Equipment Processing Report by PharmTech logo
October 2009  
ABOUT US PHARMTECH.COM

Production Lines
Reducing Supercooling during
the Lyophilization of Biologicals

The manufacturing process, which influences a drug’s safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

Read More at PharmTech.com

In The Mixer

New Pharmaceutical-Pump Designs
Can Provide a Competitive Edge

Economic pressures are forcing pharmaceutical manufacturers to look for ways to become more competitive. Many companies realize that they must reduce operating costs but maintain or improve product quality.

Read More at PharmTech.com

>>Coming Soon: For more articles about parenteral drugs, look for “Injectables 2009,” the November supplement to Pharmaceutical Technology.


Advertisment:
Gamma-Safe RFID Tags

GammaTag™ is the first read/write RFID tag that withstands gamma irradiation while maintaining data integrity. GammaTag provides reliable component identification from inception to disposal and simplifies sterilization, as components may be assembled complete with the tag, then gamma irradiated as a unit. Styles for repeated or single use.

Click here to visit AdvantaPure® online.


Editor's Picks
Editor's Pick product
Emerson Process Management (Austin, TX) offers its DeltaV S-series digital automation system.
Read More at PharmTech.com
Editor's Pick product
Minitab (State College, PA) offers version 3.2 of its Quality Companion software for managing and executing quality-improvement projects. Read More at PharmTech.com


Showcase (Sponsored)

Xcelience
Xcelience provides a number of defined formulation development programs that enable a faster, more cost effective path to proof of concept, in some cases reducing time to first-in-human by 45% relative to traditional formulation development. These programs provide lasting advantage through our unique combination of expertise, innovation and quality systems. 

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DJS Enterprises
Since 1991 specializing in high quality New and Used Equipment for the process and packaging Industries.


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Kavon Filter Products
Fluid-bed dryer bags

Kavon provides custom replacement fluid-bed dryer bags for US and European equipment models. The bags are appropriate for wet granulation, dry filtration, and wet and dry coating applications. The company offers flexible 1–4-bag systems in various fabrics choices and also repairs bags. Kavon Filter Products, Wall Township, NJ ¦ www.kavonfilter.com ¦ tel. 732.938.3135Since 1991 specializing in high quality New and Used Equipment for the process and packaging Industries.

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GLOBEPHARMA'S MAXIBLEND® 1-2-3 BLENDER
Interchangeable 316LSS V-Shells, Bins or Double Cones. 1, 2 and 3 cu.ft., On-casters design. All stainless steel construction. Pharmaceutical finish. PLC controls. IQ/OQ. Low maintenance. Optional: Variable speed, intensifier bar, built-in lift system to raise or lower the shell on stainless steel cart, portable safety guard, cGMP butterfly valve, NIR probes (PAT).

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Vaisala
Knowledge = Good Measurement Practice

Humidity and CO2 good measurement practice is critical to reliable and repeatable measurement. Gain more knowledge, subscribe to Vaisala Knowledge NewsLetters.

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Product Announcements
  • The Adept Quattro s650H parallel robot from Adept Technology (Pleasanton, CA) is specifically designed for high-speed manufacturing, packaging, material handling, and assembly applications.
  • Multisorb Technologies (Buffalo, NY) has introduced its APA-9000 high-speed canister dispenser for healthcare-product packaging applications.
  • The Mustang Q XT ion-exchange chromatography capsules from Pall Life Sciences (Port Washington, NY) are suitable for high flow-rate contaminant-removal applications and in the capture or removal of large molecules.
  • Farr Air Pollution Control’s (Jonesboro, AR) Zephyr III portable dust and fume collector is designed for portable handling of industrial process contamination, source capture, and periodic dust collection at various locations.
  • The DFM3 product from Copley Scientific (Nottingham, England) is a flow meter designed specifically for inhaled-product testing.


Calendar of Events
  • Oct. 28–30: 15th Annual Validation Week (Philadelphia). This three-day conference and exhibition brings together validation experts and regulatory representatives who present their experiences in validation, including process validation, computer and software validation, method validation, cleaning validation and facility qualification (including equipment). Participants attend case-study-based workshops on implementation strategies for these specific areas of validation.
  • Nov. 2–3: ISPE Facility of the Year: Innovation Showcase (Ulm, Germany). Learn about the latest, state-of-the-art developments being implemented by manufacturers in the region. The event will include case-studies on innovation and provide the background to the projects. Question-and-answer sessions and a networking reception are also scheduled.
  • Nov. 5: Manufacturing Sterile Products (Reading, UK). This new course provides an introduction to the methods used to manufacture sterile products, covering both terminal sterilization and aseptic manufacture. Attendees will develop an appreciation of the complexities of sterile-product manufacture and the associated good manufacturing practices, with particular reference to regulatory expectations. The course will be of interest to delegates new to sterile products and pharmaceutical microbiology and provide a refresher course for operators and managers returning to the field.
  • Nov. 9–10: FDA Inspections: What to Expect and How to Prepare (Dublin). Attendees will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials, and how to respond to FDA observations. This course is a refresher for all personnel involved in the FDA inspection process, and an opportunity to compare one’s internal audit system with what a leading internal audit expert believes is the best approach. The course is provided in an informal atmosphere and an easily understood format.
  • November 11–13: Reporting Failure Investigations and Process Deviations (Dublin). This comprehensive course will be most valuable to personnel in research and development, manufacturing, quality assurance, and quality-control laboratories who are involved in conducting and reporting failure investigations and deviations. This three-day workshop outlines tips and techniques to improve failure investigations and identifies proposed corrective actions that ensure successful implementation and closeout.

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Editorial: email Erik Greb
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