Equipment Processing Report by PharmTech logo
July 2011  
ABOUT US PHARMTECH.COM
Production Lines

A Hybrid Approach to Combination Products
Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

Read More at PharmTech.com

In The Mixer

Basic Equipment-Design Concepts to Enable Cleaning in Place: Part II
The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.

Read More at PharmTech.com

>>Coming Soon: For Pharmaceutical Technology's annual global review of Big Pharma's manufacturing strategies, including an analysis of manufacturing investment and rationalization, see the August issue.

 
Troubleshooting Editor's Picks

Erratic Recovery-Test Results

We’re attempting to validate a clean-in-place process using total organic carbon as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?


Read More at PharmTech.com

Editor's Pick product

Editor's Pick product

BETE Fog Nozzle’s HydroWhirl Poseidon rotating tank-washing nozzle combines slow rotation and a high-impact spray pattern.
Read More at PharmTech.com
Editor's Pick product

HPX-PT pretorqued holders from Continental Disc incorporate high-strength steel socket head cap screws to ensure accurate loading and sealing of the HPX rupture disc.
Read More at PharmTech.com
 
Showcase (Sponsored)
Fette Compacting now offers the FE55, a tablet press that delivers unprecedented levels of productivity, flexibility and availability.  The FE55 is clad in easily-detachable, FDA-certified high-performance polymer panels and offers 360-degree access. The FE55 has the ability to produce single- and double-layer tablets and direct pressing – the only machine of its compact size to offer all three capabilities. Click here for more info.
Editor's Pick product
 
Caron's Photostability Chambers ideal for forced degradation

Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. The 6540 series control light and temperature conditions. The 6545 series precisely control light, temperature and humidity. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. For more information visit, www.caronproducts.com/photostability
image
 

Top-Flo® SV2 sample valves are specifically engineered to be the finest in the industry and incorporate many features and benefits not found on other sampling valves. Top-Flo® SV2 sampling valves come standard with minimal internal deadleg area designed into each valve, keeping hold up volume to a minimum for accurate samples every time.
Right angle or In-Line models available from stock in sizes 1/2'' to 6'' in a variety of inlet/outlet connections.www.toplineonline.com

image
 

The PreVAS family of aseptic single-use dosing systems by Bosch represents a new chapter in dosing system technology. PreVAS is the first completely pre-assembled, and pre-sterilized dosing system available for the clinical and production pharmaceutical and biotech filling market that is supplied with supporting validation documentation. http://boschpackagingpharmana.wordpress.com/prevas

image
 

GoIndustryDoveBidLive & Webcast Auction
July 28, 2011
Mylan Pharmaceuticals
Late Model Pharmaceutical Pilot, Lab/Packaging Equipment
Etobicoke, Ontario, Canada
www.go-dove.com/event-15525

image

Product Announcements
  • Bosch Packaging Technology’s GKF 702 capsule-filling machine was designed to produce small batches in the laboratory.
  • EMD Millipore has introduced the NovaSeptum 60-mL bottle, the latest addition to its NovaSeptum product line for sterile sampling of pharmaceutical manufacturing processes.
  • Emerson Process Management’s Baumann 85000 sanitary pinch valve is designed for low flow rate, low-pressure control of sterile liquids within the biotechnical and pharmaceutical industries.
  • The No. 949 cleanroom oven from Grieve can heat vials electrically to 500 °F and is appropriate for Class 100 rooms.
  • Silcon Med-X tubing from NewAge Industries is platinum cured for a high degree of purity.


Calendar of Events
  • July 28–29: Sterilization Procedures: Technology, Equipment, and Validation (Los Angeles). This basic course covers the microbial, scientific, technological, and statistical foundations of sterilization methods. Those who have knowledge of established processing procedures but lack a clear picture of the scientific principles of microbial destruction will benefit from this course.
  • Aug. 15–16: Best Practices for Facilities and Utilities Design, Qualification, and Monitoring—Applying the Life-Cycle Concept (Los Angeles). This course will help those in pharmaceutical and biotechnology manufacturing who are responsible for vendor selection and controls, design, construction, installation, verification, and qualification of facilities, utilities, and their associated computerized controls.
  • Aug. 22: Ensuring Operational Excellence in Bioprocessing (Boston). Biopharmaceutical firms are currently adopting best practices from other highly competitive industries early in the development process and customizing these approaches to operational excellence. This course will provide an overview of these approaches and how they work, as well as case studies of how these innovations have been applied in bioprocessing and elsewhere.
  • Aug. 22–25: The Bioprocessing Summit (Boston). This conference is specially formulated to focus on the most pressing challenges of bioproduction. From cell-line selection and transfection to biopreservation, scale-up, and bioreactor design, this event explores the bioprocesses that continually consume time and resources.
  • Aug. 24–26: IVT’s 8th Annual Method Validation (Philadelphia). This three-day course is designed for employees who manage or execute the validation of analytical methods for the quality control of small- and large-molecule pharmaceuticals and biopharmaceuticals.



FindPharma
Search
PharmTech Poll: Highly potent APIs

Does the increasing demand for highly potent active pharmaceutical ingredients justify the high costs associated with upgrading manufacturing containment systems?

Vote Now!
 
PharmTech Resources:
Web Seminars
Whitepaper Library
Our Blog:
PharmTech Talk
Find Pharma Careers
Newsletter Archives
Videos:
PharmTech TV
Subscriptions


Advertising: visit www.PharmTech.com
Editorial: email Erik Greb
| Subscribe | Send Feedback | Advertise With Us | Visit PharmTech.com |

You are subscribed to %%list.name%% as %%emailaddr%%. Click here to unsubscribe or edit your member profile.

To ensure delivery to your inbox, please add us to your address book. If you need help doing this, click here.

Advanstar Communications provides certain customer contact data (such as customers' names, addresses, phone
numbers and e-mail addresses) to third parties who wish to promote relevant products, services and other
opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact
information available to third parties for marketing purposes, simply call (toll free) 866-529-2922 at any time, or
fax us at 218-740-6417. Outside the U.S., please phone 218-740-6395. Contact us by mail at Advanstar
Communications Inc., 131 West First St., Duluth, MN 55802-2065, USA.