market share amongst generic manufacturers means that there is no place for inefficient process within the profit margins expected in this sector of activity. The generic manufacturer must ask three key questions.
WHITE PAPER: Basic Principles Of Dry Granulation And Roller Compaction Technology
GUIDE: A Guide To IBC Blending And Handling Systems
GUIDE: How To Choose And Use Vibratory Feeders And Conveyors
BROCHURE: EZx Contaminant Detection System
NEWS: Mylan Launches Generic Antara Capsules
» Packaging
WHITE PAPER: How To Eliminate Inspection Labor Costs On Blister Packaging Lines
By Hermann Carbone, Bonfiglioli Engineering SPA
Production of tablets and capsules is carried out in cleanrooms and under stringent procedures as per GMP requirements. However, the process also relies on machines and machine operators, whereby misappropriate handling can result in a faulty blister pack containing micro leaks in the packaging, thus allowing air and moisture to enter the blister and damage the product.
PRESENTATION: Nondestructive Package Testing: Driving Sustainable Operations
PRODUCT: Metal Detectors
PRODUCT: Bosch Checkweigher: KWE 4000 Series
PRODUCT: Versa GP: Checkweigher
» QA/QC
WHITE PAPER: Signature Requirements For The eTMF
By Kathie Clark, Wingspan
Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision making, we've researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
ARTICLE: Building Productivity: Automating Time And Attendance In Manufacturing
PRODUCT REVIEW: Documentum D2 And FirstDoc: A Comparison
NEWS: Sartorius Stedim Biotech Expands PAT Portfolio By Adding Sensor Technology For Real-Time Biomass Measurement
» Logistics
WHITE PAPER: Efficiencies Of Natural Convection In Passive Pallet Shippers
By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick, ThermoSafe, Sonoco Protective Solutions
Bulk transportation of temperature-sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. This imperative has prompted pharmaceutical companies to look at more efficient and economical means of temperature-controlled distribution. Passive packaging systems are one of the proven and repeatable methods for international bulk shipments of temperature-sensitive products.
CASE STUDY: A Healthcare Company's Quality Manufacturing Issues Required A Time-Definite Delivery Solution
CASE STUDY: Asterand's Solution To Improve Shipment Integrity And Security For Tissue Samples
PRODUCT: Remote Monitoring
» Critical Environments
WHITE PAPER: 4 Factors To Consider For Effective Cleanroom Design
By Rick Dobson, AES Clean Technology
You have been tasked by senior management to look into purchasing a cleanroom environment for a possible new product line. The mandate is that the cleanroom system provider must guarantee temperature, humidity, pressurization, and classification. As with any purchase, it is always best to be an educated buyer and have researched the options available to you. Knowing what questions to ask and what the cumulative effect is from the answers will make for a sound decision process and an overall successful project.
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 which provides absolute separation between the operator and product.
PRODUCT: Integrated Containment Systems
PRODUCT: Purifier Logic Class II Biosafety Cabinets
PRODUCT: Hybrid Isolator Solves Containment Challenges With High-Potency APIs
» Inspection
PRODUCT: High-Speed Headspace Inspection Machine
PRODUCT: Pharmaceutical Yield Test Rheometer
PRODUCT: BlisterScan Nondestructive Leak Detector
SERVICE: Contract Metal Detection Services
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