| This Newsletter Is Sponsored By:
|
Mettler-Toledo Hi-Speed
Need laboratory accuracies in production environments? Want to reduce costly overfills and eliminate false rejects? Mettler-Toledo Hi-Speed is your checkweigher source for sustained accuracy and reliability even at high rates. Our SQC/SPC program completes the link between the laboratory and factory floor.
Click here for more details on how we can protect your profits and enhance productivity through checkweighing.
|
|
|
| Top Editorial From The Third Quarter | | Good Manufacturing Practice Guidance For Active Pharmaceutical Ingredients
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess
| | Understanding The Manufacturing Process
The Manufacturing Process was created for companies and individuals to gain a complete understanding of the basic requirements needed to make tablets and capsules. The objective is that the reader will gain a quick, yet comprehensive understanding of solid dosage operations used in the manufacturing process
| | Validating Software Systems To Comply With cGMP And 21 CFR Part 11 Regulations
When it comes to 21 CFR Part 11 and computer systems validation, regulated companies are purchasing configurable electronic quality management systems from software manufacturers that may have little or no experience with validation
| | Strategic Outsourcing: The Growing Trend In The Pharmaceutical Industry
Over the last few years, the licensing standards of regulatory authorities have grown increasingly strict and, with global competition, cost pressures have intensified. In this competitive market, technologies are obsolescing faster than ever while the demand for quality continues to rise. The need for specialized knowledge and improved quality control, coupled with soaring process costs, are driving many pharmaceutical companies to rethink their strategies
| | How To Clean Your Tanks In Less Time And Achieve Better Results
Process improvement and cost reduction are key motivators today in the CPI. Yet, there's one area that is often overlooked when current procedures and operations are being evaluated: tank cleaning. It's an unfortunate oversight since a change in tank cleaning methods can result in dramatic increases in production uptime, a reduction in the amount of labor required for cleaning and cost savings on water, cleaning chemicals, energy, and wastewater disposal
Other Top Articles
| | Zeta Potential In Pharmaceutical Formulation
| | Tablet Inspection: A Quick Guide To Your Choices
| | Liquid Filling In Hard Gelatin Capsules — Preliminary Steps
| | Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding The Most Common Mistakes
| | 21 CFR Part 210-211 — Learning To Navigate Standards And Address Their Complexities
| | Basics Of pH Control
| | Excerpt: The Aqueous Cleaning Handbook — A Guide To Critical Cleaning Procedures, Techniques, And Validation
|
|
Featured Sponsor
Bonfiglioli Engineering
Blister Leak Tester
The Blister Leak Tester from Bonfiglioli features precision control, high repeatitivity, very low noise levels, and easy cleaning. Comes with validation documentation to comply with FDA protocols and software based on SCADA platform, configurable to comply with CFR 21 Part 11. A wide-range of devices that allow the machine to be customized for the specific needs of each process manufacturing application are optional. Download the product brochure for additional information.
|
|
|
|
| Featured Downloads |
Product Sheet: Deduster E5000S/E5000A
The E5000 Deduster from Pharmaceutical Machine Supply provides the highest conveying performance for all demands due to large helix. Buffering allows continuous operation of tablet press/capsule filling facility.
Material Safety Data Sheet: Contrex® AP: Powdered Labware Detergent
Contrex AP is a powdered labware detergent. It removes virtually any contaminant including grease, oils, blood, tissue, particulates, deposits, chemicals, and solvents. Contrex AP is phosphate-free, biodegradable, and readily disposable.
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?
Case Study: Mucon Iris Diaphragm Valves — Not Just For Controlling Powders
Over the years, the Mucon Iris Diaphragm Valve (IDV) from Kemutec Group has proved itself one of the most versatile flow control valves for dry bulk solids. Buijs Engineering of Uithoorn, The Netherlands has used a Mucon IDV to seal around tubes passing through the wall separating two cleanrooms.
Presentation: Novel Product Development Capabilities
Oregon Freeze Dry is a pioneer and the world leader in the research and application of low-temperature, low-pressure preservation of materials. Since 1963, Oregon Freeze Dry has developed innovative solutions to meet the specific product requirements and applications of its customers. This presentation describes the numerous product development capabilities that the company provides.
|
|
|
| Editor's Choice Products |
|
|
|
|
Shell and Tube Heat Exchangers
 Allegheny Bradford offers a full line of advanced sanitary shell and tube heat exchangers for all your thermal transfer needs. As the leader in the design and manufacture of stainless steel and other high alloy heat exchangers for ultra-pure applications, Allegheny Bradford sets the standard for accurate performance and trouble-free operation. Download the product brochure for complete information.
|
|
|
High Shear Mixer
The new Model 100LC High Shear Mixer being offered by Charles Ross and Son Company is designed to be the most versatile bench-top laboratory mixer available. The 100LC is the most powerful and versatile rotor/stator mixer ever built for the laboratory. A power lift makes raising and lowering the mix head as easy as pushing a button. Download the product brochure for complete information. |
|
|
|
|
|
|
|
Physica MCR Rheometer Series
 The Physica MCR Rheometer Series offers four new rheometer models plus an extensive range of accessories which stand out for technical excellence and ease-of-use. Modularity and compatibility across the Physica MCR rheometer series as well as unique features guarantee individual rheometer configurations to solve your application problems at great value for money. Download the product brochure for complete information. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Spotlight On Inspection And Leak Detection |
Product Brochure: Goring Kerr PROx X-Ray Inspection System |
The PROx is the next generation in a long line of powerful and flexible x-ray food protection systems from Thermo Scientific. Due to its unique design, it provides industry-leading detection of product defects including a wide range of contaminants and product assembly errors.
|
Product Sheet: VeriPac Blister Leak Detection |
The VeriPac 225/BLV is a non-destructive inspection system for leak detection of all types of multi-cavity blister packaging. All materials, paper, foil, plastic, laminates and all surfaces whether flat, glossy, printed or non-printed can be inspected non-destructively with this technology.
|
Brochure: Inspecting Conveyed Packaged Products |
Safeline x-ray pharmaceutical inspection systems ensure your product's integrity by scanning to confirm product count in blister packs, to ensure the presence of package inserts, verify product mass and container fill level, and eliminate broken or damaged products or packaging from your production line.
|
Product Sheet: VC 1380 Blister Packaging Benchtop Leak Analyzer | |
This benchtop leak and seal strength analyzers for blister packages provides leakage testing of tablet blister packs in a methylene blue bath. It also provides visual leakage testing under water with a precisely controlled vacuum. |
|
|
|
|
| Industry Events | PACK EXPO Las Vegas
October 15-17
Las Vegas, NV
Granulation And Coating Technology Seminar
October 16-18, 2007
Marion, IA
Regulatory Asset Management Conference 2007
October 17
San Francisco, CA
Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
October 18-19
Malvern, PA
Introduction To Freeze-Drying Technology
October 22-23
Mumbai, India
Advanced Freeze-Drying Technology
October 29-30
Mumbai, India
2007 ISPE Annual Meeting
November 4-7
Las Vegas, NV
2007 AAPS Annual Meeting and Exposition
November 11-15
San Diego, CA |
|
|
|
| Newsletter Subscription | | If your colleagues do not currently receive the Pharmaceutical Online
newsletter, and you think they should, they can subscribe very easily.
Simply forward this newsletter on to them. |
|
| Advertise Online | | Learn more about advertising with Pharmaceutical Online. |
|
|
E-mail
RSS
The PureWave DVR offers energy users dynamic subcycle protection from system disturbances originating on the transmission or distribution system. The PureWave DVR corrects voltage sags, swells, and unexpected load changes, maintaining the voltage to sensitive loads within acceptable tolerances. 
MODA-EM is an integrated software and hardware solution that improves the performance of environmental monitoring (EM) operations by eliminating the inefficiencies and reducing the error rates inherent with manual, paper-based systems. 
This gravity-fed metal detector is designed for the detection and removal of minute pieces of ferrous, nonferrous, and stainless steel contaminants. Its compact design accommodates many space-restricted areas within tablet and encapsulation rooms. 
The CVT series of inspection machines uses video camera technology to inspect vials, ampoules, cartridges, and syringes at speeds up to 600 per minute. This series specifically inspects for particulate contamination in the product, but also detects chips, cracks, and scratches, as well as burn marks in ampoules and ring codes. 
The safety of incoming bulk raw materials in both granular and fine powder form can be guaranteed by these free fall metal detectors. Suitable for a wide range of products, the MET30+ Vertical Fall Metal Detectors eliminate metallic contamination early in the production process. 
EtQ's Corrective Action and Preventive Action (CAPA) Software Module allows you to generate a corrective action or preventive action request that routes through review, root cause, corrective action taken, and verification stages. 
PAGE-flex SBF utilizes a smoothbore PFA tube, a bonded, wire braid — silicone — textile braided composite, giving this product a superior bend radius, kink and vacuum resistance. 
For the industrial water and chemical market, Beta PP provides a robust and valuable piping system solution because of its excellent impact strength, product breadth and homogeneous structure. 
This compact particle counter is perfect for less critical and non-regulated environments. It provides full-featured performance in a compact unit. 
PANalytical supports the pharmaceutical industry in meeting today's requirements for the validation of analytical instruments and compliancy with the FDA regulations 21 CFR part 11 governing the use of electronic records and electronic signatures. 
Unik II EC is a double rotary tablet press designed to meet GMP international health accreditation norms all over the world. All vital operations of the machine are regulated by state of the art PLC and touch screen controls. 
Natoli offers a variety of precision pharmaceutical metal detectors for analyzing and controlling product lines. The various metal detector systems include a robust set of optional features and readily available spare parts. All detectors are 21 CFR Part 11 compliant. Special requirements and custom orders are always welcome. 
The central focus of the Partica LA-950V2 development is speed. Fresh thinking on all aspects of instrument design and operation have resulted in a system capable of complete sample analysis sequences in one minute. 
