Newsletter | May 3, 2012

05.03.12 -- Pharmaceutical Sterility Testing: Essential Things You Must Know

Pharmaceutical Online Newsletter

In This Issue:

Featured Articles

Pharmaceutical Sterility Testing: Essential Things You Must Know
By Steven G. Richter, Ph.D, Microtest Laboratories, Inc.
Sterility testing of pharmaceutical articles is required during the sterilization validation process, as well as for routine release testing. An understanding of sterility testing is beneficial in terms of designing a validation process.


The Urgent Need For Qualified Transportation Providers In Global Clinical Research
Dr Ruediger Lomb, Global Director, Quality & Technical Compliance, World Courier
Given the high cost of conducting global clinical trials, and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain — transportation and logistics providers included — conform to GxP guidelines.


Package Leak Testing And Achieving Quality And Efficiency Standards
By Dr. Dorian Dixon
Achieving excellence in quality and efficiency standards has become the talking point within the pharma industry.

Featured Downloads

Why You Should Consider Automated In Vivo Sampling Systems
While in vitro studies are becoming more accurate, and the resulting preclinical data more likely to predict the clinical activity of a drug, in vivo studies (studies in animals) are still vital for the assessment of pharmacokinetics and drug metabolism and essential for approval of drugs and devices by regulatory bodies.


Establish Container Closure And Leachable Controls: A Life Cycle Container Closure Database
A database coupled to a statistical analysis program is an effective means for defining a control space, determining process capability of components, establishing specifications for components and drug product, and potentially correlating leachable levels to component extractable levels.


Product Brochure: Getinge Isolation Technology
Getinge has isolation technology experience and countless projects completed in a wide variety of applications, meaning that our expert designers know what works and what doesn't. Everything from isolator layout to the size of gloves is considered.


Product Catalog: Process And Control Valves
For more than thirty years, Bürkert has played an important role in revolutionizing control processes in machines and installations. Bürkert process valves demonstrate a safe investment in a safe and reliable plant.

Industry News

Merck Wins U.S. ZETIA/VYTORIN Patent Infringement Lawsuit
Grace And Formac Clinical Trial Demonstrates Novel Use Of Silica For Drug Delivery
Mylan And Pfizer Announce Epinephrine Auto-Injector Settlement Agreement With Teva
Afinitor Approved To Treat Patients With Non-Cancerous Kidney Tumors Associated With TSC
Sartorius Stedim Biotech Launches Initiative To Enhance Supply Chain Security
YES! Program Provides Immediate Metal Detectors For Manufacturers
Pharma IQ's Solubility Report
Atlantium UV Solution Affords RO Membrane Protection
Bosch Introduces Compact Inspection Unit KKX 3900 For Capsules
Watson Restructures Senior Leadership Team In Support Of Expanded Global Businesses
View more headlines

 

ICSE USA is an international exhibition and conference that connects the pharmaceutical community with outsourcing solution providers, offering a forum for business development, networking, and education. This is a not-to-be-missed opportunity for companies providing or looking for outsourcing services and solutions, including, but not limited to, contract manufacturing, clinical trials, contract research, and analytical services. Register to attend.

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Spotlight On Aseptic/Sterile Manufacturing

Case Study: Large Pharmaceutical Formulation And Sterile Storage System
IPEC provided a turnkey formulation and sterile storage system to a large pharmaceutical company in Clayton, NC.

Advances In Aseptic Blow/Fill/Seal Processing Of Pharmaceutical Liquids Improve Product Integrity And Patient Safety
Aseptic blow/fill/seal (B/F/S) systems for the processing of pharmaceutical liquids have experienced rapid and growing acceptance by the pharmaceutical industry over the past 20 years.

Achema Hall 3 / Stand A47

Top 10 Reasons To Use Rigid Wall Isolators
These days, several pharmaceutical companies are moving to single-use, flexible film isolators for the containment of potent compounds during pharmaceutical processing. Flexible film isolators have also been used for aseptic processes, such as sterility testing.

Technical Datasheet: Blow/Fill/Seal bottelpack® Type 321
In order to meet different customers' requirements, rommelag® has developed an extensive bottelpack machine program for bottle and ampoule manufacturing — including machines with 1 mold, 2 molds, and 15 rotary molds. Machine output is determined by the shape and weight of the container, the characteristics of the fill product, and the plastic material.

Achema Hall 3 / Stand A71

Cleaning Glassware Contaminated With Drug Compounds Or Chemicals
The final cleaning process of equipment involved in drug compounding is crucial, as the pharmacist must ensure the glassware can be reused without any carryover of material from the previous run, including active ingredients and excipients.

Cells Disruption By Means Of High-Pressure Homogenization
After the fermentation of cells, the culture is processed to separate the cells by means of a speed centrifuge in order to concentrate them. The collected cells are resuspended with buffer in order to prepare them for the next unit operation — the high-pressure homogenization used in order to obtain the cells disruption.

Achema Hall 4 / Stand F44
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Featured Products And Services

Flexi-Cool Immersion Coolers
Flexi-Cool Immersion Coolers

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SP Scientific

Aseptic Processing Pressure Vessels
Aseptic Processing Pressure Vessels

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Servolift LLC

LKRK Static Spray Balls
LKRK Static Spray Balls

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CSI

AbsoluteProof  (Data Integrity Protection)
AbsoluteProof (Data Integrity Protection)

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Surety LLC

Custom Synthesis And API Intermediates
Custom Synthesis And API Intermediates

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SCYNEXIS, Inc.

Conventional Dosage Form Development
Conventional Dosage Form Development

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Patheon Inc.

Water Activity Analyzer
Water Activity Analyzer

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Lighthouse Instruments

cGMP Testing Of Inhaled Products
cGMP Testing Of Inhaled Products

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Covance

PAPPIS Visual Inspection System
PAPPIS Visual Inspection System

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Daiichi Jitsugyo (America), Inc.

Solid Dose Contract Manufacturing
Solid Dose Contract Manufacturing

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Norwich Pharmaceuticals

AseptiQuik® DC Connector
AseptiQuik® DC Connector

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Colder Products Company

High-Speed Mixer Emulsifier
High-Speed Mixer Emulsifier

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Charles Ross and Son Company