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Tuesday, April 19, 2011

FW: Choosing Between Metal Detection And X-Ray Inspection

 


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In This Issue
Welcome back to the Pharmaceutical Online newsletter and our focus on inspection and leak detection. Be sure to check out the right-hand column for information from various vendors surrounding our featured topic. If you can't find exactly what you're looking for, be sure to browse Pharmaceutical Online's database of inspection and leak detection solutions.

The choice of an inspection system for your production line may seem confusing, perhaps daunting. Often there are many factors to take into consideration. Our featured article provides you with helpful tips to make an informed choice when selecting between metal detection and x-ray inspection. Also, in this edition, read about a new risk-based methodology that will effectively reduce CAPAs as a whole. Other topics covered in this newsletter include: how scientific expertise can deliver savings to your bottom line, how membrane contactors can be optimized in boiler feed water applications for removal of dissolved oxygen as well as carbon dioxide, and a study on determining product resistance of sucrose during freeze-drying. Be sure to check out our top news stories to stay current with the latest happenings in the pharmaceutical industry.
Featured Editorial
Choosing Between Metal Detection And X-Ray Inspection: Making An Informed Choice
The choice of an inspection system for your production line may seem confusing, perhaps daunting. Often there are many factors to take into consideration. On the one hand, you may need to assess the feasibility of different approaches based on detailed knowledge of the physical space available at different locations in the process. Alternatively, you may need to prepare a careful economic justification based on up-front and lifetime costs.

Beyond CAPA: Using Risk Assessment To Streamline Your Quality System
This paper describes a new risk-based methodology that will effectively reduce CAPAs as a whole. By employing this methodology, crucial CAPAs are extracted to determine the overall business impact, correct the problem, and implement the change throughout the enterprise.

Scientific Expertise Delivers Savings To Your Bottom Line
Expedited transfer to a new production site was needed for a commercially-launched lyophilized drug. Time lines were critical, as production could not continue at the original manufacturing location, and inventory levels were running low.

Boiler Feed Water Degasification Using Membrane Contactors: New Methods For Optimized Performance
This report reviews various system designs and discusses how membrane contactors can be optimized in boiler feed water applications for removal of dissolved oxygen as well as carbon dioxide. The report also highlights what advantages membrane systems have over conventional oxygen and carbon dioxide removal technologies. New methods of degassing that improve the overall performance of membrane contactors in boiler feed water systems will also be introduced.

Influence Of Concentration And Fill Depth On Product Resistance Of Sucrose During Freeze-Drying
The objective of the study described in this article was to characterize product resistance as a function of dry layer thickness for various sucrose solutions using patented SMART Freeze-Dryer technology. This new approach employs manometric temperature measurement (MTM) for the optimization of a lyophilization process during the first laboratory experiment.


Top News Stories
QSV Biologics Awarded cGMP Manufacturing Contract By Pfizer Inc.
Sepracor To Acquire Oryx Pharmaceuticals Inc. And Expand Commercial Operations Into Canada
AstraZeneca Submits sNDA For SYMBICORT For COPD Indication
FDA Approves MIXJECT, A Convenient, Easy-To-Use Drug Delivery System For Watson Pharmaceutical's TRELSTAR DEPOT And TRELSTAR LA
Dr. Reddy's Acquires BASF's Pharmaceutical Contract Manufacturing Business And Related Facility At Shreveport, LA
KaloBios Completes Patient Dosing In Its U.S. Phase 1 Trial Of Its Third Drug Candidate, KB003
Premier Research Group Plc And Octagon Research Solutions, Inc. Announce Strategic Partnership
Bilcare Global Clinical Supplies Forms Corporate Advisory Board
Oncothyreon Files Investigational New Drug Application For PX-866 Oncology Compound
Spherix D-tagatose To Be Supplied By Inalco SpA
invivodata And ClinPhone Announce Exclusive Global Partnership For ePRO Solutions
Shanghai CRO Service Alliance Adds Clinical Development Capabilities
Sepracor And Arrow Sign Global License And Development Agreement For XOPENEX/Ipratropium Inhalation Solution Combination
New Facility Will Increase Capacity For Tanks And Large Assemblies For Allegheny Bradford Corporation
Leipziger Messe Announces Date For Second L.A.B. Exhibition And Conference
Featured Downloads

Product Brochure: Beamex® MC5 Fieldbus Calibrator — Calibration
The Beamex MC5 Fieldbus Calibrator is a combination of a multifunction calibrator and a fieldbus configurator. The MC5 is a compact, easy-to-use, and field compatible calibration solution that offers a lot of functionality.


Product Sheet: G2 Silver Series IBCs
The Silver Series IBC manufactured by G2 is the highest quality and design available for the nutraceutical, food, and chemical industries. The product and non-product areas are all T-304 stainless steel. The interior has a 2B mill finish with all welds wire brushed and cleaned.
White Paper: A Guide To Successful Dissolution Testing
The perception of automation in dissolution testing differs greatly from user to user. If measurements are to be manually made, then the most labor-intensive stage is the taking of samples at the specified time periods as found in the company SOP (Standard Operating Procedure).
Product Brochure: Mastersizer 2000 Particle Size Analyzer
The Mastersizer 2000 is a practical, reliable solution to the everyday particle sizing needs of industry. Driven by Standard Operating Procedures (SOPs), the system has set exacting standards in laser diffraction particle sizing.

Editor's Choice Products
Safeline PowerPhasePLUS Metal Detectors
The PowerPhasePLUS offers two frequency metal detection capabilities, automatic product set-up, and is available in stainless steel wash-down and white-painted non wash-down versions. It features high-sensitivity and an easy-to-use LCD/LED display with a membrane key pad. Download the product sheet for complete information.
Blister Leak Tester
This benchtop leak detection and seal strength analyzer provides leakage testing of tablet blister packs in a methylene blue bath. The leakage testing of packages is measured by the vacuum loss in the chamber. Download the product brochure for complete information.

Dust Containment Systems For Tablet Coating
The Gold Series (GS) dust collector can be used in a variety of pharmaceutical dust collection applications such as tablet presses, tablet coating, fluid bed dryers, spray dryers, and general room ventilation. The GS is perfect for high-efficiency filtration in pharmaceutical manufacturing. Download the application note for additional information.
Prevas: Single-Use Dosing Systems
Prevas is the first completely preassembled, presterilized, and prevalidated dosing system available for the clinical and production pharmaceutical and biotech filling market. This allows risk-free scale up of filling operations in a single-use format. Download the product sheet for complete information.

Blue Mountain Regulatory Asset Manager
Blue Mountain Regulatory Asset Manager, built on a browser-based platform, brings together the features required for calibration management and maintenance management into a single platform, which allows everyone to retain their own processes and procedures while still collaborating with quality personnel to control the validated state of assets and processes. Download the product brochure for complete information.
MK VI Inline Capper: Inline Standard Capping Machine
This new, inline standard capping machine is fully automatic. Standard features include: machine mounted cap elevator with removable flights for floor loading of caps and reject orientation in the upper chute. It is designed for use with glass, plastic, or metal containers, and can handle container diameters up to 12 inches with a cap range of 13 to 70 mm. Request additional information from Techceuticals.

KWIK-STIK™ Plus
MicroBioLogics offers products designed to enhance your laboratory's quality control program by adding efficiency and reliability. KWIK-STIK Plus micro-organisms are designed to meet the needs of laboratories requiring QC micro-organisms that are a limited number of passages from the reference culture. Download the product sheet for complete information.
Roller Compactor: WP50N/75
Alexanderwerk, Inc. is an international supplier of roller compaction, granulation, and size reduction equipment for the pharmaceutical, food, and chemical industries. Its WP50N/75 roller compactor has a modular, compact machine design that provides a throughput up to 120 kg/hr. Download the product brochure for complete information.

Stainless Steel Wrenches
Steritool manufactures combination wrenches, open-end wrenches, and crow's foot wrenches for critical environment applications. They come with smooth, rounded edges for easy cleaning and effective sterilization. Download the product catalog for complete information.
Powdered Labware Detergent: Contrex® AP
Contrex AP is a powdered labware detergent. It removes virtually any contaminant including grease, oils, blood, tissue, particulates, deposits, chemicals, and solvents. Contrex AP works by soaking, scrubbing, or in ultrasonic cleaning baths. Download the product sheet for complete information.

Design/Consulting
As a full service resource to the biopharm industry, Electrol Specialties Company offers consulting services as well as equipment and start up services to assure the client optimal results by proper integration of process and Clean In Place (CIP). Download the product sheet for complete information.
Bins And Bin Systems
Bins and bin systems are the accepted industry standard for powder handling applications where close containment is essential. Custom Powder Systems bins and bin systems are used in virtually all powder handling and processing applications, and will be custom designed to meet your specific requirements. Download the product sheet for complete information.

Hydrosart® Cassettes For CrossFlow Filtration (TFF)
The Hydrosart membrane is a cross-linked, cellulose-based polymer that is chemically and physically stable in a broad pH range (pH 2.0 to pH 14). The membrane is naturally hydrophilic in nature, hence it exhibits extremely low non-specific protein binding and virtually non-fouling characteristics. Download the product brochure for complete information.
KBW Tablet Counting Machines
The KBW tablet counting machines provide accurate dispensing, excellent repeatability, and simple operation with fast product change. You can change parts to suit different sizes and shapes of tablets, capsules, or soft gels. Download the product sheet for complete information.

Vetter Commercial Manufacturing
Concentrate and focus your resources. Leave the details of production to Vetter, your specialist and loyal partner. Vetter Commercial Manufacturing can handle everything for you — from the initial stages of sterilization through the custom-packaging of your final product. Download the product sheet for complete information.
Getinge Clean Steam Generators (CSG)
Getinge Clean Steam generators can be easily integrated with the Getinge sterilizer control unit and with other equipment, such as sterilizers and SIP stations. The CSG is cGMP compliant for pharmaceutical applications. Download the product brochure for complete information.

KODAK ScanMate i1120 Scanner
The KODAK ScanMate i1120 Scanner transforms your paper documents into high-quality digital images that can be managed, sent, filed, and found — easily. One push of a button puts you in control of your documents and organizes your information. Download the product brochure for complete information.
InfoStrength Smart Enterprise Suite
InfoStrength empowers life science business people to develop applications for every business problem. By combining the benefits of zero infrastructure, wizard tools, powerful development features, and more, InfoStrength is changing the regulatory quality, document, and project management game — in your favor. Download the product sheet for complete information.
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Spotlight On Inspection And Leak Testing

Product Sheet: VeriPac 325/LV — Micro Leak Testing Syringes, Vials, And Other Pharmaceutical Containers
VeriPac 325/LV is a non-destructive inspection system that offers unique integrity testing approaches, permitting highly sensitive micro leak detection of empty and prefilled syringes, liquid-filled and lyophilized vials, and other rigid containers.


PowerPoint Presentation: X-Ray Inspection Equipment
This PowerPoint presentation from Eriez will focus on answering several questions surrounding X-ray inspection equipment including: How does this technology work? What can this technology do? Where can these systems be installed? How much do these systems cost? What are the safety concerns?


Product Brochure: PK V Vis Combi — Leak Testing And Visual Inspection For Ampoules And Vials
The PK V Vis Combi is a fully-automatic leak tester and visual inspection machine for ampoules and vials. It may reach an output of 400 cpm and vial size can range between 2 to 100 ml. This leak testing method is designed according to the ASTM standards and is fully validated.


Product Sheet: Pharmaceutical Technology Services
DSM Pharmaceuticals Inc. has a Pharmaceutical Technology Services Group staffed with scientists and project management professionals working in state-of-the-art laboratory facilities. This group provides direct customer support to guarantee its customers a smooth and successful transfer from research to commercial production.


Brochure: X-Ray Solutions For The Pharmaceutical Industry
X-ray powder diffraction (XRPD) is fast becoming one of the key analytical techniques in the pharmaceutical industry. This brochure describes the practical advantages of XRPD, PANalytical's revolutionary detector technology, and the company's solutions for meeting the requirements of a highly-regulated environment.


Case Study: A Healthy Outlook On Inspection
Sensitive pharmaceutical metal detectors, pipeline-style inspection systems, and checkweighers help Garden State Nutritionals provide 100% inspection and ensure quality and accuracy for hundreds of nutraceutical, herbal, and nutritional tablets, capsules, and powders.
Special Event
Join ILC Dover's Alan E. George at the Containment Of Potent Compounds event (May 29 and 30), as he discusses third-party facility validation and testing using the SMEPAC guidelines. His presentation will include details on cleanroom design and installation, cleanroom validation and certification, development of standard operating procedures for the cleanroom, and development of industrial hygiene sampling products.

Download the event brochure for additional information.

Download Alan E. George's article on the SMEPAC Guidelines here.
Industry Events
Knock-Out Compliance — Are You Ready To Win Your Next FDA Match?
May 13
Atlanta, GA

Practical Approach To Laboratory Design
May 13 and 14
Kansas City, MO

Pharmaceutical Production Batch Record Review
May 15 and 16
Malvern, PA

IQPC's 8th Contract Manufacturing Conference
May 19 to 21
San Francisco, CA

Understanding Corrosion In Sanitary Processes
May 22
Pleasanton, CA

Freeze-Drying Technology
June 2 to 4
Winchester, UK

Film Coating Technology
June 17 and 18
Natoli Technical Training Center
St. Charles, MO
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