By Dr. Guo, VP of Pharmaceutical and Quality Services, AMRI
The supply chain for active ingredients and drug products in the pharmaceutical industry is becoming more complex as globalization in the world economy continues. Globalization provides benefits for cost-effective solutions, enhanced security, and stability for the supply chain. On the other hand, companies therefore need a more sophisticated approach to manage their global supply chain. After all, suppliers in individual countries operate under their own regulatory, environmental, and cultural norms and requirements.
By Lei Li, Eli Lilly and Company
Utilization of prefilled syringes as a preferred container closure system for biologics has been increasing. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity. In 2008, the FDA further promoted container and closure system integrity (CCI) testing as a component of the stability protocol for sterile products.
By Ray Spurgeon, Eriez Product Manager - Inspection Systems
With comprehensive IQ, OQ, and PQs, the pharmaceutical industry has THE MOST stringent quality guidelines in place to ensure product consistency and efficacy. Yet when it comes to foreign object detection, most companies leave themselves vulnerable as they restrict inspection of foreign objects to the tablet press rooms using metal detectors.
Control underfill and overfill, instantly analyze and measure moisture content, or detect contaminants in packaged, bulk, and piped food and in pharmaceuticals with Thermo Scientific product inspection products.
By Andre Petric, President, Kraemer US, LLC
With the manufacturing trend toward larger batch production and continuous processing, tablet manufacturers are dealing with mounting pressures to make more tablets, in less time, but with the same high quality. In response, companies have begun to use faster tablet presses, but issues arise when their dedusters can’t keep up with the new pace. Since dedusting is an integral link between the tablet press, coating, and packaging steps, it’s important to keep the following factors in mind to avoid unnecessary problems on your line.
By Dr. Induka Abeysena and Rob Darrington, BSc, Genevac Ltd
A variety of sample concentration and evaporation methods are used in laboratories. This article will describe the basic theories of evaporation and concentration, and some of the commonly used techniques.
By Adrian Possumato, Multisorb Technologies
Pharmaceuticals are subject to a variety of degradation pathways that compromise drug safety and shelf life. By far, the greatest degradation is caused by hydrolysis and oxidation. However, other mechanisms include racemization, photodegradation, elimination, and complexation.
BioNetwork October 28 to 30, 2013 • The Ritz-Carlton, Laguna Niguel, CA
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By Dr. Egon Huefner, Bürkert Fluid Control Systems
When tablets are packaged in blisters, the plastic film must be the right temperature at the right moment: which is no easy task at an output of up to 1,300 blisters per minute. A customer-specific combination for proportional valve, temperature sensor, and controller master is using the regulation of cooling water flow. If needed, machine developers can implement 13 parallel-working temperature control circuits.